buy cialis

Do Educational Materials Need to Follow an FDA-Approved Script?

October 19, 2009 – 3:00 pm

FDA and the Federal Trade Commission wrote to Weil Lifestyle Inc. last week about marketing claims made for the firm’s Immune Support Formula. “The marketing of this product violates the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. §§ 331, 351, 352. We request that you immediately cease marketing unapproved, uncleared, or unauthorized products for the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus.”

Here is an example of Dr. Andrew Weil’s statements that have come under fire: On a Web page entitled, The Swine Flu – H1N1, with the subtitle, Swine Flu and You: “[D]uring the flu season, I suggest taking a daily antioxidant, multivitamin-mineral supplement, as well as astragalus, a well-known immune-boosting herb that can help ward off colds and flu. You might also consider. .. the Weil Immune Support Formula[,] which contains both astragalus and immune-supportive polypore mushrooms ….”

With that letter, FTC reminds the company that “the FTC Act, 15 U.S.C. § 41 et seq., requires that claims that a dietary supplement can prevent, treat, or cure human infection with the H1N1 virus, must be supported by well-controlled human clinical studies at the time the claims are made. More generally, it is against the law to make or exaggerate health claims, whether directly or indirectly, through the use of a product name, Web site name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims. Violations of the FTC Act may result in legal action in the form of a Federal District Court injunction or Administrative Order.”

Dr. Weil responded, saying that “The content that was called into question in the warning was primarily educational, including appropriate strategies to avoid getting the flu this season. It included the official recommendations for H1N1 flu vaccination from the Centers for Disease Control. The content also included comments about ingredients in Weil Lifestyle and other supplements which may help support a healthy immune system.”

Dr. Weil has taken the pages down, he says, because he supports FDA/FTC efforts.

I wonder whether Dr. Weil’s Twitter posts will come under fire, too? Here is one: “Zinc is a mineral essential for immune function during cold and flu season. Lentils and other legumes are good sources of zinc.”

Will it pass? Not sure.

Because the points called out in the FDA/FTC letter were made in what Dr. Weil calls “editorial content on the site,” and “educational,” I started wondering about something else: Does all educational material–including lifestyle advice–provided by drug manufacturers need to stick to FDA-approved labeling?

The FDA/FTC letter shows that FDA is watching all media. And as drug manufacturers venture out into social media, they are fretting about what they can say beyond their FDA-approved product labeling. “If we say it, we own it,” said Heidi Youngkin of J&J today at #digpharm, reported Med Ad News editor Christiane Truelove (@ChristianeTrue) on Twitter. “All copy going out must undergo review. User generated content also reviewed unless exempted.”

Such conservatism may work in patients’ favor. Truelove reported that Erik Hawkinson said today during #digpharm: “Why should I trust you? Hawkins: Because everything I put up has to be reviewed by FDA.”

Does FDA approval resonate with consumers? I went back to Twitter and did some more research. To come full circle, here are just two of today’s tweets about Dr. Weil (with names removed):

“Great products for immune boost and cold/flu: Dr. Weil Immune Support, Dr. Schultze Flu Shot. I’m just a fan–not a corporate shill! about 16 hours ago from web

“Recovering from what I believe to be the flu, but did not suffer much, which I attribute to taking astragalus (Dr. Weil recommendation). about 17 hours ago from web

Nothing about waiting for FDA approval in those words.

Daphne Allen
@daphneallen on Twitter

  1. One Response to “Do Educational Materials Need to Follow an FDA-Approved Script?”

  2. I just found this blog post about whether FDA oversight limits free speech:

    By dallen on Oct 19, 2009

Post a Comment