FDA’s Letter to Herbalife: Who’s Misleading Whom?

By Wes Siegner –

In an exercise in hairsplitting, FDA’s Mike Taylor has written to Herbalife to complain about a YouTube video, in which a former FDA official now working for Herbalife, Bill Frankos, allegedly (the video has been removed at FDA’s request) states the following:  “When I was director of dietary supplements at the FDA, I oversaw nutritional supplements, making sure they were safe and effective for use.”

As we understand his responsibilities while at FDA, Bill Frankos (with others at FDA) was responsible for making sure that dietary supplements were safe and effective for their intended uses.  FDA has many tools to fulfill this responsibility.  Unsafe dietary supplements are adulterated pursuant to the Federal Food, Drug, and Cosmetic Act (FDC Act), while products that claim to have beneficial effects that they do not have are misbranded.  The FDC Act prohibits the marketing of adulterated or misbranded dietary supplements.  FDA has the authority to, and does, issue warning letters, seize violative products, and even prosecute companies and individuals who market adulterated or misbranded dietary supplements.  Therefore, Bill Frankos’ statement seems appropriate.

At no point does FDA’s letter say that the video claims that FDA approves dietary supplements as safe and effective.  And yet FDA’s letter states that “[t]he safety and effectiveness standard referred to in the Herbalife video is the FDA standard for drug review and does not reflect what FDA does with regard to dietary supplements.”  Possibly there was more to the video than just Bill Frankos’ quoted statement that led FDA to conclude there was some implication of FDA approval, but as it has been removed from the internet, we are unable to tell.

FDA’s objections to the video are particularly questionable in light of FDA’s misleading statements in its own letter.   FDA writes that the agency “can stop marketing only by proving to a court there is inadequate information to provide reasonable assurance that the new dietary ingredient does not present a significant or unreasonable risk of illness or injury.”  This is incorrect.  FDA has multiple effective tools, short of actually going to court, that effectively stop improper dietary supplement marketing, including requests for recalls, the issuance of warning letters, and the administrative revocation of facility registrations, to name a few.  Further, given that the FDC Act is a strict liability criminal statute, most companies and corporate executives recognize that they ignore FDA concerns over safety at the peril of their own reputation and freedom.  The mere suggestion in a phone call that there might be a safety issue is often sufficient to stop marketing.

In short, under the FDC Act, FDA has sufficient authority and has the responsibility to regulate dietary supplements to assure safety and efficacy.  As is true with other FDA-regulated industries, companies marketing dietary supplements share in that responsibility.