1. In the United States, cosmetics are regulated by the FDA Center for Food Safety and Nutrition (CFSAN). CFSAN is responsible for ensuring the safety and labelling of cosmetic products. Although the FDA approves pigment additives for use in cosmetic products, the FDA does not approve cosmetic products. It is the responsibility of cosmetic manufacturers to ensure that products are safe when used in accordance with label or normal conditions of use before selling their products. The two most important regulations for the sale of cosmetics in the United States are FD&CAct and FPLA. The FDA regulates cosmetic products in accordance with the provisions of these laws. Consult 180–2403–6508 V
Does Cosmetics Need FDA Certification Before Entering the Market?
The FDA's legal authority over cosmetic products differs from the FDA's authority over other FDA-regulated products such as drugs, biologics, and medical devices. By law, cosmetic products and ingredients do not require pre-FDA marketing approval, with the exception of pigment additives. However, the FDA can pursue enforcement actions for products on the market that do not comply with the law against businesses or individuals who violate the law.
In general, manufacturers may use any ingredient in cosmetic formulations, with the exception of pigment additives and ingredients prohibited or restricted by regulation, provided that:
Ingredients and finished cosmetic products are safe under label or under normal conditions of use
The product is properly identified
The use of this ingredient will not result in cosmetic adulteration or misuse of the brand under FDA-enforced laws
2. Does the cosmetic product need FDA registration or FDA license?
By law, manufacturers are not required to register cosmetics with the FDA or submit product formulations to the FDA, nor do they need a registration number to import cosmetics into the United States. However, FDA encourages cosmetic companies to use the online registration system to participate in FDA's Voluntary Cosmetic Registration Program (VCRP). Cosmetics manufacturers, distributors, and packagers can provide information about their products currently sold in the U.S. and register their manufacturing or packaging facility locations in the VCRP database.
Template for FDA Registration Certificate
3. The process of cosmetic FDA registration
1. The customer fills in the cosmetic FDA registration application form
2. Evaluate product information
3. Customers communicate product details and product ingredients in detail
4. Complete the registration