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 are working together as the GRMA to develop consensus-based American National Standards for Good Manufacturing Practices (GMPs) in several industries. NSF International, an ANSI-accredited standards development organization (SDO), is facilitating the ANSI standards development process on behalf of the GRMA. Continue reading “GRMA is Now an Independent Nonprofit Organization”
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 CVS in San Diego. She spent an extra $4 on this Lotion because she believed the claim on the bottle: “Improves Skin’s Firmness in as little as 2 weeks.” When the Lotion didn’t firm her skin as advertised, she filed a class action against Beiersdorf, Inc. (“Nivea”) for false advertising and for selling an unapproved drug.
About a year ago, the Court dismissed Franz’s false advertising claim, and found the FDA had primary jurisdiction to decide if the Lotion was a drug. The Court stayed the case to allow Franz to petition the FDA to take enforcement action against Nivea for making skin-firming claims that Franz maintains makes the Lotion a drug that requires FDA approval. The FDA declined to take any action.
Franz filed a second amended complaint based on a single claim: Nivea is engaged in unfair competition because it’s selling the Lotion as an unapproved drug. Nivea moved to dismiss. Because the Court lacks jurisdiction, it dismisses the complaint.
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 to also be aware of, is that groups of plaintiffs’ attorneys are also beginning to get in the game by sending class action litigation threat letters to companies based on the same marketing claims. While an FDA warning letter may result in a company having to change its marketing and labeling, a class action litigation threat often also results in a payment of “attorneys’ fees” to the plaintiffs’ attorneys lest they will file suit– and even if the company has already agreed to make revisions to its labeling and marketing. Continue reading “Busy “Warning Letters” Month for Cosmetics”
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 FDA to prohibit use of the term on food labels, as well as requests by multiple Federal courts sought administrative determinations from FDA, in conjunction with litigation between private parties, regarding whether food products containing GMO ingredients or particular ingredients, e.g., high fructose corn syrup, may be labeled “natural.” Continue reading “FDA Seeks Public Input on the Term “Natural” for Food Products”
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 numerous industry trade and consumer groups, including the following: Continue reading ““Personal Care Products Safety Act” S. 1014: Proposed Legislation that will Have a Huge Impact on the Cosmetics Industry if Enacted”
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 on various cosmetic products. Below is a table summarizing each letter and the challenged claims. Notably, unlike prior Warning Letters, some of the challenged claims and statements are not as egregious as those previously challenged by the FDA. Is this an indication the FDA is beginning to cracked down more on the cosmetics industry’s willingness to play fast and loose with their marketing claims? Continue reading “More FDA Warning Letters: Strong Enforcement Continues in 2015”
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. Continue reading “FDA Warning Letter: Needling Device Exceeds Dermabrasion Exemption”