administrative agencies promulgate regulations to implement them and flesh out details, which are published in the Code of Federal Regulations.¹

Congress has directed the Secretary of Health and Human Services (HHS) and the Secretary of the U.S. Department of Agriculture (USDA) to implement laws related to infant formula. HHS is a large department with several relevant agencies, including the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the Centers for Medicare & Medicaid Services (CMS).

FDA has the primary authority over the safety and labeling of most food products in the marketplace, including infant formula. Congress granted FDA its modern powers over food products through the Food Drug and Cosmetic Act of 1938 (FDCA). Food manufacturers and distributors must comply with the FDCA before introducing food, including infant formula, into the interstate marketplace. Congress has amended the FDCA several times. In 1980, Congress enacted the Infant Formula Act to establish requirements relating to nutrient content, processing, and quality; nutrient quality control procedures and good manufacturing practices; recordkeeping, retention, and reporting requirements; and requirements related to the recall of infant formula (21 USC § 350a). As discussed below, the Infant Formula Act requires infant formula manufacturers and distributors to register with FDA and, 90 days in advance of introducing new infant formula into interstate commerce, submit a pre-market notification to FDA (21 USC § 350a). CDC monitors, investigates, and seeks to prevent outbreaks and contamination of food, including infant formula.

USDA Food Safety and Inspection Service has primary responsibility for the safety and labeling of certain foods (e.g., meat; poultry; and liquid, frozen, and dried egg products), but not infant formula. USDA’s role with regard to infant formula arises in the context of administering the federal nutrition assistance programs, including the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC),² the Supplemental Nutrition Assistance Program (SNAP),³ and the Child and Adult Care Food Program (CACFP).⁴ These programs are administered by the Food and Nutrition Service and described in more detail later in this chapter. WIC is the largest purchaser of infant formula in the country, and SNAP participants can use their grocery benefits to purchase infant

___________________

¹ The Code of Federal Regulations is “the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the federal government.” See https://www.govinfo.gov/app/collection/cfr/2024 (accessed April 19, 2024).

² https://www.fns.usda.gov/wic (accessed April 19, 2024).

³ https://www.fns.usda.gov/snap/supplemental-nutrition-assistance-program (accessed April 19, 2024).

⁴ https://www.fns.usda.gov/cacfp (accessed April 19, 2024).

formula. Further, USDA regulations for CACFP require that breast milk or iron-fortified infant formula be provided to infants participating in the program (7 CFR § 226.20(b)(2)).

Department of Health and Human Services

As discussed above, HHS is a large department and includes FDA, CDC, and CMS, which all play a role in regulating infant formula supply in the United States.

Food and Drug Administration

FDA is an operating division within HHS. Its mission includes “protecting the public health by ensuring the safety of our nation’s food supply” (FDA, 2023a). Under the authority of FDCA, FDA has promulgated regulations to implement the Infant Formula Act (21 CFR §§ 106-107). In 1982, FDA promulgated regulations on Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notification (21 CFR § 106), and amendments were made to this rule in 2014 (discussed under the “Quality Factors” section). FDA promulgated regulations related to the labeling of infant formula in 1985 (21 CFR §§ 107.1–107.100) and infant formula recalls in 1989 (21 CFR §§ 107.200–107.280).

Congress thereafter passed the Nutrition Labeling and Education Act of 1990 (NLEA) (P. L. 101-535). The NLEA modernized food labeling requirements, most notably for the Nutrition Facts panel on packaged foods and drinks, including drinks marketed for toddlers 1–3 years old (i.e., toddler drinks), but not infant formula. FDA finalized regulations to carry out the NLEA in 1993 and updated them, effective July 26, 2016, requiring manufacturers to update their labels by 2020–2021 (FDA, 2024b).

The Infant Formula Act

An “infant formula” is defined by law 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” (21 USCS § 321(z)). The 1980 Infant Formula Act, and subsequent amendments in 1986, sets forth specific requirements and directs the Secretary of HHS, who typically acts through FDA in this context, to issue regulations on nutrients, quality, and manufacturing practices of infant formula. An infant formula is deemed adulterated if it does not provide the nutrients required by the Infant Formula Act, does not meet the quality factor requirements prescribed by FDA through regulations promulgated pursuant to the Infant Formula Act, or if it is not processed in compliance with the good

manufacturing practices and quality control procedures prescribed by FDA through regulations promulgated under the Infant Formula Act (21 USCS § 350a(a)).

