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Volume 19, No. 5 / May 2005 TODAY Timely Communications from the National Nutritional Foods Association INSIDE Legal Q&A: New Food Labeling Rules Science News: Kids Need More Fiber Food and Nutrition News: USDA’s New Pyramid Supplement Company Wins Ephedra Suit “No Evidence” Warranting Ban on 10 Milligrams or Less, Says Court A Page 7 Page 12 8th Annual NNFA Natural Foods Day Tuesday, April 12, 2005 • Washington, D.C. Industry Members Rally in D.C. for Natural Foods Day O district court in Utah recently invalidated part of the Food and Drug Administration’s (FDA) ban on ephedra dietary supplements, telling the agency to revise its rulemaking as it applies to low dose ephedra. The challengers to the FDA ban, Nutraceutical Corporation and its subsidiary Solaray, Inc., successfully argued that FDA could not use a risk/benefit approach under the Dietary Supplement Health and Education Act of 1994 (DSHEA) and that FDA’s evidence did not support a ban on daily doses of ephedra dietary supplements containing 10 milligrams or less of ephedrine alkaloids. Many press announcements on this ruling have stated that it is legal to sell ephedra at any dose. However, the decision does not have such a broad impact. Rather, it affects only low dose ephedra—it does not alter the ban established by FDA against dosages in excess of 10 milligrams. This court decision says only that the record before it does not establish that ephedra at 10 milligrams presents a significant or unreasonable risk of illness or injury. FDA has the ability to appeal, and continues to have the authority to sue other companies in other districts under the existing final rule, which currently remains in effect and unchanged. Moreover, the decision does not alter those states’ laws prohibiting or restricting the sale of ephedra that remained in effect after FDA published its final rule. Therefore, a careful review of state and local laws must be considered prior to risking a national launch. The most significant finding of the Utah court is that FDA’s risk/benefit safety analysis, first applied in the agency’s decision to ban ephedra, is not legal. This finding has significant ramifications, as most in the industry agreed that such a test was inappropriate under DSHEA. ❦ For a news analysis on the court ruling, please turn to page 2. Page 6 n Tuesday, April 12, 2005, more than 165 natural product industry stakeholders from 37 states and the District of Columbia gathered on Capitol Hill for the NNFA’s 8th annual lobbying event, Natural Foods Day. The attendance of participants from across the country shattered last year’s record attendance of more than 120. NNFA members representing every component of the natural products industry educated members of Congress and their aides about NNFA’s legislative and regulatory priorities, each of which would help increase consumers’ access to—and awareness of—safe, effective, and affordable natural products. “This year’s event was NNFA’s most successful lobbying effort to date,” said NNFA Executive Director and CEO David Seckman. “With a variety of issues that pose both opportunities and challenges for our industry, participants effectively conveyed to our nation’s leaders the impact of these issues, in particular, the importance of preserving and implementing DSHEA [the Dietary Supplement Health and Education Act of 1994].” (Continued on page 4) More than 165 industry stakeholders gathered on Capitol Hill for the NNFA’s 8th annual lobbying event REGULATORY & LEGISLATIVE NEWS News Analysis Utah District Court Ruling on Ephedra FDA’s Case: Risks Outweigh Benefits The court found that FDA was obligated to demonstrate that the exact dose recommended in the product labeling presents a significant or Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), FDA has authority to remove unsafe dietary supplements and dietary ingredients from the market. DSHEA provides, among other things, that the agency can remove a supplement where it “presents a significant or unreasonable risk of illness or injury under the labeled conditions of use.” FDA has not provided any further definitions as to what constitutes a “significant or unreasonable risk.” FDA acted under this standard to ban ephedra products when it issued a final rule on dietary supplements containing ephedrine alkaloids on February 11, 2004. The final rule required all dietary supplements that contain ephedrine alkaloids at any level be removed from the market by April 2004. In the final rule, FDA, for the first time, articulated a “risk-benefit” test for dietary supplements, arguing that the term “unreasonable,” by definition, triggers some measure of utility or benefit of the product. If the risks of use of a product outweigh the benefits associated with its use, the product is not safe under this standard. In the case of ephedra, FDA found that the risks outweighed any benefits from the use of ephedra, and therefore banned the product. unreasonable Nutraceutical’s Case: FDA Failed to Consider risk of illness Dosage; Test Invalid or injury Nutraceutical filed suit challenging the final rule in U.S. District Court in Utah seeking to declare the final rule invalid, remand the issue to FDA for further rulemaking, and enjoin the agency from enforcing against the marketing of its low dose ephedra product containing 10 milligrams or less ephedrine alkaloids in a daily dose. With the recent decision, Nutraceutical succeeded on all three points. Nutraceutical’s primary arguments were: that FDA failed to make a dose-dependent determination of adulteration as required by DSHEA, as there was no evidence that products recommending 10 milligrams dosages, and labeled with extensive industry-adopted warnings, were unsafe; and, that the “risk-benefit” test was an improper analysis under DSHEA and in violation of the Administrative Procedures Act. The court concluded there was “no evidence in the administrative record pertaining specifically to doses of ephedrine at the ephedrine-alkaloid levels recommended by the plaintiffs, that is, 10 milligrams per day.” The court found that FDA was obligated to demonstrate that the exact dose recommended in the product labeling presents a significant or unreasonable risk of illness or injury. FDA did not do that with respect to 10 milligrams dosages, as FDA had no direct evidence on that level of ephedrine alkaloids. On the issue of risk/benefit, FDA found that the “plain language of DSHEA does not require a comparison of benefits and risks.” The court also found that FDA’s reliance on the device provisions of the Food Drug