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Vol. 9, No. 6 May 2006 Natural Medicine LawTM FEDS RELEASE EPHEDRA Another ephedra case is in U.S. District Court in Utah. The complaint was filed on April 21, 2006 by Emax Enterprises against FDA, HHS and CBP and claims FDA seized ephedra products contrary to law. CBP is the U.S. Customs and Border Protection. The same day the plaintiff filed a Motion for Preliminary Injunction and on April 26, the Court set a hearing for May 2. However, despite FDA’s previous adamant refusal to cooperate with plaintiff, on May 1, FDA and plaintiff told the court a hearing would not be needed because they had agreed to withdraw the Motion and that FDA had released the detained ephedra shipment. The parties also agreed that the release of the detained articles would not be used to draw adverse inferences against the FDA or any federal agency in this matter or any subsequent action. Emax is an importation broker, specialzing in Chinese goods, including dietary supplements. The complaint says that FDA’s final ban on selling ephedrine containing products issued February 11, 2004 made the sale of ephedrine alkaloidcontaining dietary supplements a crime. Under the regulation all ephedrine supplements, regardless of dose, were deemed adulterated. FDA offered no evidence that consumption of 10 mg or less of ephedrine from naturally occurring plants was associated with any serious adverse effects. At the same See EMAX -- Continued on page 14... Newsletter HERBAL MEDICINE AWARENESS WEEK RUBIN SETTLES CLAIMS FOR $225,000 May 19 to 26, 2006 in the U.K. is On March 9, 2006, the a week packed full of events to emphasize herbal medicine. The National Institutes of Medical Herbalists are having herbal walks, talks and displays all over England, Scotland and Wales in 24 cities this week, where you can spend time with a practicing herbalist walking the paths to see where herbs grow and talk about stress. Federal Trade Commission announced it had settled charges against Jordon Rubin’s Garden of Life for claiming it had studies that backed products — Primal Defense, RM-10, Living Multi, and FYI. FTC also said if the company has misrepresented its financial information, the full judgment could go to $47 million for the four products. Rubin authored, “The Maker’s Diet,” Siloam, 2004. “A little stress can be good for you but when it gets excessive, it can ruin lives. For this year’s Herbal Medicine Awareness Week, the nation’s herbalists are aiming to help you cope with stress and stress-related illness…the herbal way. This year the awareness campaign will focus on the herbal approach to treating stress-related conditions, from insomnia to tension headaches and eczema. An operation that marketed dietary supplements sold at Whole Foods Market, GNC, the Vitamin Shoppe, and on the Internet settled FTC charges that it made deceptive advertising claims about their supplements. The FTC charged that Garden of Life, Inc., a dietary supplement company based in West Palm Beach, Florida, and its founder and owner, Jordan S. Rubin, made unsubstantiated claims that their Ned Reiter, President of the supplements treated or cured a variety National Institute of Medical See GARDEN -- Continued on page 2... Herbalists, comments: “Herbal medicine can be remarkably effective In This Issue: in qualified hands. Many people self Lose to Emax..........................................1 prescribe but there are several Feds Herbal Medicine Awareness Week.....................1 Settles Claims........................................1 limitations to do-it-yourself medicine. FTC Pharmacists Talk Supplements.........................2 Although self-help can be useful in New Dietary Ingredients................................... 3 Section 403 Letters...........................................4 some circumstances, consulting a Herbs Contain Rx Drugs.. .................................5 Adopts Interim Measures........................5 professional herbalist gives access to Canada Operation Bali Stops Illegal Sales........................5 a safer, individually tailored and more Canada Says Do Not Use “NPN Pending”............6 Dynamic Health Settles Charges.......................11 effective application of herbal Supplementary Guidance on Transition...............13 Sold as Dietary Supplements...............15 medicine. Stress and stress-related Steriods Genistein Not Hazardous to Humans.................15 Library Photo Credits..............................15 illness can be complicated and we Lloyd FDA on European Aspartame Study...................17 would advise against relying on over- Trademarks for Guaiacum................................19 Unilever Spends on Hoodia..............................20 the-counter herbal medication without FTC Staff Advises FDA on QHC......................20 See AWARENESS -- Cont’d on page 23... China Sells Stevia...........................................21 China Sells Wisconsin Ginseng.........................23 Harvesting Health from the Editor.....................24 Page 2 GARDEN -- Cont’d from page 1... Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover of ailments, ranging from colds to cancer, and also made false claims of clinical proof. The settlement prohibits deceptive claims about the results of tests or studies and requires claims by the defendants to be substantiated by competent and reliable scientific evidence. The FTC’s complaint targeted claims about four dietary supplements: Primal Defense, RM10, Living Multi, and FYI. According to the complaint, the defendants made unsubstantiated advertising claims that: Primal Defense treats intractable immune disorders, asthma, irritable bowel syndrome, chronic fatigue syndrome, arthritis, lupus, colds, flu, and Crohn’s disease, and reduces users’ blood cholesterol levels; RM-10 treats cancer, helps lower users’ blood cholesterol levels, prevents and treats cardiovascular disease, and treats immune system disorders; Living Multi reduces the risk factor for diabetes and prevents diabetes-related syndromes, reduces the risk of obesity, and reduces inflammation; and FYI (For Your Inflammation) treats and prevents inflammation, including inflammation caused by arthritis, inflammatory bowel disease, sports injuries, asthma, allergies, fibromyalgia, lupus, scleroderma, and other inflammatory conditions. The FTC also alleged that the defendants made false claims that clinical studies prove that: Primal Defense reduces users’ blood cholesterol levels by 25 percent or more; improves users’ energy levels, memory, and concentration; and mitigates the symptoms of most patients with chronic lymphocytic leukemia stage II; RM-10 treats immune system disorders and cancer; May 2006 Living Multi has a proven nutritional formula; and FYI treats rheumatoid arthritis and reduces the effects of inflammation. Garden of Life and Jordan Rubin will pay $225,000 in consumer redress as part of the settlement. If it is found they misrepresented their financial status, they will be responsible for the full judgment of more than $47 million – the total gross sales of the four dietary supplements. The settlement also prohibits the defendants from making claims similar to the ones challenged in the FTC’s complaint, unless they have competent and reliable scientific evidence substantiating the claims. Furthermore, the settlement requires the defendants to have such evidence whenever they make any claim about the health benefits, performance, efficacy, safety, or side effects of any food, drug, or dietary supplement, or any program that includes such a product. The defendants also are prohibited from misrepresenting the results of any test or study when marketing such products and programs. Natural Medicine LawTM Injunction and other relief was signed on March 30 as well. The case is Civil # 06-CV-80226, Southern District of Florida (West Palm Beach). Karen Mandel Muoio, Esq. of Washington, D.C. represented the FTC and Sean Michael Ellsworth, Esq. of Ellsworth, Gonzales & Roppolo of Miami Beach represented the defendants. Michael Ostheimer or Karen Muoio, FTC Staff, 202-326-2699 or 202-326-2491 can tell you more. w w w. f t c . g o v / o p a / 2 0 0 6 / 03gardenoflife.htm. PHARMACISTS TALK Lectures and posters about dietary supplements took place at the March 17-21, 2006 meeting of the American Pharmacists Association in San Francisco. About 7,000 pharmacists attended. One general talk was about An Evidence-Based Approach to Vitamins and Natural Remedies, one poster by several pharmacists and a faculty member, and one talk by NML’s editor to a joint meeting of APhA and the American Society for The Commission vote to authorize Pharmacy Law. staff to file the complaint and stipulated final order was 5-0. The The Evidence-Based Approach complaint and stipulated final order speaker was Karen Shapiro, were filed in the U.S. District Court Pharm.D. of the Rancho Los Amigos for the Southern District of Florida National Rehabilitation Center in the on March 8, 2006 under 15 USC Los Angeles Department of Health Sec. 53. Summons were issued for Services. Dr. Shapiro’s subjects were Jordan Rubin and Garden of Life, fish oils, cholesterol-lowering Inc. on March 13. U.S. Judge products such as oats, psyllium, soy, Donald M. Middlebrooks set the trial plant sterols, and policosanol, general for October 30, 2006 in an order multivitamins, and vitamins for signed March 23, an Order macular degeneration, ginkgo, approving an earlier filed Stipulation Huperazin A, and natural weight loss was approved, the case closed on products. March 30, 2006 by Judge Middlebrooks. A Stipulated Final Order and Judgment for Permanent See PHARMACISTS -- Cont’d on page 12... NEW DIETARY INGREDIENTS May 2006 supplement contains one or more new dietary ingredients that have not been More 75-day notices are being filed. present in the food supply, but your A few applicants are filing reformatted notice does not comply as it does not notices after FDA advises of the contain a description of the new agency’s concerns. Some of these dietary ingredient., the conditions of reformatted notices do not have use, the history or other information enough new data to get FDA to that establishes that it would be accept the notices. The agency might expected to be safe when used as have to tell an applicant after the recommended. Because the resubmission that FDA will not be information submitted is insufficient to able to review the papers again until allow FDA to make a determination, new data is submitted. Applicants if the product is marketed without should call FDA if they do not submitting a notice that meets the understand what the agency wants requirements of 21 CFR 190.6, the them to put in the application for a product will be considered to be NDI. There are ten new notices adulterated and introduction into summarized in this issue of NML. interstate commerce is prohibited. None of them were accepted as The FDA letter was signed by Susan J. Walker, M.D. Docket No. 95Sadequate by FDA. 0316, RPT 290, received at the Aminocare Products, LP of Dockets Office September 9, 2005, Houston, Texas, filed an NDI notice entered into the docket September by letter dated May 27, 2005 under 12, 2005, and posted on a web page 21 CFR 190.6 pertaining to new created September 27, 2005. dietary ingredients, and listed a dietary OYC International, Inc. of supplement named, Brain Longevity, Andover, Massachusetts, sent a NDI, containing curcumin, L-alanine, Larginine, Glycine, L-ornithine, L- dated June 16, 2005, to FDA serine, L-Threonine, L-valine and concerning the ingredient, Elastase Piperine. The letter claimed that a (Pancreatopeptidase E), to be sold Google™ search disclosed over in a tablet form. The main ingredient ® 128,0000 products containing amino is Elaszym , discovered in the human acids, another disclosed over 26,000 pancreas in 1949. The dosage is curcumin products, and another three tablets daily. The method of disclosed over 2700 products manufacture was not disclosed and containing piperine. Based on these some of the clinical evaluation, circumstances, the letter said, “Given pharmacokinetics and toxicity data the omnipresent availability and use discussed porcine elastase. Much of of these ingredients throughout the the background data was published world, Aminocare believes this in Japanese journals. FDA product, when used as recommended responded to Ted Kottcamp by letter in the labeling, to reasonably be of August 9, 2005 from Susan J. expected to be safe.” FDA reviewed Walker, M.D. stating that the notice the submission and by letter dated was incomplete because it did not August 15, 2005 responded to Azad include: (1) a description of the dietary Rastegar saying that the submission supplement, (2) the level of the dietary makes clear that the company has ingredient in the dietary supplement, determined that the dietary and (3) the conditions of use Page 3 recommended or suggested in the labeling. FDA’s letter said the cited references were only abstracts and these must be accompanied by reprints or complete copies of the references, plus translations into English if any are foreign languages. In addition, the notice did not include a documented history of uses of the new ingredient. The