FDA Adds Cosmetic Manufacturers to Import Alert for Drug Claims

The US Food & Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has re-issued Import Alert #66-38, which scrutinizes cosmetic manufacturers importing antiaging products into the United States that make drug claims. When cosmetic manufacturers are found to make drug claims on their imported cosmetic products, they are issued a regulatory letter and placed on Import Alert #66-38's Yellow List. The alert, titled "Skin Care Products Labeled as Anti-Aging Creams," was first issued on June 8, 1988.

The Yellow List names the manufacturers or suppliers of the products and places them under "intensified surveillance," which means the CDER will continue to check the manufacturer's products for drug claims until the products are in compliance.

Import Alert #66-38 was re-issued on April 1, 2010, when the CDER added 93 cosmetics products with antiaging claims and four firms to the Yellow List. These products claim to "counteract, retard or control" the aging process, as well as "rejuvenate, repair or restructure" the skin. Any additional claims related to an inner structural change in skin are also considered drug claims, reports the agency.

Some advocates, such as Benjamin L. England, founder of www.fdaimports.com, believe that the FDA is in the process of better enforcing drug claims in cosmetics. Others, such as David Steinberg, C&T magazine columnist and president of Steinberg & Associates, find that little has changed. According to Steinberg, "There have only been rumors about more warning letters going out." He noted, "It is a shame that imports are subject to more review than domestic products. How about a level playing field?"

More in Claims/Labeling