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MoCRA Submission Encouraged by Dec. 29, 2023; Enforcement Delayed

Nov 8, 2023 | Drug & Biologic Product Submissions, Pharmaceutical

The Food and Drug Administration (FDA)  announced today, November 8, 2023, that it will be ready to accept registration and listing information for the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by the statutory deadline of December 29, 2023 and encourages companies to meet that deadline. However, it will delay enforcement for a period of six months until July 1, 2024. FDA has also stated that it anticipates electronic submission, technical assistance documents and paper submission forms will be available in early December 2023.

As the FDA is encouraging cosmetic companies to meet the statutory deadline, we encourage you to begin working towards compliance as soon as possible. To have your questions answered or learn about Reed Tech MoCRA services, contact us at [email protected] or +1-215-557-3010.

View our recent MoCRA webinar now.

What is MoCRA?

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law on December 29, 2022. This law, which provides a major overhaul of existing cosmetic regulations, requires the Food and Drug Administration (FDA) to create Good Manufacturing Practices for all cosmetics manufacturers. The law states that these established practices must include mandatory reporting of serious adverse health events caused by cosmetic products and mandatory testing of asbestos levels. This law will also include updates to cosmetic listing requirements. Interestingly, this is the first major change to cosmetics regulations since the enactment of the Federal Food, Drug, and Cosmetic Act established in 1938.

What is a cosmetic?

The FDA defines a cosmetic as a product (excluding pure soap) intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. Some products that are seemingly cosmetics can actually be considered a drug under the law depending on the product’s intended use. The term “cosmeceuticals” is often used within industry but the FDA does not recognize such a category and the term has no meaning under law. Products commonly referred to as “personal care products” refer to a wide variety of health and beauty items, but many are governed under the definition of cosmetics.

Why Reed Tech?

As a reliable, trusted partner with unique expertise, world-class service and more than 15 years of SPL experience, Reed Tech is best positioned to support your MOCRA compliance efforts. Subject-matter experts are ready to help you meet the 12/29/23 deadline. Reed Tech expertly supports:

  • Establishment registrations and product listings for cosmetics: SPL preparation and submission via Reed Tech data collection form
  • US Agent Services for foreign-based entities

Reed Tech is an industry-leading submitter of electronic drug registration and listing information (eDRL) to FDA with nearly two decades of experience, since the conception of SPL in 2005. Questions about electronic submissions? Reach out to our subject-matter experts at [email protected] or +1-215-557-3010.