A U.S. Agent is 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.

A Responsible Person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the cosmetic label.

A U.S. Agent can act as the Responsible Person only if they are the manufacturer, packer, or distributor of the cosmetic product listed on the label.

Yes, companies based outside the U.S. can be the Responsible Person.

Facility Registration must occur within 60 days of first engaging in the manufacturing or processing of cosmetic products for the U.S. market. Product Listing Registration must occur within 120 days of marketing the product in the U.S.

All companies that sell cosmetic products within the United States are required to register. Exemptions (https://www.unitedsafetyagents.com/mocra-exemptions)include meeting the definition of a small business and do not sell any of the non-exempt products, and products that are required to register for Drugs and Devices under chapter V of the FD&C Act.

A cosmetic facility includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the U.S. A facility does not include any of the following: - Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location; - Cosmetic product retailers, individual sales representatives, direct sellers, retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location; - Hospitals, physicians' offices, and health care clinics; - Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer; - Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services; - Trade shows and other venues where cosmetic product samples are provided free of charge; - An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale - An establishment that solely performs one or more of the following with respect to cosmetic products: - Labeling, - Relabeling, - Packaging, - Repackaging, - Holding, -Distributing.

All facilities that manufacture or process cosmetic products for distribution in the U.S. are required to register. Exemptions (https://www.unitedsafetyagents.com/mocra-exemptions)include meeting the definition of a small business and facilities that are required to register for Drugs and Devices under chapter V of the FD&C Act.

An FEI Number or a FDA/Firm Establishment Identifier is a unique identifier assigned by the FDA to identify firms associated with FDA-regulated products.

An FEI number is required to submit a Facility Registration. FDA uses a facility's FEI Number as the cosmetic facility's registration number.

FDA provides a two week timeline to provide an FEI Number for your facility.

A Certificate of Registration confirms FDA's approval of Cosmetic Facility Registration or Product Listing Registration and names USA as your company's appointed U.S. Agent. The Cosmetic Facility Certificate of Registration is tied to the Facility's FEI number. The Product Listing Certificate of Registration is tied to the Responsible Person and includes Product Listing numbers for every product registered.

In order to sell/distribute your products, many cosmetic buyers, cosmetic brokers and other businesses in the cosmetic industry require proof of MoCRA Registration. Share this Certificate with all parties and secure for your records as part of the MoCRA Records Maintenance requirements.

A serious adverse event is one that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection, significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended or under conditions of use that are customary or usual.

As your company's U.S. Agent, USA will help facilitate communication between your company and the FDA. Once the Responsible Person notifies USA of the Serious Adverse Event, our Agents will provide you with the proper forms and information to be completed and delivered to the FDA.

Reach out to USA immediately. The FDA expects to receive information regarding the Serious Adverse Event no later than 15 business days after such information is received by the responsible person.

Yes, registration requires annual renewal regardless of any changes.

Yes, there are exemptions. To be exempt from MoCRA registration, your company must be a small business and does not produce cosmetic products that fall into the non-exempt list. Additionally, a facility and/or product that is subject to drug facility registration and drug and drug devices registration under Chapter V of the FD&C Act, are exempt from MoCRA registration. Learn more about MoCRA Registration exemptions.(https://www.unitedsafetyagents.com/mocra-exemptions)

Yes, the Responsible Person for each product provided for a trade show as a free sample or a gift is required to submit a Product Listing Registration.

As long as each of the items within the Multi-Item Kit have their own Product Listing submission, the Multi-Item Kit does not need to be submitted as a unique item.

Products that share the same base formulation but differ only by color, fragrance, or flavor must each be submitted separately under Product Listing Registration. Each variation will receive its own unique Product Listing number.