According to Angela Diesch, an attorney specializing in the cosmetics and personal care sector with law firm Greenberg Traurig, a recent import alert issued by the FDA puts the spotlight on claims made on the labels of imported skin care products in the US.
“I have previously written regarding the importance of auditing cosmetic claims to avoid crossing the line from cosmetic to drug. In January, the FDA issued an import alert, “Skin Care Products Labeled as Anti-Aging Creams” that is a good reminder for any company,” stated Diesch.
Effective anti-aging products make claims difficult
Increasingly sophisticated and effective anti-aging products mean that claims regarding efficacy now often dip into the realms of the physiological, which during the course of the last year has seen some of the biggest players in the US anti-aging skin care category get into hot water with the FDA.
Big players such as L’Oréal and Avon have both been asked to change their labeling and marketing claims on anti-aging products because anti-wrinkle claims have been judged to touch on the physiological, therefore putting them in the drug category.
According to Diesch, whether or not anti-aging claims can put a product in the drug category are often down to semantics, but either way, this is an area that has to be approached with extreme caution with regards to specific claims.
What the import alert specifies…
“There are numerous skin care products on the market with exaggerated "anti-aging" claims which cause the products to be unapproved new drugs,” the FDA import alert states.
“Examples of such claims are that the products "counteract," "retard," or "control" the aging process. Claims that the product will "rejuvenate," "repair," or "restructure" the skin may also be drug claims.”
Likewise, the document also points out that a product claiming that the molecules in an anti-aging formulation might be absorbed and then expand to “lift wrinkles upward”, is a claim that specifies a physiological change that could cause it to be classified as a drug.