TIE has covered several recent cases in which public health regulations have been struck down on First Amendment grounds, from graphic warnings on cigarettes, regulation of smoking, pharmaceutical data mining, and, in an older Supreme Court case, the advertising of alcohol. Bans on off-label promotion of drugs are currently at risk as well.
But somehow I had missed last month’s decision from a federal district court in Connecticut which struck down the FDA’s proposed “qualified health claim” (QHC) concerning green tea claims regarding breast and prostate cancers. (h/t to the excellent FDA Law blog). No one is forcing green tea companies to make health claims, but if they do, the FDA wants the claims to be accurate.
The good news for the government was limited: the FDA can prevent its name from being used without permission when a company promotes a product (at 35-36); the court didn’t demand that the FDA prove that its regulation was the “least restrictive” workable rule; and the court allowed the FDA to block “inaccurate and misleading” health claims (at 43-44).
But the court struck down the FDA’s proposed QHC as a First Amendment violation. The offending text?
The “FDA does not agree that green tea may reduce that risk” [of breast or prostate cancer] (at 50)
From the opinion:
Although the portion of the FDA’s disclaimer conveying the strength of scientific evidence supporting the health claim is appropriate under the First Amendment, the portion of the disclaimer stating that the “FDA does not agree that green tea may reduce that risk” suffers from the same constitutional infirmities as the modified disclaimers at issue in Alliance I and II. The placement of this language immediately after Fleminger’s claim that “drinking green tea may reduce the risk of breast or prostate cancer” has the effect of negating any relationship between green tea and the reduction of breast or prostate cancer and therefore effectively swallows the entire claim. The negation of the proposed health claim with this portion of the disclaimer represents an impermissible restriction on Fleminger’s commercial speech. (at 50)
It’s a remarkable decision on how empirical science, public health and the First Amendment are being interpreted in federal courts. See the FDA Law blog for more.