Medical Author: Melissa Conrad Stoppler, MD
Medical Editor: Jay W. Marks, MD
When shopping for cosmetics or skin-care products, you'll frequently see products that are labeled hypoallergenic. Implicit in this term is that these products are less likely to cause allergic reactions than other cosmetic products and that these products will be gentler or even safer for the skin than other products.
However, the U.S. Food and Drug Administration (FDA) counsels that consumers should realize that no federal standards or regulations exist governing the use of the term hypoallergenic. In other words, the decision as to whether or not a cosmetic may be labeled as hypoallergenic lies solely with the manufacturer. And this term may be applied without any demonstration or proof that the product causes fewer allergic reactions than others.
When labeling of cosmetics as hypoallergenic first became popular, the FDA attempted to regulate use of the term. In 1975, the FDA issued a regulation governing use of the term hypoallergenic, stating that a cosmetic product could be labeled hypoallergenic 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. But this regulation was subsequently declared invalid by U.S. courts, leaving manufacturers free to apply the term as they wish, without any required testing to prove that a product is hypoallergenic.
The FDA Office of Cosmetics and Colors fact sheet notes that the ingredients used to make all cosmetic products are basically the same throughout the industry. Decades ago, harsh ingredients were sometimes used that indeed caused adverse reactions in some users, but these ingredients are no longer used in the cosmetic manufacturing process. Scientific studies demonstrating that certain products or classes of products cause fewer adverse reactions than others on the basis of "hypoallergenicity" are lacking.
The bottom line is that the term hypoallergenic has very little meaning and is primarily used as a marketing tool. It's important to understand that it is impossible to guarantee that a cosmetic or skin-care product will never produce an allergic reaction. Since the FDA does require that cosmetic ingredients be listed on product labels, consumers who have had allergic reactions or problems with a specific substance can avoid purchasing products that contain these substances.