Nutrient requirements

Through the Infant Formula Act, as enacted in 1980, Congress set forth specific nutrient requirements for infant formula. The Infant Formula Act expressly allows FDA to issue regulations to revise the list of nutrients or the required level of required nutrients (21 USCS § 350a(i)). For example, FDA used this authority to include selenium as a required nutrient for infant formula and establish minimum and maximum values for selenium (FDA, 2013), effective as of June 22, 2016 (FDA, 2015b).

Infant formula that meets these federal nutrient requirements and is intended for use by healthy, term infants is referred to in this report as “non-exempt” infant formula. In contrast, exempt infant formula may differ in nutrient requirements to meet the needs of the “specific disorders or conditions for which the formula is represented for use” (21 CFR § 107.50(c)).

Exempt infant formula

Exempt infant formula is defined by FDA as an “infant formula intended for commercial or charitable distribution that is represented and labeled for use by infants who have inborn errors of metabolism or low birth weight, or who otherwise have unusual medical or dietary problems” (21 CFR § 107.3). FDA set forth specific requirements for exempt infant formula because “infants that consume exempt infant formulas are at even greater risk of adverse outcomes due to a nutritional insufficiency or deficiency in the diet due to their relative immaturity or their medical condition” (FDA, 2016a). FDA promulgated regulations that a manufacturer must meet to sell exempt infant formulas at retail and for exempt formula not available at retail, meaning prescribed by physicians, dispensed at pharmacies, or “distributed directly to institutions such as hospitals, clinics, and State or Federal agencies” (21 CFR § 107.50).

Exempt infant formulas that are available at retail are “typically represented and labeled for use to provide dietary management for diseases or conditions that are not clinically serious or life threatening, even though such formulas may also be represented and labeled for use in clinically serious or life-threatening disorders” (21 CFR § 107.50(b)(1)). These include post-discharge premature infant formula and hypoallergenic formula. Exempt infant formulas that are not available at retail are those that are “generally represented and labeled solely to provide dietary management for specific diseases or conditions that are clinically serious or life threatening and generally are required for prolonged periods of time” (21 CFR § 107.50(c)(1)).

___________________

⁵ “Quality factors means those factors necessary to demonstrate the safety of the infant formula and the bioavailability of its nutrients, as prepared for market and when fed as the sole source of nutrition, to ensure the healthy growth of infants” (21 CFR § 106.3).

anthropometric data for each infant (body weight for age, body length for age, head circumference for age, and weight for length) in the test group and the control group to the 2009 CDC growth charts; and

5. Compare the data on formula intake of the test group with a concurrent control group or groups and a scientifically appropriate reference (21 CFR § 106.96(b)).

The regulation also states:

Manufacturers of exempt infant formula can deviate from FDA regulations for quality control procedures “because of unusual or difficult technological problems in manufacturing” the exempt infant formula in accordance with the standards required for non-exempt infant formulas (21 CFR § 107.50(d)(4)).

Nonetheless, FDA explained in a 2016 guidance document that

Therefore, FDA recommended that manufacturers of exempt infant formulas “follow, to the extent practicable,” the Final Rule published on June 10, 2014, in the production of exempt infant formula products (FDA, 2016a).

Labeling

Through its authority under the FDCA (21 USC §§ 321, 343, 350a, 371), FDA set forth regulations for specific labeling requirements for infant formula that differ from those for the rest of the food supply. Infant formula labels must disclose nutrient information per 100 calories listed (21 CFR § 107.10); a use-by date, specific language around directions for use, including a “pictogram depicting the major steps for preparation”; a statement indicating that parents should consult their physicians about the use of infant formulas, such as “USE AS DIRECTED BY A PHYSICIAN”; and a warning statement in “close proximity to the “Directions For Preparation and Use” that cautions against improper preparation or use of an infant formula, such as “THE HEALTH OF YOUR INFANT DEPENDS ON CAREFULLY FOLLOWING THE DIRECTIONS FOR PREPARATION AND USE” (21 CFR § 107.10(b)(4)). As required for all

products, the infant formula labels must also disclose an ingredient list as well as a statement of identity (21 CFR § 101.4), and the claims on the labels cannot be false or misleading (21 USC § 343(a)(1)); otherwise the product is considered misbranded.

Manufacturers of exempt infant formula can deviate from FDA regulations for labeling requirements if “necessary because label information, including pictograms and symbols required by those regulations, could lead to inappropriate use of the product” (21 CFR § 107.50(d)(4)).

