The Validated Hypoallergenic Cosmetics Rating System: Its 30-year Evolution and Effect on the Prevalence of Cosmetic Reactions

Its 30-Year Evolution and Effect on the Prevalence of Cosmetic Reactions

Vermén M. Verallo-Rowell


Dermatitis. 2011;22(2):80-97. 

In This Article

"Hypoallergenic" Cosmetics

The use of the term "hypoallergenic" in cosmetics was started in the 1950s by copywriters to infer that these cosmetics produced fewer allergies than other cosmetics of the same kind. This was based on quasi-medical claims such as "absence of perfume ingredients"; "natural"; "'dermatologist-,' 'allergy-,' or 'clinically tested"'; or "safe for sensitive skin."[1] The US Food and Drug Administration (FDA) proposed in February 1974 (and issued in June 1975) its "final regulation" on the use of the claim "hypoallergenic," requiring scientific tests to show significantly lower rates of adverse reactions in human skin from the use of products with the "hypoallergenic" claim versus products without it. Two producers of hypoallergenic cosmetics—Almay (New York) and Clinique (New York)—challenged this rule in court with the charge that the FDA had no authority to issue it. The US Court of Appeals for the District of Columbia decided that the regulation was invalid because "the FDA's definition of the term hypoallergenic was unreasonable and that the Agency had not demonstrated that consumers perceive the term hypoallergenic in the way described in the regulation."[2]

In a questionnaire survey of how dermatologists view the term "hypoallergenic cosmetic," 86% responded that the concept is valuable and that they would recommend such products for atopic patients and those with fragrance or preservative allergies. However, many respondents were much less likely to do so for infants, toddlers, and elderly persons; members of different ethnic groups; those who have had cosmetic surgery; those with acne or diabetes; or those who work in occupations or environments of high allergenic risk.[3] Dermatologists obviously expect better evidence of potential benefit to their patients from a cosmetic that labels itself as able to reduce cosmetic reactions.