CFR

106.120—New formulations and reformulations.

(a) Information required by section 412(b)(2) and (3) of the act shall be submitted to Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.

(b) The manufacturer shall promptly notify the Food and Drug Administration when the manufacturer has knowledge (as defined in section 412(c)(2) of the act) that reasonably supports the conclusion that an infant formula that has been processed by the manufacturer and that has left an establishment subject to the control of the manufacturer may not provide the nutrients required by section 412(g) of the act and by regulations promulgated under section 412(a)(2) of the act, or when there is an infant formula that is otherwise adulterated or misbranded and that may present risk to human health. This notification shall be made, by telephone, to the Director of the appropriate Food and Drug Administration district office specified in part 5, subpart M of this chapter. After normal business hours (8 a.m. to 4:30 p.m.), contact the FDA Emergency Call Center at 866-300-4374. The manufacturer shall send a followup written confirmation to the Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and to the appropriate Food and Drug Administration district office specified in part 5, subpart M of this chapter.

Code of Federal Regulations

[47 FR 17025, Apr. 20, 1982, as amended at 54 FR 24891, June 12, 1989; 61 FR 14479, Apr. 2, 1996; 66 FR 17358, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001; 75 FR 32658, June 9, 2010]

Tips