and Cosmetic Act was misplaced, and emphasized that dietary supplements are not to be treated as drugs or medical devices in terms of their safety review. There is no requirement in DSHEA that supplements “demonstrate a benefit as a precondition to sale.” What Does This Mean for Industry? As a result of the ruling, some companies will be able to re-launch ephedra products of 10 milligrams per does or less. However, the prospect of ephedra’s return to the market has already ignited a firestorm of criticism from the press, members of Congress and consumer groups who have long questioned FDA’s ability to keep unsafe products off the market under DSHEA. In fact, one federal legislator has already called for hearings to revisit the ban and the law, arguing that the safety standards established by DSHEA do not provide adequate power to FDA to safeguard consumers from unsafe dietary supplements. ❦ For more information about what retailers and manufacturers can and cannot do as a result of the ban, please see the article on the next page. 2 www.nnfa.org NNFA Today, Volume 19, No. 5 / May 2005 REGULATORY & LEGISLATIVE NEWS Snapshot What You Need to Know about the Ephedra Ruling A s a result of a district judge’s recent ruling that partially lifted the Food and Drug Administration’s (FDA) ban on the dietary supplement ephedra, NNFA has been fielding many questions from its retail and manufacturer members about what the decision means for the industry in both the long and short term. For instance, NNFA has learned that retailers are now being approached by ephedra manufacturers or their representatives about putting ephedra products back on store shelves. Although the court decision leaves room for interpretation and an appeal by the FDA is anticipated, following is some clarification and guidance in complying with the court decision. Q A The decision only applies to ephedra products with 10 milligrams or less and only within Utah’s Was the ban on ephedra overturned? No. The ban on ephedra products of more than 10 milligrams per dose is still in effect. The ruling only invalidated the ban on ephedra products with 10 milligrams or less of ephedrine alkaloids and with important restrictions, as indicated below. Q A Can retailers and manufacturers begin selling ephedra products again? • The decision only applies to ephedra products with 10 milligrams or less and only within Utah’s Central Division district court jurisdiction. FDA may challenge sales outside of that jurisdiction. • Only in single and daily doses of 10 milligrams or less. • Only in states that have not prohibited or restricted sale of ephedra. Q A What are the risks of selling ephedra? Liability. NNFA understands that no insurance companies are currently underwriting coverage for either manufacturers or retailers who sell ephedra. This means NNFA Today, Volume 19, No. 5 / May 2005 Central Division full exposure financially in the event of a civil lawsuit. To date, there have been numerous lawsuits regarding the use of ephedra products for damages in the millions of dollars. Enforcement action. Those retailers or manufacturers selling ephedra product in any federal court district other than Utah’s Central Division can still be sued by the FDA. district court jurisdiction. FDA may challenge sales outside of that jurisdiction Ruling reversal. If FDA appeals the ruling, and indications are it will, there is no guarantee the recent Utah decision will be upheld. Should the ruling be overturned, the ban on all ephedra products—regardless of dosage and where they are sold or manufactured— will remain in force. Availability. While the ban on ephedra products of 10 milligrams or less sold in the United States has been lifted—with important restrictions—an embargo on imports remains in effect. This means that foreign shipments of ephedra product to the United States can be turned away at the point of entry. As further events develop, NNFA will continue to inform its members about the effects of this important court ruling. ❦ www.nnfa.org 3 REGULATORY & LEGISLATIVE NEWS 8th Annual NNFA Natural Foods Day Tuesday, April 12, 2005 • Washington, D.C. 1 Industry Members Rally in D.C. for Natural Foods Day 2 3 1) More than 165 participants attend Natural Foods Day 2005. Morning session guest speakers: (2) Eric Juzenas, (3) Kathy Kulkarni, and (4) Paul Coates. 5) Attendees pick-up “goodie bag” leavebehind materials for their congressional meetings. 4 5 6) NNFA President Paul Bennett testifies before a House subcommittee. 6 4 www.nnfa.org (Continued from page 1) The event consisted of an early morning briefing session and breakfast before participants adjourned to attend pre-arranged meetings with various congressional leaders. The day concluded with a reception honoring NNFA’s Congressional Champions. At the morning session, political insiders, including NNFA’s lobbyists updated the participants on the industry’s most pressing legislative issues and provided tips on how to communicate the industry’s priorities effectively. In addition, attendees were addressed by key government officials, including Paul M. Coates, director of the National Institute of Health’s Office of Dietary Supplements; Kathy Kulkarni, legislative director for Rep. Frank Pallone (D-N.J.); and Eric Juzenas, former Agriculture Committee counsel for Sen. Tom Harkin (D-Iowa). Attendees then spent the afternoon in meetings with lawmakers and key staff members from their districts and states. During NNFA Today, Volume 19, No. 5 / May 2005 REGULATORY & LEGISLATIVE NEWS “We need health care, not sick care. Kids can buy junk food at school, but not vitamins.” —Sen. Tom Harkin 1 1) Carrol Wells of Honey Bee Natural Foods outlines key issues to a legislative staffer. 2 2) Todd Hurley (left) of No Name Nutrition with Rep. Steve King. 3 3) Bob Norman of Vitamer Labs discusses industry issues. 4 “I’ve always been proud to work with NNFA, because we have so many of the same goals. As long as I’m here, DSHEA is going to live.” —Sen. Orrin Hatch 5 these meetings, constituents asked members of Congress to support Rep. Juanita Millender-McDonald’s (D-Calif.) Healthy People, Healthy Choices Act of 2005 (H.R. 161), which would provide grants to promote proper nutrition and diet supplementation among minorities. Participants also emphasized the need for dietary supplements to receive the same tax treatment as drugs and over-thecounter medications, as mandated by the Dietary Supplement and Healthy Meal Replacement Tax Parity Act (H.R. 1545) recently introduced by Rep. Chris Cannon (R-Utah). Attendees also stressed the importance of increased research funding for the NIH Office of Dietary Supplements and the National Center for Complementary and Alternative Medicine. The evening concluded with a reception featuring the presentation of NNFA’s 2005 Congressional Champion Awards. On hand to receive their awards were Sens. Harkin and Orrin Hatch (R(Continued on page 15) NNFA Today, Volume 19, No. 5 / May 2005 4) Debra Short (left) of Debra’s…Naturally meets with her congressperson’s assistant. 