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Dear Mr. Morgenthaler,
Sun City, AZ
Praise for Oxnard, CA |
FDA Moving to Dismantle DSHEAThe hard-won natural health freedoms ensured by the Dietary Supplement Health and Education Act (DSHEA) of 1994 could be overturned! Using the adverse media attention surrounding the herbal supplement ephedra as a lever, the Food and Drug Administration (FDA), with the blessing of the Department for Health and Human Services (HHS) and at the request of U.S. Senator Dick Durbin (D-IL), has reopened the comment period on the DSHEA legislation. If the forces backing this measure are successful, DSHEA may be amended so that any and all dietary supplements can be banned! What is DSHEA?The FDA regulates nutritional supplements (including ephedra) differently than "conventional" foods or drugs (both prescription and over-the-counter medications). Under the terms of the Dietary Supplement and Health Education Act of 1994, manufacturers are responsible for establishing their own manufacturing practice guidelines and making sure a dietary supplement is safe before putting it on the market. Once a dietary supplement is marketed, the FDA must demonstrate that the product is unsafe before it can take regulatory action against the dietary supplement.It is interesting to note that DSHEA was enacted to assure consumers that nutritional supplements are beneficial. It was enacted from the standpoint that if these supplements help support health and fight disease, then the FDA should be responsible for legislation to assure they are manufactured and labeled properly. The laws relating to protecting consumers from dangerous foods have existed for decades and also apply to supplements. Good manufacturing practicesFollowing the DSHEA act, on November 20, 1995 representatives of the dietary supplement industry submitted an outline for CGMP (current good manufacturing practices) regulations for dietary supplements and dietary supplement ingredients to the FDA.FDA representatives evaluated the outline and determined that it provided a useful starting point for developing CGMP regulations. Nonetheless, they believed that the industry outline did not address certain issues that should be considered when developing a proposed rule on CGMPs for dietary ingredients and dietary supplements. For example, the industry outline did not address specific controls for automatic, computer-controlled, or assisted systems. But while Congress considered it a "national priority" to ensure public health and safety, the FDA has had its own agenda of trying to put supplements into a "dangerous" category with GMPs that are close to drug standards. If the FDA were sincere about making sure consumers get what they pay for, it certainly would not have taken almost 8 years to come up with a new proposal. All that really needed to be done in the first place was to add a method for substantiating label dosage claims to existing food manufacturing GMPs. Simple. Now, instead of heeding the advice of the dietary supplement industry, the FDA is listening with an open ear to the editors of the nation's leading medical journals, who have joined the growing chorus of voices from the pharmaceutical industry calling for changes in the way dietary supplements are regulated. For instance, in a recent editorial that appeared in the Journal of American Medical Association, the authors wrote, "If dietary supplements have or promote such biological activity, they should be considered to be active drugs. On the other hand, if dietary supplements are claimed to be safe because they lack or have minimal biological activity, then their ability to cause physiologic changes to support "structure /function" claims should be challenged, and their sale and distribution as products to improve health should be curtailed."1 Chronology of events 2
The FDA needs to get its act together!The FDA has the power to regulate harmful supplements if they are proven to be harmful. Yet, it's important to note that the FDA has never removed a dietary supplement from the market EXCEPT tryptophan, which is still illegal despite its safety record.Why does the FDA need more power if they already have the power to remove any supplement that is proven unsafe? Adding more regulations to a bureaucracy that is somehow unable to act on its own regulations is not the answer. Having this bureaucracy do what we pay them for is step one. Having them not lie to the public about their hands being tied would also help. The FDA has had an adversarial relationship with the nutritional supplement industry for decades (why has it taken 8 years for them to come up with proposed regulations for supplement GMPs?) and guess why. Because of the potential competition with the pharmaceutical industry. Hey, who wants a healthy population when the sick need drugs? Improving one's health with nutritional supplements decreases profits for the drug industry, the biggest industry in the world. Ironically, a study just published in the April 17 issue of The New England Journal of Medicine found that one in four people who walk out of the doctor's office with a prescription may be headed for trouble from an adverse drug event, and that more than a third of those unwanted and potentially dangerous side effects could