Claims

All claims on food products that are regulated by FDA, including infant formula, are required to be truthful and not misleading (21 USC § 343). There are two categories of claims displayed on food labels in the United States for which FDA has specific regulatory requirements: (1) nutrient content claims and (2) health claims (also referred to as authorized health claims) (FDA, 2024c). There are two other categories of claims displayed on food labels for which FDA has provided guidance: (1) qualified health claims and (2) structure/function claims for infant formula only (FDA, 2016c, 2024c). There may also be uncategorized statements on infant formula and other breast-milk substitute labels, such as “#1 pediatrician recommended” and “12–36 months.” As discussed below, FDA directly regulates nutrient content claims and health claims, exercises enforcement discretion for qualified health claims, and provides publicly available guidance on structure/function claims for manufacturers.

Nutrient content claims characterize the level of a nutrient in the food; they can be express or implied (21 CFR § 101.13). Nutrient content claims may be displayed on infant formula if they describe “the percentage of a vitamin or mineral in the infant formula, in relation to a Reference Daily Intake” for infant formula (unless such claim is expressly prohibited by regulation) (FDA, 2023b). Examples of nutrient content claims permitted for infant formula include factual statements that the formula “is unsweetened or contains no added sweeteners,” or is “unsalted” if such statement refers to the taste of the food (FDA, 2023b).

Health claims characterize the relationship of a nutrient to a disease or a health-related condition (21 CFR § 101.14). Health claims must be supported by “significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence” (21 CFR § 101.14). Manufacturers may petition FDA for the authorized use of a new health claim or may use health claims that FDA previously authorized. There are no authorized health claims for infant formula (FDA, 2023c).

Qualified health claims describe the relationship between a food and reduced risk of a disease or health-related condition and are based on limited scientific evidence (FDA, 2024c). Because the evidence does not meet the “significant scientific agreement” standard, qualified health claims

must include a “disclaimer or other qualifying language to accurately communicate to consumers the level of scientific evidence supporting the claim” (FDA, 2024c). To use a qualified health claim, manufacturers submit a petition to FDA, but unlike for health claims, FDA does not approve them by promulgating a regulation for use of the claim. Rather, the agency determines whether to exercise enforcement discretion for them, meaning that FDA does not object to use of the qualified health claim, as long as it bears the appropriate disclaimer and meets the conditions for use of the claim (Pomeranz and Harris, 2019). For example, FDA has indicated it will exercise its enforcement discretion for qualified health claims for infant formula related to whey-protein partially hydrolyzed infant formula and reduced risk of atopic dermatitis (FDA, 2017).

Last, structure/function claims describe the role of a nutrient or ingredient intended to affect or maintain the normal structure or function of the body (FDA, 2016b). FDA has not promulgated regulations related to structure/function claims for any food, and Congress has not required them to do so. Like all statements on food labels, structure/function claims must be truthful and not misleading (21 USC § 343; FDA, 2016b). FDA issued a draft guidance document in 2016 recommending that infant formula manufacturers and distributors substantiate their structure/function claims using the “competent and reliable evidence” standard used for dietary supplements (FDA, 2016b).⁶ However, FDA did not finalize the guidance document. FDA does not require the submission of such evidence, but FDA’s interpretation of its authority for infant formula includes the ability to request substantiation of structure/function claims from infant formula manufacturers. FDA also noted that this draft guidance did not apply to “labeling claims that suggest that the product contains constituents found in breast milk or that the product is ‘closer’ to breast milk than other formulas” (FDA, 2016b).

WHO identified concerns that nutrition, health, and structure/function claims can be “misleading, confusing, or could lead to inappropriate use” (WHO, 2017). Such claims may lead to consumer confusion in two distinct ways. First, claims may inappropriately lead caregivers to believe that infant formula is equivalent to—or better than—breast milk for the health and nutrition of their infants (Romo-Palafox et al., 2020), leading to increased use when a parent may have otherwise chosen to breastfeed. Second, claims may confuse caregivers on the relative benefits or necessity of specific infant formulas or ingredients for their infant’s needs. This

___________________

⁶ FDA suggested this standard for infant formula but does not enforce it. FDA’s draft guidance proposed a similar standard to dietary supplements, which would require evidence supporting a claim to be based on “findings from well-designed and controlled intervention studies in an appropriate population of U.S. infants or infants with similar nutrition and general health status” (FDA, 2016b).

confusion makes it difficult for caregivers to differentiate among various formulas and brands (Romo-Palafox et al., 2020). In times of a shortage, this confusion can leave caregivers unclear about which infant formulas can be substituted for the one that their infant regularly consumes.

Recalls

The Infant Formula Act set forth requirements with respect to recalls, but directed FDA to issue regulations prescribing “the scope and extent” of the recall “necessary and appropriate for the degree of risks to human health presented by the formula subject to the recall” (21 USCS § 350a(f)). FDA promulgated regulations addressing instances and process requirements for when a manufacturer or FDA determines that it is necessary to remove infant formula from the market (21 CFR §§ 107.200–107.280; 21 USCS § 350a(f)).

