Skip to main content

FDA Issues Final Rule on Infant Formula Standards; Includes Packaging Materials

The U.S. Food and Drug Administration (FDA) issued a final rule on "Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula" (see 79 Federal Register 33057 (June 10, 2014)). This final rule affirms certain changes made to FDA's regulations by the Interim Final Rule (IFR) of the same name,published Feb. 20, 2014 in the Federal Register, and provides modifications and clarifications to other provisions set out in the IFR.

Among other things, the Interim Final Rule added section 106.40 to Title 21 of the Code of Federal Regulations (C.F.R.) to prevent adulteration of infant formula that could result from ingredients, containers, and closures. Section 106.40(b) specifies that a substance may be used as "packaging material that comes in contact with an infant formula" if it is:

  1. The subject of a food additive regulation and is used consistently with the authorized conditions of use of that regulation;
  2. The subject of an effective Food Contact Notification (FCN) and is used consistently with the authorized conditions of use in that FCN;
  3. Exempt from regulation as a food additive under FDA's Threshold of Regulation rule and its use conforms to the use identified in the exemption;
  4. Generally recognized as safe (GRAS) for use in or on infant formula or for use in infant formula packaging;
  5. Authorized by a prior sanction by FDA or the U.S. Department of Agriculture (USDA); or
  6. Not a food additive because it is not reasonably expected to become a component of food or otherwise affect the characteristics of food.

Futhermore, section 106.40(d) requires infant food manufacturers to develop written specifications for ingredients, containers, and closures and procedures to determine if the specifications are met.(For more information on the IFR, see the article, FDA's Interim Final Rule on Infant Formula Standards Includes Packaging Materials.)

The Infant Formula Act of 1980 created section 412 of the Food, Drug, and Cosmetic Act. As part of the Anti-Drug Abuse Act of 1986, section 412 was amended to address concerns related to the sufficiency of quality control testing, current good manufacturing practices, recordkeeping, and recall requirements for infant formula. This final rule completes implementation of the provisions of the 1986 amendments.

The rule becomes effective July 10, 2014, with a compliance date for requirements related to quality factors for eligible infant formulas of November 12, 2015 and a compliance date for the remaining provisions of September 8, 2014.