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, […]

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).