US FDA Provides Guidance On MoCRA Facility Registration 17 Weeks Before Deadline To Register
Registration Portal, Product Listing Go Live In October; Agency Plans Portal Test In September
FDA announces plans to make submission portal available in October for meeting registration deadlines for facilities and product listings under Modernization of Cosmetics Regulation Act. Guidance also provides more specifics on data that should be submitted to agency.
You may also be interested in...
FDA introduces Cosmetics Direct for registering manufacturing facilities and listing products, a little more than three months from registration deadlines set by new cosmetics regulations, and provides looks at the forms companies will need to submit. For now at least, the 29 December deadlines stand, notwithstanding stakeholder pressure for extensions or enforcement discretion.
Companies have concerns about how the FDA will respond if struggles to obtain data, or hiccups in the cosmetic product facility registration or listing process, lead to errors or deadline misses under the Modernization of Cosmetics Regulations Act. Attorneys from Duane Morris and Covington & Burling provide views on FDA’s related draft guidance, key challenges facing industry, and how the agency may proceed.
If the FDA reviews companies’ product information submitted under the Modernization of Cosmetics Regulations Act of 2022, which is due by 29 December 2023, and denies product listings deemed noncompliant, that could place products containing unapproved color additives and certain drug active ingredients, for example, in violation of the law.