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FDA: Compliance Program for Infant Formulas Updated
02 lutego 2024

FDA: Compliance Program for Infant Formulas Updated

Regulatory Update

The Food and Drug Administration (USA) has announced a significant update to its compliance program for infant formulas. This update aims at further strengthen the safety and quality of products intended for newborns and young children.

It follows an internal assessment by the FDA, conducted in September 2022. The organization recommended a thorough review of the program to ensure compliance with the latest standards and to provide greater clarity in inspection and compliance activities.


What’s New in the Update

Improved Inspection Procedures

The program provides clear instructions for inspections. It places a special emphasis on annual environmental sampling for Cronobacter and Salmonella in powdered infant formula production facilities.

Management of Positive Results

In the event of positive results for Cronobacter or Salmonella or nutrient levels above or below FDA-established requirements, the program provides detailed procedures for immediate notification and case management.

Communication with Experts

Positive outcomes during record reviews must be promptly communicated to experts in the infant food program.

Information on Associated Risks

The updated compliance program includes a detailed section on the risks associated with Salmonella and Cronobacter in infant products, as well as conditions that may lead to environmental contamination in production facilities.

New Legislative Requirements

The update also incorporates new requirements for infant formulas introduced by the Food and Drug Omnibus Reform Act of 2022.


This compliance program update is an important step in ensuring that infant formulas in the US are safe and of high quality. Additionally, it represents the agency’s ongoing commitment to protecting the health of the youngest.


How can Mérieux Nutrisciences Support you on this Topic

Mérieux NutriSciences offers specific consultancy on food destined for the US and a continuous monitoring system for alerts, regulations, and legal limits for various types of food contaminants in every target market (including the USA).

We offer advanced analytical methodologies for the precise detection of major types of contaminants in a wide range of food products. Our expertise ensures full compliance with current guidelines and regulations for the target market.

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