Download review of dietary supplements

REVIEW OF LEGAL EVENTS FOR DIETARY SUPPLEMENTS,
BOTANICALS AND HERBAL PRODUCTS March 2006—March 2008
by William J. Skinner, R.Ph., Esq.*
The last time I reviewed for you what has been happening with the laws and regulations concerning
dietary supplements, botanical and herbal products was at the San Francisco Annual Meeting in March
2006. This article will bring you a summary of what has happened during the two years since that time
until March 2008.
Herbal Medicine Awareness Week was held in the United Kingdom by the National Institutes of
Medical Herbalists. This was a week of lectures, tours and demonstrations a many points on the island
kingdom.1
The Sugar Association filed a Citizen’s Petition on March 21, 2006 asking FDA to define the term
“natural” when applied to beverages. The Association asked for consistency saying the current
situation is ambiguous.2
Jordan Rubin’s company Garden of Life settled claims with the Federal Trade Commission
concerning failure to have substantiation data for claims for several products. Rubin is the author of
the book, The Maker’s Diet, Siloam 2004. U.S. District Court for the Southern District of Florida, Case
No. 06-CV-80226, March 30, 2006.3
The American Pharmacists Association met March 17-21 in San Francisco, where 7,000 pharmacists
heard one talk about An Evidenced-Based Approach to Vitamins and Natural Remedies, saw one
poster, and another talk by NML’s editor. Karen Shapiro, Pharm.D. from Los Angeles spoke, the
poster was by several persons headed by Daniela V. Castañeda, Pharm. D. of Ohio State University,
and the editor is the same as this author who spoke about “Health and Legal Problems Arising from
Failure to Implement DSHEA.”4
The U.K.’s MHRA issued a guidance on transition of traditional herbal medicinal products under
Directive 2004/24/EC.5
Makers of illegal steroid products sold as dietary supplements were warned by FDA that the products
were unapproved new drugs in a series of warning letters.6
A panel of 14 scientists convened by the Center for the Evaluation of Risks to Human Reproduction
of the National Institute for Environment Health Sciences and National Toxicology Program generated
a 264 page report saying genistein is not hazardous to humans.7
FDA commented on the European Aspartame Study saying the agency had obtained part of the data
and would announce its decision about the study.8 By April 20, 2007, FDA would not alter its opinion
that aspartame was safe.9
1
www.nimh.org.uk
www.fda.gov for Docket No. 2006P-0094.
3
www.ftc.gov/opa/2006/03gardenoflice.htm.
4
A PowerPoint presentation by William J. Skinner is available on www.natmedlaw.com.
5
www.mhra.gov.uk.
6
www.fda.gov/foi/warning_letters/g5739d.pdf and g5738.pdf, g5737.pdf and g5736.pdf.
7
NTP-CERHR Expert Panel Report on … Genistein, http://cerhr.niehs.nih.gov/chemicals/genisteinsoy/genistein/Genistein_Report_final.pdf.
8
www.fda.gov/bbs/topics/NEWS/2006/NEW01369.html.
2
1
Unilever announced on April 10, 2006 that it was completing the first phase of studies of hoodia
extract with Phytopharm, LLC and had committed another £3.5 million to continue studies.
Another Ephedra case was in the U.S. District Court of Utah on April 21, 2006 again. This time Emax
Enterprises sued FDA for seizing Ephedra products illegally. But FDA agreed to release the products.
Case No. 2:06-cv-334.
The Federal Trade Commission staff advised FDA in January how to deal with qualified health
claims to craft regulatory levels of differentiation of scientific certainty. This concerned how FDA
might apply enforcement discretion when there was no unqualified significant scientific agreement.10
The information became available in April.
China began selling ginseng as being grown in Wisconsin and the Ginseng Board started a legislative
battle to stop it.11
The big event may have been in May 2006, when the NIH held a consensus conference on
multivitamins and minerals (MVM) concluding after two days and a previously commissioned review
of reported journal research, that there was not much evidence for taking these products except in the
case of preventing macular degeneration and the use of calcium and vitamin D to help reduce colon
polyps and improve bone strength. But many people needing MVM are not getting them. More
clinical studies are needed to know for sure how MVM affect health. NIH mailed copies of the report
to requesters.12
Artemesia was being used to make very effective antimalarial drugs and groups like Technoserve
were helping farmers in Africa learn how to grow this plant for the manufacturers.13
In New Zealand, inspectors discovered prescription drugs in Asian herbal preparations.
