FDA Infant Formula Updates: New Labeling Guidance, Call for Enhanced Safety Measures, and Draft Protein Efficiency Ratio Testing

4 min

Infant formula manufacturers should be aware of several recent actions taken by the Food and Drug Administration (FDA).

First, on March 8, 2023, FDA published a letter to the infant formula industry calling for improved microbiological safety of powdered infant formula. Largely a response to recent Cronobacter spp. illnesses and issues arising in connection with the prior manufacture of infant formula, the letter is a "call to action" for the industry to:

  1. "elevate" production and process controls under 21 CFR 106.6(c) to prevent adulteration of infant formula,
  2. fully comply with cGMP and other notification and manufacturing control requirements under 21 CFR parts 106 and 117,
  3. consider certain concerns outlined by FDA (discussed below) in evaluating existing processes and production controls, and
  4. adhere to notification requirements for adulterated and misbranded formula. FDA has met with certain firms in the industry to lay out its concerns about powdered infant formula manufacturing facilities.

Specifically, these concerns include water control in dry production areas, the use of environmental monitoring to verify the effectiveness of controls, appropriate corrective actions for isolating pathogens, supply chain controls for biological hazards, and identifying all biological hazards. FDA specifically states that "The powdered infant formula manufacturer must evaluate any known or reasonably foreseeable hazards associated with these raw materials or other ingredients, determine if they require control at the supplier, and if they do, establish a supply chain program for those raw materials or other ingredients (see 21 CFR 117.405(a)(1))."

FDA is conducting inspections of domestic and foreign infant formula suppliers because of its concern over biological pathogens, and notes that the risk of certain pathogens is still present for toddler drinks intended for persons of age 12 to 36 months. Therefore, the agency "encourages industry to evaluate its practices to mitigate the potential risk of Cronobacter spp. and other biological hazard contamination in all foods for infants and young children."

Notably, firms are continuing to issue recalls for powdered infant formula in response to Cronobacter spp. concerns, including as recently as last week.

Second, on March 6, 2023, FDA issued infant formula labeling guidance that updates its originally issued guidance from September 2016. The guidance offers the agency's latest thoughts on how infant formulas should be labeled with respect to the statement of identity, nutrient content claims, health claims and qualified health claims, as well as technical issues, such as the directions for preparation and use, use-by date, warning statements, allergen warnings, and more. FDA reiterates its concern from its previous guidance that it has observed an increased use of nutrient content claims and provides examples of claims that it would likely not consider to be misleading, such as a claim for "premature and low birth weight infants regarding the added amount of protein, because the higher level of protein is essential for the growth and development of this population."

Finally, earlier this year on February 9, 2023, FDA issued draft guidance that could affect the kind of information submitted to the agency when a New Infant Formula is brought to market. Specifically, the guidance explains how Protein Efficiency Ratio (PER) testing should be conducted when a New Infant Formula Notification (NIFN) is submitted. This PER testing is already required in NIFNs to provide assurance to the agency that the manufacturer's protein is of high enough quality for the infants who will use it. FDA is currently seeking comments by May 11, 2023.

In sum, these actions reflect FDA's dedication of resources to the infant formula industry. For example, FDA recently requested a $372M increase in its previous budget, citing specific budgeting needs for modernizing infant formula oversight and empowering consumers to make healthier food choices. The budget request is part of a larger effort to reorganize FDA from its more "siloed" operations style, which comes as a response to criticism over the agency's handling of the infant formula response during COVID-19. FDA hopes its reorganization proposal will be finalized in the fall. In the meantime, FDA's actions on infant formula continue apace.

If you have any questions regarding how the proposed regulations may affect your business or would like our assistance in preparing comments, please contact the authors of this alert.

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Venable has recently covered the Federal Trade Commission's new guidance regarding claims about the benefits and safety of health-related products, Health Products Compliance Guidance (in a webinar and a blog post). If you have any questions about the guidance or how it could affect your business, please let us know.

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