FDA RAISES WARNING FLAGS FOR MARKETING OF CBD PRODUCTS

Happy New Year! 2019 was quite the year in many regards. One such area was the significant growth of the CBD marketplace. In response, in the last quarter of the year, the Food & Drug Administration (“FDA”) got busy issuing warning letters and posting consumer notices regarding the safety and use of cannabidiol ("CBD"). For [...]

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 [...]

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 [...]