have been prevented with better prescribing practices and doctor-patient communication. The FDA should put more attention on safeguarding consumers from the drug industry—which is where the real danger lies—and on working with the AMA (American Medical Association) to encourage better communication between the pharmaceutical companies and physicians, and between physicians and patients. Rather than introduce new laws, which would unnecessarily expand the authority of the Food and Drug Administration and restrict the ability of consumers to access a variety of safe and beneficial supplements, Congress should instead investigate and oversee ways in which the Food and Drug Administration can make full use of its current and more-than-adequate authority as granted by the Dietary Supplement Health and Education Act (DSHEA). And it should certainly pay more attention to the manufacturing of dangerous pharmaceuticals. Act Now!We encourage you to send an email, a fax or a letter to your Senate and Congressional representatives, to the FDA and to HHS and demand that your constitutional and fundamental human health rights not be restricted by a government agency that is heavily influenced by lobbyists for the pharmaceutical industry.Ask yourself this: Who would benefit from the proposed amendments to DSHEA? Your health and right to natural therapies or the pharmaceutical companies who profit from disease? If the FDA manages to ratify the legislative changes they are seeking, alternatives to unsafe, ineffective and expensive patented drugs will be restricted. Instead, the multi-billion dollar pharmaceutical "business with disease" will continue to grow … and you might eventually need a prescription for your nutritional supplements. Here's a sample letter for your use, made available by the National Nutritional Foods Association. NNFA is recognized for its strong, aggressive lobbying presence in Washington, D.C., where it serves as the industry watchdog on regulatory and legislative matters: Dear -------, As your constituent, I urge you to oppose any efforts by your fellow Senators to pass S. 722, the so-called Dietary Supplement "Safety" Act, recently introduced by Senator Richard Durbin. I am deeply concerned that rather than passing this new act which would unnecessarily expand the authority of the Food and Drug Administration - Congress should instead investigate and oversee ways in which the Food and Drug Administration can make full use of its current and more-than-adequate authority as granted by the Dietary Supplement Health and Education Act of 1994. I have read that the Durbin bill, despite its title, would allow no more consumer protection than current law provides. It does, however, contain new and discretionary enforcement powers that would significantly undermine many of the freedoms that American consumers of dietary supplements like myself hold dear. If adopted, this bill would subject nearly all vitamins, minerals, herbal products and other supplements to a level of scrutiny that is both unwarranted and unnecessary. Products that have been used safely and beneficially for hundreds—and in some cases, thousands—of years would be subject to clinical evaluation using standards that are at the complete discretion of the FDA. I am concerned that this bill, by questioning the safety of any dietary supplement that receives even one complaint, will result in potentially hundreds of products being removed from the marketplace. Under this new legislation, the FDA has complete discretion to make this determination, regardless of whether the product was used under conditions cautioned against by the manufacturer on the label. By almost every measure, and by a wide margin, dietary supplements can be used more safely than conventional foods and OTC (over the counter) drugs. Yet this legislation exempts foods in these product categories from being classified as stimulants. Specifically, the bill unfairly excludes the most common "stimulant" ingredient in foods—caffeine. I ask you to oppose this extreme and unnecessary legislation and instead take the opportunity to encourage and support the FDA in fully utilizing its enforcement powers as granted by DSHEA. I look forward to hearing your thoughts on this important matter. Sincerely, Your name Contact your representatives now before it's too late! Secretary of Health and Human Services Tommy G. Thompson 200 Independence Avenue, SW Washington, D.C. 20201 202-690-7000 http://www.dhhs.gov HHS can be contacted at: http://www.hhs.gov/ContactUs.html Food and Drug Administration Mark B. McClellan, M.D., Ph.D. Commissioner of Food and Drugs U. S. Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857-0001 1-888-INFO-FDA (1-888-463-6332) The FDA can be contacted at: http://www.fda.gov/comments.html Contact your local senate and congressional representatives. Log on to http://www.house.gov and http://www.senate.gov and enter your zip code in the field located on the top left-hand side of the web page. In some districts, you must enter your full nine-digit zip code, but the web site provides a link to the United States Postal Service. After entering your zip code, follow the online instructions for contacting your local representatives. References:
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