The structure function claims on many dietary supplement products do not comply with federal law, a government report released on Wednesday concluded. The report recommends greater regulatory powers for FDA to bring products into compliance.
Industry sources reacted negatively to the assertion that FDA needs new statutory powers, but were more accommodating on the report’s suggestions on how the claims notification process should be tightened up.
The report, conducted by the Office of Inspector General of the United States Department of Health and Human Services, looked at the claims on 127 dietary supplements in the weight loss and immune support categories. The report looked at the label language and what kind of evidence was cited to back up the claims, to judge compliance with FDA-mandated notifications and disclaimers and to see how many claims trended over into prohibited disease claim territory.
The report said that the popularity of structure/function claims is on the rise, and maintains that problems with the use of these claims is on the rise, too.
Report cites thin supporting evidence
The report’s broad conclusions were these: Many claims were not backed by evidence from human studies. Of the human studies supplied by manufacturers in response to HHS requests, few appeared to satisfy FDA recommendations in every respect in terms of study design and relevance to the meaning of the claim. It also found that 20% of the supplements in the sample were making prohibited disease claims and that 7% lacked the disclaimer that is supposed to accompany every structure function claim.
The report went on to recommend that FDA should seek additional statutory authority to regulate label claims to make sure that suitable evidence exists to back up the claim, to make sure that proper label notifications are in place and to make sure companies are not making illegal disease claims. In addition, it said FDA needs to clean up its tracking of who is making what claims, and who has complied with the requirement of a 30-day prior notification of the use of a claim on a product.
Immediate reaction: Report overreaches
Reaction from trade groups and industry observers was swift and decisive.
“The Office of Inspector General reviewed just 127 supplements out of an estimated 29,000 products on the market. This small sample of supplements shouldn’t smear the entire industry,” said John Shaw, executive director and CEO of the Natural Products Foundation.
Speaking with NutraIngredients-USA at the Council for Responsible Nutrition’s Day of Science in Laguna Beach, CA, Steve Mister, president and CEO of the organization, said, “What’s most disappointing is that this was not a random sampling [of the industry].”
“The vast majority of the industry, including our members, is doing the right thing. These reports give good companies a black eye,” he said.
The small sample size and big conclusions also was an issue for Marc Ullman, who has worked with the Natural Products Foundation’s Truth in Advertising industry self-regulation effort.
“They are recommended sweeping changes to the law, the imposition of vast new regulatory burdens on FDA based on the fact that (a small number) of dietary supplements didn’t pass substantiation. To me it seems quite a reach,” Ullman, an attorney with the New York-based firm Ullman, Shapiro & Ullman, told NutraIngredients-USA.
“I cannot fathom the kind of broad generalizations they made based on this kind of sample size.”
Nuanced response to report’s recommendations
Regarding the recommendations, Mister said CRN was very supportive of FDA to do more, especially when it came keeping better track of health claim notifications, which companies are supposed to send in 30 days prior to a product hitting the market. But the first recommendation, calling for FDA to seek ‘statutory authority to review substantiation for structure/function claims to determine whether they are truthful and not misleading,’ is a non-starter, he said.
“This sounds like pre-market approval to us,” Mister said.
“I do hope that FDA sees that some of this is targeted towards them,” he added. “The agency needs to manage the information they already have. Structure/function claims and registrations need to be catalogued to be accessible.”
The methodology of the report divided up the supplements more or less equally between the weight loss and immune sectors, and also about equally between supplements purchased in retail outlets on the Internet.
This last detail interested Tony Young, legal counsel for the American Herbal Products Association, especially in relation to the finding that 20% of products were making disease claims.
“An interesting question would be whether those were products purchased off the Internet or in retail stores.
“We expect that there is a higher standard out there to get products on retail shelves and that most of the major retailers don’t carry products that make that kind of claim,” he said.
No public health risk
At the end of the day, Young said, there is no imminent public health risk in the report’s findings.
“Whether FDA should expend substantial resources doing the kinds of things that were suggested is a decision that FDA would have to make with regard to all of the other public health priorities,” he said.
The report might go overboard in its enforcement recommendations, Ullman said, but that doesn’t obviate legitimate questions about how some companies market their products.
“As an industry we need to recognize—and we do recognize—that there is a problem,” he said, going on to cite NPF’s Truth in Advertising effort and CRN’s cooperation with the National Advertising Division as appropriate ways to self-police label claims.
“Everybody in our industry argues that there should be more enforcement with respect to unlawful disease claims so there is pretty much unanimity on that,” Young said.
With additional reporting by Stephen Daniells.