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The Report ~ February 3, 2012 ~
NDI notifications won’t solve problem of product adulteration, CRN says in response to NEJM commentary “We are well-aware that some people share Dr. Cohen’s perspective that dietary supplements should be regulated like pharmaceutical products, and his personal call for pre-market approval legislation for our industry is not new. Nor is it a viewpoint shared by the majority of consumers who take dietary supplements,” CRN’s Duffy MacKay said in a statement released by the association in response to a guest commentary “Assessing Supplement Safety – The FDA’s Controversial Proposal,” by Pieter Cohen, M.D., published last week online in the New England Journal of Medicine (NEJM). CRN’s statement cited data from itsannual Consumer Survey on Dietary Supplements showing 97 percent of supplement users report they are “confident about the safety, quality and effectiveness of nutritional or dietary supplements.” In addition, the statement noted that the Dietary Supplement Health and Education Act (DSHEA) provides balance between FDA regulatory authority and consumer access to a variety of safe, affordable products. Dr. MacKay also addressed Dr. Cohen’s mistake of conflating the problem of adulterated products with issues addressed in the New Dietary Ingredient Notification Draft Guidance. “In calling for more stringent oversight of legitimate supplement products, [Dr. Cohen] holds up a poster child for the problem of illegally spiked products,” Dr. MacKay observed. “The product Dr. Cohen references in his commentary, by law is illegal and not a dietary supplement,” he explained, noting that Dr. Cohen refers to the manufacturer of this product as a ‘respected company’ when in fact it is a company that broke a myriad of existing laws, including adding undeclared ingredients—specifically drugs—to the product. “We agree with Dr. Cohen that this is a dangerous situation for consumers and further believe the criminals responsible for these dangerous acts should be put in jail,” Dr. MacKay stated. CRN’s response to the NEJM piece was covered in several trade publications. See CRN in the News.CRN 2011 Annual Report now available online Success through teamwork, engagement and service is how CRN is summing up its achievements in its 2011 Annual Report. The final year of the association’s previous three-year strategic plan, 2011 saw the association make great progress toward its strategic objectives. Working to hold back overreaching legislation and burdensome regulation, analyzing scientific studies and providing balance and perspective, and spotlighting the contrasts between responsible companies and those who would mislead consumers, CRN staff worked with its highly engaged member company representatives to reach its goals. The CRN 2011 Annual Report highlights CRN’s most significant achievements. Each CRN member company executive contact will receive a copy of the report by mail in the upcoming weeks, and it is now available on CRN’s Members Only website. The Annual Report is a great tool for showing your non-member colleagues the value of CRN and encouraging membership—and CRN members are urged to share the document. For more information, contact Carl Hyland (202-204-7674).Google changes AdWords policy Google recently announced changes to its current AdWords policy regarding advertising of healthcare-related products and services. The updated policy will no longer prohibit the promotion of DHEA and melatonin products and no longer categorizes L-Glutamine as an anabolic steroid. It also clarifies that Google AdWords prohibits the advertising of products that contain unapproved, dangerous, or illegal ingredients and those that make unapproved, false or misleading health claims. The policy also provides a list of unapproved pharmaceuticals and supplements. CRN sent a letter to Google’s director of Public Policy in December 2011 following the discussion of concerns about Google’s policy at the association’s October Board meeting. The letter expressed concerns about Google’s restricted products list, specifically the mis-classification of L-Glutamine as an anabolic steroid, and offered to provide recommendations and suggestions. “We're pleased to see Google made changes to its policy to allow advertising of these legal products and more closely reflect what the law requires,” CRN’s Rend Al-Mondhiry observed. Contact Rend Al-Mondhiry for more information (202-204-7672).AJCN publishes CRN letter highlighting need for personalized nutrition CRN’s Taylor Wallace recently wrote to the American Journal of Clinical Nutrition (AJCN)in support of findings presented in the November 2011 issue in the article, “Dietary supplement use is associated with higher intakes of minerals from food sources,” and to contribute to the overall discussion involving the intake of minerals resulting from the use of dietary supplements by consumers. In his letter, published in the February issue of AJCN, Dr. Wallace noted that very little is known about the variation of intakes of minerals between supplement users and nonusers. He emphasized that one purpose of dietary supplements is to supplement the diet of those with low or inadequate daily intakes of essential nutrients, to help them meet the Recommended Dietary Allowance (RDA) set forth by the Institute of Medicine (IOM). But, he noted, intakes that exceed the RDA do not necessarily lead to adverse events, and in many cases, intakes above RDA can provide additional health benefits. “Whereas exceeding the UL for minerals is certainly not preferable or beneficial to health, the long-term benefits of dietary supplements in helping the majority of consumers meet the RDA in the absence of a diet rich in fruit, vegetables, and whole grains, as shown by data in [this] article, warrants their use by those individuals who do not meet the recommendations of the Dietary Guidelines for Americans and the [Dietary Reference Intake] values set by the [IOM],” Dr. Wallace wrote. “The nutrition community should begin to reach out to the medical community with robust data as presented in