## Facts

- Plaintiffs were individuals and entities with financial and organizational interests in dietary supplements containing vitamins C and E.
- Plaintiffs petitioned FDA to authorize a dietary supplement label health claim stating: “Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers.”
- FDA denied the petition, concluding the evidence did not satisfy the regulatory standard for authorizing health claims and that the claim was misleading because evidence against the claim outweighed evidence supporting it.
- Plaintiffs sued federal health and FDA officials in their official capacities and the United States, alleging constitutional violations (primarily First Amendment commercial speech), statutory violations under the Food, Drug, and Cosmetic Act, and arbitrary-and-capricious agency action under the Administrative Procedure Act.
- Plaintiffs sought a preliminary injunction preventing FDA from taking action to stop use of the claim either as written or with reasonable qualifying disclaimers.

## Issues

1. Whether FDA’s categorical refusal to permit the proposed antioxidant-vitamin/cancer-risk claim, including with qualifying disclaimers, likely violated the First Amendment protection for truthful, non-misleading (or potentially misleading) commercial speech.
2. Whether plaintiffs satisfied the preliminary-injunction factors: likelihood of success on the merits, irreparable harm, balance of equities, and the public interest.

## Decision

- The court granted plaintiffs’ motion for a preliminary injunction.
- The court found plaintiffs showed a substantial likelihood of success on the merits of their First Amendment claim because FDA likely could not impose an outright ban when consumer-deception concerns could be addressed through disclaimers.
- The court found irreparable harm based on the temporary loss of First Amendment rights and associated economic harms from being unable to communicate the claim.
- The court concluded the balance of equities favored allowing speech with reasonable disclaimers rather than continuing a categorical prohibition.
- The court held the public interest supported access to truthful, appropriately qualified health information while still protecting consumers through disclaimer language.

## Legal Principles

- Commercial speech that is not inherently misleading cannot be banned if the government can achieve its consumer-protection interests through less speech-restrictive means such as accurate, succinct disclaimers.
- Under Central Hudson, restrictions on commercial speech must be appropriately tailored; a categorical prohibition is suspect where qualification can mitigate misleadingness.
- Speech that is only potentially misleading generally must be regulated through disclosure or qualification rather than suppression.
- Preliminary injunctive relief requires a showing of likelihood of success, irreparable harm, favorable balance of equities, and alignment with the public interest.
- The loss of First Amendment freedoms, even for limited periods, constitutes irreparable injury supporting preliminary relief.

## Conclusion

The court preliminarily enjoined FDA from preventing use of an antioxidant-vitamin cancer-risk reduction claim where the record contained some supporting evidence and the claim could be rendered non-misleading through reasonable disclaimers, making a categorical prohibition likely unconstitutional under commercial-speech doctrine.


Whitaker v. Thompson, 248 F. Supp. 2d 1 (D.D.C. 2002)