US Updated Compliance Program for Infant Formula

On October 6, 2023, the U.S. Food and Drug Administration (FDA) released its updated compliance program for infant formula, which incorporates valuable insights gained from several years of experience. This program provides detailed elaboration of inspections, sampling, laboratory analysis and regulatory strategy. Enterprises importing infant formula products should pay attention to the following updated requirements.

Import Sample Collection:

Infant formula surveillance samples will be collected for imported products while in the import status, as necessary:

1. Upon the request of the Center for Food Safety and Applied Nutrition (CFSAN) compliance program monitor.

2. When instructed as part of an assignment.

3. Upon identification through import system screening.

4. When adverse findings are observed during examination. Adverse conditions that warrant laboratory analysis may include damage during transit or storage, concerns regarding inadequate storage temperature conditions, unusual odors, or evidence of over-labeling.

Detention recommendations:

Import divisions will submit a detention recommendation case for infant formula when:

1. Samples are positive for one or more microbiological analytes of public health significance. The most common analytes are Salmonella and Cronobacter.

2. Samples are violative for the content requirements in abbreviated or comprehensive nutrient analysis.

   a. Any nutrient content in the product deviates from the specified range (section 412(i) of the FD&C Act and in 21 CFR 107.100.);

   b. The analyzed calorie, total fat, and/or sodium content exceeds the value declared on the label by 20% or more;

   c. The nutrient content of any added vitamin, mineral, protein, or linoleic acid does not meet or exceed the declared value on the label;

   d. An exempt infant formula is found, through analysis, to contain a nutrient(s) that it is specifically formulated to exclude;

3. The product is misbranded in a significant way, including

a. Failure to declare an allergen;

b. Failure to bear required nutrient information;

c. Unauthorized nutrient content or health claims;

d. Failure to bear required information in English;

e. Failure to bear directions for use.

CFSAN will conduct a concurrent review of the detention recommendation case to determine if it should be added to the detention without physical examination, based on the relevant circumstances.