A defense of the FDA's letter to Herbalife

A defense of the FDA's letter to Herbalife

The FDA wrote a letter to Herbalife, a dietary supplement manufacturer, in December. It was not a warning letter, mind you, just a letter saying the FDA is concerned about an Herbalife broadcast ad and YouTube video which, in the FDA's view, mischaracterized the FDA's role regarding dietary supplements. 

If the name "Herbalife" sounds familiar, it may be because of a very public battle going on between hedge fund investor William Ackman and the company.  Herbalife is a multi-level marketing company, which means people who distribute Herbalife products are compensated for the sales of others they bring is as Herbalife distributors.  Ackman thinks Herbalife is actually a pyramid scheme, and has made a billion dollar bet that the company's stock will decrease in value.  In November, Herbalife agreed to a $15 million settlement of a class action lawsuit brought by a distributor who alleged its business model is just that: a pyramid scheme. 

 

In its letter, the FDA was concerned about a statement made by a former FDA employee, Vasilios H. Frankos, Ph.D., in the video. Dr. Frankos said:

When I was director of dietary supplements at the FDA, I oversaw nutritional supplements, making sure they were safe and effective for use.

The FDA thought this could mislead consumers into thinking the FDA had actually determined that Herbalife's supplements are safe and effective, which it had not, in fact, done.The FDA's letter pointed out that it does not review dietary supplements for safety or effectiveness before they are marketed.  It asked the company to take down the video, and the video is no longer available. If you click on the link, the explanation is that that a video "Herbalife Helping Millions . . ." was taken down due to a "copyright claim by HerbalifeIntl."

So I  thought it a bit nit-picky of the FDA Law Blog to take umbrage at the FDA's letter. First, if the video was taken down due to a "copyright claim," and there is no evidence that the FDA's letter had any effect whatsoever on Herbalife's decision, why the need to defend the company? And against what?  The FDA didn't threaten any action against Herbalife.

But the blog post is more illuminating for what it says about DSHEA and the word-parsing skirmishes that go on between the FDA and the supplement industry.  And let me say here that I have the greatest respect for FDA Law Blog.  It is a product of Hyman, Phelps & McNamara, which is, according to its website, the "largest dedicated food and drug law firm in the country."  Food and drug law is incredibly complex and they are experts who represent the food, drug and supplement industry. I subscribe to their blog because they excel at their job. 

I'll give you a flavor of their beef with the FDA's letter:

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.

The post then takes issue with the FDA's claim about its ability to stop marketing products that pose safety risks by pointing out that the 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. 

Do you think the average consumer understands all these niceties?  Of course not.  In fact, many consumers think that the FDA passes on the safety and effectiveness of dietary supplement before they go on the market. And many consumers are flummoxed by "structure and function" claims that dietary supplements are allowed to make.  (So is the FDA.)

DSHEA is designed to allow the dietary supplement companies to sell products to consumers that, for the most part, they don't need. Products that may, in fact, not be good for them at all. As long as the law doesn't care about consumers, the FDA will have to work with the hand its been dealt by Congress. As long as DSHEA is the law, there will be plenty of words like "adulterated" and "misbranded" to parse, plenty of opportunities to argue with the FDA's or the supplement companies' interpretation of the law.  But let's not be fooled into thinking DSHEA has anything to do with the consumer. So, please, spare us this type of sentiment, which closes the FDA Law Blog's post:

In short, under the FDC Act, FDA has sufficient authority and has the responsibility to regulate dietary supplements to assure safety and efficacy. 

That was never the point of DSHEA. And no one can legitimately argue that the FDA assures the "safety and efficacy" of dietary supplements.

Points of Interest 1/10/2015
They Do Not Shrug Down Under

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