this article…We must push forward as a scientific community with the concept of personalized nutrition and for the ability to allow for targeted interventions when it comes to helping consumers choose healthier diets and, if necessary, dietary supplements,” he concluded. Contact Taylor Wallace for more information (202-204-7660) CRN scientist to serve on ABC advisory board CRN’s Duffy MacKay has been invited to sit on the advisory board of the American Botanical Council (ABC). ABC positions itself as the leading independent, nonprofit, international member-based organization providing education using science-based and traditional information to promote the responsible use of herbal medicine. ABC selected Dr. MacKay, a licensed Naturopathic Doctor with hands-on experience as a practitioner in the field of integrative medicine, in recognition of his many outstanding accomplishments in the field of herbs and medicinal plants. Dr. MacKay may be called on to advise ABC on a variety of editorial and/or policy matters, or for assistance with ABC’s peer review process for its publications, including HerbalGram, HerbClip, and other ABC publications. Contact Duffy MacKay for more information (202-204-7664).Book on GMPs is indispensable guide for industry “Bill Mead’s primer Dietary Supplement Good Manufacturing Practices – Preparing for Compliance, should be required reading for every quality control department in the supplement industry,” CRN president Steve Mister advises. Past president and CRN consultant, Annette Dickinson, Ph.D., wrote the forward to this book, which dissects FDA’s lengthy regulations and preamble, making the details of a very complicated rulemaking understandable so the requirements can actually be implemented. The book, described as a “one-stop how-to roadmap,” explains not only what the rule requires but also how to comply, and why each topic is critical in passing inspection. “Conscientious firms will want to read cover to cover before the FDA inspector knocks on the door,” Mr. Mister notes. CRN/VIRGO GMP webinar now available on demand If you missed the webinar on what industry can do better with regard to passing good manufacturing practices (GMP) inspections, you missed some really valuable information—straight from FDA and industry experts. But, never fear, you can still learn from those presentations by purchasing on-demand access to the webinar. For CRN members, the webinar is $149 per log-on site, so you can gather a group of colleagues and learn together. The on-demand webinar is available for a limited time only, so purchase access today at VIRGO’s website.
Rep. Burton announces retirement Rep. Dan Burton (R-IN) announced last week that he will not run for reelection to Congress and will retire at the end of the current session. A co-chair of the Dietary Supplement Caucus (DSC) and long-time industry friend and supporter of consumer access to dietary supplements, Rep. Burton was first elected in 1982. A poll earlier this month showed Rep. Burton narrowly leading the Republican primary field, but pulling only 29 percent support. New chairs take the helm of Government Relations committees CRN’s Government Relations Committee (GRC) and newly formed Government Relations State Subcommittee (GRSS) recently announced new chairs. Florence Okaro of NBTY will now chair the GRC and Ken Rowe of Airborne will chair the GRSS. CRN members interested in participating in these committees should contact Ingrid Lebert at (202-204-7699).
Ballot initiative circulating in California to require GMO labeling CRN has learned of a pending referendum in California concerning genetically modified organisms (GMOs) that could potentially affect dietary supplements. A petition has been filed with the state attorney general’s office and the petitioners are currently collecting signatures to get the proposal to a vote. The petition deals broadly with all food, thereby including dietary supplements, which are regulated as a category of food. Of most concern to CRN is a labeling requirement for food concerning a GMO whose language is reminiscent of California’s Proposition 65. The petition would require labeling on raw or processed food offered for sale to consumers if food or any of its ingredients contain or are made from plants or animals with genetic material that has been changed in specified ways. It permits private attorneys to bring lawsuits for failure to provide the required warnings, similar to the “bounty hunter provisions” of Prop 65. According to CRN’s Mike Greene, “It is unclear whether the petitioner will obtain the signatures they need to get the measure placed on the ballot, but CRN will continue to monitor all activity. Signatures are due in June. If they reach the level of signatures required, then it could go to a vote in November. CRN will be working with others in the food industry.” Please contact Mike Greene (202-204-7690) for more information.
ODS announces 2012 practicum, Mister to speak The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) is again offering its four-day educational practicum on dietary supplements June 4–7 in Bethesda, Md. The intensive practicum, open to selected faculty, students, and practitioners in health-related disciplines such as nutrition, food science, pharmacology and pharmacognosy, exercise/kinetics, medicine, dentistry, nursing, and complementary and alternative medicine (CAM), provides a thorough overview of dietary supplements and supplement ingredients. The practicum will emphasize the importance of scientific investigation to evaluate the efficacy, safety, and value of supplement products and ingredients for health promotion and disease prevention as well as how to best carry out this type of research. Participants will also meet with various stakeholders—Congressional representatives, the dietary supplement industry, consumer advocacy groups, and media—who study, advocate, regulate, or educate about dietary supplements. CRN president Steve Mister, who has presented at the ODS practicum for several consecutive years, will again speak at this year’s session. See the ODS website for details on the practicum.
