Busy “Warning Letters” Month for Cosmetics

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 [...]

More FDA Warning Letters: Strong Enforcement Continues in 2015

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 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 [...]

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, [...]

Cosmetic? Drug? How Puffery May Cause Your Product to be a Drug

The post "When Puffery Crosses the Line" discussed the basic tenets of puffery, or seller's puff, in cosmetic advertising.  In addition to running the risk that advertising claims may fall into the realm of false advertising, classic cosmetic puffery may also cause a cosmetic to be a drug under the Federal Food, Drug, & Cosmetic [...]