ESI’s international technical team provides consulting services to the Cosmetic Industry to adapt to regulatory developments in the EU and North America, with support for FDA Registration, Training, and 1st and 2nd Party Audits.

The new requirements set by the U.S. FDA for cosmetic companies

The U.S. FDA, through a guidance titled “Cosmetic Good Manufacturing Practices” issued in June 2013, initiated a process of harmonizing its regulations with ISO 22716:2008 for Cosmetic GMPs.

In December 2022, the United States ratified the Modernization of Cosmetics Regulation Act (MoCRA), which extends the regulatory authority of the U.S. Food and Drug Administration (FDA) to cosmetic companies, introducing many significant changes that involve the application of a range of new regulations for companies that manufacture and distribute cosmetics in America.

Some of these new regulations will come into effect as early as 2023.

According to MoCRA, a “facility” refers to any establishment that produces or processes cosmetic products distributed in the United States. Such establishments must comply with the FDA’s GMPs.

The FDA is tasked with establishing regulations that will impact the entire lifecycle of cosmetics, from production to marketing. The new requirements include several obligations:

  • Mandatory FDA Registration for companies involved in Import, Export, Production, Storage, and Distribution, starting from December 2023;

  • Mandatory appointment of a “Responsible Person”;

  • Requirements for maintaining records on Safety of Ingredients used, Adverse Events, Implementation of GMPs, establishing a Recall Plan, Labeling, declaration of allergens in fragrances, etc.

Companies will need to update label information to include:

  • A U.S. address;
  • A U.S. phone contact or an email address where the “Responsible Person” can receive adverse event reports.
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