FDA warning letters focus on unintentional drug claims for cosmetics

A crop of FDA warning letters have been sent to a number of companies in recent weeks warning about unintentional drug claims, which according to one law expert underlines the need to audit product claims.

Three warning letters have been sent out in recent weeks by the FDA, and although the companies are mainly focused on medicated topical products, the warnings still need to be heeded by cosmetic and personal care companies, says Angela Diesch, an attorney at GreenbergTraurig, a California-based practice.

“While they may not be addressed to “cosmetic” companies, they are a good reminder of the importance of auditing label, marketing, and advertising claims,” said Diesch.

Warning letters went out to medical-related skin care providers

The warning letters went out to Health Care Products, Diabetes Division, concerning two of its Zostrix skin care products, Anastasia Marie Laboratories for its Diapedic treatment and The Magni Group for a number of medicated skin care products, to treat shingle-, diabetic- and other medical related skin care issues.

Having reviewed marketing and advertising claims related to these products, the FDA sent out warning letters stating that some of the product claims violated The Federal Food, Drug and Cosmetic Act, with specific reference to drug claims that might pertain to the diagnosis, cure, mitigation, treatment or prevention of disease.

“Disease is any condition of the body— for example, wrinkles due to aging, dryness, skin damage due to sun exposure,” said Diesch.

“On the other hand, a ‘cosmetic’ is defined as an article intended to be ‘rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance’.”

FDA warning letters focused on anti-aging claims last year

Towards the end of last year, the FDA cracked down on product claims relating to a number of major anti-ageing brands, with companies such as Avon, L’Oreal and Janson Beckett amongst the biggest players to be targeted over claims that their products can help treat wrinkles.

The FDA is especially keen to point out that companies marketing anti-aging products avoid making claims that such treatments can have a physiological impact on the body or the appearance, which according to its definition of a cosmetic product, gives it a drug claim.

“Claims that the product will ‘rejuvenate,’ ‘repair,’ or ‘restructure’ the skin may also be drug claims. A claim such as ‘molecules absorb and expand, exerting upward pressure to lift wrinkles upward’ is a claim for an inner structural change that would usually cause a product to be a drug,” stated Diesch.