Courtesy of NOW Foods
The September 2010 Consumer Reports article entitled “Dangerous Supplements” highlights 12 dietary supplements the authors claim are potentially dangerous. This article has led to numerous news stories that have aired on national TV programs. However, supplement maker NOW Foods believes these stories contain inaccurate and misleading information. This may well discourage consumers from availing themselves of the benefits that nutritional supplements convey, and needlessly raise the specter of danger.
Consumer Reports and the related media stories refer to the supplement industry as operating with little FDA [U.S. Food and Drug Administration] oversight. The reality is that the supplement industry is regulated by the FDA, with manufacturers being audited by the FDA to ensure they meet cGMP requirements (Good Manufacturing Practices). The FDA also regulates labels: all claims must be truthful and not misleading, all ingredients must be listed on the labels, and companies must have documentation to prove claims that must be maintained. Any new supplement ingredient introduced must go through a vetting process with the FDA before it can be legally marketed, similar to the FDA drug approval process in terms of demonstrating safety.
Numerous FDA commissioners have stated that they do have ample authority to regulate the supplements industry – they just don’t have the resources. This is why the industry has long, and very loudly, supported legislation to give FDA more resources to crack down on the fringe companies that do not follow the laws regulating the industry. Also, the FDA has the legal authority to remove from the marketplace any dietary ingredient that they determine to be dangerous.
Supplements have a proven track record of safety, in fact a much better track record than pharmaceuticals, over-the-counter (OTC) medicines and even common foods. For example, the most recent annual report of the American Association of Poison Control Centers published in the Journal of Clinical Toxicology reported zero accidental deaths from dietary supplements. Consumers should be more concerned about acetaminophen adverse events, which cause a large number of deaths (estimates vary widely, but usually range between 3,500 and 10,000), liver failures and ER visits annually.
Additionally, most of the herbs listed in the article are not widely available, and certainly not sold by the vast majority of the industry. To broadly characterize dietary supplements as dangerous on the basis of a handful of products that they claim may be potentially unsafe, is sensationalism that discredits the proven safety record of this product category and fails to recognize that millions of Americans choose to take supplements every day because they derive significant benefits from them.
In a related article, Michael McGuffin, the head of the American Herbal Products Association (AHPA) had this to say.