Under the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, FDA’s authority has been expanded with a focus on the safety of cosmetic products. This includes a requirement for the registration of facilities that manufacture or process cosmetic products distributed in the U.S. (with certain exceptions), and identifying a responsible person charged with meeting the requirements of the regulation as the manufacturer, packer or distributor, whose name appears on the cosmetic product label. Any adverse event associated with the use of a cosmetic product (death, birth defects, significant disfigurement to name a few) can trigger FDA action.
Among the key provisions MoCRA gives FDA are:
· Mandatory facility registration and product listing, including a list of ingredients in the cosmetic product
· Access to records related to a cosmetic product
· Mandatory recall authority for adulterated or mislabeled cosmetic products
· Safety substantiation, including studies, tests, research, etc.
· Product labeling requirements
· Establishing regulations for good manufacturing practices consistent with national and international standards.
Recently within the industry in general, and also within the health and safety field, cosmetics have come under closer scrutiny for consumer exposures to, and health impacts of:
· Nanomaterials in skin care products
· Metal and microbial contamination of tattoo inks
· Hair relaxers and hair straighteners
· Titanium dioxide used as a color additive in cosmetics
· Talc-containing cosmetics
· PFAS in cosmetics
· Formaldehyde in cosmetics
If you need assistance with verification that your products are safe, or the identification of potentially harmful substances in your products, please contact us on (770) 866-3200.
Materials Analytical Services’ laboratory has many years of experience in testing cosmetic products for the presence of potentially harmful chemicals and constituents in cosmetics through its Consumer and Building Products Testing Program.