Understand and prepare for new FDA regulations for Cosmetics companies.

MoCRA Facility Registration and Product Listing Requirements for manufacturers or responsible persons:

  • Due December 29, 2023
  • Updated within 60 days of a change
  • Annual product listing updates
  • Establishment renewal every two years
  • Electronic submissions strongly recommended

Fill out the form below to request an appointment with a subject-matter expert

FDA has recently released draft guidance on the Modernization of Cosmetics Act of 2022, commonly known as MoCRA. This guidance addresses the first of many compliance requirements for industry—cosmetic product facility registration and listing. The first submission deadline relating to MoCRA is right around the corner, on December 29, 2023 with enforcement by FDA July 2024.


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.

What is SPL?

While a paper alternative will be made available, FDA has stated that they strongly encourage electronic submission of registration and product listing information to facilitate efficiency and timeliness of data submissions and management.

SPL is an XML document markup standard approved by Health Level 7 and previously adopted by the FDA for electronic Drug Registration and Listing (eDRL)Unique Device Identification (UDI), Lot Distribution Reports (LDR) and other structured content submissions. Reed Tech has been managing SPL submissions for vendors since the FDA SPL program inception over 15 years ago.

Take the MoCRA Readiness Survey

RT - LS - 20210831 - General - Checklist Icon Blue - IMGDetermine how your regulatory compliance team will answer specifics around documentation, standard operating procedures, complaints and recalls and product data. Answering these questions will be a major indicator to gauge your strategy for compliance. We invite you to take the survey!