A warning letter sent jointly by FDA and the Federal Trade Commission takes a double-pronged approach toward cracking down on a supplement marketer's claims regarding the H1N1 flu virus.

This is slightly new territory for FTC, which appears to have altered its usual enforcement strategies, according to an attorney who previously worked at the commission.

In the Oct. 15 warning to Weil Lifestyle regarding its Immune Support Formula, FDA takes issue with the firm's use of the titles "The Swine Flu - H1N1" and "Swine Flu and You" on its ¹ Web site, which suggests Weil is marketing an unapproved drug.

The page touts the formula's immune-boosting herb astragalus, which Weil claims "can help ward off colds and flu," the letter says.

FTC, on the other hand, takes a broader tack, reminding Weil that any supplement claims must be supported by adequate clinical data.

An Oct. 16 release by Weil said the firm removed the FDA/FTC-referenced content for review.

Tucson, Ariz.-based Weil defended the content, calling it "primarily educational, including appropriate strategies to avoid getting the flu this season."

As with other FDA warnings for allegedly fraudulent H1N1 remedies, Weil is given 48 hours to respond to the warning's concerns (² 'The Tan Sheet' Sept. 7, 2009, In Brief).

However, this breaks new ground for FTC, according to attorney Anne Maher.

"The 48-hour deadline is unprecedented," Maher, of Kleinfeld, Kaplan & Becker in Washington, said in an e-mail. "FTC has traditionally given companies at least two weeks - and often more - to respond."

Additionally, even though FTC has typically distinguished its approach to health benefits claims from FDA's, in the letter it does not appear to, she said.

In the letter to Weil, "FTC appears to be backing away from this distinction" by showing as much interest in stopping the claims altogether as in receiving substantiation for the company's flu claims, Maher said.

Maher previously worked as FTC's designated liaison with FDA and the Department of Agriculture.

The joint warning may reflect a trend toward greater FDA/FTC cooperation. FTC's Consumer Protection Director David Vladeck recently announced a working group between the agencies that will evaluate supplement and drug claims and share information about enforcement activities (³ Also see "FTC Intensifies Health Claims Scrutiny, Enforcement Strategies" - Pink Sheet, 12 October, 2009.).

A spokeswoman for FDA's Center for Drug Evaluation and Research said the working group allows FDA and FTC to "foster an interactive and complementary relationship and identify where the agencies can effectively leverage each other as resources" in protecting the public.

In jointly examining claims, FTC may lean on FDA expertise on ingredient content and safety, while FDA may "rely on FTC for determination of the adequacy of advertising claims and to stop deceptive and unfair advertising practices," CDER said.

- Dan Schiff ( ⁴ d.schiff@elsevier.com )

FTC Stakes New Territory, Joins FDA In Warning On H1N1 Claims

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