5) NFD participants celebrate the conclusion of a successful day at the evening reception. 6) Attendees at the evening reception where NNFA honored congressional champions. 6 2005 Congressional Champions Sen. Harkin Sen. Hatch Rep. Barrett Rep. Cannon Rep. MillenderMcDonald Rep. Pallone www.nnfa.org 5 REGULATORY & LEGISLATIVE NEWS By Sidley Austin Brown & Wood, NNFA General Counsel New Food Labeling Rules The first and most immediate food labeling change is the new trans fat labeling requirement Q I heard there are a number of new food labeling regulations, including a trans fat listing, allergen labeling and possibly calories or serving sizes disclosures. Could you tell me a little about each of them? A There are a number of new labeling issues that one should be aware of to plan for label changes and consumer questions regarding new information. Trans Fat Labeling The first and most immediate food labeling Calori change is the new trans fat labeling % requirement. This is the first change Total Fat 13g to the Nutrition Facts label since Saturated Fat 5g the Nutrition Labeling and EduTrans Fat 2g cation Act (NLEA) regulations Cholesterol 30mg were finalized in 1990. Effective Sodium 660mg January 1, 2006, all food products, Total Carbohydrates even those for infants and children, must have a Nutrition Facts listing declaring the quantitative amount per serving of trans fat, unless the product contains less than 0.5 gram per serving of total fat, and no claims are being made about fat, fatty acids, or cholesterol content. Trans fat is to be listed under saturated fat, and both are indented below total fat. Keep in mind: Calories 260 • This new rule will also apply to dietary supplements that contain a reportable amount of trans fat (0.5 grams or more per serving). • There is no established Daily Value amount for trans fat, and so there will not be a need for percent Daily Value declaration. • In addition, because of the absence of a Daily Value amount, FDA has not permitted nutrient content claims for trans fat to date. Food Allergens A second new label requirement is to declare food allergens on food labels. In August 2004, Congress passed the Food Aller- 6 www.nnfa.org gen Labeling and Consumer Protection Act of 2004, which requires food labeling of the eight major foods or food groups that are considered allergens. These include milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soy beans. Contains The law requires either: a stand alone Peanuts statement that includes the word “Contains”, followed by the name of the food source from which a major food allergen is derived; or a listing of the common or usual name of the major food allergen in the list of ingredients followed, in parenthesis, by the food source from which the major food allergen is derived. In those cases where there is a specific tree nut, fish or crustacean, the specific type of nut or species of fish or crustacean is required. Keep in mind: • This applies to flavorings, coloring, and incidental additives that contain allergens, which previously could have been listed under more general terms. • This law is self-implementing, and therefore, FDA is not required to propose additional rules; however, FDA has stated that it will publish further guidance on the statute shortly, in order to provide its interpretation of the requirements. • This law takes effect January 1, 2006. New ANPRs Finally, there are two new Advanced Notices of Proposed Rulemaking (ANPRs) where FDA is seeking comment on two areas of food labeling. These may or may Nutrition Fac Serving Size 1 cup (228g) not result in label changes. Servings per container 2 Calorie Declaration Amount per serving Calories The first ANPR addresses the Calories 260 % Da prominence of the declaration of the amount of calories per serving. FDA is questioning whether there should be a new mechanism to highlight the amount of calories per serving on a food product, either in (Continued on page 16) NNFA Today, Volume 19, No. 5 / May 2005 SCIENCE NEWS Children Need More Fiber From Healthnotes Newswire, a news service of Healthnotes, Inc. A merican preschool-age children do not get enough fiber from their diets, reports the Journal of the American Dietetic Association (2005, vol.105: 221–225). Inadequate fiber intake may increase these children’s risk of developing heart disease and other chronic illnesses. As dietary habits formed before age two tend to carry into adulthood, it is critical to introduce and emphasize nutritious foods to children as their tastes develop. Fiber, the indigestible carbohydrate and woody portion of plants, comes from foods such as whole grains (brown rice, whole wheat), legumes (peas, beans, lentils), fruits, and vegetables. Eating high-fiber foods can decrease the risk of heart disease, diabetes, high blood pressure, and some types of cancer. Adequate fiber intake is also necessary to ensure regular bowel movements, guarding against constipation and the development of diverticular disease (a disorder of the colon). The National Academy of Sciences recommends a daily fiber intake of 14 grams per 1,000 calories for adults and children. This Dietary Reference Intake (DRI) is higher than the amount previously recommended by the American Health Foundation and the American Academy of Pediatrics. The new study assessed the average daily intake of fiber by two- to five-year-old children. Foods eaten by over 5,000 children were tracked for two days as part of the Continuing Survey of Food Intake by Individuals. Average daily fiber and nutrient intake were then calculated. Dietary intake data of two- to three-year-olds was compared with that of four- to five-year-olds. Children who ate the most fruits, vegetables, and grains consumed more fiber than children who ate less of these foods. Two- and three-year-olds consumed less dietary fiber on average than four- and five-year-olds. Foods like applesauce and fruit cocktail contributed the most fiber to the children’s diets. Lesser amounts were obtained from soy and other legumes, high-fiber cereals, grain-based fatty foods such as pizza, and high-fat salty snacks. Of note, the consumption of high-fiber fruits and NNFA