term be defined as "very unlikely to cause adverse reactions," arguing that such a definition would better facilitate economic, efficient and accurate testing by providing an objective standard chosen by the Commissioner against which a manufacturer could measure a particular cosmetic's risk of producing an adverse reaction. And in support of this argument plaintiffs compiled an impressive list of dermatologists who supported defining "hypo-allergenic" objectively. The Commissioner considered this possibility. 40 Fed. Reg. 24444 (June 6, 1975). However, he concluded that a definition which conveyed to the consumer that a particular cosmetic was safer than some other competitive products was a superior one.
This decision had the support of a number of relevant factors in the Administrative record. First was that a significantly greater number of consumers believed that "hypo-allergenic" meant "safer than competitors" rather than "very safe." Second was the fact that a comparative definition would be more helpful to consumers trying to decide what cosmetics to buy. An objective definition would not convey much meaningful information since, as the AMA's Committee on Cutaneous Health and Cosmetics noted, adverse reactions to cosmetic products are relatively rare today overall and that there is little distinction in risk of reaction among established brands. Administrative record at 1594. Therefore, under an objective definition, if one cosmetic in a particular market could qualify to use the word "hypo-allergenic," then likely all or nearly all could qualify and the usefulness of the term to consumers would disappear. Cf. 40 Fed. Reg. 24443, 24445 (June 6, 1975). A third factor was that if a manufacturer wished to convey to the consumer that a particular cosmetic was objectively safe, the rule would not prevent him from doing so. The manufacturer simply would not be able to use the word "hypo-allergenic" or similar words to this end. 40 Fed.Reg. 24444 (June 6, 1975). This being the case, manufacturers would not be substantially disadvantaged by the decision to define "hypo-allergenic" in comparative terms.
Given these three factors, the Commissioners decision to choose a comparative definition was based upon a consideration of the relevant factors and was reasonable.
Having determined that the comparative definition was the proper one, the Commissioner was then left with prescribing the mechanism by which a particular product could be tested to determine whether it could use the term "hypo-allergenic" in accordance with the comparative definition. The Commissioner chose a directly comparative test mechanism, in which a manufacturer would test his product against a number of competitors, and suggested this type of test in the proposed rule. 39 Fed. Reg. 7292 (Feb. 25, 1974). The Commissioner thereafter considered the alternative objective tests that various commenters proposed as substitutes for the proposed rule test. He determined that no objective test had been suggested which would come sufficiently close to assuring that only those cosmetics which were "less likely to produce adverse reactions than a significant number of their competitors" would be permitted to use the term "hypo-allergenic" on their labels. 40 Fed. Reg. 24444 (June 6, 1975). It is this Court's opinion, based on the foregoing, that the Commissioner's decision to retain the comparative test in the regulation was a rational and reasonable one. Plaintiffs' argument for setting this portion of the rule aside is without merit.
The second argument advanced by the plaintiffs is that the regulation is arbitrary and capricious in including within its requirements such terms as "allergy tested" and "dermatologist tested" as terms similar to "hypo-allergenic." The Commissioner took the position that these terms definitely convey to consumers that a particular cosmetic is comparatively less likely to cause adverse reactions. 40 Fed. Reg. 24450 (June 6, 1975). This conclusion of the Commissioner is supported by rational inference from the FTC survey and is nowhere refuted in the record. The Commissioner further found that the danger of confusing the consumer by the use of these terms could be eliminated by explaining the term in such a manner so as to make it objective. For example, "allergy tested" could be expanded with great ease to state "This product has been allergy tested and produced a rate of adverse reaction of ten per million consumers," making it clearly an objective rather than a comparative statement. Based upon these considerations and others, the Commissioner decided that the terms "allergy tested" and "dermatologist tested" should be subject to the requirements of the rule. This decision is, in this Court's view, reasonable and plaintiffs' argument for setting aside this portion of the regulation must also fail.
Based on all of the foregoing, the Court is of the opinion that the Commissioner has presented a rational basis for his actions which are being challenged here. This being the case, the Court finds that the regulations being challenged are not arbitrary and capricious and that they can not be set aside by the Court. See National Association of Food Chains, Inc., et al. v. Interstate Commerce Commission, et al., 175 U.S. App. D.C. 346, 535 F.2d 1308 (D.C. Cir. 1976) (decided May 18, 1976).
It is therefore this 30th day of June, 1976,
ORDERED that defendants' motion for summary judgment be, and the same hereby is, granted; and it is
FURTHER ORDERED that plaintiffs' motion for summary judgment be, and the same hereby is, denied; and it is
FURTHER ORDERED that judgment be entered for the defendants.
John J. Sirica / UNITED STATES DISTRICT JUDGE