FDA Wants to Strengthen U.S. Infant Formula Market with Long-Term National Strategy

Posted in Food Policy,Our Blog on January 22, 2025

Following recent years’ infant formula market contamination events and subsequent vital product shortages, the U.S. Food and Drug Administration (FDA) is looking at the industry under a microscope. A long-term national strategy was recently announced aimed to “increase the resiliency of the U.S. infant formula market.”

What exactly does that entail?

Let’s take a look. But first, some history.

Infant Formula Market Received Warning Letters Plus Outbreak

Three infant formula manufacturers, ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC received warning letters from the FDA. These official warnings were made in response to facility inspection observations and their recall process in response to Cronobacter sakazakii contamination.

Other actions were taken against Abbott Nutrition in response to an outbreak involving at least four infants, resulting in two deaths. These cases spanned Minnesota, Ohio, and Texas.

Recalls were initiated for Abbott’s Similac, Alimentum, and EleCare powdered formula products.

During the course of the outbreak investigation, product samples and facility visits were performed across the country. The results of those inspections were startling.

In addition to products we feed our most vulnerable members of society handled, in some cases unsafely, another realization was made. There are very few infant formula manufacturers.

Hence the shortage when some of the manufacturers needed to recall their products.

Next Step in a Series of Movements to Strengthen Infant Formula Market

The FDA has been working on this problem since its initial response to the Cronobacter outbreak from infant formula and discovery of problems in both production and supply chains in the infant formula market contributing to shortages.

In March 2023, the FDA continued the movement with an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market document which “collected observations, described immediate actions, and detailed short-term plans to improve the resiliency of the U.S. infant formula supply.”

That was a short-term band-aid. But a long-term solution was needed.

Urgently!

Enter the new document.

“The Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market.”

The plan includes five objectives:

• Objective 1: Ensure the Proper Oversight of Safe Infant Formula Production
• Objective 2: Strengthen the Resiliency of the Infant Formula Supply Chain
• Objective 3: Continue to Work with U.S. Government Partners at the Federal, State, Local, Territorial, and Tribal Levels Involved in the Production, Distribution, or Sale of Infant Formula
• Objective 4: Ensure Timely Communication with Industry, Consumers, and Other Stakeholders on Infant Formula Issues of Public Health Significance
• Objective 5: Continually Evaluate Authorities for Infant Formula, While Ensuring Necessary Regulation and Guidelines are Clear and Science Based

Big goals.

But what do they mean?

Objective 1: Ensure the proper Oversight of Safe Infant Formula Production

Seems simple enough. Except, the FDA already serves as oversight for the infant formula market and has done so for a long time.

I expect this means that their oversight activities will be increased.

The long-term plan indicates that in addition to those existing roles, the agency will need to be “actively engaging to improve the science upon which our oversight of safe production practices is based.”

This includes activities such as:

• Surveillance activities like food safety inspections and sampling at least annually.
• Setting annual targets for microbiological and nutritional analysis for foreign manufacturers annually. The FDA’s annual surveillance inspection will still apply to these companies.
• Amp up training for investigators and supporting staff to ensure inspections are “robust, thorough, and focused.” Activities like interactive in-person workshops and continued education for those involved in the inspection process.
• Research and improve knowledge that will help prevent contamination of infant formula with an emphasis on Cronobacter sakazakii. The National Advisory Committee on Microbiological Criteria in Foods will be tapped for this objective.

Objective 2: Strengthen the Resiliency of the Infant Formula Supply Chain

The FDA does not directly have sway as a supply chain monitor, but previous infant formula market shortage demonstrated a need for some sort of change. This objective is expected to be accomplished by increasing the FDA’s “visibility into the infant formula supply” to help “forecast and mitigate any potential disruptions.”

Without expressed authority, that is easier said than done.

However, the agency has managed to worm their way into those aspects of the infant formula market since the problem blew up in 2022.

While likely on a voluntary basis, with a strong suggestion that cooperation will make things easier for these companies, the FDA will continue to “gather and analyze critical information from both producers and consumers of infant formula on the state of the U.S. infant formula market.”

