Register Formula Notice For Free

Facilities that manufacture, process, pack, or hold food that is intended for human or animal consumption in the United States must register with FDA before beginning these activities.

Any establishment, with certain exemptions, engaged in manufacturing, repacking, relabeling or salvaging drug products for U.S. distribution is required to register with FDA. Some exemptions include: Pharmacies that: Operate in conformance with local laws regulating the practice of pharmacy and medicine.

Does FDA approve infant formulas before they are marketed? No, FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements and infant formula manufacturers must notify the FDA prior to marketing a new formula.

Identifying and Reporting a Problem If you have concerns about infant formula, contact your health care provider and FDA at 1-888-INFO-FDA (1-888-463-6332), or you can file a report online at MedWatch.

Section 415 of the FD&C Act (21 U.S.C. 350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA.

Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers. All trading partners must be authorized. To be authorized, wholesale distributors and third-party logistics providers must be appropriately licensed and report licensure and other information to FDA annually.

The Federal Food, Drug, and Cosmetic Act (FFDCA) defines infant formula as "a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk" (FFDCA 201(z)).