Dietary Supplements are now Safely Regulated

TIMELINE:

1994 The Dietary Supplement Health and Education Act (DSHEA)


• Requires manufacturers to follow Good Manufacturing Practices (GMP) set by the FDA


     o GMPs were fully implemented between June 2008 and June 2010


• Continues to define dietary supplements as Food


• Regulates labels

     o All claims must be truthful and not misleading

     o All ingredients must be on the labels

     o Documentation to prove claims must be maintained

• Approves pre-existing dietary ingredients already on the market as of October 15, 1994

     o Common vitamins, minerals, herbs

     o “Grandfathering” was twice applied to pharmaceuticals already on the market:

     o  The 1938 Food, Drug and Cosmetic Act & 1962 Kefauver-Harris Amendments

• Requires pre-market submission to the FDA of all New Dietary Ingredients marketed after October 15, 1994

     o The agency questions the majority of submissions

     o The agency has the power to reject applications; and has done so

     o This is analogous to pharmaceuticals where all drugs entering the market after October 10, 1962 require an FDA submission/approval process


1997 Food and Drug Administration Modernization Act (FDAMA)

• Provides for health claims based on an authoritative statement by a scientific body of the U.S. government or the National Academy of Sciences

• Such claims may be used only after submission of a health claim notification to FDA



2002 The Public Health Security and Bioterrorism Preparedness and Response Act

• All food manufacturers, including dietary supplement manufacturers, are required to be registered with the government and give advance notification of raw materials imports



2003 The FDA Consumer Health Information for Better Nutrition Initiative

• Provides for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation

     o Such health claims must be qualified to assure accuracy and non-misleading presentation to consumers



2004 The Anabolic Steroid Control Act amendment

• Bans steroid precursors sold as dietary supplements

     o The FDA and DEA have authority to take action against adulterated products



2006 The Dietary Supplement and Nonprescription Drug Consumer Protection Act

• Requires reporting of all serious adverse events (AERs) for both dietary supplements and OTC drugs


The Food Allergen Labeling and Consumer Protection Act


• Requires label disclosure of the 8 major allergens that cause 90% of all food allergies



2010 The most recent annual report of the American Association of Poison Control Centers

• Published in the journal Clinical Toxicology

• Reports zero reports of accidental deaths from dietary supplements



     Full implementation of mandatory federal cGMPs was completed in June

• All manufacturers & suppliers are now bound by FDA standards of safety and documentation



     The Dietary Supplement Full Implementation and Enforcement Act

• Introduced in Congress to increase funding for FDA enforcement of dietary supplement laws



     The Food Safety bill

• Includes enhanced mandatory recall authority for all foods, including dietary supplements

• Expected to pass Congress soon

Vitamins Are FDA-Regulated

Contrary to popular myth and The Healthy Skeptic (LA Times 3/1/10), the federal FDA (Food and Drug Administration) already regulates dietary supplements such as vitamins, minerals and herbs. These are NOT “unregulated” products. What actually makes critics’ teeth grind is the fact that vitamin formulas do not need specific pre-approval from the federal regulators, which is the true endgame of many skeptics. But all ingredients used in nutritional supplements before mid-October of 1994 are already pre-approved by the FDA under an often-misrepresented law called DSHEA, which also requires all new dietary ingredients to be submitted to the FDA for pre-market review before a product is sold. This gives the agency a chance to review the required submission of safety and efficacy data before any new ingredient can be sold, and the power to veto its introduction.

Dietary supplement manufacturers are already required to submit label claims along with scientific documentation to the FDA, but are paradoxically required to use a label disclaimer that the agency has not evaluated the formula. Vitamin makers are already registered with the government, are already prohibited from making medical/drug claims for dietary supplements, and are already required to identity-test and list all ingredients on product labels. A recent adverse event reporting law promptly lets the FDA know of virtually any problem requiring medical attention in order to trigger recalls and new label warnings. Under DSHEA, the FDA can regulate the manufacture of all dietary supplements, an oversight that was dramatically improved over the past 3 years with the rollout of mandatory Good Manufacturing Practices. Obviously, this is not an “unregulated” industry, even if enforcement can be improved in some areas.

Advocates of pre-approval of dietary supplement formulas want to import a highly flawed and controversial Canadian health care program in a misguided effort to give our own unelected government bureaucrats absolute power over already-regulated vitamin products. Many Canadians now cross the border to buy American supplements because their own government arbitrarily delays entry of new products for years at a time, miserly approving only 42% of products that have been submitted with all of the required safety and efficacy documentation. This is not a free market model, does not work well, and is not worth copying.

