Qualified Health Claims: The Commercial Speech Battle Continues

By Alexander J. Varond* & Diane B. McColl –

As noted in our blogpost less than two months ago, the U.S. District Court for the District of Columbia held that FDA acted unconstitutionally in Alliance for Natural Health, US v. Sebelius when the agency limited qualified health claims (“QHCs”) concerning selenium and reduced incidence of certain cancers proposed by Wellness Lifestyles, Inc.  In part, the court held that FDA erred when it “completely eviscerated plaintiff’s claim” rather than adopting a less restrictive approach such as drafting “short, succinct, and accurate disclaimers.”  We viewed the Alliance for Natural Health (“ANH”) decision as potentially cementing in place a regime for FDA’s review of qualified health claims that is very favorable to health claim petitioners. 

Now a new challenge to FDA’s restrictive treatment of health claims in foods and dietary supplements seeks to build on ANH’s success.  In a recently filed complaint in the U.S. District Court for the District of Connecticut, Fleminger, Inc. (“Fleminger”) contests FDA’s reaction to its proposed QHC regarding green tea and the incidence of breast and prostate cancers.  The tea maker claims that by mandating the use of specific language for the QHCs, FDA violated the company’s commercial free speech rights under the First Amendment of the U.S. Constitution.

Fleminger, which sells green tea at www.teaforhealth.com, submitted its health claim petition to FDA on January 27, 2004.  The company claimed that its green tea QHC was based upon two separate studies.  In its June 30, 2005 enforcement discretion letter response, FDA acknowledged that, although the studies were “weak,” they did point to “limited credible evidence” that green tea may provide some benefit against prostate and breast cancers.  However, FDA stated that stronger, more credible studies did not show an effect of green tea on either prostate or breast cancer.  Thus, FDA decided to allow only the following heavily qualified claims:

Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests that drinking green tea may reduce this risk.  Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer.

One weak and limited study does not show that drinking green tea reduces the risk of prostate cancer, but another weak and limited study suggests that drinking green tea may reduce this risk.  Based, on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of prostate cancer.

Fleminger’s petition for administrative review was denied on August 19, 2008.  FDA justified its denial by stating that the two QHCs “provide the ‘precise language’ that allow Plaintiff’s qualified health claims to be ‘truthful and not misleading.’” 

Subsequently, on February 22, 2010, FDA issued a warning letter to Dr. Sin Hang Lee of Fleminger that threatened “the seizure of [Fleminger’s] illegal products and injunctions against manufacturers and distributors of those products.”  The FDA also reasserted that Fleminger was required to use  without modification, only the exact QHC language that FDA set forth in its enforcement discretion letter.

Fleminger responded by filing a complaint in the U.S. District Court for the District of Connecticut, asserting that FDA essentially required the company to “choose between speaking exactly as [FDA] wish[es], remaining silent, or risking adverse action for its own commercial speech in violation of the First Amendment.”  Furthermore, it alleges that by forcing Fleminger to use the “government’s speech or none at all,” FDA failed to use the “least restrictive means of preventing any alleged deception of consumers who choose to purchase [Plaintiff’s] green tea.” In addition, the complaint charges that FDA’s prohibition on Plaintiff’s speech was overly broad and amounted to an unconstitutional prior restraint.

A ruling in Fleminger’s favor would confirm that FDA’s ability to allow only severely restricted and narrow QHCs has been  drastically reduced.  Such a success would send yet another strong signal to the agency that FDA needs to revamp its strict approach toward food and dietary supplements QHCs.

* Law Student