European Parliament voted on tougher rules for health claims for food.14
The
On June 22, 2006, the Supreme Court of the United States dismissed certiorari as improvidently
granted in a per curiam opinion in Laboratory Corp. of America v. Metabolite Labs, Inc., No. 04-607
concerning whether there was a monopoly in the patents for homocysteine tests for vitamin deficiency.
Justice Breyer, Stevens and Souter joined in a dissent from the dismissal of the case saying that a
correlation between the levels of homocysteine the levels of folic acid and vitamin B12 was not a
patentable claim and the Supreme Court should have decided the case.15
Also in June of 2006, the U.S. Senate continued its work on amendments concerning adverse drug
reactions caused by dietary supplements and non-prescription drugs. FDA reached over 18,000
structure/function claim reviews by June 2006 and sent letters of rejection to almost 900 by this time.16
9
http://www.cfsan.fda.gov/~lrd/fpaspar2.html.
www.ftc.gov FTC File No. V060005.
11
Wall Street Journal, March 8, 2006.
12
The Report and other summaries can be found by a search for on www.nih.gov.
13
www.tns.org for the Technoserve non-profit organization.
14
www.medsafe.govt.nz/May2006/photos.htm.
10
15
www.abanet.org/publiced/preview/briefs/march06.html#lab. Also see
www.supremecourtus.gov/opinions/p5slipopinion.html.
16
Congressional Record, June 21, 2006, pages S6285-87.
2
The Federal Trade Commission released information in August 2006 about its investigation of the
Sagee Group, USA and Xiao Hua Li, the president of the company. FTC had banned the company
from making claims for one herbal product and fined it $1.3 million for violating previous orders. The
claims were for Dia-Cope a product claimed to cure diabetes and Sagee which was touted for
Alzheimer’s and a list of neurological diseases.17
Federal Marshals seized dietary supplements in Ft. Walton Beach, Florida on September 5, 2006 that
were made by Advantage Neutraceuticals, Inc. These products had claims for use in cancer, arthritis,
and seizures, some on cassette tapes and on Internet sites, typically associated with drug products.18
Royal Numico N.V announced in August 2006 that it would sell a nutritional product to treat
Alzheimer’s disease that was in clinical trials. As of February 2008 the product continues in studies.
The government of Nigeria took several actions since September to establish and improve traditional
medicine in that country. A high level committee was appointed to develop and commercialize natural
products and create an awareness of the values of herbal medicine.
By September 2006, the European Union had issued its positive list and discussion papers for
limiting dietary supplements in products.19 Consumers in the U.K. began to request opportunities for
derogation from the limits and other groups want firm upper limits.
Researchers led by Halcyon Skinner, Ph.D., at Northwestern and Harvard reported that 400 IU daily
of vitamin D use cut the risk of pancreatic cancer in half.20
In the 10th Circuit a three judge panel reversed a U.S. District Court decision that FDA had presented
no evidence concerning the use of 10 mg or less of Ephedra when FDA banned its use. 21 Later on
October 16, 2006, the full 10th Circuit would affirm the three judge panel decision in Neutraceutical
Corp. et al v. Von Eschenbach, et al, Docket No. 05-4151.
A negligence suit over hepatitis and a liver transplant was thrown out of U.S. District Court in
Nebraska22 when orders were entered removing two black cohosh experts from the case. This case
was one utilizing the Daubert23 decision of the SCOTUS. Grant et al v. Pharmavite, et al, Case No.
8:05-cv-00066.
A lawsuit the California Women’s Law Center and its executive director for failure to have a
warning label on O-T-C progesterone products against a group of sellers was dismissed by a Los
Angeles Superior Court Judge ruling that a change in law limiting suits to persons injured and actually
suffering did not include a person acting as a private attorney general who was not injured or
suffering.24
17
FTC v. Sagee USA Group, Inc. and Xiao Hua Li, U.S. District Court for the Central District of California, Civil No. 0410560-GPS, August 9, 2006.
18
www.fda.gov
19
http://ec.europa.eu/food/food/labellingnutrition/supplements/food_supplements.pdf.
