By Ricardo Carvajal –
The U.S. District Court for the Northern District of Connecticut has ruled that FDA’s qualified health claim (“QHC”) regarding the relationship between green tea and the risk of breast and prostate cancer violates the First Amendment. In a prior posting, we commented on Fleminger, Inc.’s constitutional challenge to FDA’s QHC. We won’t belabor the history here, as it is recounted in the court’s decision. Suffice to say that Fleminger proposed this QHC: “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.” FDA modified the claim to read: “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 the claim.” The court ruled that FDA’s disclaimer effectively negated the claim, and was therefore an impermissible restriction on speech.
Although FDA’s QHC was found unconstitutional, the news is not all bad for FDA. Applying the framework established by the Supreme Court in Central Hudson, the court reached the following conclusions:
- “It is beyond doubt that the FDA’s interest in preventing consumer confusion and protecting public health is a substantial interest which justifies the FDA’s imposition of appropriate disclaimers in connection with qualified health claims.”
- “FDA has a substantial interest in preventing consumers from assuming the FDA has approved the qualified health claim…. Absent the FDA’s express agreement, a proposed health claim cannot include specific reference to the ‘FDA’ in its marketing.”
- The First Amendment does not compel FDA to permit the use of a proposed disclaimer that is inaccurate and misleading (e.g., use of the phrase “credible but limited evidence” where an association between a substance and reduced risk of a disease is found in a single case-control study, but contradicted by two stronger studies).
- “[T]he First Amendment does not require the FDA in every case to conduct an empirical study in connection with a petition for a qualified health claim demonstrating that the petitioners’ proposed disclaimer language is misleading or inaccurate or that consumers will mistakenly believe that the FDA approved the proposed health claim.” FDA’s “expert assessment and analysis of the level of scientific evidence” can suffice.
- FDA’s disclaimer must “strike a reasonable fit between the government’s ends and the means chosen to accomplish those ends.” The FDA’s characterization of the evidence supporting the claim as “very little scientific evidence” was accurate, and therefore passed muster. However, the requirement to place the disclaimer “FDA does not agree that green tea may reduce that risk” immediately after the claim “drinking green tea may reduce the risk of breast or prostate cancer” effectively negated the claim.
Notably, the court dismissed the relevance of the settlement in Alliance for Natural Health U.S. v. Sebelius, which provided for the use of a disclaimer similar to the one rejected as unconstitutional in this case. Although the court recognized that FDA has an “interest in using consistent disclaimer language,” the disclaimer in the Alliance case “was not the subject of any court’s review under the First Amendment and is not identical to the disclaimer at issue.” FDA must now take another stab at drafting a permissible disclaimer – one guaranteed to be parsed very closely.