FDA definition
of "Hypoallergenic"
Text copied directly from the FDA web site http://www.cfsan.fda.gov/~dms/cos-224.html
Hypoallergenic cosmetics are products that manufacturers claim produce fewer allergic reactions than other cosmetic products. Consumers with hypersensitive skin, and even those with "normal" skin, may be led to believe that these products will be gentler to their skin than non-hypoallergenic cosmetics.
There are no Federal standards or definitions that govern the use of the term "hypoallergenic." The term means whatever a particular company wants it to mean. Manufacturers of cosmetics labeled as hypoallergenic are not required to submit substantiation of their hypoallergenicity claims to FDA.
The term "hypoallergenic" may have considerable market value in promoting cosmetic products to consumers on a retail basis, but dermatologists say it has very little meaning.
Below is a 1978 FDA Consumer magazine article that provides additional information on the term "hypoallergenic".
(A Federal court has struck down an FDA regulation requiring cosmetic manufacturers to conduct tests to back up any claim that a product is "hypoallergenic." The decision means the term has no real meaning in the marketplace, but the list of ingredients now required on cosmetics can help consumers determine if there is any significant difference between "hypoallergenic" products and competing brands that don't make this claim.)
Ever since the days when "She's lovely, she's engaged, she uses Ponds" became one of the best known advertising slogans in America, cosmetics manufacturers have pursued consumers with promises of everything from new beauty to a new lifestyle. Indeed, with cosmetics--perhaps more than with any other type of product--promotion is the key to sales success. Recognizing this, manufacturers have used a wide variety of appeals to break into or increase their share in this lucrative market.
For many years, companies have been producing products which they claim are "hypoallergenic" or "safe for sensitive skin" or "allergy tested." These statements imply that the products making the claims are less likely to cause allergic reactions than competing products. But there has been no assurance to consumers that this actually was the case.
For the past four years, the Food and Drug Administration has been working to clear up this confusion of claims by establishing testing requirements that would determine which products really are "hypoallergenic." But late last year, the U.S. Court of Appeals for the District of Columbia ruled that FDA's regulation defining "hypoallergenic" was invalid. This means there is now no regulation specifically defining or governing the use of the term "hypoallergenic" or similar claims. And because of the lengthy procedural steps required to establish a new regulation, that is likely to be the situation for some time to come.
Where does that leave consumers?
Consumers concerned about allergic reactions from cosmetics should understand one basic fact: there is no such thing as a "nonallergenic" cosmetic--that is, a cosmetic that can be guaranteed never to produce an allergic reaction.
But are some cosmetics less likely to produce adverse reactions than competing products?
By and large, the basic ingredients in so-called "hypoallergenic" cosmetics are the same as those used in other cosmetics sold for the same purposes. Years ago, some cosmetics contained harsh ingredients that had a high potential for causing adverse reactions. But these ingredients are no longer used. FDA knows of no scientific studies which show that "hypoallergenic" cosmetics or products making similar claims actually cause fewer adverse reactions than competing conventional products.
FDA's ill-fated regulation on "hypoallergenic" cosmetics was first issued as a proposal in February 1974. It said that a cosmetic would be permitted to be labeled "hypoallergenic" or make similar claims only if scientific studies on human subjects showed that it caused a significantly lower rate of adverse skin reactions than similar products not making such claims. The manufacturers of cosmetics claiming to be "hypoallergenic" were to be responsible for carrying out the required tests.
Numerous comments on the proposal were received from consumers, consumer groups and cosmetic manufacturers. Some people urged a ban on the use of the term "hypoallergenic" on grounds that most consumers don't have allergies. Others suggested that the term be banned because allergic individuals cannot use "hypoallergenic" products with any assurance of safety. A number of cosmetic manufacturers complained about the requirement for product comparison tests to validate claims of hypoallergenicity. Among other things, they said the tests would pose an undue economic burden on them.
In responding to the comments, FDA pointed out that the proposed regulation was not intended to solve all problems concerning cosmetic safety. The primary purpose of the regulation, the Agency said, was to clear up confusion about the term "hypoallergenic" and to establish a definition that could be used uniformly by manufacturers and understood by consumers.
FDA issued its final regulation on "hypoallergenic" cosmetics on June 6, 1975. Although the final regulation did require comparative tests, procedures for carrying out the tests were changed to reduce the costs to the manufacturers.
The new regulation was quickly challenged in the U.S. District Court for the District of Columbia by Almay and Clinique, makers of "hypoallergenic" cosmetics. The two firms charged that FDA had no authority to issue the regulation, but the court upheld FDA.
The firms then appealed to the U.S. Court of Appeals for the District of Columbia, which ruled that the regulation was invalid. The appeals court held that FDA's definition of the term "hypoallergenic" was unreasonable because the Agency had not demonstrated that consumers perceive the term "hypoallergenic" in the way described in the regulation.
As a result of the decision, manufacturers may continue to label and advertise their cosmetics as "hypoallergenic" or make similar claims without any supporting evidence. Consumers will have no assurance that such claims are valid.
However, cosmetics users who know they are allergic to certain ingredients can take steps to protect themselves. FDA regulations now require the ingredients used in cosmetics to be listed on the product label, so consumers can avoid substances that have caused them problems.
Margaret Morrison is a staff writer with FDA's Office of Public Affairs.
U.S. Food and Drug Administration
FDA CONSUMER, April 1978
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