FDA to tighten infant formula safety with new regulations and inspection guidelines

The US FDA has developed a “Long-Term National Strategy to Increase the Resiliency of the US Infant Formula Market” with action points and updated information for stakeholders.

The report follows the 2023 Immediate National Strategy release, implemented in response to the 2022 infant formula recall and subsequent product shortages.

The agency says that minor disruptions have occurred but have not led to significant shortages. It details disruptions tied to supply chains due to product recalls, natural disasters and regulatory actions on products failing to meet FDA requirements for infant formula.

Apart from strengthening the market, the long-term strategy seeks to improve information sharing, protect the supply chain, encourage new manufacturers and enhance supply chain insight.

The agency says many US infants rely on infant formula for some or all of their nutrition, so it seeks to ensure they have access to safe and adequate products as a top priority.

National-level efforts

The FDA explains that the government has been making “significant strides” on security and safety supply chain fronts since the launch of the immediate national strategy.

It has led to partnerships between federal agencies, like the FDA, the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services and the US Department of Agriculture (USDA).

The FDA is responsible for oversight, preventing contamination and protecting the supply chain, while the USDA’s Special Supplemental Nutrition Program is essential for ensuring the resilience of the infant formula supply.

The long-term strategy seeks to improve information sharing, protect the supply chain, encourage new manufacturers and enhance supply chain insight.Supply chain boost 

The FDA says that to enhance its oversight of safe infant formula production, it will conduct annual surveillance inspections, collect samples for microbiological and nutritional analysis and help improve infant formula training.

Additionally, it will hold workshops and implement the FDA’s Strategy to “Help Prevent Cronobacter sakazakii Illnesses Associated with Consumption of Powdered Infant Formula.” 

The agency says it seeks to discuss best practices with industry while improving structural changes and processes, including handling consumer and whistleblower complaints. Last year, the FDA issued a new warning about possible Cronobacter contamination of three products made for infants. 

Chain resilience and continued partnerships

The FDA seeks to continue gathering and analyzing important information from producers and consumers to identify and mitigate vulnerabilities. 

It details plans to enhance its assessment process, track in-stock rates, create new models and work with the industry to analyze supply chains to safeguard their integrity and encourage diversification. 

Additionally, the agency plans to review pre-market submissions, support manufacturers in meeting regulatory requirements, and reinforce the need for Redundancy Risk Management Plans for the specialty infant formula industry.

The international harmonization of regulatory requirements and participation in the Codex Committee on Nutrition and Foods for Special Dietary Uses will be in focus.

The FDA says it will continue working with government partners to strengthen the infant formula supply chain.

To safeguard the public’s health in the infant formula market, the FDA claims it is making every effort to incorporate the best available scientific data.It works with the Department of Health and Human Services, CDC and manufacturers to develop safe substitutes. With the USDA, it focuses on ensuring adequate reserve planning and distributing consumer education materials. The USDA also updates its Guide to Coordinating WIC (Women, Infants, and Children) Service During Disasters.

Communication and science 

To safeguard the public’s health in the infant formula market, the FDA claims it is making every effort to incorporate the best available scientific data. 

It says the focus is improving communication with producers, consumers and medical professionals to improve compliance, manufacturing and risk management practices. 

To provide up-to-date information to all affected groups, including consumers of specialty infant formulas, the agency will partner with major formula producers, manufacturers and medical groups to develop educational materials and support policies for breastfeeding and infant and maternal health.

The FDA reveals it is evaluating new scientific, production and regulatory information to update existing regulations on infant formula. It is also looking into current testing requirements for pathogens in finished infant formula products. The agency says it will publish documents based on the assessments to inform producers of changes.

For example, research indicates that infant formula checks can be optimized with stratified sampling patterns.

The agency recently set maximum levels for lead in baby food such as fruits, vegetables, yogurts and cereals in an effort to reduce infant exposure to harmful contaminants. 

Nutrition Insight discussed infant innovations with experts from dsm-firmenich, FrieslandCampina Ingredients and Morinaga Milk to explore key innovations and trends in infant nutrition, focusing on synbiotics and lactoferrin for immunity and Bifidobacteria for gut health. We also discussed vital nutrients like folate for healthy fetal development and alternatives to breast milk with Gnosis by Lesaffre, Valio and AB-Biotics.

We also discussed new vitamin A formulations and carbon-neutral farming practices, as the industry is prioritizing transparency, clean labels and eco-conscious solutions to satisfy parents and regulators.