Today, Volume 19, No. 5 / May 2005 vegetables (such as blueberries, raisins, squash, and broccoli) was too low to contribute to total fiber estimates. Fiber intake was far below the DRI in all of the children, even those who ate the most fiber. In fact, fiber intake did not meet previous lower recommendations. The high-fiber diets eaten by the children were also rich in other nutrients including iron, folic acid, and vitamins A and C. However, calcium and vitamin B12 intakes were lower among those children with the highest intake of fiber. Vitamin B12 is found in animal products such as dairy products, chicken, and red meat. The decrease in this nutrient in the more fiber-rich diets may reflect lower consumption of these foods. High-fiber foods may also have replaced some calcium-rich dairy products, leading to a lower intake of this important nutrient in children with high-fiber diets. In addition, fiber itself may interfere with calcium absorption. The overall benefits of a high-fiber diet, however, far outweigh any potential deficiencies. Eating a whole-foods diet that includes calcium-rich vegetables and some dairy products should ensure adequate intake of calcium and vitamin B12. It appears that fiber intake by preschoolers is much lower than it should be. Public health programs and pediatricians should emphasize the importance of eating fiber-rich foods like whole grains, fruits, and vegetables, to young children and their parents. ❦ Inadequate fiber intake may increase children’s risk of developing heart disease and other chronic illnesses —Kimberly Beauchamp, ND ® Healthnotes Inc. (HNI, www.healthnotes.com) is the premier provider of reliable, easy-to-use health, food, and lifestyle information for Web sites and interactive touchscreen kiosks. Used by leading supermarkets, pharmacies, and natural product stores in the United States, Canada, and the United Kingdom, Healthnotes® Retail Solutions empowers consumers to make educated decisions and drives product sales—online and in-store. HNI also generates Web applications that are licensed to e-commerce and healthrelated Internet sites worldwide. www.nnfa.org 7 SCIENCE NEWS Sweet Potato Variety Helps Control Type 2 Diabetes in Clinical Trial This literature summary is part of the HerbClip, an educational mailing service of the American Botanical Council Caiapo (Ipomoea batatas) has been eaten in Japan as a traditional food for treatment of anemia, hypertension, and diabetes 8 T ype 2 diabetes is caused by insulin resistance and impaired insulin secretion. Treatments include diet, exercise, medications, and insulin. A white sweet potato, called Caiapo (Ipomoea batatas), cultivated in the mountains of Kagawa Prefecture in Japan, has been eaten there as a traditional food for treatment of anemia, hypertension, and diabetes. In recent years, it has been developed as a nutraceutical product and is consumed and sold as a supplement for the prevention and care of type 2 diabetes. A preliminary study in men with type 2 diabetes found that Caiapo (four grams per day for six weeks) lowered the total and low-density lipoprotein (LDL) cholesterol levels and lowered blood glucose by increasing insulin sensitivity without affecting insulin secretion. The objective of the present study was to verify the findings of the preliminary study and to increase the number of participants and the study duration. Sixty-one patients with type 2 diabetes participated in this placebo-controlled, randomized, double-blind study. Patients consumed four grams of Caiapo per day or placebo once a day for 12 weeks. Blood glucose, cholesterol, triglycerides, and HbA1c (a measure of long-term glucose control) were monitored. HbA1c significantly decreased after two and three months of treatment with Caiapo compared to placebo (P<0.001). Both groups had significant weight loss and statistical analysis could not rule out the possibility that weight loss contributed to the improvement in HbA1c. Fasting blood glucose decreased in both groups, but to a greater degree in the Caiapo group (P = 0.03). After three months of treatment, 48.3 percent of the patients consuming Caiapo had mean fasting blood glucose levels below the upper normal limit compared to 7.7 percent of those in the placebo group. Blood pressure did not change. At the end of treatment, cholesterol levels in the Caiapo group where significantly lower than those in the placebo group (P<0.05). There was no significant effect on triglyceride levels. Caiapo was well tolerated. Adverse events were minimal but were mainly gastrointestinal. www.nnfa.org This study confirmed the beneficial effects of Caiapo on glucose and serum cholesterol levels in type 2 diabetic patients. The study also showed for the first time an improvement in long-term glucose control. However, the exact contribution of weight loss on the effects observed was not quantified. The authors hypothesize that since glucose levels continued to decline when the weight loss had stabilized, Caiapo had an effect on glucose beyond that caused by weight loss. Caiapo may have increased the body's sensitivity to insulin. Caiapo-induced improvement in insulin sensitivity would not be responsible for the decrease in cholesterol levels. Therefore, an unidentified compound could be responsible for the cholesterol-lowering effect. The authors conclude that Caiapo aids in the management of type 2 diabetes. ❦ —Heather S. Oliff, Ph.D. The American Botanical Council provides this summary and the above article as an educational service. ABC does not warrant that the data is accurate and correct, nor does distribution of the enclosed article constitute any endorsement of the information contained or of the views of the authors. To join ABC, call (512) 926-4900 or visit www.herbalgram.org. NNFA Today, Volume 19, No. 5 / May 2005 SCIENCE NEWS Science Briefs Men Benefit from Antioxidant Supplementation Supplementing with modest amounts of antioxidants including vitamins C and E, betacarotene, zinc, and selenium can help reduce the risk of cancer and all-cause death in men, according to a study in the Archives of Internal Medicine (2004, vol.164: 2335-2342). Antioxidants are compounds that protect cells from damage by free radicals, which are believed to be a cause of degenerative changes associated with aging and other health issues. The study included 7,713 healthy women between the ages of 35 and 60 and 5,028 healthy men between the ages of 45 and 60. Participants were randomly assigned to receive either an antioxidant supplement combination of vitamin C, vitamin E, betacarotene, selenium, and zinc; or placebo. At the