About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

1 1 (May 21, 2022)

handle is hein.crs/govefvg0001 and id is 1 raw text is: Cogesoa Resarc Serv iiic May 21, 2022 Infant Formula Shortage: FDA Regulation and Federal Response Some media sources report that as of May 8, 43% of infant formula was out of stock nationwide. This garnered widespread concern and significant congressional attention. This shortage may pose severe health risks for some infants. This In Focus provides an overview of initial federal response actions to the infant formula shortage. On February 17, 2022, the Food and Drug Administration (FDA), in collaboration with the Centers for Disease Control and Prevention (CDC), announced it was investigating consumer complaints received from September 2021 to January 2022 of infant illness attributed to powdered infant formula. FDA's initial findings identified, among other concerns, positive results for bacterial contamination in a manufacturing facility owned by Abbott Nutrition (Abbott). FDA advised consumers to cease using certain infant formula products from Abbott. Subsequently, the manufacturer initiated a voluntary recall of select powdered infant formula products. As FDA's investigation continued, the recall was expanded to include additional specialty powdered infant formula products. On March 22, 2022, FDA released its initial inspectional observations of the conditions found in the facility and determined that the manufacturer had not yet minimized the threat to public health. These initial observations did not constitute final FDA determination on whether the conditions in the facility were in violation of the Federal Food, Drug, and Cosmetics Act (FFDCA). As of April 29, 2022, Abbott had committed to completing enhanced testing of stored product batches before deciding whether to release those products. Abbott's voluntary recall of infant formula product, coupled with other factors such as ongoing supply-chain issues, contributed to a widespread shortage of infant formula products. Infant Formula Manufacturer Overview Infant formula is typically available in one of three forms: a dehydrated powder that is added to water before serving; a ready-to-feed formula that can be given directly to an infant; or a concentrated liquid tat must be diluted. In recent years, manufacturers reduced infant formula manufacturing to increase production of products meant to supplement breastfeeding and formula derived from nondairy sources. Some industry experts have attributed this shift to broader U.S. trends showing a general increase in breastfeeding. According to a 2020 IBISWorld industry report on the infant formula industry in the United States, the industry is dominated by four major manufacturers (see Table 1). Disruptions in the infant formula supply chain were noted as early as August 2020. The report notes that the COVID- 19 pandemic caused both a surge in demand and a disruption in global supply chains for infant formula products. Table I. U.S. Infant Formula Manufactures and Market Share, August 2020 Manufacturer Market Share (%) Abbott Laboratories 48.1 Mead Johnson 20.0 Perrigo 11.6 Nestle 7.7 Othera 12.6 Source: Jack Curran, Infant Formula Manufacturing, IBISWorld, August 2020. a. The report states that in 2020, no manufacturer in the other category accounted for more than 10% of total revenue. These manufacturers are individually characterized as small, independent operators. Infant Formula Imports According to FDA, the United States normally produces 98% of the infant formula it consumes, with the primary source of imports coming from trading partners in Ireland and the Netherlands. FDA infant formula regulations apply equally to infant formula manufactured domestically or abroad. Manufacturers whose infant formula products are imported into the United States may have to contend with higher costs of manufacturing to meet FDA specifications. Additionally, those products face compound duties that have averaged approximately 25% on imports over the past decade for a small market share of American consumers. These factors may make the United States a relatively unattractive market for foreign manufacturers. FDA Re ulation of Infant Formula Products cad R esponrst Shortage FDA Regulation of Infant Formula Products The FFDCA defines infant formula as a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk (FFDCA §201(z)). FDA regulations define an infant as an individual aged not more than 12 months old (21 C.F.R. §105.3(e)). As a food product, infant formula must comply with the laws and regulations governing food 9ttps://crsreports.congress.gov

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline.

Purchase Access

Already a HeinOnline Subscriber?

Log In

profiles profiles most