Tuesday, June 8, 2010

What's going on With Supplements

Dietary supplementsDietary Supplements Image by Andrei Z via Flickr
As promised, here is the result from the GAO study on supplements:

Dietary supplements, Fortified foods,  and vitamins are a huge market in the US:  the market for dietary supplements alone is $23.7 billion in 2007.  According to a 2007 National Health Survey, over half the adults in the US have reported using a supplement.   These supplements are really not regulated BEFORE they hit the market; They are regulated only AFTER a complaint has been registered and the FDA must show that the product has a significant or unreasonable risk, or is adulterated before it can be removed from the market.  This approach is not an effective one.  Take the case of ephedra:  It took thousands of complaints, a number of deaths and  10 years from the initial complaint to remove ephedra from the market.

Under the Federal Food, Drug and Cosmetic Act, companies must report adverse effects to the FDA; adverse effects are defined as health effects that result in death, hospitalization, birth defects, or major medical/surgical interventions.  In short, you gotta get really sick for a company to report your problem.  If you get a minor problem like a headache or tummy ache, no one is tracking it.   Also, the law does not require supplement companies to register severe adverse effects.  Unlike drugs and food, supplements don't have to register.

To counter this, health care practioners and individuals can register health effects; so this might be one approach for the disabled community to take.  If we all start policing our own supplements and reporting to the authorities, we will at least get bad effects from supplements on the authorities' radar. The FDA is also starting to include supplements in its Common Good Manufacturing Practice which is expected to go into effect later this year.

The FDA has just started a partnership with WebMD to educate people on the results of its studies.  So we may wish to keep an eye on the WebMD website for updates on supplements.

The FDA believes that the side effects from supplements are under-reported: it thinks that the total number of side effects-- mild, moderate, and severe -- is really closer to 50,000.  The FDA is developing MedWatchPlus to assist in reporting problems with supplements.  So, if you are having a problem with a supplement that you think the Feds should know about, you can go to MedWatchPlus and report it.

The FDA has devoted very few resources to keeping our supplements safe and has conducted relatively few inspections.  The FDA has not issued any guidance as to the regulations for supplement ingredients.  The FDA does not have mandatory recall over supplements, either.  The boundary between supplements and food is not always clear and this leads to a regulatory murky area where agencies do not have the jurisdiction to regulate a product.

The FDA is also watching over manufacturer's claims for their products.  At least once, the FDA has clamped down on claims for products treating Autism.  In 2002, Humphrey Labs was cited for false claims about its taurine products' ability to treat autism.

According to the GAO, Canada seems to have the most comprehensive monitoring of supplements. In Canada, companies are required to obtain a product license to market natural health products, which include a range of products, such as vitamin and mineral supplements, herbal remedies, and other products, based upon their medicinal ingredients and intended uses. The product licensing application must include detailed information about the product, ingredients, potency, intended use, and evidence supporting the product’s safety and efficacy. Approved products are assigned a license number that is displayed on the product label. Manufacturers, packagers, labelers, and importers of natural health products must obtain a site license to perform these activities. To obtain a site license, a firm must provide evidence of quality control procedures that meet government standards for good manufacturing practices. Firms are required to report any serious adverse reactions associated with their products within 15 days and must provide information summarizing all adverse reactions, including mild or moderate events, on an annual basis.

To create this report, the GAO consulted with the following groups in addition to the FDA:  National Institutes of Health, Federal Trade Commission, and Department of Agriculture. California Department of Public Health’s Food and Drug Branch , Environmental Protection Agency and the New York State Task Force on Life and the Law, American Beverage Association, American Herbal Products, Association, Consumer Healthcare Products Association, Council for Responsible Nutrition, Grocery Manufacturers Association, National Advertising Division of the Council of Better Business Bureaus, and Natural Products Association, Center for Science in the Public Interest, Consumers Union, and Public Citizen, American Association of Poison Control Centers; American Medical Association; California Poison Control System; New York City Poison Control Center; U.S. Pharmacopoeia; Baylor College of Medicine; Critical Path Institute; Center for Advanced Food Technology, Rutgers University; Stony Brook University; Center for Consumer Self Care, Department of Clinical Pharmacy, and Osher Center for Integrative Medicine, University of California, San Francisco; and the University of California, Berkeley.

If I were to add to the list of stakeholders, I would have encouraged the GAO to seek out representatives from the various groups that represent health concerns, children and the aging.  I think it's good to have the government, industry and academics weigh in... but what about us, the users of the product?

So the upshot of this is that between the increased research into autism, the evaluation by NIH of complementary and alternative medical treatments for autism, and the GAO and FDA looking into the manufacturing and advertising of the claims.  I have a feeling that chelation will be one of the areas that the government will focus on.   We may have some of our other supplements yanked from the shelf because they are being adulterated.

I don't fear government regulation in this area.  I want safe products.  This isn't to say that I am advocating a return to medicine in all cases.  Just that simply ALL supplements are not ALL good.  Some supplements will continue to be good, effective alternatives to medicine.  Whether I change the word "some" to "many" will depend on how well the supplement industry has policed itself.

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