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FDA Releases MoCRA Draft Guidance

Aug 9, 2023 | Drug & Biologic Product Submissions, Pharmaceutical and Cosmetics

On August 7, 2023, the Food and Drug Administration (FDA) released draft guidance providing recommendations and instructions pertaining to the collection and submission of information related to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), specifically, to assist persons submitting cosmetic product facility registrations and product listings to FDA.

According to FDA, the draft guidance, “Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry,” describes MoCRA requirements for facility registration and product listing, and the exemptions under MoCRA for certain small businesses. Under MoCRA, submission of information about existing cosmetic product facilities and products is required no later than Dec. 29. Facility registration information is to be updated within 60 days of a change and registration to be renewed every two years. Additionally, any updates to a product listing, such as a change in product ingredients, are to be provided annually.

The draft guidance states that the information cosmetic companies had entered into the voluntary cosmetics registration program (VCRP), which ended on March 27, 2023, will not be transferred into the new electronic registration system. The information previously submitted to the VCRP differs from that required by MoCRA and therefore, would not satisfy the requirements.

Notably, 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.

The FDA has noted that they will be accepting comments on the draft guidance until September 7, 2023.

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.

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.