GRMA is Now an Independent Nonprofit Organization

GRMA is Now an Independent Nonprofit Organization

As I previously announced, I Chair the GRMA Joint Committee on the Good Manufacturing Practices for Cosmetics. I am excited to share after 4-years of hard work by so many of its members, the Global Retailer and Manufacturers Alliance ("GRMA") is now an official, independent nonprofit organization! Many major retailers, manufacturers, trade associations and certification bodies [...]

Unintentional Drug Claims on Cosmetics Not Actionable

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

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

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 [...]