FDA Warning Letter: Needling Device Exceeds Dermabrasion Exemption

FDA Warning Letter: Needling Device Exceeds Dermabrasion Exemption

On January 9, 2015, the FDA issued a warning letter to Derma Pen, LLC, claiming the company's micro-needle dermabrasion device is an adulterated and misbranded Class 1 medical device and challenging the marketing of the company's line of "cosmeceuticals" as misbranded drugs. FDA asserts that the automated micro-needling device, which uses a stamping action to [...]

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. Distinguished lawyers and regulatory experts representing the cosmetics and personal care industries will share their knowledge, experience and insight on the latest legal and regulatory developments impacting the cosmetics industry. This 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, [...]

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: Any person may request [...]

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). In the [...]