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 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.

Continue reading “Unintentional Drug Claims on Cosmetics Not Actionable”

Even More July Warning Letters…

Even More July Warning Letters…
  1. Today the FDA posted an additional 5 warning letters issued at the end of July to cosmetics companies addressing drug claims. The letters were issued to:  MiN New York;  Lavian Ltd.; Peter Thomas Roth Labs, LLC; TPR Holdings LLC; and Finally Pure, LLC. The challenged claims were very similar to those claims addressed in the other warning letters issued earlier in the month as discussed in my earlier post here.

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 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”

FTC Challenges “All Natural” & “100% Natural” Claims

FTC Challenges “All Natural” & “100% Natural” Claims

On April 12, 2016, the Federal Trade Commission (FTC) announced agreements with four cosmetics companies to settle charges by the FTC that the companies falsely advertised their products as “all natural” or “100% natural” even though their products contained synthetic ingredients.  The FTC also issued a complaint against a fifth company. If you have attended one of my presentations, it is likely you have heard me speak extensively on this subject and FTC’s announcement last week would have come as no surprise.  Continue reading “FTC Challenges “All Natural” & “100% Natural” Claims”

“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 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”

Claim Substantiation– Who’s Responsibility is it?

Claim Substantiation– Who’s Responsibility is it?

Although regulatory actions regarding cosmetics products generally involve the finished product cosmetics manufacturer or marketer, scrutiny in other industries by the FDA, the FTC, and the National Advertising Division (“NAD”) against suppliers provides a valuable warning. In particular, although a supplier is generally not the entity advertising directly to the consumer purchasing a cosmetics product, recent regulatory actions show that claims by ingredients suppliers must meet the same level of scrutiny as the finished products being presented to consumers at the retail shelf. Suppliers, manufacturers, and marketers are responsible for checking the facts first.  Blindly relying on upstream supplier claims can lead not only to regulatory action, but also indemnity claims resulting from consumer lawsuits.  Continue reading “Claim Substantiation– Who’s Responsibility is it?”

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. Continue reading “Looking Good in the Eyes of the Law: 2015 Cosmetics Compliance Seminar”