Under the Infant Formula Act, manufacturers are required to promptly notify FDA if it has “knowledge which reasonably supports the conclusion” that an infant formula it processed did not contain the required nutrients or is otherwise adulterated or misbranded (21 USCS § 350a(e)). Starting 14 days after such recall, the manufacturer must report to FDA the actions it is taking to implement the recall at least once every 14 days until the recall is terminated (21 USCS § 350a(f)). Within 15 days of the recall, FDA shall “review the actions taken under the recall to determine whether the recall meets” the requirements prescribed in the regulation (21 USCS § 350a(f)). FDA must conduct this review at least once every 15 days until the recall is terminated (21 USCS § 350a(f)).

Under the Infant Formula Act, if FDA determines that an infant formula presents a risk to human health, it can require a recall (21 CFR § 107.200). In this instance, the manufacturer must “immediately take all actions necessary to recall shipments of such infant formula from all wholesale and retail establishments, consistent with recall regulations and guidelines” issued by FDA (21 USCS § 350a(e)). Further FDA must require the manufacturer of the recalled product to request retail establishments carrying the recalled infant formula to post a notice of the recall at the point of purchase for the time prescribed by FDA “to inform the public of such recall” (21 USCS § 350a(f)). Indeed, FDA requires “the notice to be displayed at retail establishments directed to consignees, distributors, retailers, and members of the public” (21 CFR § 107.230).

Inspections

FDA inspects facilities that manufacture infant formulas (registered facilities both in the United States and internationally) following review of the materials submitted in advance of the introduction of a new formula and then inspects them annually (FDA, 2024a). FDA requires manufacturers to develop and follow a written audit plan that is available at the manufacturing facility for FDA inspection (21 CFR § 106.94).

The audit plan must include “procedures that set out the methods the manufacturer uses to determine whether the facility is operating in accordance with current good manufacturing practice, with the quality control procedures that are necessary to ensure that an infant formula provides” required nutrients, and in a manner designed to prevent adulteration of the infant formula (21 CFR § 106.94).

Personal importation

Some consumers directly import infant formula from other countries whose manufacturers are not registered with FDA. As a result, the formula does not necessarily comply with the Infant Formula Act’s requirements (e.g., labeling, nutrients) (Caron and Grose, 2020). Consumers generally purchase such imported products online (Szalinski, 2021), as they are not legally permitted to enter interstate commerce (FDA, 2024a). In a 2021 national survey, 13.8 percent of parents of infants reported feeding their infant European formula (DiMaggio et al., 2022). In one such instance, FDA determined that formulas imported by consumers that did not meet FDA requirements presented a risk to infants (e.g., the manufacturer failed to adhere to FDA regulations to disclose if an infant formula contains less than 1.0 mg/100 kcal of iron). In that case, FDA coordinated with the manufacturer and the manufacturer then recalled 21 products under four brand names from the U.S. market (FDA, 2021).

The Food Safety Modernization Act

In January 2021, President Obama signed the Food Safety Modernization Act (FSMA) into law in an effort to shift the focus of federal food safety efforts toward prevention rather than response (Pomeranz, 2015). FSMA requires each foreign and domestic food facility registered with FDA to engage in hazard analysis, identify and implement preventive controls, and prepare a written plan to address those hazards that must be made promptly available to FDA upon request (21 USC § 350g). FDA used its authority to promulgate regulations under FSMA and FDCA to require “every facility to have its own written food safety plan (21 CFR § 117.126).” These regulations are now part of good manufacturing practice requirements for the majority of the food supply.

In 2015, FDA promulgated regulations titled, “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (21 CFR § 117.1 et seq.) which apply to all FDA-regulated foods, including those that have their own specific current good manufacturing practice regulations (21 CFR § 117.1). Infant formula was explicitly not excluded from FSMA requirements (FDA, 2015a). FDA explained that its regulations to implement FSMA filled gaps in its current good manufacturing practice and quality control procedure regulations for infant formula (FDA, 2015a). In particular, FDA highlighted that its regulations to implement FSMA uniquely address the potential presence

of environmental pathogens in the food processing environment (FDA, 2015a).

Pursuant to FDA’s 2015 regulations, manufacturers must have a “written food safety plan” that must include:

• hazard analysis,
• preventive controls,
• supply chain program,
• recall plan,
• procedures for monitoring the implementation of the preventive controls,
• corrective action procedures, and
• verification procedures (21 CFR § 117.126).