20
Find this article on www.aacr.org.
21
U. S. District Court for Utah, Civil No. 108802, 2:04-CV-409-TC is the original case.
22
U.S. District Court of Nebraska, September 8, 2006.
23
Daubert v. Merrill-Dow Pharmaceuticals, 509 U.S. 579 (1993).
24
Correspondence and pleadings from attorneys in case.
3
FDA notified owners of 15 websites on October 2006 that they were violating the law concerning
their claims for dietary supplements’ ability to cure diabetes.25
The Office of Dietary Supplements issued its 5th annual report in 2006 on Advances in Dietary
Supplement Research containing summaries of the 25 most important papers published in 2005.26
Canada’s Natural Product Directorate continues to pour out updated regulations and application
forms. The agency also issued a policy statement on raw materials in November 2006.
Near the end of 2006 President Bush signed the Dietary Supplement and Nonprescription Drug
Consumer Protection Act that contains provisions for reporting adverse events for both categories of
products and making falsification of reports subject to penalties.
The listing of the atun tree in the Ambonese Herbal (1692) for diarrhea led to modern medical
researchers to test the drug in cases of dysentery and this was explained the U.S. edition of the British
Medical Journal in the December 23, 2006 issue.
FDA at the end of 2006 told makers to stop selling products with quinine for leg cramps.27
Canada established a policy to distinguish between compound of natural health products and
manufacturing of the same. The product resulting from practicing health care does not require a
product license, but if the pre-health care volume increases, it may become manufacturing.28
Congress enacted and the President signed the Dietary Supplement and Nonprescription Drug
Consumer Protection Act on December 22, 2006. This law calls for reporting serious adverse effects
from both classes of products on the FDA Medwatch form and prescribes data collection and record
storage requirements.29
The Federal Trade Commission announced on January 4, 2007 that it persuaded four companies to
agree to pay $25 million in fines for fraudulent weight-loss claims. The products were Xenadrine
EFX, CortiSlim, TrimSpa, and One-A-Day WeightSmart.30
In January 2007 New York’s Assemblyman Felix Ortiz introduced some bills to require dietary
supplements to have reliable and substantiated evidence of the “improvement” they accomplish.31
FDA gave a headache to thousands in February 26, 2007 by sending warning letters to twenty sellers
of ergotamine products telling them to comply with the law in 15 days. FDA said it concluded in 1972
that these old products were new drugs and must comply with the safety and efficacy rules.32
25
FDA news release at www.fda.gov/bbs/topics/NEWS/2006/NEW01494.html.
http://ods.od.nih.gov/Research/Annual_Bibliographies.aspx
27
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Quinine
28
www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/pol/policy_compoundpolitique_compose_e.htm.
26
29
S. 3546, signed December 22, 2006. http://thomas.loc.gov/cgi-bin/query/z?c109:S.3546:
FTC v. Window Rock Enterprises, Inc., U.S. District Court of Central California, Civil No. CV04-8190; FTC v. Robert
Chinery, Jr. RTC Research & Development LLC, U.S. District Court for the District of New Jersey, Civil No. 05-3460;
USA v. Bayer Corporation, U.S. District Court for New Jersey, Civil No. 07-01; and In the Matter of Goen Technologies
Corp., Nutramerica. Trimspa, Inc., and Alexandrer Szynalski (aka Alexander Goen), Federal Trade Commission, File NO.
042 3127.
31
See website for the New York State Assembly. www.assembly.state.ny.us
32
www.fda.gov/foi/warning_letters/g6240d.htm and nearby files.
30
4
The next day FDA issued a Guidance concerning products use in CAM that generated many replies
claiming the guidance was confusing. The guidance stated FDA had choices in classifying some CAM
products as foods, drugs, or dietary supplements under the Act.33
The EU Herbal Medicinal Products Committee made several new reports in January and February
2007 concerning herbal monographs.34
The Lancet reported in volume 369, page 757, concerning the use of artemesinin-derivatives in
combo forms for malaria treatment.