safety data provided was for Elastase as a drug, not as a dietary supplement. Based on the information submitted FDA is unable to determine if the supplement will reasonably be determined to be safe. Marketing of such a product in interstate commerce is prohibited. Docket No. 95S-0316, RPT 291, received at the Dockets Office September 30, 2005, entered into the docket September 30, 2005, and posted on a web page created October 18, 2005. Loders Croklaan B. V. of Wormerveer, The Netherlands, wrote FDA on June 17, 2005 to send an NDI notice for PinnoThin™ FFA, consisting of pine nut oil fatty acids. The pine nuts are from the Korean pine (Pinus koraiensis). Its “applications” were described as “suitable as ingredient in dietary supplements in various forms, including softgels, capsules, and supplement bars and similar products. … Loders Croklaan recommends that dietary supplement manufacturers formulate products to provide a daily intake of 3.0 g PinnoThin™ FFA 30 – 60 min before See DIETARY INGRED. -- Cont’d on p. 7... www.NatMedLaw.com for Natural Medicine TiesTM Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover Natural Medicine LawTM Page 4 May 2006 Natural Medicine LawTM SECTION 403 LETTERS Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover supplements must be ingested. The Here are a few more Letters of FDA letter did not refer the writer to any other office in the agency. Rejection that demonstrate how FDA Docket. No. 97S-0163, Ltr.857, is regulating health claims for dietary received at Dockets Office on supplements. February 17, 2006, entered into the Docket on February 16, 2006, and Sedona Laboratories, Inc. of posted on the FDA Website on Cottonwood, Arizona, write FDA on March 6, 2006. December 23, 2005, to give notice that it would use certain claims for the Enzymatic Therapy, Inc. of product iFlora™YC-7, namely, Green Bay. Wisconsin, wrote FDA “Helps balance normal vaginal on January 7, 2006, stating that it and intestinal microflora after would soon use certain claims for the antibiotic use.” The product product, Remifemin® Good Night, contains seven different bacillus strains namely, “[A]nd a safe alternative of probiotics in a proprietary blend for women in whom estrogen and it is packaged in 145 mg therapy is contraindicated.” FDA vegetarian capsules and bottles of 60 responded by letter of January 26, capsules. The label claims 15 billion 2006 from Susan J. Walker, M.D. to cells per capsule. FDA responded Michael P. Devereux, to advise him to Mo Kang, senior scientist, by letter that the italicized wording made the of January 12, 2006, from Susan J. product a drug and if this wording is Walker, M.D. stating that the used the product would be regulated statement cited above in italics as a drug. FDA did not comment on suggests that the product is used as a the claims that stated: “Uncontrolled drug to treat, prevent, or mitigate a reports, postmarketing surveillance, disease. Therefore, if the claim is and human clinical trials of more than used, the product will be regulated 2,800 patients demonstrate a low as a drug. Docket No. 97S-0163, incidence of adverse events (5.4%). Ltr. 856, received at Dockets Office Of the reported adverse events, 97% on February 16, 2006, entered into were minor and did not result in the Docket on February 16, 2006, discontinuation of therapy, and the and posted on the FDA Website on only severe events were not attributed March 6, 2006. to Cimicifuga treatment. Confirms the Transdermal Products International of Bristol, Pennsylvania, wrote FDA on January 5, 2006 to give notice that it would use some claims for the product, Insect Repellant Patch, an external product, each patch containing 75 mg of Thiamine (vitamin B1). FDA responded to William Newbauer by letter of January 17, 2006 from Susan J. Walker, M.D, signed by Linda S. Pellicore, Ph.D. stating that external use products do not qualify as dietary supplements under the Act as dietary safety of specific Cimicifuga extracts, particularly isopropanolic preparations (RemiSure™ black cohosh), for use in women experiencing menopausal symptoms…”. Docket No. 97S0163, Ltr. 858, received at Dockets Office on February 162006, entered into the Docket on February 16, 2006, and posted on the FDA Website on March 6, 2006. Beulah Land Corporation of Oak Park, Illinois, wrote FDA on January 19, 2006, in seven unsigned Photo Courtesy of Lloyd Library and Museum letters, each about a separate product. These products were named, Female Age Well, Menopausal Support, EnhanceMENt Plus, Paracid-BGone, De-Yeast Plus, Pro-Cartilage and Lipid Balance. All were stated to be dietary supplements on the labels. The ingredients were listed for each product on the letter and/or label of the product attached to the letter. FDA responded to the president on January 26, 2006 from Susan J. Walker, M.D. stating that the following statements were of concern: for Female Age Well Menstrual Support, “[M]ay help with … chronic fatigue;” for EnhanceMENt Plus, “Natural alternative to Viagra…;” for Paracit-B-Gone, “[A]ssist in conditions such as parasite infections, intestinal dysbiosis for De-Yeast Plus, “[H]elpful for conditions such as Candida Albicans, intestinal dysbiosis;” stomach flu and irritable bowel syndrome;” for Pro-Cartilage, “[H]elp with joint injuries…;” See SECTION 403-- on page 18... Natural Medicine LawTM May 2006 Page 5 Natural Medicine Law Around the W orld World Director-General of Health Dr. Karen Poutasi of New Zealand on March 1, 2006 warned against taking two herbal products after government tests revealed they contained undeclared prescription medicines for weight loss and erectile dysfunction. The Natural Health Products Directorate and the Health Products and Food Branch Inspectorate have recently developed and implemented interim measures that will ensure the The Ministry of Health Medicines continuity of the exportation of Safety Authority (Medsafe) has Canadian-made natural health shown that the herbal weight loss products to foreign markets. product Li Da contains the Under current legislation, natural prescription medicine sibutramine, which is prescribed for overweight health product companies cannot (obese) patients who have not been hold both a site license and able to lose weight using a low calorie establishment license. This has been diet and exercise. Sibutramine can a source of concern for certain cause increased blood pressure and Canadian exporters of natural health heart rate and cannot safely be taken products who, until January 1, 2006, by a range of people, including those held valid establishment licenses, and with glaucoma, mental illness and based on these, were able to obtain severe liver or kidney problems. It Certificates of Pharmaceutical should not be used in combination with Product (CPP). CPPs speak to the other medicines such as some regulatory status of a product and are antidepressants and migraine a service offered by Health Canada treatments, Dr. Poutasi says. Reductil to facilitate the exportation of is the prescription drug containing Canadian health care products. sibutramine that is approved in New Health Canada’s initial solution to Zealand. this situation was the development of See MEDICINES ACT -- Cont’d on p. 11... a dual licensing system that would allow Canadian natural health product companies to hold both licenses. As reported in the Spring/ Summer issue of the NHPD Quarterly Report, work on this initiative began in 2005 and was to be completed by December 31, 2005 before the coming into force of the site licensing provisions of the Natural Health Products Regulations. Unfortunately, due to the dissolution of Parliament in late November 2005, Health Canada was unable to Big Ben and Parliament in London See CANADA -- Continued on page 6... OPERATION BALI STOPS ILLEGAL SALES OF MEDICINES The Medicines and Healthcare products Regulatory Agency (MHRA), headquartered in London, led an operation, on 27 April 2006 at a residential address in Peterborough. The house is believed to be connected with an Internet site which sells and supplies unlicensed lifestyle medicines called Kamagra, Tadamax, and Lovegra, which are sold for the treatment of male erectile dysfunction. Around 3,000 Kamagra tablets, 168 Tadamax tablets, 160 Lovegra tablets and 95 sachets of Kamagra and Apcalis jellies were seized, worth more than £17,000, together with computer equipment. The visit was part of a larger nationwide operation (known as “Operation Bali”) that involved MHRA enforcement and intelligence officers investigating 27 Internet sites, all offering illegal medicines. The MHRA officers visited various private and business addresses related to Internet sites supplying unlicensed medicines claiming to treat obesity, impotence, herpes and other ailments. Officers seized unlicensed medicines, computers, documents and cash. The police accompanied the MHRA officers in a number of cases and arrests were made by the Sussex Police and Thames Valley Police in connection with offences under the Misuse of Drugs Act. Operations were also conducted in Reading, Worcestershire, Hayes, Bedford, Wigan, Hailsham, and Newhaven. As a result of these operations, a See OPERATION BALI -- on page 6... Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover CANADA INTERIM MEASURES FOR EXPORTATION OF NATURAL HEALTH PRODUCTS HERBS CONTAIN RX DRUGS Page 6 CANADA-- Continued from page 5... Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover complete this project before the end of the calendar year. With the site licensing provisions now in force since January 1, 2006, the establishment licenses that certain natural health product companies once held are no longer valid and these companies can no longer obtain CPPs for exportation. The Department is aware of the pressing need to find a long-term solution to this dilemma and continues to explore and consider options. In the meantime, interim measures have been adopted that will allow natural health product companies to continue to obtain CPPs, provided that the following four conditions are met: 1) the company must hold a valid site license; 2) the company must have held a valid establishment license in the 2005 calendar year; 3) the company must have had an inspection by the Inspectorate and within the last 3 calendar years (2003-2005) and found to be compliant with drug GMPs, 4) and the product for which the CPP is requested must have a valid DIN, DIN-HM or NPN. May 2006 in effect for a period of ten months, starting March 1, 2006 and ending on December 31, 2006. Though only temporary, the interim measures will ensure that the export operations of many Canadian natural health product companies can continue unhindered for the remaining calendar year, until a more permanent solution can be identified. CANADA ADVISES DO NOT USE “NPN PENDING” ON LABELS Natural Medicine LawTM product will be authorized for sale by Health Canada when in fact it may not, should the NHPD’s assessment conclude that there is insufficient evidence to support the product’s safety and efficacy. The designation “NPN” should only appear on the labels of natural health products that have been authorized for sale by Health Canada. OPERATION BALI -- Cont’d from page 5... number of internet sites have been closed down. “The MHRA has a coordinated operation Natural Health Products officials in conducted against the sale and supply of illegal Canada have advised companies and unlicensed medicines over the currently awaiting a product license internet. There is an increased risk to NOT to label their products with the the public from obtaining medicines statement “NPN Pending.” Those through unregulated websites. companies that have already labeled Patients are advised to obtain their products in this manner should medicines following a consultation not include this statement on future with a qualified doctor and through a shipments, lots and batches of their properly licensed and regulated pharmacy.” Mick Deats, Head of products. Though not explicitly written in the Natural Health Products Regulations, including the statement “NPN Pending” on the label is a direct violation of Part 1, Section 9 of the Food and Drugs Act which clearly prohibits individuals and companies from labeling, packaging, treating, processing, selling or advertising any drug or natural health product in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. Only those natural health product companies meeting all four conditions will be eligible for a CCP under the interim measures. Natural health product companies will not be inspected and will not be issued an establishment license or a certificate of compliance for their natural health products. Companies holding both an establishment license and a site license and that have natural health products that have received DINs, Individuals and companies labeling can also obtain a CPP for their natural their products with the statement health products during this interim “NPN Pending” should cease this practice immediately. Including this period. statement on the label gives the false The interim measures will remain impression to consumers that the Intelligence and Enforcement at the MHRA. The MHRA release said it is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all its work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. MHRA keeps watch over medicines and devices, and takes any necessary action to protect the public promptly if there is a problem. If an individual is convicted of offenses under the Medicines Act 1968, they can be sentenced to a maximum of two years imprisonment and/or an unlimited fine. Where appropriate the MHRA will use the Proceeds of Crime Act 2002 to determine whether or not benefits were accrued through criminal activity and will recoup illicit earnings if the individual is found guilty. Press Office 020 7084 3535/ 3564 or [email protected] Out-of-hours 07770 446 189 DIETARY INGRED. -- Cont’d from p. 3... May 2006 product was similar to another formulation reviewed under the NDI process, namely, Nutratech, Inc.’s product Diosmin Complex, a 90%/ 10% formulation. The product is made into tablets of 600 mg and recommended at one tablet per day with a maximum duration of use of three months, but not recommended for use by children or pregnant or nursing women. The cover letter stated that the data is “virtually all of the same information” submitted by Nutratech. FDA responded by letter of September 6, 2005 to Mr. Rubin from Susan J. Walker, M.D. stating that the agency would complete its evaluation to determine whether the product is a dietary supplement within the meaning of 21 USC 321(ff) and send you a notice explaining FDA’s decision. FDA said that the lack of response to a notice does not constitute a finding that the ingredient is safe or is not adulterated. Docket No., 95S-0316, RPT 293, received at the Dockets Office September 30, 2005, entered into the docket October 3, 2005, and posted on a web page created October 26, 2005. [There is no follow-up letter stating this product is a dietary supplement on the FDA website as of April 28, 2006.