## Facts

- Thompson Medical Company marketed “Aspercreme,” an over-the-counter topical analgesic whose active ingredient was trolamine salicylate; the product contained no aspirin (acetylsalicylic acid).
- Thompson’s advertising repeatedly invoked aspirin, including claims that Aspercreme delivered “the strong relief of aspirin right where you hurt,” and used product name and imagery suggesting an aspirin equivalence.
- In 1981, the Federal Trade Commission brought an administrative complaint alleging false and misleading advertising in violation of FTC Act §§ 5 and 12, based on (1) lack of adequate scientific support for efficacy and comparative claims and (2) misleading implications that Aspercreme contained aspirin or its equivalent.
- After an administrative hearing, an ALJ found violations; the Commission affirmed and issued a final order.
- The order prohibited efficacy/comparative representations (including comparisons to aspirin or competitors) unless supported by at least two adequate and well-controlled clinical studies.
- The order also required Thompson to disclose in advertising and labeling that Aspercreme does not contain aspirin.
- Thompson petitioned for review, primarily challenging the two-study substantiation requirement and the compelled “no aspirin” disclosure.

## Issues

1. Whether the FTC lacked authority to regulate drug advertising while the FDA conducted an ongoing comprehensive over-the-counter drug review.
2. Whether substantial evidence supported the FTC’s finding that Thompson lacked a reasonable basis for Aspercreme’s efficacy and comparative claims.
3. Whether the FTC could require, as prospective relief, substantiation in the form of at least two adequate and well-controlled clinical studies.
4. Whether substantial evidence supported the FTC’s finding that the advertisements conveyed a misleading net impression that Aspercreme contained aspirin or provided aspirin-equivalent relief.
5. Whether the FTC could compel an affirmative disclosure that Aspercreme does not contain aspirin as a remedy reasonably related to the deception.

## Decision

- The court denied Thompson’s petition for review and affirmed the FTC’s order in full.
- The FDA’s ongoing review did not displace the FTC’s authority to police deceptive drug advertising.
- The FTC permissibly applied the “reasonable basis” substantiation doctrine to Thompson’s health-related efficacy and comparative claims.
- The requirement of at least two adequate and well-controlled clinical studies for future efficacy/comparative claims was upheld as supported by the record and consistent with the FTC’s remedial authority.
- The “no aspirin” disclosure requirement was upheld as appropriately tailored to correct the misleading impression created by the advertising.

## Legal Principles

- The FTC may regulate deceptive or misleading drug advertising even when the FDA is conducting a broad regulatory review; the agencies’ roles are not mutually exclusive.
- An advertisement may be deceptive when the advertiser lacks a reasonable basis to substantiate objective efficacy or comparative claims, particularly for health-related representations.
- The FTC may require “competent and reliable scientific evidence,” including well-controlled clinical studies, as substantiation for drug efficacy and comparative claims when warranted by the nature of the claims and the record.
- Deception analysis turns on the net impression of the advertising, including implied claims created by product names, imagery, and comparisons, not solely literal truth.
- The FTC may order affirmative corrective disclosures where necessary to prevent or remedy deception, so long as the remedy is reasonably related to the unlawful practice and not unduly burdensome.

## Conclusion

The D.C. Circuit upheld the FTC’s findings that Aspercreme advertising was misleading and insufficiently substantiated, and it sustained remedial provisions requiring two well-controlled clinical studies for future efficacy/comparative claims and a clear disclosure that the product does not contain aspirin.


Thompson Med. Co. v. FTC, 791 F.2d 189 (D.C. Cir. 1986)