FDA requires every person that owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the US to submit cosmetic facility registration with FDA.
FDA also requires that for each cosmetic product, the responsible person must submit to FDA a cosmetic product listing.
Key terms under MoCRA:
CONTRACT MANUFACTURER — a facility that manufactures or processes a cosmetic product on behalf of another entity.
COSMETIC PRODUCT– a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.
DUNS NUMBER — The Data Universal Numbering System (DUNS) number is a unique nine-digit identification number issued by D&B. The DUNS Number is sites specific. Therefore, each distinct physical location of an entity (such as branches, divisions, and headquarters) may be assigned a DUNS number.
FACILITY – any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.
Excluding:
- Beauty shops and salons
- Cosmetic product retailers
- 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
FEI – FDA Establishment Identifier – It is also known as the Firm or Facility Establishment Identifier. The FEI number is a unique identifier assigned by the FDA to identify firms associated with FDA-regulated products. FDA intends to use a facility’s FEI number as the cosmetic product facility’s registration number.
MANUFACTURING OR PROCESSING OF A COSMETIC PRODUCT – means engaging in one or more steps in the making of any cosmetic product by chemical, physical, biological, or other procedures, including manipulation, sampling, testing, or control procedures applied to the product.
OPERATOR – a person who has management authority over an establishment.
OWNER – a person who has an ownership interest in an establishment.
RESPONSIBLE PERSON – the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.
SMALL BUSINESSES — means responsible persons, and owners and operators of facilities, whose average gross annual sales in the U.S. of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of certain cosmetic products:
- Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual
- Cosmetic products that are injected
- Cosmetic products that are intended for internal use
- Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.
Liberty Management Group Ltd. can help you with FDA MoCRA regulations & US Agent service.
Namrata
Regulatory Consultant
support@libertymanagement.us