FAQS
Common FDA Terms
Adverse Event
An Adverse Event is a harmful or unexpected reaction to a cosmetic product, especially when it leads to significant medical outcomes or visible damage. Serious incidents must be documented and submitted to the FDA by the Responsible Person with supporting details.
Facility
Any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.
FEI (FDA Establishment Identifier)
The FEI Identification Number is a unique number assigned by the FDA to identify firms involved with FDA-regulated products. It can be obtained at no cost and is necessary prior to registering a facility with the FDA.
Product Listing
A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
Responsible Person
The Responsible Person is the manufacturer, packer, or distributor whose name appears on the product label.
US Agent
The U.S. Agent is the person, which includes an individual or business entity, that resides in the U.S. or maintains a U.S. place of business and is physically present in the U.S.
Questions About Cosmetic Product Registration
Is anyone exempt from FDA registration?
Businesses with less than $1 million in annual U.S. cosmetic sales may qualify for an exemption from FDA facility registration and product listing. However, they are still required to fulfill responsibilities such as reporting adverse events. We highly recommend that all companies, even those exempt, voluntarily complete product and facility registration to ensure faster customs processing and smoother interactions with the FDA.
What information is needed to register my products?
- Pictures of the ingredient labels on your physical product.
- A spreadsheet file of your ingredients in descending order of predominance.
- Your manufacturing facility's FEI number.
- General information such as a contact person, address, and phone number.
When should I register my products?
MoCRA cosmetic product registration came into full effect on July 1, 2024. As a result, all cosmetic products sold in the U.S. must be registered, and new products must be registered within 120 days of their marketing. As soon as you have a tangible product with final labeling, you can proceed with FDA registration.
How often does my registration need to be renewed?
Cosmetic Product Listings need to be renewed annually, even if there are no changes to the product formula. Manufacturing facilities should be renewed biennially, or every two years.
Can I transfer my FDA compliance services from another company?
YES! Many companies choose to switch to Regicheck because of our affordable pricing and skilled service. We'll ensure that your MoCRA listings comply with FDA requirements while saving you both time and money. There is no fee for transferring your services from another provider.
For more information, please email us at: support@regicheck.com