conclusion of the study researchers determined the risk of cancer was 29 percent lower, and in all-cause death 36 percent lower, in men taking the supplement regimen than those taking placebo. No similar effect was seen in women participants. Fish Oil Fights Arthritis According to a study published in Nutrition (2005, vol.21: 131-136), sufferers of rheumatoid arthritis (RA) can reduce their symptoms by supplementing with fish oil. Additional benefits can also be gained by supplementing with olive oil. Fifty-five participants with RA were randomly assigned into one of three groups taking either fish oil capsules, fish oil capsules with extra virgin olive oil on salads, or soy oil placebo. Symptoms and ability to function were assessed at clinical visits at the start of the study, after 12 weeks, and after 24 weeks. Blood was analyzed to measure markers of inflammation and disease progression. At the conclusion of the study, both groups taking oils experienced significantly more improvements than the group taking placebo. Additionally, those taking fish oil and olive oil had a greater improvement in a blood marker of the disease. While fish oil fatty acids may help relieve RA symptoms, sufferers may be advised to add olive oil in their diet as well. Stroke sufferers can help reduce chances of hip fracture B Vitamins for Hip Health in the years A study published in the Journal of the American Medical Association (2005, vol.293: 1082-1088), reports that stroke sufferers can help reduce their chances of sustaining a hip fracture in the years after their stroke by supplementing with folic acid and vitamin B12. These vitamins have been effective in combating increases in homocysteine levels, which earlier studies have suggested is toxic to bones by reducing both bone density and quality of bone tissue. Two years after the study, average homocysteine levels among study participants decreased by 38 percent in the group taking folic acid and vitamin B12, and increased 31 percent in the group taking just placebo. The study suggests that both folic acid and vitamin B12 can help prevent bone fractures by reducing the level of homocysteine in the body. ❦ after their stroke with folic acid and vitamin B12 Education Event NNFA Announces Web Conference for Final GMP Rule Within 72 hours of the Food and Drug Administration’s (FDA) publication of a final regulation on good manufacturing practices (GMPs) for dietary supplements—which could occur at any time—NNFA will hold a Web conference highlighting the most important and pressing aspects of the rule. The conference is ideal for those involved with regulatory affairs, production, quality assurance/control, and legal functions. For more information about this event, please visit www.nnfa.org/services/training/webcast.htm NNFA Today, Volume 19, No. 5 / May 2005 www.nnfa.org 9 FOOD & NUTRITION NEWS Healthy Essentials Healthy Essentials is aimed at providing member retailers with valuable health information. Please share this feature with your employees and customers. A Brief, Brief History of Vitamins “There occur in various natural foods, substances which cannot be absent without serious injury to the peripheral nervous system… These substances are easily disintegrated… which shows that they are complex substances and cannot be replaced by simple chemical compounds.” A Dutch doctor named Gerrit Grijns made that statement in the course of his research in the relatively new field of nutrition at the end of the 19th century. The statement would later become known in the scientific community as the “vitamin concept.” But it was a biochemist from Poland, Casimir Funk, who, in the beginning of the 20th century, gave us the term for the substances Grijns described. Funk grouped these trace nutrients, deficiencies in which seemed to be the cause of diseases such as beriberi, pellagra and scurvy, into a class called “amines.” Since their role in human health seemed so important, he further coined them “vital amines,” which was eventually shortened to vitamins. Building on the mounting research on these nutrients, an American scientist and contemporary of Funk’s, named Elmer V. 10 www.nnfa.org McCollum, discovered that one type of nutrient could be dissolved in fat and another type in water. He called these respectively “factor A” and “factor B,” a naming convention that ultimately lead to today’s classification of vitamins as either fat-soluble or water-soluble. Since last month’s Healthy Essentials focused on B vitamins, which constitute all known water-soluble vitamins except vitamin C, this month’s column will explore the fat-soluble category. Solubility, So What? Solubility determines a lot about a vitamin: how it is absorbed into and transported by the bloodstream, whether it can be stored in the body, and how easily it is excreted from the body. Water-soluble vitamins are absorbed directly into the bloodstream and travel freely throughout the body. They are not stored in tissues in great amounts and excesses are excreted in urine. Because of this, the risk of immediate toxicities of any of the water-soluble vitamins is not as great as with fat-soluble vitamins. The latter are absorbed into the lymph and travel in the blood with protein carriers. Because they can be stored in the liver or with other lipids in fatty tissues, some fat-soluble vitamins can build up to toxic concentrations. NNFA Today, Volume 19, No. 5 / May 2005 FOOD & NUTRITION NEWS It’s Easy as A, D, E … and K The four fat-soluble vitamins, A, D, E, and K, are found in fats and oil of foods. They play many diverse roles in the body, including directing cell conversion, storage and release of substances, regulation of protein production, prevention of oxidative damage to tissues, and allowing blood to clot. They cannot be absorbed in the body without bile. (In the stomach, enzymes in the watery digestive juices can’t get at the fats, since they tend to separate from the watery juices. The gallbladder secretes bile, which emulsifies fats, allowing the enzymes to bind to and digest them.) Once absorbed, fat-soluble vitamins are stored in the liver and fatty tissues until the body needs them. However, this capacity for being stored can also lead to a build-up of the vitamins to toxic levels. Deficiencies in the fat-soluble vitamins can occur if the body is consistently deprived of them. Diseases that produce fat malabsorption can cause loss of vitamins dissolved in undigested fat. In addition, people on diets extremely low in fat run the risk of being deficient in these vitamins because low-fat diets interfere with their absorption. Vitamin A: First