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 [...]