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Cell Vitals ‘Revolution’ Quelled? FDA Warns About Stem-Cell Claims

This article was originally published in The Tan Sheet

Executive Summary

Claims promoting Cell Vitals’ ReLuma skin care line render the products unapproved drugs, FDA says. Marketed as “A Revolution in Stem Cell Skin Care,” the products feature cytokines and growth factors harvested from adult stem cells that send “grow and divide” signals to aging skin cells, the firms says.

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FDA’s letter to Essential Wholesale – one of two drug claim warnings issued to cosmetics firms in November – highlights claims for non-monograph ingredients that render the firm’s offerings drugs, according to the agency. The letter followed an inspection of the company’s facility in April 2014 and a review of its website.

Antioxidant Claim Concerns In FDA Warning To Personal Care Ingredient Firm

FDA’s letter to Essential Wholesale – one of two drug claim warnings issued to cosmetics firms in November – highlights claims for non-monograph ingredients that render the firm’s offerings drugs, according to the agency. The letter followed an inspection of the company’s facility in April 2014 and a review of its website.

Rash Of FDA Warning Letters Raises Questions For Cosmetics Industry

EAS Consulting rep John Bailey, who directed FDA’s cosmetics program in the 1990s and served as PCPC chief scientist through July of 2011, offers his view on the six warning letters issued to cosmetics firms between Sept. 7 and Oct. 5. It’s too early to say whether FDA is taking a more aggressive stance on cosmetics claims, but firms “need to be aware,” Bailey says.

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