FDA’s Warning To Lash-Growth Firm Shows Risks In Third-Party Claims
This article was originally published in The Rose Sheet
An April 18 FDA warning letter to Lifetech Resources LLC demonstrates that cosmetics firms will be held accountable when their websites feature third-party claims and testimonials that cross into drug marketing territory.
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Just because the use of a substance in a cosmetic product, in this case prostaglandin-derivative methylamide-dihydro-noralfaprostal, has a physiological effect does not mean it's a medicinal product by function, advises the Advocate General of the Court of Justice of the EU in a recent opinion. While the opinion does not bind the CJEU to any decision, it may impact discussions elsewhere with regards to these substances, for example in the US.
Expect new faces in coming meetings of the US-based CIR’s Expert Panel for Cosmetic Ingredient Safety, which may tackle reviews of prostaglandin analogs and skin-lightening kojic acid on top of its usual slate of programmed safety assessments.
R&F will establish funds totaling $38m to put the kibosh on claims of fraud and unfair competition in US federal and state class actions, while maintaining it never intended its prostaglandin analogue-containing Lash Boost to impart drug-like structure and/or function effects on the human body. The settlement does not require R&F to stop selling Lash Boost or reformulate the product.