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Modernization of Cosmetics Regulation Act (MoCRA)

Modernization of Cosmetics Regulation Act (MoCRA) is the 2022 US law that gave FDA its biggest expansion of cosmetics authority since 1938, adding facility registration, product listing, adverse event reporting and safety substantiation.

2022 US federal Enforced by FDA Public Law 117-328, Division FF, Title III

What it requires

Facilities that manufacture or process cosmetics for US distribution must register with FDA and renew every two years, and the responsible person, usually the brand on the label, must list each product and update listings annually. Responsible persons must report serious adverse events within 15 business days, keep safety substantiation records, and since December 2024 include domestic contact information on labels for adverse event reports. FDA gained mandatory recall authority. Good manufacturing practice rules had not been finalized as of 2026.

Why it matters

MoCRA makes cosmetics brands that sell online formal FDA-regulated responsible persons with label and reporting duties. A label missing a US address, phone number or website for adverse event reports is noncompliant, and imports can be held. For example, a Korean skincare brand selling through its own site and a US 3PL is the responsible person and must list products with FDA and print a domestic contact on labels, while the 3PL should be able to trace lots if FDA orders a recall.

Related laws

Sources

  1. FDA: Modernization of Cosmetics Regulation Act of 2022 (MoCRA) fda.gov

Not legal advice.