Not Even Dr. Weil Can Escape FDA and FTC H1N1 Claims Scrutiny

On October 15, 2009, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued a joint H1N1-related warning letter to for claims the Internet retailer published for its Immune Support Formula. The agencies said the company had made illegal claims about the Immune Support Formula being a prevention, treatment or cure for the H1N1 flu virus in people.—which is owned by Weil Lifestyle LLC and sells products under the name of the well-known integrative medicine guru Andrew Weil, MD—pulled the content in question from its Website in response.

The warning illustrates how careful supplement marketers must be when making claims for immune-support products. The agencies said the warnings are part of the “urgent measures” being taken to protect consumers from products that claim to ward off or treat the deadly swine flu, which is now widespread in 41 states.

“The FDA continues to consider the sale and promotion of fraudulent H1N1 influenza products to be a possible threat to the public health and in violation of the Federal Food Drug and Cosmetic Act,” Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs, said in a statement. “The FDA has an aggressive surveillance program to detect fraudulent H1N1-related products and will take prompt action to stop the marketing of fraudulent H1N1 influenza products and will hold those who are responsible for doing so accountable.”

Although the claims made for Weil's Immune Support Formula come no where close to the fraudulent H1N1 claims made by some other supplement marketers, the FDA did take issue with these statements made on the site:

• "[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 ...."

• "The Immune Support Formula contains astragalus. . . . Astragalus ... is used traditionally to ward off colds and flu and has been well studied for its antiviral and immunity-enhancing properties."

• "Th[e] synergistic combination of immune modulators [found in the Immune Support Formula] is especially useful for those who tend to get every bug that goes around during the winter."

• "Worried About Flu? Dr. Weil's Immune Support Formula can help maintain a strong defense against the flu. It contains astragalus, a traditional herb that boosts immunity. Buy it now in one click, and start protecting your immune system against flu this season."

In a statement on the site, Weil wrote that all “Weil editorial content is reviewed for compliance with FDA /FTC guidelines,” that he “directed the Website team to remove the FDA/FTC-referenced content for review,” and that he “fully support[s] the FDA/FTC task force in its efforts.”

NBC’s Today Show was among the news outlets that ran stories about the Weil warning and the government’s other H1N1 warnings, which have gone out to numerous supplement marketers since the virus began spreading in April of this year.

Related NBJ links:

FDA Increases Enforcement Efforts, Warns Internet Marketers About Swine Flu Claims

McLemore: ‘There Is No Question That a New and Improved FDA is Emerging’

Weil: We Need to Create a Completely New Culture of Health and Medicine

Related NPICenter links:

FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet

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