(a) The criteria in subpart B of this part describe the labeling requirements applicable to infant formula under section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 343). Failure to comply with any regulation in subpart B of this part will render an infant formula misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act.

(b) The criteria in subpart C of this part describe the terms and conditions for the exemption of an infant formula from the requirements of section 412(a), (b), and (c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(a), (b), and (c)). Failure to comply with any regulations in subpart C of this part will result in withdrawal of the exemption given under section 412(h)(1) of the Federal Food, Drug, and Cosmetic Act.

(c) Subpart D of this part contains the nutrient requirements for infant formula under section 412(i) of the Federal Food, Drug, and Cosmetic Act. Failure to comply with any regulation in subpart D of this part will render an infant formula adulterated under section 412(a)(1) of the Federal Food, Drug, and Cosmetic Act.

(d) An exempt infant formula is subject to the provisions of § 107.50 and other applicable Food and Drug Administration food regulations.

The following definitions shall apply, in addition to the definitions contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the act):

Exempt formula. An exempt infant formula is an infant formula intended for commercial or charitable distribution that is represented and labeled for use by infants who have inborn errors of metabolism or low birth weight, or who otherwise have unusual medical or dietary problems.

Manufacturer. A person who prepares, reconstitutes, or otherwise changes the physical or chemical characteristics of an infant formula or packages or labels the product in a container for distribution. The term “manufacturer” does not include a person who prepares, reconstitutes, or mixes infant formula exclusively for an infant under his/her direct care or the direct care of the institution employing such person.

References. References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.