Certificate FDA Registration For Cosmetics: U.S. Legal Compliance

When businesses wish to sell cosmetic products in the U.S., they must comply with the United States Food and Drug Administration (FDA) regulations. One of the most common processes is FDA registration. However, understanding the certificate FDA registration can be challenging. In this article, UCC will explore what this certificate is, its contents, and important considerations for businesses looking to comply with FDA requirements.

1. What is an FDA Registration Certificate for Cosmetics?

After the registration process is approved, the FDA does not provide an official certificate. However, businesses will receive an FDA Establishment Identifier, which serves as a unique reference for their registration. Additionally, the U.S. Agent will provide an official certificate to confirm that the production facility has completed the registration. This certificate, in turn, helps businesses prove their registration validity to partners and authorities when necessary.

Furthermore, food manufacturers and processors must register their facilities with the FDA and renew this registration every two years. Therefore, the FDA registration certificate serves as confirmation that the product has been registered with the FDA.

2. Information Included on the FDA Cosmetic Registration Certificate

The FDA Certificate verifies a company’s compliance with FDA regulations and serves as official confirmation of its registration. Specifically, key details on the certificate include:

• Title: “Certificate of FDA Registration.”
• Company Name & Address: The full name and address of the company or cosmetic manufacturing facility.
• Registration Information: FDA Establishment Identifier (FEI), FDA Registration Number, U.S. Agent Registration Number.
• Effective & Expiration Dates: Validity and renewal dates of the registration.
• Certificate Number: A unique tracking number.
• Signature: The signature of an authorized FDA representative or the U.S. Agent.
• Notices: Responsibilities of the involved parties and legal notices.
• Logo: The U.S. Agent company logo.
• Contact Information: Details for the issuing authority of the certificate.

3. Important Notes to Remember

• The Certificate FDA Registration For Cosmetics is issued by the U.S. Agent, as opposed to being issued directly by the FDA.
• FDA registration does not equate to product approval: Registering with the FDA does not mean the FDA has approved the individual cosmetic product. Rather, it simply confirms that the manufacturing facility complies with FDA regulations.
• MoCRA and Exemptions: The Modernization of Cosmetics Regulation Act (MoCRA) provides certain exemptions for small businesses. However, these exemptions do not apply to manufacturers of products that:
  • Frequently come into contact with the eye mucous membranes (e.g., eye makeup).
  • Are injected (e.g., injectable beauty treatments).
  • Are for internal use (e.g., ingestible beauty products).
  • Change the appearance for more than 24 hours without removal being part of normal use (e.g., extended-wear or semi-permanent makeup)

4. UCC’s Role in FDA Registration

Furthermore, UCC ensures comprehensive, cost-effective solutions with no hidden fees, ultimately saving businesses both time and money. As an official U.S. representative, UCC also offers optimal pricing that is specifically tailored to customer needs. In addition, the company focuses on quick processing times, responsive communication, and efficient solutions, all of which are crucial in helping businesses meet regulatory requirements.

Should you have any inquiries regarding the FDA or U.S. representation, please feel free to contact UCC at +13 607 398 022 for a more detailed consultation.