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 [...]

“Handmade” Claims Next Target for Class Action Litigation?

“Handmade” Claims Next Target for Class Action Litigation?

In December 2014, Maker's Mark was hit with a putative class action lawsuit challenging its use of the claim "Handmade." According to the complaint, Maker's Mark Whisky's manufacturing process uses a mechanized and/or automated process with little to no human supervision, assistance, or involvement.  If the whiskey was originally "handmade,"  does the subsequent mechanization cause the [...]

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 [...]

Are You Ready? It’s Time to Comply with the California Air Resources Board’s New Reporting Requirements

Are You Ready? It’s Time to Comply with the California Air Resources Board’s New Reporting Requirements

  Are you ready?  It is time to comply with the California Air Resources Board’s ("CARB") new reporting requirements-- The 2013 Consumer & Commercial Products Survey.  All companies selling "chemically formulated consumer and commercial products in or into California MUST report their 2013 sales and formulation data. Under California law, CARB is authorized by law 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, [...]

Sunscreen Innovation Act Approved by President Obama

On November 26, 2014, the Sunscreen Innovation Act (S. 2141) was approved by President Obama and became law.  The Sunscreen Innovation Act is intended to streamline the process by which the FDA will review new sunscreen ingredients. The following is a summary of some of the key features of the Act: Any person may request [...]

“Unscented” Cosmetic Claims Don’t Pass “the Smell Test”

“Unscented” Cosmetic Claims Don’t Pass “the Smell Test”

A putative class action lawsuit was filed early last week against Church & Dwight, Proctor & Gamble, Revlon, Dial Corporation, and Henkel Corporation, for allegedly misleading consumers by labeling their respective deodorants as "unscented," when, per the complaint, they products all have "a noticeable and unmistakable scent." The plaintiff seeks to represent a nationwide class [...]

Protecting Your Brand Requires Zealous Policing of Your Marks—Not Just Registration

Protecting Your Brand Requires Zealous Policing of Your Marks—Not Just Registration

Having a federally registered mark does not mean your brand is safe from potential infringers. Instead, protecting your brand requires zealous policing of your marks.  As an example, in September, a European cosmetics company, Kroma EU, filed a trademark infringement suit in Florida against the Kardashian sisters alleging they began marketing a competing makeup line, [...]

Class Certified in “Organic” Cosmetic Lawsuit Against The Hain Celestial Group

Hain Celestial Group, Inc. has faced a number of lawsuits challenging the labeling and advertising of its various brands.  In fact, since 2008, Hain has faced at least seven putative class actions as well as one action by a competitor. The suits have challenged the company's use of “organic,” “natural,” “pure & natural,” “100% vegetarian,” [...]

J&J Escapes Class Action over “Restores Enamel” Claims– & FDCA Prevails

On November 4, 2014, a New York federal judge granted J&J's motion to dismiss a putative class action lawsuit which accused J&J of using false and misleading labeling to market its Listerine mouthwash.  In J&J's motion, it argued that the claims were preempted by the federal Food, Drug, and Cosmetics Act (FD&C Act). In the [...]