The FDA issues update on cosmetics marketed as drugs

The FDA issues update on cosmetics marketed as drugs

The US Food and Drug Administration has issued a warning to cosmetics companies that use unrealistic promises to market their products.

The FDA issues an update on its website today warning cosmetics companies against making unsubstantiated claims which would require their products to be classified as drugs, rather than cosmetics.

A product is considered to have the properties of a drug if it claims to change the body’s structure or functions, or is used to treat or prevent disease.  Examples include anti-ageing products that are marketed as promoting collagen production or hair products that are said to stimulate growth.

FDA has issued warning letters  to brands selling topical skin care, hair care, and eyelash/eyebrow preparations, highlighting product labelling and descriptions on websites. In its warning letters, the agency instructs companies to remove any drug claims from their product descriptions or seek FDA approval to market such products as drugs.

Companies which have recently been targeted by the FDA over this issue include L’Oreal, Strivectin, Hemp Oil Care and Natural Organic Solutions.

Linda Katz, Director of FDA’s Office of Cosmetics and Colors, said, “Consumers need to know that these drug claims have not been proven to FDA when they are making a decision to purchase one of these products. These products must be evaluated by FDA as drugs before the companies can make claims about changing the skin or treating disease.”

US federal law defines a cosmetic, in part, as a product designed for “cleansing, beautifying, promoting attractiveness, or altering the appearance.” Unlike drugs, the law does not require FDA approval of cosmetics before they go on the market.

According to Katz, many companies have crossed the line between saying that their products will enhance a person’s appearance to stating that they will make structural changes to the skin, and even prevent or treat certain medical conditions, such as acne, rosacea, eczema, and psoriasis.

Katz adds that FDA has been tracking claims made about cosmetic products for several years and has seen a proliferation of unlawful claims on the Internet and on product packaging. “You walk into a store and see shelves of wonder products. If they’re going to be making drug claims, the products need to be evaluated as drugs,” she commented.

If companies fail to comply, FDA may take additional action beyond a warning letter, which could include removal of a product from the market.

Some products are both cosmetics and drugs. Examples include anti-dandruff shampoos and antiperspirant-deodorants, as well as makeup with SPF (sun protection factor) numbers. They must meet the requirements for both cosmetics and drugs, as applicable.

 

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