—Ed.] the most substantial daily meal or 3.0 g … between meals…. The ingredient is intended for use by persons who wish to increase their satiety feeling, and as a result reduce their food intake.” FDA responded by letter of September 1, 2005 from Susan J. Walker, M.D., signed by Linda Pellicore, Ph.D. stating the agency was concerned about the evidence submitted. FDA said the notice fails to adequately identify the new ingredient since the manufacturing process is not clearly described. And FDA said the composition of the ingredient is described in a semiquantitative way. The evidence discusses the consumption of nuts and the use in food of nuts, but there was no evidence of the use in food of fatty acids derived from nuts. Other information submitted did not relate how it was similar to the new ingredient. And there was no safety evaluation of the material used in the two week, 18-person clinical study. For these and other reasons, FDA advised that the product may not be reasonably be expected to be safe when used as recommended and may be adulterated under the law. Introduction of such a product into interstate commerce is prohibited. Docket No. 95S-0316, RPT 292, Leonard Lee of Cathedral City, received at the Dockets Office September 30, 2005, entered into the California, sent FDA by letter of June docket September 30, 2005, and 15, 2005, notice of two new posted on a web page create d ingredients – Toona Sinensus, and Heracleum Lanatum. These October 18, 2005. ingredients were each given a Docket Stragen Pharma of Geneva, number by FDA. Toona Sinensus or Switzerland, through Paul D. Rubin, Chinese cedar is a deciduous tree Esq. of Patton Boggs LLP, in whose shoots and leaves have been Washington, D.C., wrote to give eaten in China. Submitted with basic FDA an NDI by letter of June 22, descriptive information was a 2005 concerning the new ingredient, Cytotoxic Activity in Human Lung Diosmin (95/5) Complex, containing Cancer Cells report by several 95% diosmin and 5% hesperidin. The persons at the Tajen Institute of cover letter pointed out that this Technology in Taiwan which Page 7 concluded that both an aqueous crude extract of leaves and a MeOH extract of leaves possess an antiproliferative effect on all three cell types of NSCLC (non-small-cell lung cancer). The only form or use mentioned was “content 70% of the tablet, in powdered form.” There was not much more information included in the public file. FDA responded by letter of September 1, 2005 from Susan J. Walker, M.D., signed by Linda Pellicore, Ph.D., stating that the notice does not comply with 21 CFR 190.6 and is incomplete. Not included in the notice were: 1) an original and two copies; 2) a description of the dietary supplement(s) that contain the new ingredient; 3) the level of the new ingredient in the dietary supplement; and 4) the conditions of use recommended in the labeling of the dietary supplement. The information submitted describes the parts of the tree, fruit, and leaves, but does not provide information about the product that is to be marketed. In addition, the reference articles relied upon for safety are citations or abstracts and there were no reprints or copies. And there was no documented history of use of the ingredient in the food supply. The information about use in Chinese medicine does not provide a history of use as a food. Based on the information in the notice, FDA cannot make an evaluation of the safety of Toona Sinensis. Therefore, because insufficient information was provided for FDA to make a determination that the product when used as recommended is reasonably expected to be safe, under the law it is considered adulterated and may not be entered into interstate commerce. Further, FDA said the information See DIETARY INGRED. -- Cont’d on p. 8... Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover Natural Medicine LawTM Page 8 Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover Photo Courtesy of Lloyd Library and Museum DIETARY INGRED. -- Cont’d from page 7... indicates that the ingredient is intended to treat a medical condition and it may be subject to regulation as a drug under the Act. Docket No. 95S-0316, RPT 294, received at the Dockets Office September 30, 2005, entered into the docket October 3, 2005, and posted on a web page created October 26, 2005. Leonard Lee of Cathedral City, California, sent FDA by letter of June 15, 2005, notice of two new ingredients – Toona Sinensus, and Heracleum Lanatum. These ingredients were each given a Docket number by FDA. Heracleum Lanatum (Michx.) or American Cow Parsnip is a perennial growing 2 to 4 meters tall and hardy in zone 5. It has been eaten and used as a medicinal plant widely for many diagnoses in Chinese medicine and by the American Indians. There was some information about furarocoumarins (psoralen) and their photosensitizing properties. The only form or use May 2006 mentioned was “content of tablet 30%, in powdered form.” There was not much more information included in the public file. FDA responded by letter of September 1, 2005 from Susan J. Walker, M.D., signed by Linda Pellicore, Ph.D., stating that the notice does not comply with 21 CFR 190.6 and is incomplete. Not included in the notice were: 1) an original and two copies; 2) a description of the dietary supplement(s) that contain the new ingredient; 3) the level of the new ingredient in the dietary supplement; and 4) the conditions of use recommended in the labeling of the dietary supplement. The information submitted describes the physical characteristics and edible uses, but does not provide information about the product that is to be marketed. In addition, the reference articles relied upon for safety are citations or abstracts and there were no reprints or copies. And there was no documented history of use of the ingredient in the food supply. The information about use in Chinese medicine does not provide a history of use as a food. Based on the information in the notice, FDA cannot make an evaluation of the safety of Heracleum Lantatum. Therefore, because insufficient information was provided for FDA to make a determination that the product when used as recommended is reasonably expected to be safe, under the law it is considered adulterated and may not be entered into interstate commerce. Further, FDA said the information indicates that the ingredient is intended to treat a medical condition and it may be subject to regulation as a drug under the Act. Docket No. 95S-0316, RPT 295, received at the Dockets Office September 30, 2005, entered into the docket October 3, 2005, and posted on a web page Natural Medicine LawTM created October 26, 2005. Global Cancer Strategies Ltd. of Vancouver, Canada, advised FDA by letter of June 23, 2005 of a new dietary supplement, ProhibitRx, containing six botanical ingredients: Vietnamese Sophora (Sophora tonkinensis Gapnep), bistort (Polygonum bistota), heal all (Prunella vulgaris L.), perennial sowthistle (Sonchus brachyotus), dense fruit dittany (Dictamnus dasycarpus Turcz), and air potato (Dioscorea bulbifera). The supplement is also described as ACAPHA. The dietary supplement will contain 600 mg of ProhibitRx in a film coated tablet with a suggested dose of 1.8 g per tablet to be taken three times a day. The product is designed for distribution in the United States. The product has been approved by the Chinese State Food and Drug Administration for treatment of esophageal dysplasia and stomach problems. The product is manufactured by Central Pharmaceutical Co. Ltd., Tianjin, China. The contents and manufacturing method is didacted from the public record. The recommended use of the product is by healthy adult males and females seeking to support health of their epithelial tissues in the oropharyngeal and respiratory tissues, as support for normal respiratory function in a smoke-rich environment, for those exposed to second-hand smoking, and support ability of the body to cope with a polluted environment, and help minimize the risks to long-term health posed by exposure to environmental toxins. A history of use in Chinese medicine was described. Evidence of safety and toxicology was didacted as confidential. FDA See NEW DIETARY INGRED -- Cont’d p. 9. NEW DIETARY INGRED -- Cont’d from p. 8... responded by letter of September 9, 2005 from Susan J. Walker, M.D. to Dr. T. P. Chiang, stating that the agency has concerns about the information upon which the conclusion is supported that the dietary supplement will reasonably be expected to be safe. FDA said the notice fails to adequately describe ACAPHA as there is no mention of the herb ratio to solvent in the manufacturing process. The degree of concentration cannot be determined. In addition, the standardization of the content of the alkaloid, matrine, present on one of the six ingredients is not stated. Thus it is unclear to what extent matrine contributes to the components. There was no information about the history of use of these ingredients as food. The relationship of the materials used in animal safety studies to the final product was not clear. For these reasons, the notice does not provide an adequate basis to conclude that ACAPHA when use under the conditions recommended will reasonably be expected to be safe. Therefore, the product may be adulterated and may not be introduced into interstate commerce. Docket No. 95S-0316, RPT. 296, entered into the docket on October 3, 2005, and posted to the FDA web site on October 26, 2005. Vigonic (International) Ltd. of Kowloon, Hong Kong, through Robert DeWitty, Esq. of Baltimore, on August 11, 2005 submitted a notification of New Dietary Ingredients, contained in a dietary supplement known under the trademark, VI-28. The new Natural Medicine TiesTM www.natmedlaw.com May 2006 ingredients are radix ginseng, cornu cervi pantotrichum, fructus cnidi, semen cuscutae, and kaempferiae rhizome. The notifier admitted that none of the ingredients were marketed in the U.S. prior to October 15, 1994, and that it is believed radix ginseng was marketed before that date, but does not possess conclusive proof of this latter fact. The notice claims these ingredients are “other botanicals” as defined in DSHEA. The notice states: “As CORNU CERVI PANTOTRICHUM is used to increase the total dietary intake and is not classified as a botanical, the Latin binomial and author are not required to be included.” The notice then states that the information upon which Vigonic has concluded the supplement is reasonably to be expected to be safe is attached which overcomes the initial state of adulteration. Arguing that FDA has not promulgated any regulation setting standards for the information to be provided, it is bound by the Act. The information provided was relied upon by the manufacturer to conclude the supplement is reasonably expected to be safe. The file contains another notice and explanatory letter dated August 29, 2005 which defined FDA’s request for information about cornu cervi pantotrichum as one that concerned whether the Chinese characters following the Englishlanguage terminology was a translation of the English-language terminology. The explanatory letter asserted that this was the case, giving as an example that the term “horn glue” was translated to “lujiao jiao,” being a Chinese translation of the English. Also in the public file were documents identifying “Provided Information” for cornu cervi pantotrichum, another describing “Provided Information” for Radix Ginseng, and a third describing Page 9 “adulteration” under DSHEA, the conditions of use of the dietary supplement, and the amount per serving size. The later document also contains an argument that a determination by FDA based on inadequate information must be addressed to the conditions of use indicated by the manufacturer and that a failure to supply information directed to these conditions of use will make the determination arbitrary and capricious. FDA responded by letter to Robert DeWitty, dated October 13, 2005, from Susan J, Walker, M.D., signed by Linda Pellicore, Ph.D., stating that the agency has concerns about the evidence on which Vigonic relies to support the conclusion that VI-28 will reasonably be expected to be safe. FDA stated it was unable to identify any of the new ingredients used to make VI-28. The information provide about cornu cervi pantotrichum is that it is “pilose antler,” “deer antler,” and “deer velvet.” The notice did not specify which species within the genus Cervus , FDA commented, and said that some material refers variously to spotted deer, red deer, North American elk and Cervus elaphus nelsoni, but it is unclear if any, all or none of these species will be the source of cornu cervi pantotrichum used in the product. There were other areas of lack of clarity in the notice. FDA concluded that it could not identify the ingredients, how the ingredients relate to the evidence of safety, or how that information was used in evaluating the safe use of the dietary supplement under the conditions of use. Finally, FDA said there was no description of the manufacturing process used to combine the five new ingredients or of the VI-28 product. For these reasons, FDA concluded the DIETARY INGRED. Cont’d on p. 10... Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover Natural Medicine LawTM May 2006 Natural Medicine LawTM Burningham, Esq. from Susan J. Walker, M.D., signed NEW DIETARY INGREDIENTS -- Continued from page 9... submission did not provide an adequate basis to conclude by Linda Pellicore, Ph.D., stating that the agency had that VI-28 will reasonably be expected to be safe when concerns because the agency was unable to determine used under conditions recommended. Therefore, the the identity of the new ingredient. The description of the product may be adulterated and may not be introduced specification and physical attributes were inadequate to into interstate commerce. Docket No. 95S-0316, RPT describe the identity. There was no chemical description 297, received in Dockets Office on November 22, 2005, or manufacturing information from which FDA might have entered into Docket on November 22, 2005, and posted determine the identity. The dosage form was not described and the products that will contain the ingredient were not on a Web page updated December 7, 2005. described. FDA said that because the identity of the One more letter was in the public file from Lyle Jaffe, new ingredient was unclear, it is unclear how the ingredient Division of Dockets Management, advising Robert M. is similar to the substances described in the safety data. DeWitty that his petition requesting FDA to take FDA says the toxicity study in “six rats” that found 100% administrative action to clarify the FDA letter received in mortality at the highest doses does not appear to provide response to a pre-market notification for VI-28, was a basis to support a determination that chronic received and assigned Docket No. 2005P-0495/CP1 consumption of the ingredient will reasonably be expected to be safe. For these reasons, FDA said the new and filed on December 21, 2005. ingredient notice provides inadequate information to Albion Laboratories, Inc. of Clearfield, Utah, sent provide reasonable assurance that the ingredient does FDA a 75-day pre-market notification of an new dietary not present a significant or unreasonable risk of illness or ingredient by letter of August 24, 2005 concerning its injury. Introduction of such a product into interstate product, Manganese Glucosamine™, containing 100 mg commerce is prohibited. Docket No. 95S-0316, RPT. of Manganese Glucosamine™, delivering the RDA dose 298, received in Dockets Office on December 13, 2005, of 5 mg of manganese and a dose of 43 mg of entered into Docket on December 1, 2005, and posted glucosamine. The conditions of use were described as: on a Web page updated January 4, 2006. “oral supplementation in typical dosage forms as a Natural ASA of Industrivelen, Norway, sent FDA a supplement to other sources of manganese and glucosamine in the diet. When administered in the Daily September 1, 2005 letter giving notice of its new dietary Dosage stated above, consistent with manganese RDA, ingredient, Omega-3 PL, containing a mixture of additional glucosamine dosage level to levels more typical phospholipids and triglycerides with a small amount of for glucosamine supplementation. Alternatively, ethyl esters and free fatty acids. Didacted from the public Manganese Glucosamine™ can be dosed at levels record were part of the name of the ingredient, the targeting the adult DRI upper limit of 11 mg manganese. manufacturing process, the description of the dietary A daily dose of 220 mg of Manganese Glucosamine™ supplement containing the ingredient, the history of use, delivers the adult DRI upper limit of 11 mg of manganese and the assessment of safety. FDA responded by letter and 95 mg of glucosamine, thus reducing the amount of of November 18, 2005 to Egil Nilsen, business additional gluscoamine supplementation required from development manager, from Susan J. Walker, M.D., other sources.” The history of use section of the notice signed by Linda Pellicore, Ph.D., stating that FDA had claimed that the safe use of the constituents of Manganese concerns about the evidence submitted as a basis for the Glucosamine™ was well documented and it listed the Natural ASA conclusion that new ingredient would references and provided copies. The notice claimed that reasonably be expected to be safe when used as Manganese Glucosamine™ was a dietary ingredient recommended. FDA states, but NML cannot confirm because it was a combination of a mineral and another because of the many redactions, that the product will be dietary substance. The composition of the product was used by consuming 3 g or 1 capsule 3 times daily with confidential as are the product specifications and MSDS meals. FDA says the ingredient may also be used in for the starting materials. The safety data disclosure nutrition bars and liquid formations providing a similar indicated the product was tested in “six animals” at 2000 dose. But FDA goes on to say it is unclear whether mg/Kg with survival in good health (until necropsy) and these bars and liquid formulations will be marketed as in “three female animals” at 5000 mg/Kg who all died within 24 hours. FDA responded by letter to Brent See NEW DIETARY INGREDIENTS --Continued on page 11... Page 10 Copyright 2006 by Muscatatuck Publishers, Inc. For Information on photocopying, see Inside Cover Natural Medicine LawTM May 2006 Page 11 “It is illegal to sell or supply prescription medicines without dietary supplements or conventional foods. And FDA the purchaser having a prescription from a registered says it was unable to determine the identity of Omega-3 medical practitioner. Distributors, importers and sellers Phospholipids, primarily because “the source of the are responsible for ensuring the products they import or concentrated fish oil and the identity of the triglyceride sell do not contain any undeclared prescription carrier (marine or vegetable) used to produce your medicines,” Dr. Poutasi says. “It is also illegal for an ingredient are not described. Furthermore, the products individual to possess personal supplies of a prescription of the various inter-esterification reactions are not medicine without first having obtained a medical identified or described. The notification addresses the practitioner’s prescription for them.” safety of DHA and EPA, but not the other components. There is no history of use of the material called Omega“Consumers need to be cautious as there may be other 3 Phospholipids, and there is no way to evaluate the safety herbal products at risk of containing prescription information provided as applied to the Omega-3 medicines or toxic substances. There are many examples Phospholipids. For these reasons, the notice does not in the international literature where ‘herbal’ products for provide an adequate basis to conclude the product will the treatment of impotence or for weight loss have been reasonably be expected to be safe. Therefore, the found to contain prescription medicines.” products using the ingredients may be adulterated and the products are prohibited from interstate commerce. Further information is available on the Medsafe website: Docket No. 96S-0316, RPT. 299, received at the http://www.medsafe.govt.nz/hot.htm New Zealand and Dockets Office, December 13, 2005, entered into the Docket on December 14, 2005, and posted on FDA’s website updated page on January 4, 2006. MEDICINES ACT -- Continued from page 5... A second herbal product Nasutra, has been found to contain the prescription medicine Sildenafil, which is prescribed for the treatment of erectile dysfunction. Sildenafil is known to interfere with some heart medication and could be fatal to some individuals. “Consumers should immediately stop taking these two products,” Dr. Poutasi Nasutra Li Da says. Sildenafil is also known as Viagra. Australia are linked in enforcement efforts concerning these kinds of illegal medicinces. “People who have taken Li Da or Nasutra should seek medical advice from their doctor if they are: taking other medicines; have felt unwell when taking the products; or DYNAMIC HEALTH OF FLORIDA if they have become unwell after they stopped taking the SETTLES FTC CHARGES products.” The two products were discovered following routine testing, surveillance activities and through Marketers of Pedia Loss, a purported children’s weightinformation received by Medsafe. loss product, and Fabulously Feminine, a supposed female libido enhancement product, have agreed to settle Federal Action is being taken with respect to the distributors of Trade Commission charges that they made false and these products and further investigations by Medsafe are misleading claims about their products. FTC announced underway into the importation and supply of the products. the settlement April 6, 2006. www.natmedlaw.com FTC’s complaint alleged that the defendants could not support claims that Pedia Loss causes weight loss in overweight or obese children ages six and over, and that See DYNAMIC HEALTH -- Continued on page 19... Copyright 2006 by Muscatatuck Publishers, Inc. For Information on photocopying, see Inside Cover NEW DIETARY INGREDIENTS -- Continued from page 10... Page 12 Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover Photo Courtesy of Lloyd Library and Museum PHARMACISTS -- Continued from p. 2... Dr. Shapiro said the American Heart Association recommended fish high in omega-3 oils twice a week when no cardiovascular heart disease is present and when CHD is present, at least one gram per day of omega3 oils in supplement form. The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) recommends fish oils as an alternative treatment for lowering triglycerides. 1 to 4 g or more daily will decrease triglycerides by 25% to 50%. Fish oils are also being used for cancer prevention, CSA-induced toxicities, bipolar disorder and depression, dry eye syndrome and other conditions. Oats are recommended at one cup per day to decrease LDL 5 mg/dl. Psyllium 10 to 12 g per day, divided can decrease LDL by 5% to 15%. Soy 25 g per day can decrease LDL by 10%. Plant sterols taken 1 to 8 g, divided in 2 or 3 doses per day, can decrease LDL 10% to 15%. May 2006 Natural Medicine LawTM Policosanol 5 mg twice a day will Castañeda, Pharm.D., Marialice S. lower LDL 11% to 27% and increase Bennett, R.Ph., Esperanza J. HDL 11% to 25%. Carchaced de Blanco, Ph.D. and Laura Hall, Pharm. D. Assistant Multivitamins are popular and Clinical Professor at Ohio State worthwhile, according to Shapiro, University College of Pharmacy and and combination products containing Columbus Neighborhood Health Vitamin A (beta –carotene 14,320 Centers, Inc. The study confirms a IU), Vitamin C (ascorbic acid 226 fairly simple message: patients are not mg.), Vitamin E (dl-alpha tocopherol being asked by health care acetate 200 IU), Zinc oxide 34.8 mg, professionals about herbal/natural and Cupric oxide 0.8 mg were used products; patients are treating in the National Eye Institute age- respiratory, central nervous system related study that showed a slowed and gastrointestinal symptoms with progression of macular degeneration. herbs; and a system to document Arch. Ophthalmology 2001; 119: herbal/natural product use is needed. 