This will be achieved by activities like:

• Improvement in processes to assess formula supply, market challenges, manufacturer inventory, and other “leading indicators.”
• Strengthen pre-market review for new infant formula submissions. The agency plans to prioritize reviewing these submissions to help prevent shortages in the infant formula market by allowing more companies to fill those roles.
• To help ensure these new companies maintain compliance and have robust preventative plans, the FDA will assist in ensuring they have the appropriate roles and risk assessment activities in place, through creation of key roles within the company.
• Evaluate foreign suppliers as a backup plan. Having nutritional and safety data already available can streamline the introduction of additional manufacturers to quickly enter the infant formula market to reduce the risk of future shortages.

Objective 3: Continue to Work with U.S. Government Partners at the Federal, State, Local, Territorial, and Tribal Levels Involved in the Production, Distribution, or Sale of Infant Formula

Yes. That is a mouthful. Essentially, the FDA wants to work with all levels of government to achieve this long-term goal. At the national level, the FDA has a wide view. But boots on the ground see a narrower field.

For example, local health departments receiving reports of infant illness. State sampling activities discovering contamination during routine surveillance. And so on.

These activities will include:

• Continuing to work with the Department of Health and Human Services (HHS) for risk management planning. As well as The Centers for Disease Control and Prevention (CDC) to develop information on safe infant formula substitutes.
• Collaboration with the United States Department of Agriculture (USDA)/Women, Infants and Children (WIC) program to strengthen infant formula contract flexibilities.
• Continuing communication and collaboration activities with the Council of State and Territorial Epidemiologists as Cronobacter has been upgraded to a nationally notifiable disease.

Objective 4: Ensure Timely Communication with Industry, Consumers, and Other Stakeholders on Infant Formula Issues of Public Health Significance

The FDA explains that “public health is a shared responsibility.” Coordination with all involved in the infant formula market is key.

Gathering the knowledge through continued research, as explained in Objective 1 is great and all. But if those who need to know never get the message. Well. What’s the point, right?

The FDA plans to achieve this objective by:

• Hosting webinars to provide detailed information about processing and critical control points for both new and existing participating companies. Maintaining regular communication with existing major infant formula producers to keep an eye on potential shortages of both products as well as raw materials and ingredients.
• Developing more educational materials as well as reorganizing and translating those for use by consumers, medical professionals, and industry.
• Continuing to work with the American Academy of Pediatrics and other related groups to help support the nutritional aspect of improving requirements.
• Creating a joint memorandum of understanding (MOU) between the USDA’s Food and Nutrition Service and the American Academy of Pediatrics to promote those collaborations.
• Working with HHS, CDC, and other partners to develop materials on how caregivers can substitute infant formula when breast milk or preferred infant formula is unavailable in the case of future recall or supply shortages.
• Working with appropriate agencies to notify the public of recalls.

Objective 5: Continually Evaluate Authorities for Infant Formula, While Ensuring Necessary Regulation and Guidances are Clear and Science-Based

The FDA has recently been given more authority over the infant formula industry. However, the agency believes that “there is more the FDA can do with guidance documents and rulemaking to ensure that producers and potential entrants into the infant formula market have the information they need.

Essentially, the FDA needs more length on their leash to achieve the desired results. A strengthened infant formula market that benefits all.

So. They intend to make the most of the authority they have been granted.

Aspects of achieving this objective include:

• Continued evaluation of new scientific, production, and regulatory information to maintain better, up-to-date regulations.
• Evaluate existing testing requirements for pathogens in finished infant formula products to determine if changes should be made.
• Promote infant formula market health and diversification, particularly for specialty formulas for certain dietary needs to ensure availability.
• Continue to advance legislative proposals that will strengthen the FDA’s regulatory oversight and enforcement tools.
• Secure additional funding and resources to continue the work they are doing and expand.
• Request authorization to grand the FDA mandatory authority for remote access of records for all critical food manufactures.

Thoughts?

These are big plans. Many of which are just continuations of existing work. Others strengthen the FDA’s ability to do the work. Others still will benefit the industry and consumers with a plan to keep products in the hands of consumers who need it.

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By: Heather Van Tassell (contributing writer, non-lawyer)