21 C.F.R. § 106.110

New infant formula registration

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(a) Before a new infant formula may be introduced or delivered for introduction into interstate commerce, including a new infant formula for export only, the manufacturer of the formula shall register with the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling, and Dietary Supplements, Infant Formula and Medical Foods Staff (HFS-850), 5001 Campus Dr., College Park, MD 20740-3835.

(b) The new infant formula registration shall include:

(1) The name of the new infant formula;

(2) The name of the manufacturer;

(3) The street address of the place of business of the manufacturer; and

(4) The name and street address of each establishment at which the manufacturer intends to manufacture such new infant formula.

Notes of Decisions

Cited in 2 cases (2 in the last 5 years), 2021–2024 · leading case: Ferry v. Mead Johnson & Co., LLC (D. Conn. 2021).

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Ferry v. Mead Johnson & Co., LLC (D. Conn. 2021). “§ 350a(c)(1), (d); 21 C.F.R. §§ 106.110 , 106.120. The Defendants argue that the FDA’s pre-approval process for drugs is identical in all important respects to the FDA’s registration and notification procedure for infant formulas.”

P & L Dev., LLC v. Gerber Prods. Co. (E.D.N.Y 2024). “PLD shall have the right to terminate this MOU if, Gerber fails to file the notice required by 21 CFR 106.110 with the FDA with respect to at least two of the Initial Products on or before December 31, 2021.”

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