The Canadian Health Food Association said that The Journal of the American Medical Association
report in its February 28, 2007 issue concerning a meta-analysis of antioxidant supplements ignores a
large body of scientific evidence supporting the benefits of antioxidant supplements.35
Many dietary supplement products were denied entry into the U.S. in January 2007 and reported by
FDA in its OASIS reports throughout the year.36
Royal Numico, N.V in The Netherlands announced in its fourth quarter report for 2006 that it had
resolved all but 6 of the 392 ephedra legal claims filed against it.37
Canada clarified is natural health product licensing strategy in April 2007 saying that all Natural
Health Products with Drug Identification Numbers must obtain a valid product license and Natural
Product Number (NPN) no later than December 31, 2009.38
Gaia Herbs, Inc. finally won the lawsuit against it by Vitacost, Inc. a Florida E-retailer, claiming
antitrust violations for not selling Vitacost its products. After several amended complaints, the
plaintiffs were unable to state a cause of action because it could not state an antitrust violation with
facts and data.39
In early May 2007 the GMP regulations proposed in 2003 were still somewhere between FDA and
OMB, but were not released until June.
During May 2007 Neutraceutical Corp. filed a Writ of Certiorari with the United States Supreme
Court over the 10th Circuit decision40 on the Ephedra ban. The Solicitor General argued not to take the
case and the court decided not to take it on May 14.41
The U.K. Crown Printer arranged with the Royal Pharmaceutical Society to publish and distribute
the Rules and Guidance for Pharmaceutical Manufacturers for the first time.42
33
www.fda.gov/cber/gdlns/altmed.pdf.
Fro example, see www.emea.europa.eu/pdfs/human/hmpc/mlwp/15212606en.pdf.
35
www.chfa.org or Natalie Cajic at 1-800-661-4510.
36
http://www.fda.gov/ora/oasis/ora_oasis_ref.html.
37
See, www.numico.com for 4th quarter/full year results.
38
www.hc-sc.gc.ca/dhp-mps/prodnatur/bulletins/din_trans_e.html.
39
Vitacost, Inc. v. Gaia Herbs, Inc., U.S. District Court for the Southern District of Florida, Case NO. 9:06-cv-81141, April
2, 2007.
40
Neutraceutical Corp. et al v. von Eschenbach, et al, Docket No. 05-4151, 10th Circuit Court of Appeals, October 16,
2006.
41
Neutraceutical Corp. et al v. von Eschenbach, et al, Docket No. 06-922, Supreme Court of the United States, May 14,
2007.
42
www.pharmpress.com
34
5
Also during May, the Wellness Letter published by the School of Public Health at the University of
California at Berkeley recommended Horse Chestnut extract for treatment of hemorrhoids.43
On May 9, 2007, the United States Senate passed S. 1082 by a vote of 96 to 1 containing the Food
and Drug Administration Revitalization Act of 2007 and the Prescription Drug User Fee Amendments
of 2007. Senators Hatch and Harkin clarified that this bill does not pertain to dietary supplements
during the debate on passage.
On June 25, 2007, FDA published the final version of Good Manufacturing Practices for Dietary
Supplements and another proposed regulation on testing components of dietary supplements in volume
72 Federal Register 34751-34958. These are to be implemented over the next three years.
An economic report on OTC health care in Bulgaria claims 12 to 17% annual growth in various
product classes.44
NML reported during the first five months of 2007 that refusals of dietary supplements to enter the
United States had increased with the largest number being from China, followed by India, then at much
lower levels imports from the U.K., France and Canada were denied import status.45
FDA takes action against dietary supplements labeled for erectile dysfunction and sends warning
letters.46
And FDA started strengthening processes to defend the nation’s food supply from harmful
production and imports after scares with U. S. grown spinach and other vegetables bearing disease
causing bacteria and viruses, plus the adulteration and mixups of plastics in pet foods.47
FDA announced in July that it would update its guidance documents for manufacturers of “medical
foods” and started collecting data.48
The American Herbal Products Association conducted a telephone conference call program on the
GMP regulations with several speakers. This was conducted to help manufacturers and retailers
understand how the new regulations would apply to them.49
Canada announced new rules for use of boron in natural health products on July 16, 2007.50 New
Zealand and Australia on the same day announce that the two countries are putting on hold a plan to
jointly approve and enforce laws pertaining to therapeutic products.51
43
www.wellnessletter.com/html/wl/wlAskExperts.html.
