Friday, January 05, 2007

If FDA were as Powerful as FTC

What a difference three little letters make: FDA vs. FTC.

FTC has powers far beyond those of mortal FDA -- it can impose fines, force the liquidation of assets, and put liens on property to collect settlement fees, all of which the FDA cannot do -- or has never done to my knowledge.

And the FDA is powerless to go after marketers of dietary supplements. According to an entry in wikipedia: "Because FDA is only given as much authority as Congress has granted the agency, the Agency cannot take certain actions outside of its mandate. One such area where this has caused confusion is with dietary supplements. Unlike drugs, the FDA does not pre-approve dietary supplement on their safety and efficacy. FDA can only take enforcement action against dietary supplements only after FDA discovers that a certain dietary supplement is unsafe."

The FTC, however, has the power and recently demonstrated that power by reaching "New Year's" resolutions with four major weight-control pill marketers, one of which was Bayer. See the FTC press release.

The marketers of TrimSpa, for example, will pay $1.5 million to settle FTC allegations that their weight-loss claims were unsubstantiated. According to the FTC's complaint, the marketers had inadequate scientific evidence to support their advertising claims that TrimSpa causes rapid and substantial weight loss and that one of its ingredients, Hoodia gordonii, enables users to lose substantial amounts of weight by suppressing appetite.

Many ads for "TrimSpa Completely Ephedra Free Formula X32" featured testimonials. Celebrity Anna Nicole Smith claimed to have lost 69 pounds in eight months by using TrimSpa. Look! She has a waist!

Celebrity Endorsements: Clear and Prominent Disclosure
It's interesting to note that FTC has a position on Celebrity endorsements that is absent in any FDA "guidance" regarding Rx marketing: endorsers of products -- celebrity or ortherwise -- must provide "clear and prominent disclosure of any relationship that would materially affect the weight [pun intended?] or credibility given to a user testimonial or endorsement."

Perhaps if it could, FTC would go after celebrity endorsers of Rx products. Sally Field, for example. Ms. Field (Sally) is the celebrity spokesperson for Roche Therapeutics' award-winning (see "Awards: The Good, The Bad, The Ugly") "Rally With Sally For Bone Health" promotion for the drug Boniva. Nowhere on the Boniva web site, or in the print and TV ads featuring Sally can I find any disclosure that she is paid for her endorsement. I guess FDA assumes this is understood by consumers, although FTC apparently does not make that kind of assumption with regard to non-Rx endorsements.

Sally is also touting the benefits of Boniva in the press: "I feel it's kind of a miracle," she is quoted as saying in The Oregonian (see "Sally Field, Boniva, and Media Ethics" in the Got Bones? health blog).

You won't see the FTC go after Roche, however. The FDA and FTC have agreed that Rx products are the FDA's turf, which makes it much easier for "legitimate" pharmaceutical companies to sponsor outrageous "miracle" claims by paying celebrities to say whatever they like.

Pharma Companies Cut Better Deals with FTC
But even when the FTC has jurisdiction over a legitimate drug company -- eg, Bayer -- it's powers are more limited than when it goes after small fry like the TrimSpa folks.

The Bayer Corporation will pay a $3.2 million civil penalty to settle FTC allegations that advertisements for One-A-Day WeightSmart multivitamins violated an earlier Commission order requiring all health claims for One-A-Day brand vitamins to be supported by competent and reliable scientific evidence. The proposed Bayer consent decree, however, is for settlement purposes only and
does not constitute admissions by the settling defendants of law violations. Sweet!

Whereas FTC imposes criminal penalties and fines, FDA sends letters. But that's a topic for a future post.

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