of the Fats While it was the first of the fat-soluble vitamins to be discovered, vitamin A remains today the focus of much study because of its versatile activity in the body. It has functions in eye health, the immune system, maintenance of body linings and skin, bone growth, cell development and reproduction. Three forms of vitamin A are active in the body. Retinol is stored in the liver, which makes it available to the body’s cells. The cells convert retinol to its two other active forms, retinal and retinoic acid. The most abundant sources of vitamin A are liver and fish oil. Dairy products and fortified cereals can also be good sources. In plants, this vitamin only exists in its precursor form as carotenoids. Once inside the body, the precursors are transformed to the active vitamin form. Beta-carotene has the highest vitamin A activity of all the carotenoid precursors. D, The Non-Essential Essential This vitamin is distinct among all others because the body can synthesize all it needs with help from sunlight alone. If one gets enough sun each day, there is really no need of vitamin D from food sources. In this sense, it is not essential. Because deficiencies in it can lead to diseases, however, it is essential. NNFA Today, Volume 19, No. 5 / May 2005 D’s most important role is maintaining blood levels of calcium. It does this by increasing absorption from food and reducing urinary excretion of the mineral. Both functions help spare the calcium stored in bones from being used by the cells of the many other tissues in the body that require calcium and, therefore, preserves bone integrity. Vitamin D also plays a role in immunity and is needed for adequate blood levels of insulin. Cod liver oil and foods fortified with vitamin D are excellent sources of the vitamin, though deficiencies are usually remedied with supplementation. Vitamin E: Antioxidant Extraordinaire Vitamin E is on the front lines, so to speak, in the fight against oxidative damage. It actually sacrifices itself to oxidation to protect polyunsaturated fats and other vulnerable components of the cells from being oxidized. In addition to its antioxidant functions, vitamin E also has a direct affect on inflammation, blood cell regulation, connective tissue growth, and genetic control of cell division. Vitamin E is found in many foods. Wheat germ oil, nuts and seeds, whole grains, egg yolks, and green leafy vegetables all contain vitamin E. The main function of vitamin K is to help synthesize proteins that help clot blood K is for Clotting The main function of vitamin K is to help synthesize proteins that help clot blood. If blood did not clot (that is, turn from liquid to solid), wounds would not stop bleeding. Before surgery, clotting time of a person’s blood is measured. If clotting time is slow, vitamin K will be administered to reduce bleeding during surgery. Unfortunately, K only helps when there is a deficiency in the vitamin, not in cases where a person has other bleeding disorders, such as hemophilia. Vitamin K is also necessary for proper bone formation. Working with vitamin D, it helps bones produce a protein that enables them to bind with minerals they need. Vitamin K can be obtained from a nonfood source—intestinal bacteria. Food sources include green, leafy vegetables like spinach, kale, collards, and broccoli. Other significant sources include soybean, olive, cottonseed, and canola oils. ❦ Sources: “The Nobel Prize and the Discovery of Vitamins” by Kenneth J. Carpenter (nobelprize.org/medicine/ articles/carpenter); Healthnotes.com; Nutrition Concepts and Controversies by Frances Sizer and Eleanor Whitney www.nnfa.org 11 FOOD & NUTRITION NEWS USDA Reveals New Food Pyramid T he U.S. Department of Agriculture (USDA) recently unveiled MyPyramid, a new symbol replacing the Food Guide Pyramid introduced in 1992. The new pyramid is part of an overall food guidance system that emphasizes the need for a more individualized approach to improving diet and lifestyle. MyPyramid incorporates recommendations from the 2005 Dietary Guidelines for Americans, released by USDA and U.S. Department of Health and Human Services (HHS) in January (see the February and March 2005 issues of NNFA Today for more information on the guidelines). The dietary guidelines provide advice for and to be active every day. The symbol represents the recommended proportion of foods from each food group and focuses on the importance of making smart food choices in every food group, every day. The system emphasizes taking small steps to improve diet and lifestyle each day, as is suggested by the pyramid’s slogan, “Steps to a Healthier You.” Physical activity, a new element in the dietary guidelines, is also emphasized. The Web site, www.MyPyramid.gov, allows consumers to get more customized information to help make the recommendations fit their own needs. Individuals can key in their age, gender and physical activity level so that they can get a more personalized recommendation on their daily calorie level. Features on MyPyramid.gov MyPyramid Plan – provides an estimate of what and how much food one should eat from the different food groups by entering one’s age, gender and activity level. MyPyramid Tracker – provides more detailed information on one’s diet quality and physical activity status by comparing a day’s worth of foods eaten with current nutrition guidance. Relevant nutrition and physical activity messages are tailored to the user’s desire to maintain current weight or to lose weight. people about how proper dietary habits can promote health and reduce the risk of major chronic diseases. MyPyramid was developed to carry the messages of the guidelines and to make Americans aware of the vital health benefits of simple and modest improvements in nutrition, physical activity and lifestyle behavior. While NNFA supports the overall recommendation in the guidelines that Americans meet their nutritional needs by consuming healthier foods, such as whole grains and by avoiding processed foods, the association believes the guidelines take only a small step in the right direction in recognizing the role of dietary supplements in an adequate diet, particularly for populations with special needs. According to the USDA press release, the MyPyramid symbol is designed to encourage consumers to make healthier food choices 12 www.nnfa.org Inside MyPyramid – provides in-depth information for every food group, including recommended daily amounts in commonly used measures, like cups and ounces, with examples and everyday tips. The section also includes recommendations for choosing healthy oils, discretionary