44
www.bharatbook.com
Natural Medicine LawTM Newsletter, Study in Vol. 11, No. 1, July 2007, p.9 www.natmedlaw.com to search for the
article.
46
See www.fda.gov for warning letters concerning True Man and Energy Max.
47
www.fda.gov/consumer/updates/carvershock061109.html.
48
www.cfsan.fda.gov/~dms/medfguid.html.
49
A summary of this telephone conference is published in Natural Medicine LawTM Newsletter, Vol. 11, September and
November 2007 issues. www.natmedlaw.com to search for the articles.
50
www.hc-sc-gc.ca/dhp-mps/pubs/natur/boron_information_bore_e.html.
51
www.beehive.govct.nz for document ID 30061.
45
6
The American Herbal Products Association asked FDA to make seven changes in the GMP
regulations on July 25.52 At this point tracking what FDA is doing to petitions became difficult
because FDA stopped listing and linking in the Daily Dockets and only placed some of the materials
before the public. It became as though FDA had decided that only the petitioner would be affected and
the remainder of the world only had to wait and see what FDA’s decision would be.
The FDA produced a four person film to introduce the GMP regulations to interested viewers and
learners. It is still available at http://fda.yorkmedia.com/fda/catalog and there is no charge to view it.
Forbes.com broke a story in August 2007 about USANA being cited by Barry Minkow saying the
company shorted it shares and makes money by a pyramid scheme selling through distributors.53 And
in Texas, the state Attorney General sued Mannatech and related entities for an illegal marketing
scheme of selling dietary supplements through distributors with profits going to charity.54 At about the
same time, the Internal Revenue Service trial of one of Mannatech’s top distributors was concluded
with convictions for tax evasion in the State of Washington.55 Gebauer was terminated a few days
later by Mannatech for violating company policies.
In August the Federal Trade Commission concluded a case charging Sili Neutraceuticals LLC and
Brian McDaid doing business as Kaycon, Ltd of being a hijacker spammer selling hoodia products and
HGH products.56
Throughout the summer the European Committee on Herbal Medicinal Products approved several
processes and monographs of herbal medicines for use.57
FDA issued a report on nanotechnology in dietary supplements and other regulated products ion
July 25, 2007. This report reminds makers of responsibility for making sure of safety if nano
ingredients are used.58
By this time the year it became evident that FDA had stopped linking dietary supplement
documents on its website for use by consumers or industry. The “Daily Dockets” were mostly blank
on the website and only a rare document was linked under the docket number on a daily basis. At the
same time FDA stopped maintaining the individual dockets by adding files to them, so the use of the
Freedom of Information Act (FoIA) was crucial to being able to ask for information. FDA did not
openly explain what was happening or why. FoIA posed problems of delay in getting information
from FDA unless it was a personal or company filing of your own.
In August FDA warned consumers not to use red yeast rice products as they are unsafe dietary
supplements for treating cholesterol without physician supervision.59
52
Natural Medicine LawTM Newsletter, Vol. 11, No. 2, September 2007. wwwnatmedlaw.com to search for articles.
www.forbes.com for the story Hard to Swallow, August 8, 2007 by Evelyn M. Rusli.
54
http://www.oag.state.tx.us/consumer/lawsuits.php#32
55
U.S. v. Gebauer, U.S. District Court for the Western District of Washington, Case NO. CR06-122JLR, August 10, 2007.
56
U.S. District Court for the Northern District of Illinois, Case No. 07C4541, August 13, 2007.
57
www.emea.europa.ed/pdfs/human/hmpc/3148707en.pdf.
58
A Report of the U.S. Food and Drug Administration Nanotechnology Task Force, pp 28-29.
www.fda.gov/nanotechnology/taskforce/report2008.pdf.
59
www.fda.gov/medwatch/report.htm.
53
7
The National Center for Complementary and Alternative Medicine at the National Institutes of
Health continued to issue fact sheets for botanicals and issued monographs for Bitter Orange,
Chamomile, European Elder, and Hoodia.60
In September the Archives of Ophthalmology reported in Vo. 125, p. 1225, September 2007, that
higher dietary intake of lutein/zeaxanthine is associated with decreased likelihood of neovascular
AMD, geographic atrophy, and large or extensive intermediate drusen.
