Industry Responds to Consumer Reports Attack

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, not monitored, 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, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow (sida), germanium, greater celandine, kava, lobelia, and yohimbe. (The article also provides a “safe” list: calcium, cranberry, fish oil, glucosamine sulfate, lactase, Lactobacillus probiotics, psyllium, pygeum, SAM-e, St. John’s wort, 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 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.

The Natural Products Association (NPA; Washington, DC) agreed: “A number of the mentioned products are actually illegal drugs-not supplements-and only available from those violating the laws.”

For instance, said Steven Dentali, PhD, chief science officer, American Herbal Products Association (AHPA; Silver Spring, MD): “AHPA has recommended since 1996 against the oral use of any herb that contains toxic pyrrolizidine alkaloids-including coltsfoot and also comfrey….The Food and Drug Administration declared in 2001 that it considers any product for oral use that contains toxic pyrrolizidine alkaloids to be adulterated, and the Federal Trade Commission has also acted against the sale of such products.”

In addition, 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 supplements 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.”

Associations also underlined that, contrary to the article’s implications, the industry is regulated.

In a response article in USA Today, CRN’s Mister wrote: “FDA can seize adulterated supplements, detain questionable ingredients at the border, ban products that pose significant risks of injury or illness, and use criminal sanctions of the Food Drug & Cosmetic Act to prosecute those who market unsafe supplements….FDA doesn’t need new laws; just more resources and political will.”