H.R. 3778: Formula 3.0 Act

This bill provides duty-free treatment to certain infant formula and infant formula base powder.

The bill defines infant formula base powder as a dry mixture of protein, fat, and carbohydrates that requires only the addition of vitamins and minerals in order to meet the definition of the term infant formula in the Federal Food, Drug, and Cosmetic Act. It must be (1) imported by a party that has been determined by the Food and Drug Administration (FDA) to be authorized to lawfully market infant formula in the United States or has received a letter of enforcement discretion from the FDA relating to the marketing of its infant formula in the United States, and (2) intended to be used in manufacturing infant formula in the United States.

The bill also removes the limitation on the aggregate quantity of certain infant formula containing oligosaccharides (carbohydrates) that may enter the United States in any calendar year.

Written by the Congressional Research Service, Library of Congress.