U.S. District Court Strikes Down FDA’s Qualified Health Claim for Green Tea and Breast and Prostate Cancer

Mar 22, 2012   

After nine years of ongoing litigation, on February 23, 2012, the U.S. District Court for the Northern District of Connecticut struck down the U.S. Food and Drug Administrations (“FDA” or the “Agency”) proposed qualified health claim (“QHC”) regarding the relationship between green tea and the risk of breast and prostate cancer. The FDA generally requires the use of qualified health claims on a food or dietary supplement product labeling when a claim characterizes a relationship between a substance in the food or dietary supplement and a disease or health-related condition that does not meet the Agencys significant scientific agreement standard. If a manufacturer chooses to make such a claim, the manufacturer must use a disclaimer that limits or “qualifies” the statement in such a way that does not mislead consumers about the nature of the products underlying scientific support. (See the FDAs position on qualified health claims here.)

Fleminger, Inc., a manufacturer of green tea products, proposed a QHC to the FDA, which read: “Green tea may reduce the risk of breast and prostate cancers. The FDA has concluded that there is credible evidence supporting this claim although the evidence is limited.” The FDA, however, modified the proposed claim to state: “Green tea may reduce the risk of breast or prostate cancer. FDA does not agree that green tea may reduce the risk because there is very little scientific evidence for this claim.” In its decision, the court ruled that the FDAs proposed disclaimer effectively negated Flemingers claim, and constituted an impermissible restriction on commercial speech in violation of the First Amendment. In applying the Central Hudson test, this court held that “there are less burdensome ways in which the FDA could indicate in a short, succinct and accurate disclaimer that it has not approved the claim without nullifying the claim altogether.” Furthermore, the court held that in order for the FDAs disclaimer to be constitutional, it must “strike a reasonable fit between the governments ends and the means chosen to accomplish those ends.”

As a result, the FDA must now either start anew and develop a QHC that is consistent with the courts findings or take an appeal. Although the court ultimately decided that the FDA overstepped its constitutional limitations by requiring Fleminger to use an overly restrictive qualified claim, the courts decision does not entirely disfavor the FDA. The courts decision emphasized the FDAs authority to impose appropriate disclaimers for QHCs due to the Agencys substantial interest in preventing consumer confusion and protecting the public health. In addition, the FDA is not required to permit the use of a proposed disclaimer that is inaccurate or misleading to consumers. Rather, the FDA, through its expert analysis and judgment, may use its statutory and regulatory authority to determine the appropriate level of scientific evidence required to maintain and uphold its protective goals. This case highlights the caution with which the FDA must approach its future development of QHCs. Now, courts will likely closely scrutinize the phrasing of the FDAs proposed QHCs to ensure that the Agency does not infringe on a manufacturers constitutionally protected commercial speech.

For more information on qualified health claims for food and dietary supplement products, please contact us at (305) 350-5690 or contact@fidjlaw.com.