As the issues and controversies over food and beverage labeling continues, the US District Court, District of Connecticut ruled that the qualified health claim that the FDA attempted to require a green tea manufacturer to use violates the First Amendment.
Health claims on food and diet supplements are regarded as commercial speech and FDA regulation of these claims is analyzed by the court with multi-step framework. At the threshold the court must determine if the claim concerns unlawful activity or is misleading, and if the answers are no, the claim is protected by the First Amendment. In this case, in 2004 a green tea manufacturer wanted to use the following statement in their marketing:
“Daily consumption of 40 ounces of typical green tea containing 710 μg/ml of natural (-) -epigallocatechin gallate (EGCG) may reduce the risk of certain forms of cancer. There is scientific evidence supporting this health claim although the evidence is not conclusive.”
The FDA’s 2005 response concluded that there was not “credible evidence to support a claim with respect to all other types of cancer” and found that based on various studies the link between green tea and reduced breast cancer was highly unlikely, as was the link between green tea and reduced prostate cancer list. The FDA suggested these modified statements:
(i) 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; and
(ii) 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.
The tea manufacturer countered and asked the FDA to consider these statements instead:
(i) Drinking green tea equivalent to that consumed by Asian Americans may reduce the risk of breast cancer in women. There is credible evidence supporting this claim although the evidence is limited; and
(ii) Drinking green tea equivalent to that consumed by the residents living in Hangzhou, China may reduce the risk of prostate cancer. There is credible evidence supporting this claim although the evidence is limited.”
These statements were also rejected by the FDA, and despite the manufacturer’s disagreement, no new health claims were formally submitted. In 2010 the FDA issued the manufacturer a warning level, alleging that their website contained unauthorized health claims. In the case that followed the manufacturer argued that the FDA’s suggested statements do not further the interest of the government and first being the interest in “accurately conveying the strength of the scientific evidence” and the second to “prevent the mistake assumption that the FDA endorses a claim”.
Ultimately the court found that while the health claim being made was weak, the FDA’s suggested language burdens speech more than necessary to remedy the weakness of the claim. The court stated 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 it altogether.”
Each side’s motion for summary judgment was granted in part and denied in part and the qualified health claim was sent back to the FDA for further revision.
Fleminger Inc. v. HHS, U.S. District Court, Northern District of Connecticut, February 12, 2012. Civil Action No. 3:10cv855