## Facts

- The Federal Trade Commission brought an administrative complaint under § 5 of the Federal Trade Commission Act against Pfizer, Inc. challenging advertising for its over-the-counter sunburn medication, “Un-Burn.”
- Pfizer’s advertising represented that Un-Burn would rapidly relieve sunburn pain by anesthetizing nerves in sunburned skin.
- The complaint focused on the implication that Pfizer possessed adequate scientific support for the advertised performance claims when the advertising ran, rather than primarily alleging the claims were affirmatively false.
- Pfizer asserted it had support for the claims based on internal medical staff views about topical anesthetics, review of medical literature on active ingredients, and comparison to competitors’ advertising for similar ingredients.
- The FTC concluded Pfizer did not possess competent scientific testing substantiating Un-Burn’s advertised performance claims at the time of dissemination.
- Pfizer discontinued the challenged advertisements after the complaint issued, but the FTC proceeded and issued a cease-and-desist order, which Pfizer sought to have reviewed by the full Commission.

## Issues

1. Whether making affirmative, objective product performance claims without a reasonable evidentiary basis prior to dissemination constitutes an unfair or deceptive act or practice under § 5 of the FTC Act.
2. What considerations determine whether an advertiser had a “reasonable basis” for substantiating an objective claim at the time it was made.
3. Whether advertising may be deceptive when it implies scientific substantiation exists, even without expressly stating that tests or studies prove the claim.

## Decision

- The Commission sustained the cease-and-desist order against Pfizer.
- The Commission held that making affirmative objective product claims without possessing a reasonable basis before dissemination violates § 5.
- The Commission treated objective performance claims as carrying an implicit representation that the advertiser has supporting evidence meeting reasonable consumer expectations, absent a qualifying disclosure.
- The Commission adopted a fact-specific approach to substantiation and identified multiple considerations (later known as the “Pfizer factors”) for evaluating whether an advertiser had a reasonable basis.
- The Commission concluded Pfizer’s asserted support (internal opinions, literature review, and competitor ad comparison) was insufficient for the drug-related pain-relief claims conveyed in the advertising.

## Legal Principles

- An advertiser must possess and rely upon a reasonable basis for objective product claims before disseminating them; lack of prior substantiation can violate § 5 even if the claim might later prove true.
- Objective claims may constitute implied substantiation representations: they can communicate that the advertiser has adequate supporting evidence even without stating “tests prove” or similar language.
- Whether substantiation is adequate depends on overlapping considerations, including:
  - the type and specificity of the claim;
  - the type of product;
  - the possible consequences of a false claim;
  - the degree of consumer reliance; and
  - the type and accessibility of evidence capable of supporting the claim.
- For health, safety, and drug-related efficacy claims, reasonable consumer expectations may require a valid scientific or medical evidentiary basis, and the need for rigorous testing increases with claim specificity, potential harm from error, and foreseeable reliance.

## Conclusion

The Commission held that § 5 prohibits disseminating objective performance claims without prior, reasonable substantiation and articulated a multi-factor framework for judging what evidence is required, including liability for ads that imply scientific support the advertiser does not possess.


In re Pfizer, Inc., 81 F.T.C. 23 (1972)