1436. Lutein may also improve macular degeneration at 10 mg per The poster was displayed at the day. JAMA 1994; 272: 1413-20. San Francisco meeting among rows and rows of other posters. Many Gingko use at 120 mg to 240 mg subjects were covered. Some daily, divided into 2 doses, in a concerned therapy management. To product containing 24% flavone just identify the topics of each poster glycosides can support modest would have taken several hours. To memory improvement, Shapiro said, study them all to an understanding of and may reduce the concentration what was being done and concluded, needed of omeprazole and possibly would have taken days. But since other drugs. Huperzine A is derived March, the study has proceeded, and from a Chinese herb Huperzia NML contacted the authors for more serrata and used for Alzheimers. information. Dr. Castañeda [The National Institute on Aging is responded recently with more data. recruit for a 150 person study at this time. Study No. NCT00083590. – The five health centers have 18,037 Ed.] 100 to 200 mcg per day is used patients, 66% of whom are uninsured, to obtain modest delay in symptom 62.% women and 78.5% over 18. progression. They are primarily indigent and homeless in the Columbus, Ohio area. Shapiro mentioned the weight loss The study goals remained the same products Dexatrim ® Natural from the beginning. In March the Ephedrine Free Formula and researchers reported 85 people in the Hydroxycut ®Advanced Weight Loss study, now they report 130, closer Formula – Ephedra Free as products to the goal of 200. None of the 130 to consider. Also products containing patients had been asked about herbal/ bitter orange peel. St. John’s Wort, natural products in the past 12 given 300 mg three times daily for months. A minority of whites and mild to moderate depression may be African Americans use herbals. obtained, but there are minor side Though much smaller numbers of effects and many interactions. people, the Hispanic, Asians and A poster was by Daniela V. See PHARMACISTS --Cont’d on p.13... PHARMACISTS-- Cont’d from p. 12... May 2006 clarifying the FDA implementation of American Indians use herbals in higher DSHEA, plus a complete list of all numbers than do not. special regulations applicable to natural health products. The talk also Among the 130 persons, 45 used describes the billions in costs to the herbals. The reasons they use herbals American public from the failure of are varied, including family traditions, Federal agencies to promote the use more effective than Rx, no doctor visit of vitamins, minerals, and others is required, safer than Rx, someone natural substances for a list of recommended, and they improve conditions. The talk is available as a health. The recommendations to use Powerpoint presentation on herbals came primarily from family, www.natmedlaw.com. Go to the List and only a few from health care of Articles page and scroll to the providers. Almost half the 45 users bottom. The List of Articles page is were occasional or always users located under “Products and before going to a health care Services.” There is no charge to look provider. 61.5% of the users and learn. Copy the list of regulations obtained symptom relief from herbal that apply to dietary supplements. use and only 33% told the doctor Review these when considering they had treated the symptoms. whether to market or file notices of claims. Share this with your friends. The researchers realize their questionnaire is not validated, the sample size is small and does not SUPPLEMENTARY represent the clinic population. In the GUIDANCE ON future, they hope to identify and target TRANSITION commonly treated symptoms, identify the safety of commonly used T raditional herbal medicinal products, and identify and avoid products (Directive 2004/24/EC, possible drug interactions. amending Directive 2001/83/EC) requires supplementary guidance that For more information, contact: has been developed in response to a Daniela Castañeda, Pharm.D., number of queries received by the Ambulatory/Community Care MHRA about the end of transitional Resident, The Ohio State University, protection under the Directive on College of Pharmacy, 500 West 12th traditional herbal medicinal products. Ave., Columbus, OH 43210, Tele: Please note that this guidance (915)276-4608, Email at: represents MHRA’s view and cannot [email protected] be taken to be a definitive statement of the law. This can only be given by The final talk on natural products at the courts. Where you have any the pharmacists’ annual meeting was doubts about your obligations, you by NML’s editor to a meeting should always consult your own cosponsored by the American professional advisors. Any enquiries Society for Pharmacy Law. The title relating to the transitional of the talk was “Health and Legal arrangements or this note should be Problems Arising From Failure to addressed to Implement DSHEA.” This talk [email protected]. documents the delays in proposing regulations, holding meetings and Page 13 Relevant provisions of the Directive on Traditional Herbal Medicinal Products Regulation 4(1) of the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 (“the Herbals Regulations”) of the regulations states that: • No traditional herbal medicinal product shall be (a) placed on the market, or (b) distributed by way of wholesale dealing, unless a traditional herbal registration has been granted by the licensing authority (which is in force, and which has been granted in accordance with the Community provisions). Provisions made under Schedule 6 mean that: • Where a product has been placed on the market, lawfully, under section 12(2) on or before 30th April 2004 regulation 4(1) would not apply until 30th April 2011 to products which were on the market under section 12(2) on 30th April 2004. Q & A on the end of Transitional Arrangements and how this will operate Q: Can a product continue to benefit from transitional protection after April 2011 if the company has made an application by 30th April 2011? A: No. Starting from 30th April, no product may be placed on the market, or distributed by way of wholesale dealing, unless a registration has been granted. It is not enough that an application has been made - it must have been granted. Q: What are the timetable requirements for MHRA in See TRANSITION -- Continued on page 21... Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover Natural Medicine LawTM Page 14 May 2006 EMAX -- Continued from page 1... time, FDA exempted from the rule ephedrine alkaloidcontaining conventional foods (such as ephedra tea), regardless of the quantify of naturally occurring ephedrine alkaloids within a daily serving. Copyright 2006 by Muscatatuck Publishers, Inc. For Information on photocopying, see Inside Cover FDA then issued an import alert on July 13, 2004 asking Customs to not permit the importation of any ephedrine containing herb whether in completed dietary supplement or bulk form. The alert says release of the products may be expressly conditioned on the importer’s ability to provide documentary evidence that the products do not contain ephedrine alkaloids. Natural Medicine LawTM Neutraceutical v. Crawford requires FDA to conduct a dose dependent determination of adulteration and prove by the preponderance of evidence that a dietary supplement containing 10 mg or less of ephedrine alkaloids per daily dose were adulterated. The Import Alert states that a shipment may be permitted entry if lab tests show it contains no ephedrine. The Import Alert has no provision for the lawful entry of products containing 10 mg or less or ephedrine alkaloids. The invalidation of the Final Rule renders invalid the Import Alert. FDA has not offered any other reason for the detention and FDA has said that there would be no labeling that would permit a lawful entry of any bulk ephedra shipment. This is contrary to Neutraceutical v. Crawford. On April 5, 2005, U.S. District Judge Tina Campbell in the District of Utah ruled that FDA’s Final Rule was Second, FDA exceeds its authority and violates the invalid for two reasons. Neutraceutical v. Crawford, adulteration provisions under Neutraceutical v. 364 F.Supp. 2d at 1319-1321. Crawford by adhering to the provisions of the invalid Final Rule and invalid Import Alert. In violation of that order and without seeking a stay from Judge Campbell or the Tenth Circuit Court of Third, FDA’s actions are contrary to the Administrative Appeals, where FDA had appealed, FDA has continued Procedure Act (APA) because FDA has acted in an to enforce the Final Rule and the Import Alert. One arbitrary and capricious way without a stay of the court instance of this illegal activity was cited in the complaint, order and the plain requirements of 21 USC § 342(f)(1). namely, a shipment sent to the Salt Lake City Airport on FDA’s refusal is also a violation of the proof requirements February 22, 2006 containing some ephedrine-alkaloid of the Act and is in violation of the APA. containing dietary supplements that were labeled that the maximum daily dose shall not exceed 10 mg of ephedrine Emax asked the Court to hold the Final Rule and Import alkaloids. The next day, FDA decided to place a “Hold” Alert as unenforceable as to plaintiffs, to declare the refusal on the shipment and take samples for testing. On March in excess of FDA’s authority, to declare the actions of 21, 2006, FDA said it would discontinue the testing and FDA arbitrary and capricious, to enjoin the defendants hold the shipment. The Notice of Detention designated from enforcing the Import Alert against Emax and to enjoin April 10, 2006 for the time for taking testimony to the defendants from enforcing it against Emax as grounds establish the admissibility of the shipment. for prohibiting any future shipment. Emax also asked for attorney fees and costs. On April 4, 2006, Emax sent an Email to FDA stating that Neutraceutical v. Crawford rendered the FDA The defendants have not answered. The Plaintiff states Final Rule invalid and held FDA lacked the that it will file an amended complaint. The ephedra preponderance of the evidence to prove the shipment shipment was released. Attorneys for Plaintiff were labeled not to exceed 10 mg per daily dose of ephedrine Jefferson W. Gross, Esq., Richard D. Burbidge, Esq. and alkaloids, is adulterated, and the Import Alert was invalid Robert J. Shelby, Esq., of Burbridge & Mitchell in Salt as well. FDA stood firm saying it was relying on previous Lake City, and Jonathan Walker Emord, Esq. and Andrea communications. On April 12, 2006, FDA issued a Gallimore Ferrenz, Esq. of Reston, VA. Stephen J. Notice of Refusal for the shipment requiring it to be Sorensen, Esq., Acting U.S. Attorney in Salt Lake City destroyed within 90 days. represented the federal government. The case was assigned to U.S. District Judge Dale A. Kimball as Case The lawsuit has three causes of action. First, Emax No. 2:06-cv-334. This same District Court issued the claims FDA’s determination of adulteration was based decision in Neutraceutical v. Crawford. Then the judge on an unlawful test requiring supplements to prove a was U.S. District Judge Tina Campbell. Until now FDA benefit as a condition precedent to lawful sale. insisted that decision only applied to one company. . These products claim to be anabolic and problems associated with anabolic steroids include: liver toxicity, testicular atrophy and male infertility, masculinization of women, breast enlargement in males, short stature in children, adverse effects on blood lipid levels, and a potential to increase the risk of heart attack and stroke. “FDA takes its responsibility to protect Americans from dangerous unapproved drugs seriously. Today’s action is indicative of our resolve,” said Margaret O’K. Glavin, FDA’s Associate Commissioner for Regulatory Affairs. Consumers who have any of the products listed below should stop taking them and return them to their place of purchase. GENISTEIN IS NOT HAZARDOUS TO HUMANS An independent panel of 14 scientists convened by the Center for the Evaluation of Risks to Human Reproduction (CERHR), of the NIEHS and National Toxicology Program, reviewed recent scientific data and concluded exposure to genistein or soy formula is not hazardous to human development or reproduction. The 2.5 day meeting on March 15 to 17 resulted in a 264 page report on genistein. FDA issued warning letters for the following so-called The panel consisted of Karl K. Rozman, Ph.D., dietary supplement products: Department of Pharmacology and Toxicology, University Anabolic Xtreme Superdrol, manufactured for Anabolic Resources LLC, Gilbert, Arizona, and distributed by See GENISTEIN -- Continued on page 16... Supplements To Go, Cincinnati, Ohio Methyl-1-P, manufactured for Legal Gear, Brighton, MI and distributed by Affordable Supplements, Wichita, PHOTOGRAPHS FROM LLOYD LIBRARYAND MUSEUM Kansas These warning letters are part of FDA’s continued efforts to protect consumers from dangerous steroid products. In March 2004, FDA sent warning letters to 23 manufacturers and distributors of products containing androstenedione. Warning Letters require specific responses be made to FDA within time limits. For these letters go to: www.natmedlaw.com Page 4 - Foxglove (Digitalis purpurea) from MEDICAL BOTANY by John Stephenson, M.D. and James Morss Churchill, F.L.S. 1829 Page 8 - Valerian (Valeriana officinalis) from MEDICAL BOTANY by John Stephenson, M.D. and James Morss Churchill, F.L.S. 1829 Page 12 - Ginseng (Panax quinquefolium) from THE FAMILY FLORA AND MATERIA MEDICA BOTANICA by Peter P. Good 1847 Page 