Centers for Disease Control and Prevention

CDC is an operating division within HHS (HHS, 2024). CDC’s mission is to “protect America from health, safety, and security threats, both foreign and in the United States” (CDC, 2024). CDC accomplishes this mission by conducting surveillance and investigations, critical scientific research, and providing health information that protects the nation against dangerous health threats when they arise. CDC provides guidance, such as on safe handling of infant formula, as well as investigates any reported outbreaks associated with infant formula consumption (CDC, 2022a, 2023a).

Notifiable disease surveillance

CDC conducts national surveillance to understand disease and the spread of disease to control outbreaks (CDC, 2022b,c). In 1902, Congress directed the U.S. Surgeon General—who is tasked with providing the best available scientific information to improve the health and reduce the risk of illness and injury—to improve the uniformity of national notifiable disease data, and since 1912 annual summaries of notifiable diseases have been released (CDC, 2022d). CDC, together with the Council of State and Territorial Epidemiologists, generates the list of notifiable diseases and conditions, and each state voluntarily informs CDC when a person meets the disease criteria (CDC, 2022d). Designating a condition as nationally notifiable can support investigations into the source of outbreaks (e.g., Cronobacter sakazaii infections linked to infant formula) by helping ensure that timely, complete, and accurate information is available for illnesses that may be part of outbreaks. Prior to 2022, Cronobacter sakazakki was not a notifiable disease (CDC, 2022d).

___________________

⁷ https://www.cdc.gov/breastfeeding/data/ifps/index.htm (accessed April 13, 2024).

⁸ https://www.cdc.gov/breastfeeding/data/mpinc/index.htm (accessed April 13, 2024).

State WIC agencies are responsible for providing up to the maximum amount of exempt infant formulas in situations where reimbursement is not provided by another entity. To receive reimbursement for an exempt infant formula, a medical statement of need must be signed by a licensed physician indicating that an infant is considered disabled according to USDA’s regulations. A recognized medical authority specified by the state agency is also authorized to sign a statement of need if the infant has medical or other special dietary requirements necessitating exempt infant formulas (21 CFR § 107.50).

In addition to infant formula, Medicaid provides reimbursement for medical foods, but it is not uniform across all states as there is no legislative mandate for coverage (USDA, 2015; Weaver et al., 2010). Proposed legislation in 2021 would have provided for Medicaid coverage of medical foods (Patient Access to Medical Foods Act, H.R. 56, 117th Cong., 2021-2022), but the bill did not become law.

U.S. Department of Agriculture

USDA oversees 16 U.S. federal food and nutrition assistance programs. Three federal nutrition assistance programs, WIC, SNAP, and CACFP, provide benefits that may include infant formula.⁹ The arm of USDA that oversees these programs is the Food and Nutrition Service. The USDA Economic Research Service also plays a role in conducting economic research on these programs to inform USDA decision making.¹⁰ The USDA Agricultural Marketing Service plays a role in administering programs that create marketing opportunities for U.S. food producers, including infant formula.¹¹

WIC

WIC serves pregnant and postpartum women, infants, and children under age 5 “from families with inadequate income” who are at “special risk with respect to their physical and mental health by reason of inadequate nutrition or health care, or both” (42 USCS § 1786). In addition to

___________________

⁹ Congress authorized pilot programs for each program for years before making them permanent and over the years amended the programs (IOM and NRC, 2013; Oliveira et al., 2002).

¹⁰ https://www.ers.usda.gov/ (accessed April 19, 2024).

¹¹ https://www.ams.usda.gov/ (accessed April 19, 2024).

providing nutrition education, breastfeeding support (see Appendix I), and referrals to health care and social services, WIC provides nutrition benefits for participants to purchase specific foods designed to meet their nutritional needs (USDA, 2023a). Infant formula is provided to infant participants who are not fully breastfed (7 CFR § 246.10). In fact, WIC participants are estimated to have consumed more than half of the infant formula in the United States in 2018 (USDA, 2022).

WIC is authorized by the Child Nutrition Act of 1966 and became a permanent program in 1975. WIC is not an entitlement program. Instead, funding is provided through the annual appropriations process, and there is no guarantee that funding will be sufficient to serve all eligible people who seek to participate. In 2023, an average of 6.6 million people participated in WIC per month at a cost of $6.7 billion for the year.¹² Approximately, 38,000 retailers were authorized to redeem WIC benefits in fiscal year 2020 (Hodges et al., 2024).

SNAP

SNAP provides food assistance benefits via an electronic benefit transfer (EBT) card that is used to purchase food at SNAP-authorized retailers (USDA, 2024a). SNAP is an entitlement program, meaning that there is enough funding dedicated to the program for every eligible individual to participate. The permanent program was established in 1964, with SNAP’s stated goal to “alleviate…hunger and malnutrition” and “strengthen the Nation’s agricultural economy” (7 USCS § 2011). SNAP is dedicated to addressing food insecurity by increasing the “food purchasing power for all eligible households who apply for participation” (7 USCS § 2011). SNAP is by far the largest food and nutrition assistance program in the United States, with an average of 42 million people participating each month in 2023 and a program cost of $113 billion for that year (USDA, 2024b). SNAP participants can use their SNAP benefits to purchase any infant formula from SNAP-approved retailers. More than 250,000 retailers are authorized to redeem SNAP nationally (USDA, 2024c).

CACFP

The purpose of the CACFP is to

___________________

¹² https://fns-prod.azureedge.us/sites/default/files/resource-files/wisummary-3.pdf (accessed April 19, 2024).

Additionally, CACFP “provides reimbursements for meals served to children and youth participating in after-school care programs” and for “children residing in emergency shelters” (USDA, 2024d). It is an entitlement program, meaning that there is enough funding dedicated to the program for every eligible individual to participate.

In CACFP, breast milk, iron-fortified infant formula, or portions of both “must be served to infants birth through 11 months of age” (7 CFR § 226.20(b)). CACFP institutions and facilities “must offer at least one type of iron-fortified infant formula” and, therefore, meals containing breast milk or iron-fortified infant formula are eligible for reimbursement (7 CFR § 226.20(b)). CACFP institutions and facilities may purchase infant formula online or in person from retailers (e.g., local, regional, or national vendors), pharmacies, and membership-based warehouses (USDA, 2023b). A parent may decline the CACFP-provided infant formula and provide breast milk or their own iron-fortified infant formula for their infant’s consumption while in the care of the CACFP facility (7 CFR § 226.20(b)(2)(i)). In fiscal year 2022, CACFP averaged about 4.6 million participants daily and served about 1.9 billion meals at a cost of $3.9 billion (USDA, 2023b).

Federal Trade Commission

President Woodrow Wilson signed the Federal Trade Commission Act into law in 1914, establishing the Federal Trade Commission (FTC, n.d.a). Under this Act (15 USC §§ 41-58), as amended, FTC is empowered, among other things, to

1. Prevent unfair methods of competition and unfair or deceptive acts or practices in or affecting commerce;
2. Seek monetary redress and other relief for conduct injurious to consumers;
3. Prescribe rules defining with specificity acts or practices that are unfair or deceptive, and establishing requirements designed to prevent such acts or practices;

4. Gather and compile information and conduct investigations relating to the organization, business, practices, and management of entities engaged in commerce; and
5. Make reports and legislative recommendations to Congress and the public.

Therefore, FTC’s mission is to promote competition among businesses and protect consumers (FTC, n.d.b). FTC provides oversight for infant formula marketing to ensure that it is truthful and not misleading (15 USC § 55(a)(1)).

Trade-Related Entities

Trade of infant formula and upstream ingredients used in manufacturing infant formula are regulated by entities such as the Office of the U.S. Trade Representative, U.S. International Trade Commission, and the Department of Commerce.

Office of the U.S. Trade Representative

In 1963, President John Kennedy created an Office of the Special Trade Representative (STR) in the Executive Office, and in the 1970s, Congress expanded STR’s responsibilities to include the trade agreements programs (USTR, n.d.a). A 1980 executive order

The office’s authority has since been further expanded, and USTR now develops and coordinates U.S. international trade, regulates commodities, and directs investment policy and oversees necessary trade-related negotiations with other countries (USTR, n.d.b). Part of USTR’s mission includes providing oversight for the trade of infant formula and infant formula ingredients and setting goals for trade (USTR, n.d.b).

U.S. International Trade Commission

The U.S. International Trade Commission (USITC) is an “independent, nonpartisan” agency that provides “high-quality, leading-edge analysis of international trade issues to the President and the Congress” (USITC, n.d.). USITC has provided executive briefings on trade on topics

related to infant formula such as the complicated history of infant formula tariff-rate quotas as well as on shortages, supply, and trade dynamics (Ahmed, 2022; Gehrke, 2023).

Department of Commerce

The U.S. Department of Commerce creates conditions for economic growth for communities by driving U.S. economic competitiveness, strengthening the domestic industry, and increasing job growth.¹³ The National Institute of Standards and Technology (NIST) now resides within the Department of Commerce, and it advances measurement science standards and technology. NIST has provided reference materials to ensure the quality of nutrient measurements related to infant formula (NIST, 2023).

INTERNATIONAL FRAMEWORK FOR INFANT FORMULA

This section of the report describes the international infant formula safety and nutrient requirements and the international code of marketing of breast-milk substitutes.

Comparison of U.S. and International Infant Formula Safety and Nutrient Requirements

The Codex Alimentarius (Codex) is “a collection of standards, guidelines and codes of practice adopted by the Codex Alimentarius Commission (CAC).” CAC is the central part of the Joint Food and Agricultural Organization (FAO)/World Health Organization (WHO) Food Standards Programme and was established in 1963 to protect consumer health and promote fair practices in food trade (FAO, n.d.). The purpose of Codex is to “guide and promote the elaboration and establishment of definitions and requirements for foods to assist in their harmonization and in doing so to facilitate international trade” (FAO/WHO, 1981). Codex standards are not considered a substitute for or an alternative to national legislation. In 1981, CAC set standards for infant formula and formulas for special medical purposes intended for infants (FAO/WHO, 1981). This standard was revised in 2007 (CXS_072). A standard for follow-up formula for older infants and a product for young children was established in 1987 and revised in 2023 (CXS_156) (FAO/WHO, 2023). The Codex standard

___________________

¹³ https://www.commerce.gov/ (accessed April 19, 2024).

describes nutrient maximums and minimums in both units per 100 kilocalories and units per 100 kilojoules for infant formulas.

A key question explored by this committee is how international standards and standards set by other individual countries compare to U.S. standards for safety and nutrient content. To answer this question, the committee compared selected nutrient content standards for infant formula in the United States (FDA, 2023c), Canada (Government of Canada, 2024), Australia and New Zealand (FSANZ, 2023), England (UK Legislation, 2020), and the European Economic and Monetary Union (EU Commission, 2016). The nutrient standards for each country can be found in Appendix F. In the instances assessed, it appears that the content of infant formulas meets the standards of the countries in which they were produced, and these international standards are similar, although not identical, to those of the United States. During a crisis in which U.S. domestic production cannot meet demand, importation of infant formulas produced in accordance with these countries’ standards could support normal growth and development of infants in the United States.

Nuanced differences exist between the nutrient requirements for nonexempt term infant formula from the Food Standards Australia New Zealand, Canada, United Kingdom, and the European Union’s European Food Standards Agency (EFSA) compared to those in the United States. These differences can result in labeling that is not consistent with FDA regulations (DiMaggio et al., 2019). For example, European-based labels do not always contain the entire list of FDA-required nutrients in FDA-required units of measurement. Furthermore, European-based labels also provide the average nutrient content where the U.S.-based labels are required to list the minimal nutrient content guaranteed by the expiration date and thus complicate reciprocal approval. Some differences may be attributed to how these regulatory bodies have incorporated the Codex standard into their requirements or other factors, such as differences in language or other information that is required or allowed to be on the label. The Codex standard provides ranges for the nutrient content so countries can adapt the standard to the needs of their population. The Codex standard for infant formula defines an infant as a person not more than 12 months of age, which is consistent with the definition of an infant in FDA regulations.

In addition to the infant formula standard, Codex has a standard for follow-on formula for older infants, who are from age 6 months up to 12 months of age. However, in the United States, older infants are not defined separately and the regulations for infant formula apply to the product that is fed to an infant from birth through 12 months of age. Consequently, the Codex standard that incorporates staging of formula based on age does not have a comparable standard in the United States.

normal growth (NASEM, 2024). The findings from that report were not available for consideration by this committee.

International Code of Marketing of Breast-Milk Substitutes

In 1981, the World Health Assembly (WHA) of WHO adopted the International Code of Marketing of Breast-Milk Substitutes (the Code) after it was passed by 118 countries.¹⁴ The United States was the only country to vote against its adoption (Brady, 2012). The aim of the Code is

___________________

¹⁴ https://www.who.int/publications/i/item/9241541601 (accessed March 26, 2024).

The Code is directed to governments and their health authorities; infant formula manufacturers and distributors, including their sales and marketing personnel; health care systems; health care providers and community health workers, as applicable; and civil service groups, including nongovernmental organizations, professional groups, and consumer organizations (WHO, 1981). The Code focuses on breast-milk substitutes, which were originally intended to include infant formula and complementary foods and drinks for infants and young children up to 24 months of age (Soekarjo and Zehner, 2011). In 2016, WHO adopted WHA Resolution 69.9 to expand the definition of breast-milk substitutes to include milk-type products specifically marketed for feeding to infants and young children up to 36 months of age, rather than 24 (WHO, 2017).¹⁵ See Appendix G for a detailed explanation of the Code.

Beyond infant formula, the drinks that are marketed as breast-milk substitutes in the United States include transition formulas (marketed for ages 9–18 months or 9–24 months) and toddler drinks (marketed for ages 12–36 months) (Pomeranz and Harris, 2019). Transition formulas are regulated as infant formula in the United States (FDA, 2023b). Toddler drinks are regulated the same as other processed foods and drinks (Pomeranz and Harris, 2019).

During a shortage of infant formula, some parents of formula-fed infants may look to other methods to fulfill their infant’s nutritional needs. The Code’s inclusion of breast-milk substitutes that take forms other than infant formula is relevant in times of shortage. In particular, the Code states that products such as sweetened condensed milk, which is not suitable for infant feeding, should not be labeled with instructions on how to modify it for that purpose (WHO, 1981, Article 9). Similarly, the Code applies to toddler drinks, which can be misconstrued by caregivers as being appropriate alternatives to infant formula based on unclear labeling (Romo-Palafox et al., 2020).

WHO provided guidance in 2017, clarifying that one goal of WHA Resolution 69.9 is to ensure that infant caregivers can distinguish between infant formula and other products to provide infants with “age-appropriate and safe” breastmilk substitutes (WHO, 2017). In particular, the WHO guidance document states that the promotion of breast-milk substitutes should not mislead or confuse parents to provide inappropriate products

___________________

¹⁵ This aligns with WHO’s recommendation that infants be exclusively breastfed for the first 6 months of life, with the “continuation of breastfeeding up to 2 years and beyond” (WHO, 2017).

to infants (WHO, 2017). One focus of the guidance is cross-promotion, which is defined as “a form of marketing promotion where customers of one product or service are targeted with promotion of a related product” (WHO, 2017). This is frequently accomplished when the label of breast-milk substitutes, such as toddler drinks, appears “very similar” to the label of the manufacturer’s infant formula; for example, by using the same color, fonts, and mascots, thereby “effectively promoting the latter” (WHO, 2017). Such cross-promotion “can mislead and confuse caregivers about the nutrition- and health-related qualities of commercial complementary foods, and age-appropriate and safe use of these products” (WHO, 2017). Moreover, WHO states that toddler drinks should not be marketed in a way that implies that they are “better than family foods, and mask the risks” (WHO, 2017). As such, WHO guidance states that labeling “must be accurate, detailed, and contain full and honest information to inform mothers and caregivers on optimal nutrition, and to enable them to make informed decisions” (WHO, 2017).

The Code recommends that governments adopt laws to give effect to the principles and aims of the Code (WHO, 1981, Article 11). Nonetheless, the Code also states that manufacturers and distributors of breast-milk substitutes are responsible for adherence to the Code, including notifying their personnel of their responsibilities under the Code, independent of any other measures taken for implementation (by government or otherwise). This means that even if a government has not fully implemented the Code in national legislation, manufacturers and distributers are urged to consistently comply with the Code across countries on a voluntary basis.

In 2011, U.S. Surgeon General Regina M. Benjamin issued a Call to Action to Support Breastfeeding that embraced the goals of the Code to “protect mothers from the influences of false and misleading advertising” (HHS, 2011). The Call to Action recommended that infant formula manufacturers voluntarily comply with the Code’s provisions to not advertise directly to consumers (including the provision of free samples), ensure that claims about infant formula are truthful and not misleading, and that health care providers not implicitly promote infant formula by providing venues for its advertisement (HHS, 2011). While the United States has not explicitly adopted the Code into law, certain U.S. labeling requirements are consistent with the Code (see the labeling section above and Appendix G).

FINAL REMARKS

The production and marketing of infant formula in the United States is subject to a complex regulatory environment that encompasses product

ingredients, nutritional quality, manufacturing safety, product labeling, health and marketing claims, and importation. Numerous federal departments and agencies are involved in ensuring the quality, safety, trade, and marketing of this critical product. In the event of an infant formula product supply disruption, additional regulations may be needed to address any shortages that result from these circumstances.

Although the U.S. infant formula regulatory framework is generally consistent with Codex, there are differences between U.S. requirements and those of other countries. The United States has not incorporated into law the WHO International Code of Marketing Breast-Milk Substitutes, which has been widely adopted by other countries. Despite some differences between the U.S. framework and that of other countries, during a crisis in which U.S. domestic production cannot meet demand, importation of formulas produced in accordance with standards in Canada, New Zealand, Australia, or the European Union could support normal growth and development of infants in the United States.

In the subsequent chapter, the committee will describe supply and demand in the infant formula market, factors that influence infant feeding, and the role of WIC in the market.

REFERENCES