calories and physical activity. Start Today – provides tips and resources that include downloadable suggestions on all the food groups and physical activity, and a worksheet to track what one is eating. Future enhancements to the new food guidance system will include features that make it possible for consumers to make specific food choices by group, look at everyday portions of favorite foods, and adjust their choices to meet their daily needs. Additional information about USDA’s MyPyramid is available at www.MyPyramid.gov. The 2005 Dietary Guidelines for Americans and consumer brochure are available at www.healthierus.gov/dietaryguidelines ❦ NNFA Today, Volume 19, No. 5 / May 2005 INTERNATIONAL NEWS INTERNATIONAL UPDATE British Judge Finds Proposed EU Ban on Supplements “Invalid” The British health food industry won a major victory recently when a senior judge ruled that a bid by the European Union (EU) to ban hundreds of vitamins and food supplements was flawed and therefore, “invalid.” Critics of the directive, including the more than one million Britons who signed a petition opposing it, welcomed the judge’s decision. The proposed ban was part of the Food Supplements Directive, approved by EU governments in 2002, which was designed to tighten controls on products in the health foods market including natural remedies, vitamin supplements and mineral plant extracts. The judge concluded the ban was unscientific and infringed basic EU principles of “legal protection, legal certainty and sound administration.” Contentious Codex Meeting Ends in Positive Outcome for Industry Contributed by Jim Roza, an NNFA International Committee member, who attended this meeting. A recent meeting of a Codex Alimentarius committee ended without a consensus on a proposed draft of its Principles for Risk Analysis for Food Safety due to drawn-out, contentious debate over whether it was even the charge of the committee (the Codex Committee on General Principles, or CCGP) to develop risk analysis guidelines. The deeply divided delegations ultimately agreed to move the risk analysis assessment a step backward in the process, during which time a working group would attempt to identify the object and scope or risk analysis. One of the major stumbling blocks of the proposed draft centered on the inclusion of the precautionary principle in portions of the document. The precautionary principle is a regulatory/legal principle widely used in Europe to preemptively prevent or remove a product from the market due to a lack of NNFA Today, Volume 19, No. 5 / May 2005 scientific certainty regarding a product’s safe use; even though there may be none to the contrary. The use of the precautionary principle could negatively impact supplements when establishing maximum upper limits under Codex guidelines. It could be used to keep supplement levels at RDA potencies even though there is no scientific evidence of harmful effects at higher levels. Although high potency dietary supplements have a history of safe use throughout the world and stand in stark contrast to the deaths and illnesses cause by drugs, foreign regulatory agencies in Europe and elsewhere have employed the precautionary principle under the guise that a lack of scientific certainty exists that impugns safety of dietary supplements. Some feel this paradigm is flawed because, practically speaking, one could never show that under any and all conditions a product would be safe all the time. The working group charged with determining the scope of the new draft guidelines will be co-chaired by the U.S. delegation along with delegations from Malaysia and Morocco. After all committee delegations have responded and the working group reviews and evaluates the draft content, a physical working group will be convened and their work will be considered at next year’s CCGP meeting. The impact of the committee’s work could have far reaching effects if the precautionary principle is not kept out of the document. Because precaution is inherent in any risk analysis, the inclusion of any term or footnote referring to prudence, caution or uncertainty can be an interpreted as the precautionary principle and thus could be used in a pejorative fashion against dietary supplements. Although the precautionary principle is still a potential threat, the push back a step in the process for a reworking by a committee, the majority of which opposes the precautionary principle and the committee’s involvement with risk analysis, is a positive outcome. ❦ The judge concluded the ban was unscientific and infringed basic EU principles of “legal protection, legal certainty and sound administration” www.nnfa.org 13 TRADE SHOW NEWS Significant Actions and Motions T he following significant actions and motions were approved at the April 11, 2005 meeting of the NNFA Board of Directors: • An amendment to the Policies and Procedures that removes the requirement that at least one supply director be a broker and at least one be a distributor • Association support of the Healthy People, Healthy Choices Act, a bill from the House of Representatives (H.R. 161) For more information on this bill, please visit NNFA’s online Advocacy Action Center at www.capwiz.com/nnfa/issues/ • Association support of the Dietary Supplement and Healthy Meal Replacement Tax Parity Act, a draft Senate bill (H.R. 1545) For more information on this bill, please visit NNFA’s online Advocacy Action Center at www.capwiz.com/nnfa/issues/ • Sands Expo and Convention Center in Las Vegas, Nev. as the site of NNFA 2006 and NNFA 2007, the association’s annual trade show and convention ❦ NNFA Board of Directors Executive Committee: Paul Bennett, President Harvest Moon Natural Foods, Olathe, KS David Taylor, President-Elect Nature’s Harvest Market & Deli, Tampa, FL Gary Hume, Treasurer Nutraceutical Corp., Park City, UT Debra Short, Chair, Retail Council Debra’s…Naturally, Shawnee, OK Board of Directors: Gary Barrows Bluebonnet Nutrition Corp., Sugar Land, TX Randy Dennin Capsugel, Greenwood, SC Ryan Drexler Country Life/Desert Essence, Hauppauge, NY Mark A. Fox Ideasphere, Inc., Grand Rapids, MI Soodi Kick Nuts ’N Berries, Atlanta, GA Richard League Mothers Cupboard Natural Foods, Spokane, WA Greg Leonard Tree of Life, St. Augustine, FL Jim Lewis Sunseed Natural Foods, Inc., Juneau, WI Mission Statement NNFA Today is the official publication of the National Nutritional Foods Association (NNFA). It serves as a comprehensive, authoritative source for practical information that natural food retailers and suppliers need to succeed in the marketplace. It provides thought-provoking, timely information