Cosmetic Regulatory Compliance Before Sale in the US

Richard Block

Aug 11, 2021 · 3 min read

In the United States of America, cosmetic products do not need to be registered with the government in order to be legally sold—but manufacturers and brands may choose to, anyway. (The rules are different if the cosmetic product also counts as a drug. In the United States, a product can be both, legally speaking. If a cosmetic is also a drug, it must comply with additional pre-sale regulations. See here for more information.)

Even though a company need not register every new product, it must make sure that facilities and processes are sanitary, ingredients are safe, labels are accurate, and directions for use are clear. Regulatory compliance in the US requires that products be unadulterated, safe, and properly labeled—and it is the Cosmetic Creator’s responsibility to ensure that they are.

One way that the Food and Drug Administration promotes this responsibility is by encouraging Cosmetic Creators to register products with the Voluntary Cosmetic Registration Program (VCRP). The more businesses and products that are registered with the VCRP, the more information the FDA has, and the better it can monitor the industry. Also, information from these filings is used in reviewing ingredient safety. More information on the VCRP is here.

If you are unsure how to register your product with the VCRP, you can seek the advice of a regulatory consultant, an agency, or even the manufacturer, in the event your cosmetic product was produced by a private label manufacturer or third-party producer.

A manufacturer or packer can register a manufacturing or packaging facility (called a “cosmetic establishment”) using Form FDA 2511. A manufacturer, packer, or distributor can register a Cosmetic Product Ingredient Statement, or CPIS (for individual products) with Form FDA 2512 (and 2512a if filing on paper). A CPIS can be changed or discontinued, also with Form FDA 2512 and continuation Form 2512A.

In countries other than the United States, the rules may differ. A manufacturer must make sure that the regulations are followed in each country where they do business. Check with the departments or ministries of health and of consumer affairs in each country where you plan to sell products, to make sure you are in the clear. The consular office nearest you of the destination country may also be able to help.

For products sold in the European Union, expert safety review must be performed prior to sale, product registration is required on the Cosmetic Products Notification Portal (CPNP), and a “Responsible Party” (resident in the EU) must be appointed. In addition to EU regulatory compliance, each EU member country may have rules that need to be followed before a cosmetic product can be sold there. See the EU website for more information.

Written by

Richard Block

Richard Block is an editorial jack-of-all-trades at Goldn

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