Court Dismissals of “Made in USA” Class Actions

Two cases involving allegations that companies falsely labeled their products as "Made in USA" and thereby violated California's "Made in USA" statute have recently been dismissed.  In April, the Southern District Court of California dismissed all claims against Heinz.  Then, earlier this month on June 6, the Central District Court of California dismissed all claims against Stearn's Products.  [...]

Going to Expo West? If so, join me for The Future of: Nanos, Naturals, and the Direction of Other No-Nonsense Claims in Cosmetics

Expo West in Anaheim is only a week away! Whether you are going as an exhibitor or simply plan to walk around, network, and browse, I hope you can join me for my presentation:  The Future of: Nanos, Natural, and the Direction of Other No-Nonsense Claims in Cosmetics.  In this informative and interactive session we will discuss [...]

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, [...]

“Organic” Cosmetics? A Response

Earlier this week, I saw a Twitter feed for a story published by The Associated Press called "The meaning of 'organic' hazy for nonfood items." I decided it may be helpful to provide a response--at least as to cosmetics --about a few things mentioned in the article. First, agricultural products, which comply with the NOP, may [...]

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 [...]

When Puffery Crosses the Line

“Puffery,” or "seller's puff," is an exaggerated or over the top general promotional statement that a reasonable person would not take literally. For example, the claim that “Lilly's Magic Lotion is the best lotion on the market”  would be considered puffery. The claim that the lotion "is the best" is general and a court would find [...]