16 - Evening Primrose (Oenothera biennis) from AMERICAN MEDICINAL PLANTS, by Charles F. Millspaugh, M.D., 1887 Page 22 - Goldenseal (Hydrastis canadensis) from AMERICAN MEDICINAL PLANTS,supra, 1887 Copyright 2006 by Muscatatuck Publishers, Inc. For Information on photocopying, see Inside Cover Natural Medicine LawTM May 2006 Page 15 ILLEGAL STEROID PRODUCTS Affordable Supplements SOLD AS DIETARY SUPPLEMENTS http://www.fda.gov/foi/warning_letters/g5739d.pdf FDA on March 9, 2006 warned several manufacturers http://www.fda.gov/foi/warning_letters/g5739d.htm Anabolic Resources LLC and distributors of unapproved drugs containing steroids http://www.fda.gov/foi/warning_letters/g5736d.pdf that continued distribution and sale of these products http://www.fda.gov/foi/warning_letters/g5736d.htm without approval could result in regulatory action including Legal Gear seizure and injunction. FDA is concerned that the use of http://www.fda.gov/foi/warning_letters/g5738d.pdf these products, which are marketed as dietary http://www.fda.gov/foi/warning_letters/g5738d.htm supplements and promoted for building muscle and Supplementstogo.com, LLC increasing strength, may cause serious long-term adverse http://www.fda.gov/foi/warning_letters/g5737d.pdf health consequences in men, women, and children. http://www.fda.gov/foi/warning_letters/g5737d.htm Page 16 May 2006 The general conclusions about human of Kansas Medical Center, Kansas toxicity were published on page 238 City, KS; James S. Kesner, Ph.D., with only one scientist, Dr. Rauth National Institute for Occupational Etzel, saying there was reason for Safety and Health, Cincinnati, OH; concern about soy intake among Antonia M. Calafat, Ph.D., National humans. The report is titled: “NTPCenter for Environmental Health, CERHE Expert Panel Report on the Centers for Disease Control and Reproductive and Developmental Prevention, Atlanta, GA; Elizabeth H. Toxicity of Genistein.” Copies may be Jeffery, Ph.D., Department of Food obtained at http://cerhr.niehs.nih.gov/ Science and Human Nutrition, chemicals/genistein-soy/genistein/ University of Illinois, Urbana, IL; Genistein_Report_final.pdf . Martine Culty, Ph.D., Department of Here is what the report said about Biochemistry and Molecular Biology, Georgetown University Medical soy consumption in humans. Center, Washington, DC; Jatinder “In a large multigenerational study, Bhatia, M.B.B.S., Division of Neonatology, Department of exposure to purified genistein occurred Pediatrics, Medical College of throughout fetal development as well Georgia, Augusta, GA; Ruth A. Etzel, as during adulthood. This experimental M.D., Ph.D., Anchorage Native design made it extremely difficult for Primary Care Center, Alaska Native the Expert Panel to clearly separate Medical Center, Anchorage, AK; Sue developmental toxic effects from Marty, Ph.D., Toxicology Research reproductive toxic effects. The Expert Laboratory, The Dow Chemical Panel viewed some of these diverse Company, Midland, MI; Deborah K. endpoints as a continuum from the Hansen, Ph.D., Division of Genetic maternal exposure (oral) to the effects and Reproductive Toxicology, observed in multigenerational offspring. National Center for Toxicological Even though there is a paucity of Research, Jefferson, AR; Jodi A. available human data on exposure to Flaws, Ph.D., Department of purified genistein, the Expert Panel Epidemiology and Preventive expresses negligible concern for Medicine, University of Maryland reproductive and developmental effects School of Medicine, Baltimore, MD; from exposure of adults in the general Christina Chambers, Ph.D., population. The most highly reported Departments of Pediatrics and Family exposed human population is and Preventive Medicine, University Japanese adults with ingestion of of California San Diego Medical approximately 0.43 mg/kg bw/day. Center, San Diego, CA; John A. However, adverse effects in rodent Thomas, Ph.D., Department of studies were not observed at levels Pharmacology and Toxicology, below 35–44 mg/kg bw/day. Therefore, Indiana University School of the Expert Panel feels that under Medicine, Indianapolis, IN; Patricia current exposure conditions, adults B. Hoyer, Ph.D., Department of would be unlikely to consume sufficient Physiology, University of Arizona, daily levels of genistein to cause Tucson, AZ; and David Umbach, adverse reproductive and/or Ph.D., National Institute of developmental effects. The Expert Environmental Health Sciences, Panel expresses negligible concern6 for adverse effects in neonates and Research Triangle Park, NC. Natural Medicine LawTM GENISTEIN-- Cont’d from p. 15.. Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover infants who may consume up to 0.01– Photo Courtesy of Lloyd Library and Museum 0.08 mg/kg bw/day of genistein aglycone contained in soy formula (it is noteworthy that about 1% of total genistein in soy formula is present as the aglycone; see Table 6 in the CERHR Soy Report).” “ 6 Dr. Ruth Etzel did not concur with the Expert Panel’s “negligible concern” for developmental effects in the infant population. Dr. Etzel concluded that a higher level of concern, i.e. “concern”, was justified based on the expectation that genistein induced body weight changes could exhibit a linear doseresponse relationship at low exposure levels, the fact that infants may receive no other foods than soy infant formula for up to 6 months, and the fact that exposure occurs during a critical time in infancy when any exposure may have the greatest potential to affect later neurological status and reproductive competency.” Some of the scientists produced lists of additional research projects to further determine the effects of genistein on humans. [These are GENISTEIN -- Cont’d on page 17... May 2006 GENISTEIN-- Cont’d from p.16... findings of a long-term feeding study listed in the report and should be on aspartame conducted in rats. considered by marketers desiring to Scientists from ERF concluded from make health claims for soy products. their study that aspartame causes cancer and that current uses and -- Ed.] consumption of the sweetener should The report data states that be re-evaluated. exposure to genistein continues to rise EFSA’s review of ERF’s study in the United States with estimated concluded, among other things, that soy sales in 2003 approaching $4 billion. A form of genistein is a primary, on the basis of all evidence currently naturally occurring estrogen in available to EFSA: soybeans (estrogenic chemicals in ❁ ERF’s conclusion that plants are called phytoestrogens) and aspartame is a carcinogen is can mimic the effects of estrogen in not supported by the data; the body. Genistein can be found in and foods containing soy such as soybased infant formulas, tofu, soy milk, ❁ EFSA sees no need to soy flour, textured soy protein, further review its earlier tempeh, and miso, as well as overscientific opinion on the safety the-counter dietary supplements. of aspartame or to revise the Soy-infant formulas are widely used. Acceptable Daily Intake. It is estimated that 10-20 percent of Upon learning of the ERF study infants in the United States are fed soy formula. It is often administered results, FDA requested the study to infants as a supplement or data from ERF to evaluate the replacement for maternal breast milk findings. On February 28, 2006, the agency received a portion of the data or cow’s milk. requested. We are actively reviewing the data provided by ERF and will complete our review of those data as soon as possible. When FDA FDA STATEMENT completes its review of the ERF study ON EUROPEAN data, it will announce its conclusion. ASPARTAME STUDY FDA issued this statement on May 8, 2006 in response to the European Food Safety Authority (EFSA) press release on its review of the long-term carcinogenicity study of aspartame conducted by the European Ramazzini Foundation (ERF). Since it was first approved for use in the United States, the safety of aspartame has been questioned by some. To date, however, the agency has not been presented with scientific information that would support a change in our conclusions about the safety of aspartame. Those conclusions are based on a detailed review of a large body of information, including more than 100 toxicological and clinical studies regarding the sweetener’s safety. Aspartame, a low-calorie sweetener, is composed primarily of two common amino acids, aspartic acid and phenylalanine. Each of these is also a building block for conventional foods such as protein http://www.fda.gov/bbs/topics/ NEWS/2006/NEW01369.html and natural flavor molecules. In 2005, ERF published new Page 17 “NATURAL” BEVERAGES The Sugar Association has filed a citizen petition with FDA to define what is meant by the term “natural” when applied to beverages. The petition asks FDA for consistency across Federal agencies based on the definition adopted by USDA in its Food Standards and Labeling Book. In the case of meat and poultry, the term “natural” may be used as long as the applicant demonstrates: (1) the product does contain any artificial flavor or flavoring, coloring ingredient, or chemical preservative (as defined in 21 CFR 101.22), or any other artificial or synthetic ingredient; and (2) the product and its ingredient are not more than minimally processed. Natural claims should be accompanied by a brief statement of what is meant by the term natural. This statement should appear directly beneath or beside the “natural” claim. The Sugar Associations asked that foods and beverages represented as “natural” that do not meet the regulatory criteria be deemed misbranded. The petition said the current situation is ambiguous. FDA currently allows 3,000 approved food additives and by contrast the European Union only allows 311, while New Zealand and Australia allows only 299. Using a definition of “natural” and “minimally processed” together will achieve a level of specificity that will negate the current ambiguity associated with the term “natural.” The petition points out that the Canadian Food Inspection Agency See NATURAL -- Cont’d on p.24... Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover Natural Medicine LawTM Page 18 May 2006 SECTION 403 LETTERS-- Continued from page 4... Copyright 2006 by Muscatatuck Publishers, Inc. For Information on photocopying, see Inside Cover “[H]elp to relieve pain and arthritis symptoms...;” “[R]educe pain and accelerate the inflammatory healing response for painful joint conditions, sports injury…;” and [M]ay help rebuild cartilage and alleviate pain in joint injury and other painful joint conditions.” FDA also stated that the statements made about Lipid Balance required an additional statement about it being intended to affect blood cholesterol that is already in the normal range. Therefore, FDA concluded that the italicized statements were drug claims and the products would be regulated as drugs if the statements were used. FDA also stated that since the content of the notices were not certified as true and not misleading and were not signed, they were not acceptable as notices. The failure to submit a valid notice may subject the products to further regulation. Docket No. 97S-0163, Ltr. 859, received at Dockets Office on February 16, 2006, entered into the Docket on February 16, 2006, and posted on the FDA Website on March 6, 2006. Brownwood Acres Foods, Inc. whose legal counsel, Neal D. Fortin, Esq., of Okemos, Michigan, wrote FDA on January 24, 2006 to give notice that he would use certain claims for the product Concord Grape Juice Concentrate, namely, “Helps maintain healthy blood pressure levels,” and “Resveratol … to lower cholesterol.” FDA’s Susan J. Walker, M.D. responded by letter of February 10, 2006 stating that based on reasoning in the January 6, 2000 final rule on structure/ function claims, a claim about maintenance of cholesterol levels and blood pressure must also have statements about them being intended to affect cholesterol levels and blood pressure levels that are already in the normal range, or they are disease claims. The claims presented are drug claims and the products will be regulated under the drug provisions of the Act. Docket No. 97S-0163, Ltr. 860, received at Dockets Office on February 16, 2006, entered into the Docket on February 16, 2006, and posted on the FDA Website on March 6, 2006. Beulah Land Corporation of Oak Park, Illinois, wrote FDA on February 1, 2006, to give notice that it would use certain claims for the product Beulah’s Bone Plus Pack, namely, “may help promote bone health.” The product contains Vitamin D3 1000 IU, Vitamin K 1 mg, Folic Acid 800 mcg, Magnesium 400 mg, Selenium 200 mcg, Copper 1 mg, Manganese 10 mg, Molybdenum 150 mcg, Ipraflavone 600 mg, Strontium Citrate 1000 mg, Montmorillonite 150 mg, Boron 5 mg. The label Natural Medicine LawTM suggests use of 2 packets per day. FDA responded by letter dated February 10, 2006 from Susan J. Walker, M.D., to President saying the notices are not compliant with the regulations because they are not signed and certified as to the truth and non-misleading nature of the contents. FDA did not comment further. [Notice this product does not contain calcium, so FDA could not comment on meeting the health claims for the relationship of calcium and