Posted by Alimar Private Label on 5/23/2015 to Education
Good manufacturing practice (GMP) is an important factor in helping to assure that your cosmetic products are neither adulterated nor misbranded. However, while FDA has provided guidelines for cosmetic GMP (see "Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist"), no regulations set forth specific GMP requirements for cosmetics.
In contrast, the law requires strict adherence to GMP requirements for drugs, and there are regulations specifying minimum current GMP requirements for drugs [Title 21 of the Code of Federal Regulations (CFR), parts 210 and 211]. Failure to follow GMP requirements causes a drug to be adulterated [FD&C Act, sec. 501(a)(2)(B)].
Cosmetics are not subject to FDA premarket approval. It is your responsibility to ensure that your cosmetic products and ingredients are safe and properly labeled, in full compliance with the law. Registration of a cosmetic manufacturer, assignment of an establishment registration number, filing a cosmetic product, or assignment of a CPIS number does not mean that FDA has approved the firm or its products (21 CFR 710.8 and 720.9) or that a product is a cosmetic as defined in the FD&C Act.
The FDA does not certify cosmetic manufacturing facilities. The FDA does not certify cosmetics.