Natural Foods Merchandiser

FDA and FTC warn Weil about flu product

Dr. Andrew Weil pulled his Immune Support Formula from his website after the Food and Drug Administration and the Federal Trade Commission sent him a warning saying he had made claims about its use to ward off the H1N1 flu virus.

The agencies said Weil’s Immune Support Formula “has not been approved, cleared or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus” and told him to immediately stop marketing the product.

In a statement Oct. 16 on his website, Weil said the content removed from the site “was primarily educational, including appropriate strategies to avoid getting the flu this season.”

The agencies said Weil’s website contained this passage: “(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 FDA also issued a press release warning “consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus.”

Although the warnings were aimed at Internet marketers, Susan D. Brienza, a lawyer with the Denver office of Patton Boggs LLP, a Washington D.C.-based law firm, said retailers should take note. “"There are no FDA pre-authorized health claims linking a particular food or dietary ingredient to prevention or reduced risk of swine flu (or flu in general)."

“For retailers, it’s fine to have an immune system section of their supplement aisle,” Brienza said. “Store owners may call that section immunity or strong immunity in terms of signage. But what they may not have is signage for sections marked: cold and flu season, swine flu, natural remedies for swine flu.”

Brienza said retailers also should “do a brief review of all of the immune system supplements that they carry to make sure none of those labels make any claims about swine flu or any flu. With only a few exceptions, dietary supplement labelers and marketers may not make any disease claims or drug claims-- either express (direct and explicit) or implied.”

Examples of implied claims would be: a product name suggesting "virus," or a claim such as "defense against germs and other invaders in these challenging times." She noted that such claims are forbidden for supplements by the FDA no matter how strong the company's scientific support may be.

Because of the new Obama administration and new FDA Commissioner Margaret Hamburg, the FDA has increased funding, including more compliance officers.

“FDA has already issued two notices to the supplement industry saying you may not make swine flu claims. The FDA has additional resources, which means more compliance officers at trade shows, etc.-- and maybe even retail stores.

”So if somebody comes in and asks, ‘Do you have any natural remedies for swine flu?’ the answer is, ‘No. those aren’t possible.’”

And in the meantime, the FTC has historically put considerable resources into rigorous monitoring of supplement websites, and especially now-- during this H1N1 flu outbreak.

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