S 4261

Fixing Our Regulatory Mayhem Upsetting Little Americans Act or the FORMULA Act This bill provides duty-free treatment to infant formula imported from certain countries. Specifically, the bill provides, for 180 days beginning on this bill's enactment, duty-free treatment to infant formula if the formula (1) is imported from specified countries (e.g., Australia, Japan, and the United Kingdom), and (2) was approved by the government of that country regulating such formula. The bill temporarily waives certain Food and Drug Administration regulations and requirements under the Federal Food, Drug, and Cosmetic Act for formula imported under this bill. A person who manufactures or imports formula must notify the Department of Health and Human Services (HHS) if the person has knowledge that such formula may not provide required nutrients or may be unsafe for infant consumption. If HHS determines the formula is unsafe for infant consumption, then the manufacturer or importer must immediately recall shipments from all wholesale and retail establishments. The bill makes formula imported under this bill eligible for purchase using benefits received under the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). The Department of Agriculture must maintain and publicize a list of imported formula approved for use and marketing within the country of origin and the recommended measurements for mixing or otherwise preparing the formula.