on all aspects of the natural products industry and NNFA encourages dialogue among members on professional concerns and views. The views and opinions presented by contributors to NNFA Today are their own and not necessarily those of NNFA. Further, NNFA makes no warranty or representation as to the accuracy or sufficiency of the information contributed by outside sources,and assumes no responsibility or liability regarding the use of such information. Adrienne Mastrobattista The Organic Warehouse, Stroudsburg, PA Richard Merriam GCI Nutrients, Burlingame, GA Marianne Morgan Health Habit, San Andreas, CA Matt Murray Green Acres Natural Foods Market, Wichita, KS Scott Presnall Advantage Sales & Marketing, Irvine, CA Pat Sardell Country Vitamins, Corvallis, OR Jim Smith Apple-A-Day Health World, Gadsden, AL Editorial Director: Tracy Taylor Executive Editor: George Sun Editor: Amanda Thomason Graphic Designer: Kimberly Harrigan Printing: Network Printing, San Dimas, CA 14 www.nnfa.org Send inquiries to NNFA at: 2112 E. Fourth Street, Suite 200, Santa Ana, CA 92705 (800) 966-6632 Fax: (714) 460-7444 e-mail: [email protected] Carrol Wells Honey Bee Natural Foods, Brownwood, TX John Venardos Atkins Nutritionals, Inc., Ronkonkoma, NY NNFA Today, Volume 19, No. 5 / May 2005 REGULATORY & LEGISLATIVE NEWS Industry Members Rally In Washington, D.C. for Natural Foods Day 2005 (Continued from page 5) Utah); Reps. Gresham Barrett (R-S.C.), Chris Cannon, and Frank Pallone. Unable to attend, but also recipients of awards were Sen. Rick Santorum (R-Penn.) and Reps. Dan Burton (R-Ind.) and Juanita Millender-McDonald. At the ceremony, several of the honorees lauded NNFA for its effective leadership in ensuring the vitality of the natural products industry. “I strongly believe that all of you can make a difference,” Rep. Pallone said. “You are doing a great job at getting your message out.” “We need health care, not sick care,” Sen. Harkin said. “Kids can buy junk food at school, but not vitamins.” “I’ve always been proud to work with NNFA, because we have so many of the same goals,” Sen. Hatch said. “As long as I’m here, DSHEA is going to live.” In a related event, NNFA President Paul Bennett testified before the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies on Thursday, April 14. In his testimony, Bennett outlined NNFA’s support for enhanced funding of the Office of Dietary Supplements and the National Center for Complementary and Alternative Medicine. Bennett also urged immediate approval of final good manufacturing practices (GMPs) by the Food and Drug Administration (FDA), and called for greater resources for FDA to fully implement and enforce the GMP regulations required by DSHEA. “Dietary supplements are allowing millions of American consumers to take charge of their own good health by safely and effectively preventing and treating a host of illnesses and conditions,” Bennett said. “NNFA urges the committee to fortify the congressional mandate expressed in DSHEA by investing in the scientific research which holds the key to our knowledge of the remarkable importance and value of dietary supplements.” ❦ NNFA delivers again: up to 32% off select FedEx shipping. ® Because you belong to NNFA, you’re entitled to save up to 32% on select FedEx Express and FedEx Ground shipments. It’s the FedEx Association Advantage — another great advantage for members of NNFA. Simply call 800.966.6632, ext. 236. ® ® ® Your NNFA Member Discounts Up to 32% off Select FedEx Express Shipments Up to 18% off Select FedEx Express International Shipments Up to 21% off Select FedEx Ground Shipments Up to 10% off Select FedEx Home Delivery® Shipments Discounts are off published rates and cannot be combined with other offers or discounts. Discounts are exclusive of any FedEx surcharges, premiums, or special handling fees and are not available to package consolidators. Eligibility for discounts subject to FedEx credit approval. See the terms and conditions in the FedEx Service Guide for more details. Program may be discontinued at any time, and rates are subject to change. Varying discounts apply per service. FedEx First Overnight®, FedEx SameDay®, FedEx® International Next Flight, FedEx International First®, FedEx International Priority DirectDistribution®, FedEx® 10kg Box, FedEx® 25kg Box, FedEx International Priority Plus®, and FedEx International MailServiceSM not included. Eligible services subject to change. © 2004 FedEx. All rights reserved. NNFA Today, Volume 19, No. 5 / May 2005 www.nnfa.org 15 Legal Q&A (Continued from page 6) the Nutrition Facts or on some other part of the label. FDA has gathered information that indicates that the public is concerned about calories, as well as about many other aspects of nutrition information such as saturated fat, cholesterol, carbohydrates and sodium. On April 4, 2005, FDA posed a series of questions seeking information from industry and others regarding the need for highlighting calories more specifically. Comments are due by June 20, 2005. Serving Sizes for Foods The second ANPR, also published on April 4, 2005 and open for comments until June 20, 2005, addresses serving size declarations of food products. Since the passage of the NLEA, FDA has based serving sizes on Reference Amounts Customarily Consumed (RACCs). The existing RACCs were developed in the 1970s and 1980s to establish standardized amounts upon which all nutrition information would be provided. The intention was to provide for easy food choice comparisons for consumers. FDA now is questioning whether there is a need to update those reference amounts and if so how to do that. FDA also wants to know whether there should be new rules governing when a product can be labeled as a single serving container. Finally, the Federal Trade Commission (FTC) submitted comments to FDA recommending that FDA permit truthful, non misleading claims that compare different portion sizes of foods. FDA’s current regulations regarding nutrient content claims require all comparisons to be based on a uniform amount of food. FDA is now revisiting this and requesting industry’s reaction to the FTC proposal. ❦ The National Nutritional Foods Association’s California office has moved to a new location! California NEW S! RES ADD National Nutritional Foods Association 2112 E. Fourth Street, Suite 200 Santa Ana, CA 92705 Ph: (714) 460-7732 / (800) 966-6632 Fax: (714) 460-7444 Washington, D.C. E SAM S! RES ADD 16 www.nnfa.org National Nutritional Foods Association 1220 19th Street NW, Suite 400 Washington, D.C. 20036 Ph: (202) 223-0101 Fax: (202) 223-0250 NNFA Today, Volume 19, No. 5 / May 2005