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FDA's Interim Final Rule on Infant Formula Standards Includes Packaging Materials

February 18, 2014

The U.S. Food and Drug Administration (FDA) published an interim final rule on standards for infant formula that includes a section on controls to prevent adulteration caused by ingredients, containers, and closures. Published in the Feb. 10, 2014, Federal Register (79 Fed. Reg. 7933), the interim final rule covers good manufacturing practices (GMPs), quality control procedures, quality factors, notification requirements, and records and reports for infant formula.

Among other things, the interim final rule would add section 106.40 to Title 21 of the Code of Federal Regulations (C.F.R.) to prevent adulteration that could result from ingredients, containers, and closures. Proposed § 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 and its use conforms to the use identified in the exemption letter;
  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.

In addition, proposed § 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.

Section 106.40 was first proposed in 1996 to implement amendments to section 412 of the Food, Drug, and Cosmetic Act on infant formula, which were passed by Congress in 1986 as part of the Anti-Drug Abuse Act. Since FDA proposed the regulations in 1996, there have been three comment periods, most recently in 2006. The interim final rule incorporates some changes based on the comments received, including identifying all substances that my lawfully be used for infant formula containers, closures, and packaging. Comments may be submitted until March 27, 2014 on the interim final rule, which currently would become effective on July 10, 2014.