A Washoe County District Court jury, in Nevada, awarded $135 million to three women for damages
by taking Wyeth Laboratories’ Premarin®, a product made from pregnant mare urine by an extraction
process. The case continued on appeals after revisions of the verdict by a judge in October 2007.
Nearly a year after enactment, FDA issued a regulatory guidance document for comments to
implement the Dietary Supplement and Nonprescription Drug Consumer Protection Act enacted ion
December 2006. Congress required the regulatory information by 270 days after enactment, but FDA
did not comply. Some say FDA was hoping that this law would be absorbed by the later passed as the
Food and Drug Administration Revitalization Act of 2007 and the Prescription Drug User Fee
Amendments of 2007.
The NIH Office of Dietary Supplements published its significant scientific research studies list using
a panel of experts to review the studies. There are 25 studies raised to the top in this report.61
Canada develops a new vitamin/mineral product monograph62 and revises product licensing again.63
Monographs for biotin, selenium, vitamin C and vitamin D were updated.64
Feverfew was reported in the journal Blood again as being clinically tested in humans with leukemia.
The extract is converted to a sesquiterpene lactone parthenolide so that the drug will reach deep into
tissues after the dormant cells.65
FDA announced a November 29, 2007 hearing on salt and sodium in foods in College Park to get
information concerning the petition filed by the Center for Science in the Public Interest.66
Dietary Supplements made by FullLife Natural Options, Inc. in Boca Raton, Florida, by Charron
Nutrition of Tallahassee, Florida and by General Therapeutics Corp. of St. Louis were seized by U.S.
Marshalls for numerous reasons.67
The Federal Trade Commission stopped a scam selling herbal teas and a healthcare conference
package at the end of 2007.68 Claims were being made that the teas would cure diabetes, AIDS,
60
www.nccam.noh.gov.
http://ods.od.nih.gov/Research/Annual_Bibliographies.aspx.
62
www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/multi_vitmin_suppl_info_e.html.
63
www.hc-sc.gc.ca/dhp-mps/prodnatur/bulletings/communiques/communique_oct07_e.html.
64
www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/multi_vitmin_suppl_overapercu_e.html.
65
Guzman, Blood, 2007 :DOI 10.1182/blood-2007-05-090621.
66
www.fda.gov Docket No. 2005P-0450 is supposedly open for comment until March 28, 2008, but it is not a viewable file
on FDA’s website. But see http://www.fda.gov/OHRMS/DOCKETS/FDMS/ddm-open-dockets.htm.
67
Natural Medicine LawTM Newsletter, Vol. 11, No. 3, November 2007. www.natmedlaw.com to search for these articles.
68
FTC v. McLain and five companies, U.S. District Court for the Northern District of Georgia, Civ. No. 06-CV-1692,
December 31, 2007. www.ftc.gov search under actions for 2007.
61
8
cancer, arthritis, and other diseases. The conference scam was selling a package of how to set up hotel
conferences to sell products.
FDA decided to delay for a year to February 2009 its enforcement of the Dietary Supplement and
Nonprescription Drug Consumer Protection Act. The agency decided it had to collect information on
what should be placed on the label in connection with company addresses and telephone numbers and
sought advise about requiring statements that would tell consumers to report adverse reactions in
certain ways. Comments are to go to Dockets 2007D-0491 and 2007D-0496 by March 3.69
FDA has warned seven pharmacies making illegal claims for compounded prescription products on
the Internet and issued warning letters. These warnings were probably precipitated by a Citizens
Petition filed by Wyeth Laboratories asking FDA to take regulatory action against compounding
pharmacies that produce compounded BHRT drugs.70
During the fall of 2007, the International Center for Indigenous Phytotherapy Studies reported that
Sutherlandia (Lessertia frutescens) may become more active in the fight against AIDS.71
In an Advance Notice of Proposed Rule Making FDA said it wanted to change reference values and
mandatory nutrients in Nutrition Facts panels and Supplement Facts panels on labels. The proposal
can be seen in 72 Federal Register 62149, November 2, 2007.72
On November 15, 2007 the European Court of Justice ruled that Germany’s regulations requiring a
marketing authorization to sell garlic extract capsules as a medicinal product was an obstacle to the
free movement of goods and was not justified on health protection grounds.73 The German law was
rule quantitatively the same as a restriction on import the product and paves the way for harmonization
laying down distinctions between food use and medicinal use.
