Cosmetics are articles that are intended to be rubbed, poured, sprinkled, sprayed or applied to human body for cleansing, beautifying, or altering appearance.
FDA does not approve cosmetic products or companies. Facilities that are engaged in manufacturing, processing & distribution of cosmetic products are required to comply with below FDA requirements under FDA’s MoCRA regulation.
- Facility registration
- Product listing
- Label compliance
- Comply with cGMP requirements
- Safety substantiation of cosmetic products
- Adverse event reporting system
Cosmetic products and ingredients do not need FDA premarket approval. However, FDA can enforce action against cosmetic products on the market that are not in compliance with the law. It is the responsibility of cosmetic manufacturers or distributors to ensure the safety of their products.
If the FDA determines that a product is adulterated or misbranded, there are several actions the agency might take namely; criminal penalties, detention at port or file in an injunction to prevent the company from manufacturing the product.
Liberty Management Group LTD provides assistance with Cosmetic Product Registration, Cosmetic Product Listing, Label Review and other FDA regulations.
Namrata
FDA Regulatory Consultant
support@libertymanagement.us