Product Review and Registration – USA (VCRP)
Cosmetic products for commercial distribution in the United States are not subject to premarket approval by the FDA, but, in some instances, a “cosmetic” can also be a “drug” and will need to comply with both cosmetic and drug regulations. An anti-dandruff shampoo, for example, cleanses the hair (cosmetic) but also treats dandruff (drug). In this case, the product requires registration as an over-the-counter (OTC) drug in the USA.
For cosmetics, the FDA regulates (approves) color additives and prohibits or restricts other ingredients. Some states have additional, state-specific regulations that may apply (e.g. California Proposition 65 list). Cosmetic manufacturers and distributors are legally responsible to ensure that the products they place on the market are safe, contain compliant ingredients, and have been manufactured and labeled according to the regulations.
While pre-market registration of cosmetics is not currently required in the USA, companies may participate in the Voluntary Cosmetic Registration Program (VCRP). The VCRP allows companies to file information concerning their cosmetic products (ingredients, frequency of use, etc.) with the FDA. Through the VCRP, brand owners also identify the businesses engaged in manufacture and distribution. The VCRP helps the FDA fulfill its responsibility to regulate cosmetics by cataloguing safety and distribution information, and cosmetic companies benefit both from the storage of their product information on a secure FDA server, and the ability to advertise that they have provided full disclosure to the FDA. No formal approval is granted by the FDA, but knowing that a product is notified with the government increases consumer confidence.
NHP Consulting can provide you with a complete cosmetic product evaluation for the USA, including label, formula and claim compliance reviews, format your ingredient lists and warning statements, and assist with product and facility registrations (voluntary or mandatory) as applicable.