CRN commentary included in coverage of NEJM guest editorial “The proposed guidelines are unreasonably burdensome without providing true extra protection for consumers,” CRN’s Judy Blatman was quoted in the British Medical Journal’s (BMJ) coverage of a guest commentary in the New England Journal of Medicine (NEJM), in which Pieter Cohen, M.D., of Harvard University calls for more stringent regulations for dietary supplements. Trade press coverage of the NEJM piece quoted CRN’s Duffy MacKay. “[Dr. Cohen’s] personal call for pre-market approval legislation for our industry is not new... If the supplement industry were subjected to pharmaceutical industry-like regulation, consumers would bear the burden of increased costs and reduced availability to a wide variety of products,” Dr. MacKay told NutraIngredients.com. “Additionally, a pharmaceutical-like regulatory framework is inappropriate for dietary supplements because supplements do not have the same immediate and dramatic effects as pharmaceuticals, and in general, they have a wider margin of safety,” he said. Dr. MacKay further noted that Dr. Cohen’s comments about product adulteration reinforced the erroneous impression that a tougher new dietary ingredient (NDI) guidance was critical to safety, despite the fact that supplements with undeclared active pharmaceutical ingredients (APIs) were good manufacturing practice (GMP) enforcement issues. “The product Dr. Cohen references in his commentary, by law is illegal and not a dietary supplement…This is not a problem that will be solved by more stringent NDI guidelines,” he observed. Dr. MacKay was also quoted in Natural Product Insider, Drug Store News and NewHope 360. CRN deflects inquiries on DMAA; tells trade press to give industry a chance to defend itself A NutraIngredients.com article discussing the recent recall at military bases of DMAA-containing products and the ensuing need to clarify the regulatory status of this ingredient included comments from CRN’s Duffy MacKay. “…CRN has not developed a formal position on DMAA yet. But we will be discussing this at board level…We are considering a number of issues around what DMAA should be called on the label, as there are multiple names in the marketplace…” he added. “DMAA is on the WADA (World Anti-Doping Agency) list [of prohibited substances] and it should be as easy as possible for people to determine if a product contains it,” Dr. MacKay noted. Further, he observed, “Any manufacturer should be able to demonstrate the legal validity and safety of its supplements…so we will have to watch this space.” He cautioned against rushing to judgment before companies have a chance to present their evidence. CRN calls for responsible companies to take a stand against tainted products The Olympic games can inspire fitness enthusiasts of all levels to improve performance, which could translate to new sales of legitimate products, an article in The Tan Sheet noted, but CRN’s Steve Mister observed “when there are Olympics, there will be athletes who will blame their supplements” for drug testing violations, which can result in bad publicity for the industry. “We have asked FDA to meet with us again so we can talk about the tainted products issue and see where there are areas for partnerships where industry and the agency can work together to get these products off the market,” Mr. Mister said. He reminded companies of FDA’s tip line for tainted ingredients (noted in the agency’s Dec. 2010 letter to industry). “If you get raw material and you test it and think it is not what it is supposed to be, you need to do more than reject it and send it back to the supplier,” he explained. “Yes, that means you have to pull your head up out of the bunker and take a stand, but that is what is necessary to protect the industry and everyone has a role in doing that,” Mr. Mister said. Supplements help fill nutrition gaps, says CRN “When diet simply is not enough, there are many high quality supplement products available that can help fill in the gaps,” Duffy MacKay wrote in his latest bylined article for NaturallySaavvy.com. “…the 2010 Dietary Guidelines for Americans advises that intake by Americans of some nutrients—including vitamin D, calcium, fiber and potassium—is low enough to be a public health concern,” Dr. MacKay noted. He further explained that because so many Americans’ consumption of vegetables, fruits, seafood, and whole grains is lower than recommended by the Dietary Guidelines, they might be deficient in other nutrients, as well. “In my experience as a healthcare practitioner focusing on nutrition, I would add omega-3 fatty acids, iodine, and possibly a few more to this list…”
Fish-oil supplementation enhances the effects of strength training in elderly women A recent study published online in the American Journal of Clinical Nutrition linked fish oil supplementation with improvements in muscle strength and functional capacity in elderly women. The ability of skeletal muscles to generate torque and the rate at which this torque is developed are reduced by aging due to changes in the neuromuscular system. In this study, forty-five women (age 64 ± 1.4 years) were randomly assigned to one of three groups. The control group performed strength training only, with no fish oil supplementation, for 90 days, while the other treatment groups performed the same strength-training program and received 2 grams of fish oil per day for 90 days or for 150 days (supplementation began 60 days before strength training commenced in the 150-day treatment group). No differences in the pre-training period were found between groups for any of the variables. The peak torque and rate of torque development for all muscles increased from pre- to post-training among all groups; however the effect was significantly greater in those individuals receiving fish oil supplements for the 90- and 150-day periods. Most significantly, the “chair-rising” exercise performance in the fish oil groups was higher than that of the control.
February 8, 9
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