A permanent government takeover will strangle a preventive health industry that, in America’s free market, has added jobs and exports during our recent recession. Vitamins help Americans meet basic nutritional needs in a cost-effective manner without government funding; and probably decreased some Medicare spending, according to the conclusions of authoritative Lewin Group reports. There is a complex regulatory structure for vitamins and other dietary supplements in the U.S. that is working quite well; there were ZERO deaths officially reported from these products last year even though about 2/3 of Americans use them. Claims that “vitamins are unregulated” are woefully inaccurate and should not be published by news outlets with competent fact checkers.

http://www.latimes.com/features/health/la-he-0301-skeptic-20100301,0,2486837.story

testing dietary supplements

My experience with dietary supplements is that analysis of products with multiple ingredients, especially those at low concentrations, is very difficult and requires experience with the particular supplement matrix (formula plus excipients). Random testing of products off the shelf is fraught with technical difficulties. In addition, many ingredients lack standard, universally accepted testing methods within a dietary supplement matrix, which can result in confusion. These are sophisticated issues, whose resolution sometimes is difficult for anyone trying to ascertain product quality based on limited testing and lack of relevant experience. That is why most labs prefer to test single ingredient products, a tacit admission of the uncertainties involved in testing complex formulations. Testing is not as black and white as news releases often indicate or imply. Further, extrapolation of analytical results to nutrition, health and safety issues also requires expertise in these sometimes controversial areas, which very few labs have. It is important to verify label claims, but sometimes the manufacturer's validated procedures for qualification of an individual ingredient - combined with appropriate quality controls to assure that a proper mixture has been made - may more accurately represent the quality and quantity of that ingredient in a formula than any lab results obtained by applying a single analytical test to vastly different formulations containing that ingredient.

CNN: false report on dietary supplement regulation

CNN’s erroneous report on dietary supplement regulation was corrected after my complaint and correction By Neil E. Levin, CCN, DANLA www.honestnutrition.com A recent CNN text report and the accompanying video posted on its webpage asserted that dietary supplements are “unregulated” and that label and ad claims are made without any government supervision. 1 The video was shown on the CNN television network. Of course, one need only go to the FDA's own web site to find out that this is false. Even the claim that dietary supplements are "unregulated" compared to other food categories is preposterous. The FDA says that (I have bolded certain words in these quotes to emphasize that these are mandatory rules, or regulation): "FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter)." The agency explains the scope of those regulations: "FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting [Neil's note: this has been superceded by mandatory adverse event reporting passed into law December 2006.] , and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising...Domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register their facility with the FDA." Regarding the regulation of claims and labels, the agency says: "Claims that can be used on food and dietary supplement labels fall into three categories: health claims, nutrient content claims, and structure/function claims. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, or, in the case of advertising, with the Federal Trade Commission...Manufacturers of dietary supplements that make structure/function claims on labels or in labeling must submit a notification to FDA no later than 30 days after marketing the dietary supplement that includes the text of the structure/function claim." "The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but FTC's work is directed by different laws. For more information on FTC, go to: http://www .ftc.gov/bcp/menu-health.htm. Advertising and promotional material received in the mail are also regulated under different laws and are subject to regulation by the U.S. Postal Inspection Service." Regarding new ingredients, the agency says, "The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a "new dietary ingredient." The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply." This rule does not apply to other food categories. Additionally, serious adverse event reporting (SAERs) is no longer voluntary. Manufacturers are required to report SAERs to the FDA within 15 business days of receipt, another distinction between dietary supplement regulation and rules for other regulated food categories. And the FDA, as authorized by DSHEA, is phasing in mandatory cGMPs (current Good Manufacturing Practices) for all dietary supplement manufacturers, focusing on assuring safety and proper identification of ingredients by setting strict rules for manufacturing procedures. This is another important regulatory distinction between dietary supplements and other food categories. POSTSCRIPT: I sent a short version of this correction to CNN on Monday, 1/14/08, and posted a long version on my blog. To their credit, CNN has now (1/17/08) posted a link to my blog entry (1) that had complained about the accuracy of its original report, has revised its text version on the CNN webpage to remove the errors that I pointed out to them and insert accurate quotes from the FDA website, and has pulled the video of that original report from the CNN webpage. (2) I acknowledge CNN’s corrections as responsible and applaud its efforts to quickly correct these errors when informed of them. My hope is that CNN will now be more vigilant in recognizing and challenging the common misperception that “dietary supplements are unregulated”, since even a quick fact check reveals that this is quite untrue. Even when those making these false claims are authorities, “experts” or health professionals, it would be helpful if journalists learn that such blanket condemnations are ‘red flags’ indicating that sources may be spouting personal opinions that may be inaccurate, biased, inflammatory, or even potentially libelous; and hopefully triggering a healthy skepticism instead of a mere echo. Links: 1. http://honestnutrition.blogspot.com/2008/01/cnn-false-report-on-dietary-supplement.html 2. http://www.cnn.com/2008/HEALTH/diet.fitness/01/11/hfh.supplements/index.html