bones. – Ed.] Docket No. 97S-0163, Ltr., 861, received at Dockets Office on February 16, 2006, entered into the Docket on February 16, 2006, and posted on the FDA Website on March 6, 2006. Atlas Productions, Inc. of Pompano Beach, FL wrote to FDA on January 16, 2006 to give notice that it would use certain claims for its products: Nutra/MD™ High Blood Pressure Essential Nutrients Supplement, “[D]esigned for consumers and doctors who know that many blood pressure lowering medicines can hinder or deplete essential nutrients…;” Nutra/MD™ High Cholesterol Essential Nutrients Supplement, “[D]esigned for consumers and doctors who know that many cholesterol lowering medicines can hinder or deplete essential nutrients…;” Nutra/MD™ Diabetes Essential Nutrients Supplement, “[D]esigned for consumers and doctors who know that many diabetes medications can hinder or deplete essential nutrients…;” and Nutra/MD™ Arthritis Essential Nutrients Supplement, “[D]esigned for consumers and doctors who know that many medications given to treat arthritic pain can hinder or deplete essential nutrients….” FDA responded by letter to Don Ford, M.D., P.A., from Susan J. Walker, M.D. stating that the January 6, 2000 final rule on structure/function claims (65 FR 1029) says that “a claim that a product is useful because it counterbalances the effect of a drug in depleting a nutrient of interfering with the metabolism of a nutrient would be acceptable as a structure/function claim” if the claim does not suggest that treatment of an adverse reaction that meets the definition of disease. However, the final rule also states, “if the claim expressly or impliedly suggests that the supplement is intended to augment a specific drug, d rug action, or therapy for a disease, then the statement may be considered a disease claim.” In addition, FDA said there were other statements in the labeling of these products, such as the one for Nutra/ MD™ High Blood Pressure Essential Nutrients Supplement, which states, “to aid in the prevention of cardiovascular disease risk factors.” FDA said these See SECTION 403 LETTERS -- Continued on page 19... Natural Medicine LawTM May 2006 Page 19 subject to public comment, was 5-0. The FTC will publish claims “go beyond representing the products as intended an announcement regarding the agreement in the Federal to replace nutrients lost as a consequence of the use of a Register. The agreement will be subject to public comment specific therapy. Rather, they expressly are represented for 30 days, beginning today and ending on May 5, 2006. to treat the underlying diseases for which the consumer Staff contacts are: Janet Evans or Sydney Knight, Bureau would be consuming a drug.” These, FDA said, are disease of Consumer Protection at telephone numbers: claims. The claims taken together do not represent section 202-326-2125 or 202-326-2162 and for details at the 403(r)(6) claims, but they are disease claims. If these claims are used, the products will be regulated as drugs. FTC website at: www.ftc.gov/opa/2006/04/ Docket No. 97S-0163, Ltr. 862, received at Dockets dynamichealth.htm. Office on February 16, 2006, entered into the Docket on February 16, 2006, and posted on the FDA Website on March 6, 2006. GUAIACUM TRADEMARKS This word is not in the indexes of the U. S. Patent and DYNAMIC HEALTH -- Continued from page 11... when taken by overweight or obese children, Pedia Loss suppresses appetite, increases fat burning, and slows carbohydrate absorption. The FTC also alleged that the defendants could not support claims that Fabulously Feminine will increase a woman’s libido, sexual desire, and sexual satisfaction. The FTC further alleged the defendants falsely claimed that clinical testing proves Fabulously Feminine enhances a women’s satisfaction with her sex life and level of sexual desire. Trademark Office as spelled. But if you use the asterisk (*) in searching, you can find a live mark for MADE FROM GREEN GUAIACOL. This mark is owned by the Rhodia Corporation in France as Serial No. 78/ 708595, filed September 7, 2005 in International Class 001 for chemicals, namely, compounds containing guaiacol for use in the perfume, food aromas, food manufacturing, cosmetics industries and in the manufacture of pharmaceuticals. It was first used March 31, 2003 and has been approved for publication. Defendants under the proposed agreement, Vineet K. Chhabra (also known as Vincent K. Chhabra) and his companies, Dynamic Health of Florida, LLC, and Chhabra Group, LLC, are based in Weston, Florida. The other two defendants named in the FTC’s complaint, Jonathan Barash and DBS Laboratories, LLC, previously settled the charges against them. There is also a live mark for GUAIAFAGE, Registration No. 2272069, in International Class 005, for antitussive, expectorant, descongestant (sic) in the form of liquid, tablets, capsule and injectable. This was first used May 15, 1998 by Alberto S. Bartolomea, of Puerto Rico. The registration date is August 24, 1999. The proposed agreement requires that the defendants rely on competent and reliable scientific evidence to substantiate weight loss, appetite suppression, fat burning, or carbohydrate absorption claims for Pedia Loss or any other dietary supplement, food, or drug. The defendants must have competent and reliable scientific evidence to substantiate claims that Fabulously Feminine or any other dietary supplement, food, or drug will increase a woman’s libido, sexual desire, or sexual satisfaction. The proposed order also prohibits the defendants from making unsubstantiated benefits, performance, or efficacy claims for any dietary supplement, food, or drug, and prohibits the defendants from misrepresenting any test or study. Finally, it contains recordkeeping provisions to assist the FTC in monitoring compliance. The Commission vote to accept the consent agreement, 1 From 1905 to 1988, McKesson & Robbins, a partnership in New York City, held a trademark for GUAIAQUIN, Registration No. 0052729, in International Class 001, for chemical preparations for the treatment of malarial fevers and diseases characterized by intestinal fermentation and in anemias and cachexiae. The mark was first used October 5, 1896 and has now expired. Back in 1989 FDA was revising the Over-the-Counter Drug Monographs and had originally classified See GUAIACUM -- Continued on page 20... www.NatMedLaw.com Copyright 2006 by Muscatatuck Publishers, Inc. For Information on photocopying, see Inside Cover SECTION 403 LETTERS-- Continued from page 18... Page 20 May 2006 Natural Medicine LawTM GUAIACUM -- Continued from page 19... Copyright 2006 by Muscatatuck Publishers, Inc. For Information on photocopying, see Inside Cover Phytopharm licensed the global patent rights for the extract of Hoodia gordonii, a cactus plant indigenous to guaifenesin, a synthetic compound made to similate South Africa, for incorporation into weight loss products guaiacol, as a Class III OTC ingredient. But the agency from the South African Council for Scientific and Industrial relented and allowed it to use a claim “helps loosen phlegm Research (CSIR) in 1997. (sputum) and thin bronchial secretions to make coughs more productive” based on the Vercelli study. 54 FR at [Perhaps this will mean that some Hoodia products 8499 (Feb. 28, 2989) now on the market will be required to cease and desist when Unilever focuses its intellectual property attorneys As late as July 2005, FDA was concerned about on infringers. We will watch for you. – Ed.] combination products with guaifenesin and ephedrine. 70 FR 40233 (July 13, 2005) Guaiacol did not make it into the Botanical Safety Handbook, McGuffin et al, CRC 1997. But Guaiacum Resin is featured in the British Herbal Compendia, Vol. 1, 1992. FTC STAFF ADVISES FDA ON QUALIFIED HEALTH CLAIMS The FDA held a public meeting on November 17, 2005, to present recent research on consumer perceptions of The Arco Chemical, 3801 W. Chester Pike, Newtown qualified and unqualified health claims for conventional Square, PA. is selling a guaifenesin made by new process foods and dietary supplements. In the meeting announcement, the agency sought comments on available recently. research and the implications of the research for further If you are thinking about using this mark, you need to consumer studies, and other approaches that might effectively convey to consumers the strength of supporting study how to use it with some expert guidance. health claims. UNILEVER SPENDS ON HOODIA Phytopharm plc of Cambridgeshire, U.K. announced April 10 that it has successfully completed the first stage of the Joint Development Agreement for Hoodia gordonii extract with Unilever and will now progress to the second stage which includes clinical safety studies. In its January 20, 2006 comment, the FTC staff focused on facilitating additional useful consumer research in this area. Specifically, the comment states that the staff’s review of the research presented at the November 17 meeting suggests the following findings: 1) the current FDA language for qualified and unqualified claims does not communicate the four intended levels (A through D) of scientific certainty to consumers; 2) consumers do not perceive the current FDA unqualified significant scientific agreement (SSA) claim to convey strong scientific certainty; 3) the results of the FTC’s copy tests indicate that it is possible to craft language that differentiates clearly among differing levels of scientific certainty; 4) a “report card” format performed consistently well in the ranking tests; and 5) consumer interpretation of qualifying language tends to vary widely. The comment also discusses certain implications that the findings noted above may have on future qualified health claims research. Under the terms of the agreement, Phytopharm and Unilever are collaborating on a five-stage research and development program of safety and efficacy studies with a view to bringing new weight management products to market. As part of the agreement announced in December 2004, Unilever committed to initial payments of approximately £6.5 million for the first stage and for the second stage have now committed to a further £3.5 million out of a potential total of £21 million in payments to Phytopharm. In addition, Phytopharm will receive an undisclosed royalty on sales of all products containing The Commission vote authorizing the staff to file the the extract. Unilever is also managing a separate comments, which can be found on the FTC’s Web site agronomy program and supporting the international patent www.ftc.gov, was 5-0. (FTC File No. V060005; the program for the products. staff contacts are Dennis Murphy and Pauline Ippolito, See FTC STAFF ADVISES FDA -- Continued on page 21... May 2006 FTC STAFF ADVISES FDA -- Continued from page 20... Page 21 CHINA SELLS STEVIA Bureau of Economics, 202-326-3524 or 202-326- Worldwide demand for healthy sweeteners is rising, and 3477; see related press release dated January 29, 2004.) Sunwin International Neutraceuticals, Inc. of Qufu, Shandong, China estimates that the demand for stevioside Copies of the documents mentioned in this release are in recent years is increasing at a rate of 15% to 20% available from the FTC’s Web site at www.ftc.gov and every year. The company’s aim is to get stevioside into also from the FTC’s Consumer Response Center, Room grocery stores and making it known to the general public. 130, 600 Pennsylvania Avenue, N.W., Washington, DC 20580. Call toll-free: 1-877-FTC-HELP. According to the China Stevioside Sugar Association [Readers should watch for changes in FDA’s focus on qualified and unqualified health claims for dietary supplements. FTC has been working on claims longer than FDA staff who may find FTC comments helpful, – Ed.] TRANSITION -- Contiuned from page 13... (CSSA), in 2002, worldwide demand for stevioside exceeded 1,200 tons and China supplied more than 1,000 tons, accounting for 80% of worldwide consumption of stevioside. Steadily increasing production, Sunwin stevioside production reached 150 tons in the year prior to April 24, 2004, which according to the CSSA, accounted for approximately 8.3% of the global production. Sunwin plans to manufacture and resell approximately 300 tons of Stevia in the fiscal year of 2006. processing applications for traditional herbal registrations? A: Under article 17 of Directive 2001/83/EC, Member States must take all appropriate measures to ensure that the procedure for granting a marketing authorization is completed within 210 days after the submission of a valid application. This provision also applies to traditional herbal registrations. In certain situations there is provision for “clock stops” in the timetable. Sunwin is engaged in the areas of essential traditional Chinese medicine, 100% organic herbal medicine, neutraceutical products, natural sweetener, and animal medicine prepared from 100% organic herbal ingredients. As an industry leader in agricultural processing, Sunwin has built an integrated global firm with the sourcing and production capabilities to meet the needs of consumers throughout the world. Sunwin makes and sells over 120 Chinese herbs. Q: What is the position of transitionally protected Stevoside is estimated to be approximately 200 to 300 products legally placed on the market as at 30th April times sweeter than general sucrose, but it has only 1/300 2011? of the calories and it is often referred to as the third generation of natural low calorie sweeteners. The Stevia A: Regulation 4 of the Herbals Regulations applies not rebaudiana plant, which originally grew in Paraguay and just to placing on the market, but also wholesale dealing. Brazil, was successfully introduced to China in 1970’s. Therefore, a wholesale dealer cannot distribute a product China is presently the largest domestic producer of Stevia after 30th April 2011 where that product does not have rebaudiana, and the primary producer and exporter of a registration, even if it had been placed on the market stevioside worldwide. by its manufacturer before 30th April in accordance with the transitional provision. Sunwin announced April 18, 2006, that its wholly owned subsidiary, Sunwin Stevia International Corp., has However, the product could be sold if, for example, a engaged Blue Chip Marketing and Communications to product was placed on the market by sale direct to a assist the company in marketing its Stevia to North retailer (i.e. not a wholesale dealer) on 29th April 2011, American consumers. Blue Chip, based in Northbrook, that retailer could sell the product after 30th April 2011 Illinois, and established in 1982, is a full-service marketing even if a registration had not been granted. Guidance agency which represents several Fortune 500 U.S. and issued May 2006 at www.mhra.gov.uk global brands. See STEVIA -- Continued on page 22... Copyright 2006 by Muscatatuck Publishers, Inc. For Information on photocopying, see Inside Cover Natural Medicine LawTM Page 22 STEVIA -- Continued from page 21... Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover The company claims that since the passage of the Dietary Supplement Health and Education Act of 1994, Stevia can be sold legally in the United States as a dietary supplement. Even so, it can be found in many forms in most health-food stores, and is also incorporated into drinks, teas and other items all labeled as dietary supplements. Currently the FDA requires Stevia to be labeled as a dietary supplement for sale in the U.S., the company information stated. Mr. Stanton Kawer, Chairman and CEO of Blue Chip stated “As America is faced with finding solutions to our alarming growth rates of obesity and diabetes, Sunwin Stevia is positioned perfectly as the best choice for today’s consumers. Additionally, research indicates that the traditional grocery has recognized over $25 billion in health and natural purchases are going to outside channels. Sunwin is committed to educating those consumers that Stevia can be purchased at their neighborhood grocery, making it easier to incorporate healthy products as part of their regular shopping regiment.” Mr. Laiwang Zhang, Chairman and President of Sunwin International commented “Blue Chip represents many major U.S. brands. With assistance from Blue Chip, we believe Sunwin is well suited to accomplish its goal of becoming the number one seller of Stevia in the U.S. Sunwin believes Blue Chips unique blend of expertise in the food and pharmaceutical industries is a prefect fit for our company. Blue Chip has a long and successful history of providing similar services with some of the largest companies in the United States.” May 2006 Natural Medicine LawTM Mr. Zhang concluded, “Our ambitious goal is to establish our Stevia brand as the preeminent alternative sweetener in the North American sweetener market. Entering the United States consumer market will be a significant challenge for our organization. Upon a review of the many accomplishments of Blue Chip, we believe we have assembled the right group to assist our company in working towards this goal.” On April 26, Sunwin announced that the company’s Stevia production at their newly constructed facility has reached 22 to 25 tons per month or 260 to 300 tons per year following a major renovation effort commenced in 2005. In the first three months of 2006, the company has received purchase orders in excess of 125 tons of Stevia, a 100% increase compared to same period in 2005, or 80% of Sunwin’s Stevia production for the entire 2005 fiscal year. Mr. Zhang concluded, “Our goal is to increase Stevia production to 800 to 1,000 tons per year by the end of 2007. Furthermore we plan to move forward with our marketing campaign to access the U.S. consumer market. Lastly we will continue our M&A strategy as we are presently reviewing several Stevia production facilities for acquisition.” Sunwin’s Stevia division alone could achieve approximately $12 to $15 million in annual sales in the coming fiscal year, prior to any potential acquisitions, and the potential Stevia sales in North America. Japan, known worldwide as having healthy dietary habits with a population of over 127 million people, utilizes Stevia for 30% to 40% of their entire sweetener consumption including sugar. Stevia is used as a Photo courtesy of Lloyd Library & Museum sweetener by some of the largest North American food and beverage manufacturers in their Japanese production facilities. The population of countries that currently use Stevia as a sweetener exceeds two billion worldwide. This article was prepared from press materials available at www.sunwin.biz. [Readers are invited to watch for a number of legal problems to arise with increased use of stevia. For example, an FDA Import Alert, #4506 was revised on October 27, 2005 whose subject is “Automatic Detention of Stevia Leaves, Extract of Stevia Leaves, and Food Containing Stevia.” This Import Alert states that: “unless explicitly labeled as a dietary supplement, or for use solely as a dietary ingredient in the manufacture of a dietary supplement” Districts may detain without examination all products identified on the attachment to this See STEVIA-- Continued on page 23... Natural Medicine LawTM qualified advice.” The NIMH, one of the world’s oldest professional bodies representing qualified herbalists. Established in 1864, NIMH is the UK’s leading authority on herbal health matters. To find out more about Herbal Medicine Awareness Week, please contact the NIMH head office at Elm House, 54 Mary Arches Street, Exeter, EX4 3BA or email [email protected]. The Institute’s web site can be found at www.nimh.org.uk. -- Ed. According to the website of GBW the Members of the program must pay a fee to use the Seal® and must sign an agreement that they will use only CHINA NOW SELLS Wisconsin Ginseng products on WISCONSIN GINSENG packages labeled with the Seal.® The Once a nice cash crop in Wiscon- GBW reserves the right to test the product to assure program complisin, the ginseng business has ance and periodically randomly seplummetted according to Jane lects products to be tested. These Zhang’s article March 8, 2006 Wall tests determine the purity of the prodStreet Journal. uct and assure that it is true Wisconsin Ginseng. Wisconsin ginseng was known to be superior, especially in Marathon It also claims “Wisconsin Ginseng County, known as the ginseng capiis grown to exacting standards estabtal of the world. In the early 1990s lished by the U.S. Food and Drug there were 1,600 growers, now there Administration.” are only 200. STEVIA -- Continued from page 22... alert. There was a detention of stevia extract on February 6, 2006 as indicated in the data below. Nan Hua Jia , CN 226014 LOS-DO WRE-0338150-6/26/1 45TF-99 STEVIA EXTRACT (FOOD ADDITIVE SWEETNER) 06-FEB-2006 UNSAFE ADDITIVE Stevia is on the NNFA list of botanicals used before passage of DSHEA. See www.fda.gov/ohrms/ dockets/dockets/05p0305/05p0305-cr00001-03-NNFA-Listvol1.pdf. There is no New Dietary Ingredient notice filed for stevia in Docket No. 95S-0316, but there is one that cited some stevia research. See RPT 57 on Lo Han Kuo. FDA’s import detention memo mentions to Districts that some research is going on to support a future food additive petition. A number of products containing stevia are included in Docket No. 97S-0162 that represents the FDA file for “approved” structure/function claims. Page 23 Canada purchased Wisconsin seeds in the early 1990s and then sold surplus seeds to China. By 1994 the price of ginseng dropped to 50% of previous prices. Some growers must have known they had a problem as they established the Ginseng Board of Wisconsin in 1986. The GBW is the administrator for the Wisconsin Ginseng Seal® Program. This program was developed in 1991 to protect the integrity of Wisconsin Ginseng products. The Wisconsin Ginseng Seal® program provides consumers with a simple, convenient method of identifying authentic Wisconsin Ginseng at the point of purchase. Packaged products bearing the official Wisconsin Ginseng Seal® must contain 100 percent pure Wisconsin Ginseng, grown and harvested in Wisconsin. Interestingly, the GBW has producer members in Illinois, New York and California, as well as Wisconsin. The Ginseng Board is located at: 555 N. 72nd Ave Ste 2, Wausau, WI 54401 Phone: 715-845-7300 Fax: 715-845-7300 [email protected] NATURAL -- Continued from page 17... has deemed only food or food ingredients who processing has not significantly altered the original physical, chemical or biological state can be described as “natural.” Processes such as hydrolysis or enzymolysis where the raw material is fundamentally altered to the extent that these processes manipulate the molecules of one substance to create another would preclude the “natural” claim. Other altering processes would include: hydrogenation of oils, starch-based break down processes using things like maltodextrin and modified food starch, and flour treated with agents such as potassium bromate or chlorine dioxide to boost ingredient performance. See NATURAL -- Continued on page 24... Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover AWARENESS-- Cont’d from p. 1... May 2006 NATURAL -- Continued from page 23... The USDA lists many other at Docket No., 2006P-0094, docket processes considered rather severe entered on March 21, 2006, and processes, but allows case by case Web page created on May 3, 2006. exceptions for the use of the term The Center for Science in the “natural.” Public Interested filed a letter dated The mere existence in nature should March 13, 2006 in support of the not be a factor for a qualifying “natural” petition. CSPI stated it had “natural” claim. The Petition is filed spoken to three companies that make deceptive claims and while one has said it will make changes, others have refused. CSPI said it was preparing a lawsuit to address the misuse of “Natural.” This letter was signed by Stephen Gardner, Director of Litigation for CSPI. ingredients and no directions for use going to buy such products, if FDA lets them through the regulatory maze. FDA. This particular complaint that FDA is wrong about turning down your NDI for inadequate information, caused FDA to open up a Citizens Petition docket and put resolution of the issue on a new regulatory tract that will be busy for a few more years. HARVESTING HEALTH A recent phenomenon in new dietary ingredient notifications is the attempt by filers to protect as confidential information the ingredient amounts, conditions of use, methods of manufacturer, and other information. Considering that these products have to be labeled for the consumer, the rationale for attempting to not disclose the ingredient amounts and conditions of use are baffling. The method of manufacture may be worth protecting from competitors combing the FDA files for product ideas, but the product will have to disclose ingredient amounts and conditions of use or servings on the label. Consumers would be foolish to buy any product whose ingredient contents and serving size are not on the label. FDA is unlikely allow this. So what are these submitters thinking or trying to prove by asking for confidentiality? And why is FDA granting it preliminarily? Won’t the makers have to spend a lot of money to market a product with confidential Back when some of companies were complaining about FDA’s turn down rate for new dietary ingredient notices, they were saying it is not nice to be told your product is “adulterated,” but on the whole not all of them have learned from the November 2004 open meeting on new dietary supplements. Or, could it be the industry and FDA have not made it clear yet what is expected? One notifier told FDA last year that the agency had not yet promulgated regulations on what kind of information the agency wants. That is true. And, this notifier said, as a result, FDA was stuck with enforcing the law without regulations, meaning that FDA had to accept what was given to FDA in the notices, and this “giving” shifted the burden to FDA to prove the product was not safe. That is an arguable outline for a motion in court, but it is not working before the Until a court or Congress looks at these kinds of problems, FDA has the upper hand. So, learn from the mistakes of others. Read Natural Medicine Law Newsletter and try to understand how to work with the agency. NML is proud to say, paraphrasing former Chrysler president Lee Iacoca’s advertisement on cars, “If you find a b e t t e r information source, buy it.” William J. Skinner, R.Ph., Attorney at Law, Editor