FTC, FDA ask consumers directly for help on policing claims, reporting adverse events

26-Jul-2017 - Last updated on 27-Jul-2017 at 15:43 GMT

In a communication earlier this week two regulatory agencies sought input directly from consumers about outlandish claims and adverse events relating to dietary supplements.

In a post sent out on the FDA Voice blog, Mary Engle of the Federal Trade Commission and Steven Tave of the Food and Drug Administration asked for help from consumers directly in tracking down issues with product claims on dietary supplements and with adverse events arising from the use of the products. The post was titled “Dietary supplement concerns? Tell the FTC and the FDA.”

Seeking help directly

The post read in part: “The Federal Trade Commission (FTC) and FDA have enforcement programs to protect consumers from false and misleading claims about the safety and benefits of products marketed as dietary supplements. Both agencies have authority over the marketing of these products.

“You can help. Tell the FTC or FDA if:

You bought a dietary supplement that didn’t work as advertised —or you had an adverse reaction or illness.
You’re suspicious that a company is making false or overstated claims in its labeling or marketing.
You’re concerned about the content, purity, or safety of the product.”

The blog post was brought to the attention of industry by an e-mail sent out to members by the American Herbal Products Association. One reaction from industry sources is that the move by the two agencies can be seen as a good thing, because it is yet another thing to point to prove that the industry is being actively regulated.

Reaction to GAO criticism

Dan Fabricant, PhD, president and CEO of the Natural Products Association and former head of FDA’s Division (now Office) of Dietary Supplement Programs said in his view the post was a reaction to recent criticism of the two agencies in a report by the General Accounting Office (GAO) on memory claims on supplements. In the report, issued on June 15, 2017, the GAO said: “FDA faces challenges related to limited information about the dietary supplement market, including memory supplements, to inform its oversight efforts. FDA officials said the agency is exploring ways to obtain additional market information to improve its oversight. FTC officials believe their existing tools and information are sufficient to inform its oversight efforts. While Internet marketing of dietary supplements was a concern for agencies, consumers, and industry groups, GAO found that consumer groups were unclear about FDA's and FTC's roles for overseeing supplement marketing.

“GAO recommends that FDA and FTC provide additional guidance to consumers clarifying the agencies' differing roles in their shared oversight of memory supplement and other dietary supplement marketing,” the report concluded.

“I think this is a direct reaction to the GAO telling them they need to get their act together. The perception is that FDA and FTC don’t really coordinate well together. This is FDA and FTC showing the Administration and Congress that they’re on it,” Fabricant told NutraIngredients-USA. “The both already had anonymous tip lines.”