In the December 2007 issue of the American Journal of Clinical Nutrition, Vol 86., No. 6, 1738-44, a
study by University of Catania researchers in Italy demonstrated that 2 grams of L-carnatine per day in
100 year olds would reduce fat, increase muscle mass, and facilitate physical and cognitive capacity.74
By February 2008, the European Food Safety Authority (EFSA) wants to collect data about
suspected plants and fungi in order to prepare a list of them to ban from products. List of the proposed
items are available at www.efsa.europa.eu/EFSA/efsa_locale1178620753812_home.htm.
New Zealand developed a guidance tool for use in determining whether a product was a food or a
medicine and therefore what regulatory scheme to use to regulate it.75
69
This is another example of FDA Dockets being transferred to the Federal Dockets Management System where the
dockets cannot not be easily found. FDA has stopped making input to dockets on a daily basis and leaves the task to
FDMS, but FDMS claims the dockets are available at FDA. Actually, FDA has the paper dockets, but is not letting anyone
know what is in them except by Freedom of Information Act written records requests. FDMS is at www.regulations.gov
and FDA is at www.fda.gov.
70
See www.fda.gov for warning letters and FDA comments about the products at
www.fda.gov/consumer/updates/bioidenticals010908.html.
71
http://nccam.nih.gov/news/newsletter/2007_fall/.
72
This information may be difficult to find on www.fda.gov and www.regulations.gov because of the unexpected time it is
taking to transfer FDA dockets to FDMS.
73
http://curia.europa.eu/jirisp/cgi-bin/corm.pl?lang=EN&Submit=rechercher&numaff=C-319/05.
74
www.ajcn.org.
75
Readers are invited to call New Zealand at +64 4 819 6860 if you cannot find this on the web at
http://www.medsafe.govt.nz/
9
Sulfites in dried herbs that are not declared on packages can result in severe allergies among some
people and the Blooming Herb Co. of Brooklyn, New York issued a recall of its product, Dried
Hylocereus (strawberry pear) in late 2007.
NML determined which health newsletter covers more dietary supplements and related products in
the January 2008 issue when looking at Pharmacist’s Letter, Duke Medicine HealthNews, Mayo
Clinic®Health Letter, UC’s Wellness Letter, and Tuft’s University Health & Nutrition Letter.
Throughout the twelve issues of Natural Medicine Law™ Newsletter published in the two years from
March 2006 to March 2008, there were also monthly columns about New Dietary Ingredients, Section
403 Letters or Letters of Objection, about the use of the cover plant names as trademarks, and many
specialty meetings, conferences and learning programs were described. Plus the past two years have
seen many scientific studies that are reported in NML, some under the heading of Scientific Briefs, but
these are too numerous to mention in this summary review.
* William J. Skinner, R.Ph., Esq. is editor of Natural Medicine Law™ Newsletter , published by Muscatatuck
Publishers, Inc., P.O. Box 741261, Boynton Beach, FL 33473-1261, 866-664-2900 or [email protected]
with a website where all newsletters may be viewed at www.natmedlaw.com.
During the APhA/ASPL Annual Meeting in San Diego, Muscatatuck Publishers is offering a special
price on Email subscriptions. The offer ends on April 1, 2008.
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If shipped outside of Canada,
Mexico and the U.S., an additional
postage charge of $24.00 is added.
Regular Email price is $125.00.
EMAIL SPECIAL OFFER
The same six issues are Emailed to your
Email address on the same day that
regular subscriptions.
Special Price of $49.00
for this one- time offer only.
See our ad in Pharmacy Times magazine.
Go to WWW.NATMEDLAW.COM > Order Forms > Special Price March 2008 Order Form.
Download the Order Form and send with check or credit information for Master Card, Visa or
Discover.
If you want to send the Order Form and credit information by Email, send to [email protected]
You can also FAX to 561-641-2909.
If you want to see more, go to WWW.NATMEDLAW.COM > Products and Services > Volume Index
and Search Page - There you can Google™ Search all previous issues for your topic query or view
each issue one at a time.
With the May 2008 issue there will be 66 issues covering back to July 1997 to read and search.
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