## Facts

- Fleminger, Inc., a green-tea manufacturer and retailer, petitioned the FDA to allow a qualified health claim on product labeling suggesting green tea may reduce the risk of breast or prostate cancer.
- The FDA declined Fleminger’s proposed wording and stated it would exercise enforcement discretion only if Fleminger used an FDA-drafted disclaimer.
- The FDA-required structure included the statement that the FDA “does not agree” with the claimed cancer-risk reduction because there is “very little scientific evidence” supporting it.
- Fleminger alleged the mandated disclaimer mischaracterized the scientific record and compelled speech in a way that chilled its commercial speech.
- Fleminger sued HHS, the Secretary of HHS, the FDA, and the FDA Commissioner, asserting a First Amendment violation.
- The parties filed cross-motions for summary judgment.

## Issues

1. Whether the FDA may condition permission to make a qualified health claim on the use of a disclaimer without violating the First Amendment protections for commercial speech.
2. Whether the FDA-mandated disclaimer (“FDA does not agree” and “very little scientific evidence”) is purely factual and noncontroversial and reasonably related to preventing consumer deception, or instead misleading and unduly burdensome.

## Decision

- The court granted in part and denied in part Fleminger’s motion for summary judgment and granted in part and denied in part the government’s cross-motion.
- The court held the government has substantial interests in preventing misleading health claims and protecting consumers in the food-labeling context.
- The court upheld the FDA’s authority to require some disclaimer language when scientific support for a health claim is limited.
- The court held the specific compelled phrasing at issue, particularly “FDA does not agree” coupled with “very little scientific evidence,” was not sufficiently accurate and neutral and was more extensive than necessary.
- The court required a more narrowly tailored disclaimer that more fairly conveyed the limited and inconclusive nature of the evidence.

## Legal Principles

- Product health-claim labeling is commercial speech subject to First Amendment scrutiny.
- The government may restrict false or misleading commercial speech and may require disclosures reasonably related to preventing consumer deception.
- Compelled commercial disclosures must be factual, noncontroversial, and not unduly burdensome; compelled language that is misleading or effectively forces an advertiser to convey an agency’s evaluative judgment is constitutionally suspect.
- Where the government can address deception through more limited, accurate qualifiers describing uncertainty (rather than disapproving or argumentative wording), compelled language that goes further is unconstitutional as applied.

## Conclusion

The court upheld the FDA’s general use of disclaimers for qualified health claims supported by limited evidence but held that forcing Fleminger to state that the FDA “does not agree” (and characterizing the support as “very little”) improperly compelled pejorative, misleading speech; the FDA had to permit a qualified claim accompanied by a more neutral, accurate disclosure.


Fleminger, Inc. v. U.S. Dep't of Health & Hum. Servs., 854 F. Supp. 2d 192 (D. Conn. 2012)