Unintentional Drug Claims on Cosmetics Not Actionable

Last month, a long running case against Beiersdorf, Inc., makers of Nivea, was dismissed.  I would normally prepare a summary myself, but in this case, the first 3 paragraphs of the court’s opinion provides a great summary: Five years ago, Ashley Franz purchased a $10 bottle of Nivea’s Skin Firming Hydration Body Lotion from a […]

Busy “Warning Letters” Month for Cosmetics

In July, the U.S. FDA issued four warning letters to cosmetics companies.  Although only two were prepared by the same office, there were consistent themes across the four letters.  As previously discussed here, the FDA continues to crack down on companies making what amount to drug claims on various “cosmetic” products.  But what companies need […]

FDA Seeks Public Input on the Term “Natural” for Food Products

The U.S. Food and Drug Administration (“FDA”) announced the establishment of a docket to receive information and comments from the public on the use of the term “natural” in food labeling.  The FDA’s action is in response to 3 citizen petitions asking that the FDA define the term “natural” and 1 citizen petition asking the […]

“Personal Care Products Safety Act” S. 1014: Proposed Legislation that will Have a Huge Impact on the Cosmetics Industry if Enacted

On April 20, 2015, Senators Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) introduced the Personal Care Products Safety Act (S. 1014).  This post provides a summary of keys sections of the proposed bill with a comparison to existing law. According to the press release issued by Senator Feinstein’s office, the S. 1014 has the support of […]

More FDA Warning Letters: Strong Enforcement Continues in 2015

Traveling to and attending various conferences has prevented me from posting for a couple weeks. So although I have not had time to blog, there has been much to write about– including the latest round of FDA Warning Letters.  In February and March alone, the FDA has issued at least 5 Warning Letters challenging the drug claims […]

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).