Looking Good in the Eyes of the Law: 2015 Cosmetics Compliance Seminar

Looking Good in the Eyes of the Law: 2015 Cosmetics Compliance Seminar

Join us for a day and a half legal seminar devoted to the cosmetics industry on April 17-18, 2015 in San Francisco, California. Continue reading “Looking Good in the Eyes of the Law: 2015 Cosmetics Compliance Seminar”

FDA Warning Letters: cleansers, creams, moisturizers deemed drugs by FDA

FDA Warning Letters: cleansers, creams, moisturizers deemed drugs by FDA

Under the Food, Drug, and Cosmetic Act, cosmetic products and ingredients do not need FDA pre-market approval, with the exception of color additives. As a result, FDA’s enforcement of the FDCA are taken against products already on the market.  One such enforcement mechanism is the issuance of Warning Letters.  As Warning Letters are posted, available here, I will post a summary of those letters involving cosmetic products and topical over-the-counter drug products that are often marketed by traditionally cosmetic companies (e.g., acne products, sunscreens, topical analgesics, and skin protectants).  In October and November 2014, the FDA issued 3 such letters… Continue reading “FDA Warning Letters: cleansers, creams, moisturizers deemed drugs by FDA”

Sunscreen Innovation Act Approved by President Obama

On November 26, 2014, the Sunscreen Innovation Act (S. 2141) was approved by President Obama and became law.  The Sunscreen Innovation Act is intended to streamline the process by which the FDA will review new sunscreen ingredients.

The following is a summary of some of the key features of the Act: Continue reading “Sunscreen Innovation Act Approved by President Obama”

J&J Escapes Class Action over “Restores Enamel” Claims– & FDCA Prevails

On November 4, 2014, a New York federal judge granted J&J’s motion to dismiss a putative class action lawsuit which accused J&J of using false and misleading labeling to market its Listerine mouthwash.  In J&J’s motion, it argued that the claims were preempted by the federal Food, Drug, and Cosmetics Act (FD&C Act). Continue reading “J&J Escapes Class Action over “Restores Enamel” Claims– & FDCA Prevails”