FDA Takes Cooperation with FTC to a New Level
On February 1, 2011, the U.S. Food and Drug Administration (FDA) has cited a dietary supplement manufacturer for violating not only the Food, Drug & Cosmetic Act (FD&C Act) that it has traditionally enforced, but the Federal Trade Commission Act (FTC Act), enforced by the FTC.
The similarities between the FD&C Act and the FTC Act have led the FDA and FTC to frequently engage in cooperative efforts, as the FD&C Act mandates that advertising be truthful and non-misleading and the FTC Act prohibits deceptive practices in commercial activities. Although there is some overlap in jurisdiction between these agencies pursuant to the obligations imposed by statute, this recent action raises the question of whether the FDA has stepped outside its Congressionally-authorized jurisdiction by actually enforcing the FTC Act.
While this recent FDA action goes beyond previous cooperative efforts with the FTC, this is not the first time the FDA has warned a company that it may be in violation of the laws that the FTC enforces. The FDA and FTC frequently work together. For example, in “Operation Cure All” the agencies teamed up to combat internet marketing of health products that claimed cures for various diseases without the requisite level of substantiation. Additionally, as far back as 2004 the FDA has referenced the FTC in its warning letters to companies. However, in one such letter, the FDA only warned of possible violations of the FTC Act and alerted the company that it was forwarding the letter to the FTC. The most recent Warning Letter goes far beyond this kind of notice. The Warning Letter requires the company receiving the violation to send a response to the FTC, an agency wholly separate from the FDA and charged with the task of enforcing distinct legislation.
Due to the overlapping jurisdiction of the FTC and the FDA, some points of conflicting policy often arise. One example of such conflict is in the area of dietary supplement claim substantiation. But the FTC and the FDA share jurisdiction over dietary supplement regulation, with the FDA maintaining responsibility for the labels and “point of sale” materials (like brochures, pamphlets, etc.) of dietary supplements and the FTC bearing responsibility for all dietary supplement advertisements (including websites, print and TV ads, etc.). However, the FDA will look at advertisements like product websites when determining the compliance of the product under the FD&C Act. Likewise, the FTC will examine claims appearing on product labels when evaluating dietary supplement compliance under the FTC Act.
This overlapping dietary supplement jurisdiction becomes even more complicated when it comes to the two agencies requirements for substantiation of claims. Both agencies require that claims be “truthful and not misleading.” The FTC purports to require “competent and reliable scientific evidence” to support such claims and the FDA supports this level of substantiation as well. However, as we have reported recently, the food manufacturer, POM Wonderful, LLC, has claimed that the FTC has been utilizing a new standard for substantiation in its enforcement action. This “new standard” is reflected in two published consent orders against Nestle USA and Iovate Health Sciences, Inc., in which the FTC prohibited future claims by the companies unless the claims are supported by two well-controlled, human clinical studies. The “new standard,” if POM is correct, marks a drastic change in FTC policy regarding substantiation of claims. This “new standard” is stark contrast to the FDAs policy on claims substantiation. The FDA requires competent and reliable scientific evidence to support every reasonable interpretation of a claim. Further, under section 201(ff)(3)(B)(ii) of the FD&C Act, a product is NOT a dietary supplement if it is an article authorized as a new drug for which substantial clinical investigations have begun and are announced to the public. Therefore, it is possible that a dietary supplement required to meet the FTCs alleged “new standard” for substantiation could be deemed misbranded and an unapproved new drug under the FD&C Act. While the full consequences of this “new standard” have yet to be seen, the dilemma for companies trying to maintain compliance without subjecting themselves to heightened regulation is looming.
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This entry was posted on Tuesday, March 8th, 2011 at 12:09 pm and is filed under FDA.
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