FDA Registration of Cosmetic Manufacturing Facilities
(Thursday, August 10, 2023)
Under the Modernization of Cosmetics Regulations Acts of 2022 (MoCRA) all manufacturing facilities for cosmetics must register with FDA prior to distribution of their products in the US, however, so far, the specific procedures and requirements for this were not clarified by the FDA. For example, it is not clear who needs to register, the contract manufacturer or the distributor or both. FDA released a guidance document this week to clarify the requirements but left the most important information still missing, namely how do the manufacturers submit their registration to the FDA.
The manufacturing facility for a cosmetic product is one that manufactures cosmetic products for retail distribution in the US. The facility could be located anywhere in the World. Beauty shops and salons, retailers, hospitals, physician offices, public health agencies, other public entities such as hotels or airlines that might distribute cosmetic products as gift items, or re-packagers or re-labelers of cosmetic products do not need to register even if they make slight changes to the product. Interestingly, testing labs that test cosmetic products must register with the FDA. But small businesses defined as those with an annual revenue of less than $1 million are exempt from registration unless they manufacture cosmetic products that used in eyes such as eye liners, injected cosmetic products, internal use products, or products that are intended for continual use more than 24 hours.
An eligible facility needs to register once irrespective of how many products it manufactures or whether the manufactured products are for direct sales or for another party as a contract manufacturer. The registration will identify the owner of the facility, address, owner, contact information for the responsible person, and list all products manufactured. Additional information such as website, images of the label, use environment for the product such as home use, self-use or professional use only, and ingredient list is also needed. Most of the product and contact information will not be publicly disclosed by the FDA. The FDA will not charge a fee for registration.
The guidance does not provide information about what forms to fill, the format for the registration information or the web link for where to submit the information. Information on how to submit the registration information to the FDA is expected in the near future. For now, cosmetic manufacturers can start collecting and collating information needed per the guidance document in preparation for the upcoming facility registration.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC