Does the FDA approve cosmetics before they go on the market?
Cosmetic products and ingredients are not subject to FDA or Health Canada premarket approval authority (with the exception of color additives). However, the safety and efficacy claims can be subject of scrutiny by the FDA after the cosmetic product has been marketed.
Are cosmetic clinical testing labs subject to FDA accreditation?
The answer is simply no. Currently neither the FDA, nor Health Canada, provide an accreditation or registration for laboratories performing clinical testing of cosmetic / personal care products.
“Testing labs should comply with Good Laboratory Practices (GLPs) when conducting testing on FDA regulated products but the FDA does not accredit testing labs per say” confirms Mr. James H. Hartten, a senior public affairs and regulatory analyst at Arent Fox LLP.
Why is there so much confusion then?
The answer may lie in misinformation. It is true that entities performing analytical testing of regulated products may be registered (and in some instance must be register) with the FDA and Health Canada. Although the registration cannot apply to clinical testing of cosmetic products, certain entities use the “FDA registered” or “FDA approved” claims indiscriminately, without specifying what is actually approved.
How does Evalulab conform to regulatory guidelines?
All clinical studies at Evalulab are performed by qualified professionals applying recognized scientific protocols – in full compliance with the current guidelines for Good Clinical Laboratory Practice (GCLP) and the FDA and Health Canada guidelines for regulated products (eg. sunscreens). Our mission is to provide you the tools and the guidance to substantiate your claims with truthful scientific data. Please contact me via phone at 514-735-3253 or e-mail at ekulig@evalulab.com if you require additional information.
Additional information can also be found at:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm
