These are unpredictable and unprecedented times for formula-feeding parents and their babies. Due to the magnitude and urgency of the formula shortage, several US government agencies have implemented Operation Fly Formula to increase infant formula availability. What is Operation Fly Formula, and why are formulas from other countries now allowed into the US? What do clinicians - and parents - need to know about these foreign products? Let’s unpack these questions and explore this complex topic.
Under Operation Fly Formula, the U.S. Department of Agriculture (USDA), the Department of Health and Human Services (HHS), and the General Services Administration (GSA) are partnering to import infant formulas from other nations that meet U.S. health and safety standards so they can get to store shelves faster. Operation Fly Formula was announced on May 18 by President Biden when he requested the USDA, the HHS, and the Department of Defense (DOD) to “work expeditiously to identify any and all avenues to speed importation” of infant formula.¹ As of July 22, the seventeenth mission was completed, and Operation Fly Formula has transported more than 61 million 8-ounce bottle equivalents to the US. According to the White House, additional flights are routinely being scheduled to bring more infant formula into the United States.²
As part of Operation Fly Formula, the FDA implemented the Infant Formula Enforcement Discretion Policy.³ The FDA is exercising enforcement discretion - applying it on a case-by-case basis - for the importation of infant formulas after reviewing details such as a product’s ingredients, nutrient levels, nutritional adequacy and safety, microbiological testing, labeling, and the manufacturing facility’s inspection history. The flexibilities allowed for in FDA’s discretion guidance are set to expire on November 14, 2022.
FDA’s enforcement discretion may be exercised only for certain requirements for infant formula. Some foreign infant formulas are safe and nutritionally adequate, but may not comply with all statutory and regulatory requirements. For example, a formula produced in another country may not comply with FDA’s labeling requirements for listing nutrients in a specified order, but the product may meet the agency’s nutritional requirements. In such a case, FDA may exercise enforcement discretion and allow for importation of this formula.
In the reverse scenario - an infant formula may meet FDA labeling requirements, but it fails to meet minimum nutritional requirements - FDA may not exercise enforcement discretion due to the risks associated with consumption of a nutritionally inadequate formula.
The FDA regularly updates the lists of regular and specialty infant formulas that have been authorized to be sold in US stores by the Infant Formula Enforcement Discretion Policy. As of their update on July 27, they estimate that the total estimated quantity of product approved for importation is 18.4 million cans (the equivalent of 395.6 million 8-ounce bottles of formula).⁴
Clinicians caring for families utilizing imported formulas should always check this list to verify that the formulas being consumed by their patients have current authorization.
Prior to the infant formula crisis, pediatricians, companies, and organizations like the American Academy of Pediatrics have discouraged parents from using infant formulas from other countries, citing many critical nutritional, regulatory, and safety concerns.⁵-⁷Historically, foreign infant formulas have been illegally imported into the US without any oversight from government or regulatory agencies. This scenario brings possible safety risks such as unsafe shipping and storage practices, unfamiliar labels and varying scoop-to-water ratios leading to improper mixing, different definitions for critical phrases such as “hypoallergenic”, and recall notice delays. For an overview of US vs. EU infant formulas and regulations, take this Master Class (approved for CPEUs for Registered Dietitians).
Though many US-based consumers had specific reasons for pursuing the use of foreign infant formulas prior to Operation Fly Formula (i.e., the appeal of the presence or lack of certain ingredients or other nutritional characteristics), the practice itself could not be endorsed by clinicians. Infant formula is one of the most highly-regulated products available in all of the US marketplace, and this haphazard approach posed considerable risks to a vulnerable population.
The infant formula crisis - as crises often do - has forced the changes brought by Operation Fly Formula. Infant formula is the sole source of nutrition for many infants, and leading government and pediatric agencies recognized that momentous change was necessary to provide nourishment for US infants. The Infant Formula Enforcement Discretion Policy allows for flexibilities to bring foreign products to the US market while still ensuring the safety of the infants consuming these formulas.
The infant formula crisis - while unimaginable just a short time ago - has dramatically increased the awareness of the critical and life-saving role of infant formula to countless infants and highlighted the urgent need for change in this industry. Clinicians, pediatric organizations, government agencies, and the infant formula industry must take action to ensure that this situation never happens again. It’s an opportunity to create meaningful and lasting change to our policies and regulations around a topic so foundational to the nourishment and well-being of all infants in the United States.
If you want to learn more about formula importation, counseling patients around imported products, and unregulated infant feeding practices, check out our continuing education Journal Club: Infant Feeding Trends Raise Nutrition and Safety Concerns.
¹U.S. Transportation Command Kicks Off Operation Fly Formula
²President Biden Announces Seventeenth Operation Fly Formula Mission | The White House
³Guidance for Industry: Infant Formula Enforcement Discretion Policy | FDA
⁴Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies | FDA
⁵DiMaggio DM, Du N, Porto AF. Nutritional and Safety Concerns of Infant Feeding Trends. J Pediatr Gastroenterol Nutr. 2022 May 1;74(5):668-673. doi: 10.1097/MPG.0000000000003401. PMID: 35149650.
⁶Fuchs, GJ. Imported infant formula not reviewed by FDA may pose health risks. AAP News. https://www.aappublications.org/news/2018/05/11/nutrition051118. Published May 11, 2018. Accessed July 27, 2022.
⁷DiMaggio DM, Du N, Scherer C, Brodlie S, Shabanova V, Belamarich P, Porto AF. Comparison of Imported European and US Infant Formulas: Labeling, Nutrient and Safety Concerns. J Pediatr Gastroenterol Nutr. 2019 Oct;69(4):480-486. doi: 10.1097/MPG.0000000000002395. PMID: 31107795.