Industry Responds to Consumer Reports Attack on Supplement Safety

A cover story in Consumer Reports... September issue questioning the safety of dietary supplements'”and the Food and Drug Administration...s (FDA) ability to monitor the category'”has industry on the defensive.

Titled 'Dangerous Supplements: What You Don...t Know About These 12 Ingredients Could Hurt You,' the article infers that many supplements on the market are unsafe, unmonitored, and lack the science to prove their efficacy.

Moreover, the authors provide a list of 12 ingredients on the market that they consider dangerous and linked to adverse side effects, according to information provided to them from independent research group Natural Medicines Comprehensive Database: aconite (Aconitum), bitter orange (Citrus aurantium), chaparral (Larrea tridentata), colloidal silver, coltsfoot (Tussilago farfara), comfrey (Symphytum officinale), country mallow (Sida cordifolia), Geranium, greater celandine (Chelidonium majus), kava (Piper methysticum), lobelia (Lobelia inflata), and yohimbe (Pausinystalia yohimbe).

The article also provides a 'safe' list: calcium, cranberry, fish oil, glucosamine sulfate, lactase, Lactobacillus probiotics, psyllium, pygeum, SAMe, St. John...s wort (Hypericum perforatum), and vitamin D.

FDA...s current methods of regulating industry, including its enforcement through the Dietary Supplement Health and Education Act (DSHEA), are inadequate for ensuring supplement safety, the article says. 'FDA has not made full use of even the meager authority granted it by the industry-friendly DSHEA,' write the authors, saying that DSHEA is not effective in protecting consumers in a timely fashion.

'Under DSHEA, it is difficult for the FDA to put together strong enough evidence to order products off the market. To date, it has banned only one ingredient, ephedrine alkaloids. That effort dragged on for a decade".Instead of attempting any more outright bans, the agency issued warnings, detained imported products, and asked companies to recall products it considered unsafe.'

'Because of inadequate quality control and inspection, supplements contaminated with heavy metals, pesticides, or prescription drugs have been sold to unsuspecting consumers,' the authors add.

Finally, the article questions the science, or what it says is a lack thereof, supporting the efficacy of supplements being sold. 'Of the more than 54,000 dietary supplements in the Natural Medicines Comprehensive Database, only about a third have some level of safety and effectiveness that is supported by scientific evidence....And close to 12% have been linked to safety concerns or problems with product quality.'

Industry associations are speaking out against the story, which Andrew Shao, senior vice president, scientific and regulatory affairs, Council for Responsible Nutrition (CRN; Washington, DC), called 'a little bit sensationalized' in an interview with WebMD.

'Any time you pick adverse experiences from a handful of individuals, you know it is being sensationalized. It doesn...t represent the totality of the evidence. Some of these ingredients [in the report] have been flagged by the FDA years ago,' he is quoted as saying.

Steve Mister, CRN president and CEO, pointed out in an interview with ABC News that the 12 ingredients the article calls unsafe represent just a small minority of the overall supplement market.

In an advisory to its members, the American Botanical Council (Austin, TX) pointed to what it says is a past history of 'flawed' reporting by Consumer Reports on dietary supplements. 'Though this article is flawed and incorporates inadequate information on the safety of many of the herbs, it is in numerous ways an improvement over the cover story Consumer Reports ran in May 2004. The previous cover story contained so much erroneous information on herbs that it was readily apparent that the editors had not run the article by anyone with any real experience or expertise in herbal or dietary supplement research.'

CRN also underlined that, contrary to the article...s implications, the industry is regulated. 'The dietary supplement industry is regulated by FDA, and under the law, the agency has the authority to remove from the market any product it believes to be hazardous to consumers. The dietary supplement industry has fought for stronger enforcement of regulation to further ensure consumer safety.'

'We recommend that consumers follow label directions, buy products from reputable companies, and talk with their doctors or other healthcare professionals about the supplements they take,' the association concluded.

Read the original Consumer Reports story here