US FDA Issues Warning Letters to Three Baby Formula Manufacturers

August 31, 2023: The US Food and Drug Administration ( FDA ) has issued warning letters to three baby formula manufacturers for violating the Federal Food, Drug, and Cosmetic Act (FD&C). The letters were issued to ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC.

The FDA said that the companies violated the FD&C Act by failing to establish processes to ensure that infant formula does not become contaminated during manufacturing. The agency also noted that the companies failed to investigate contamination complaints and take appropriate corrective actions.

The FDA said that the violations pose a serious risk to infants, especially vulnerable to foodborne illness. The agency requires the companies to take immediate action to correct the violations and prevent future problems.

Actionable Takeaways:

• Parents should be aware of the FDA’s warning letters and should contact their doctor if they have any concerns about the safety of their baby’s formula.
• Parents should also ensure they buy formula from a reputable source.

Practical Takeaways for Businesses:

• Businesses that manufacture or sell baby formula should take the FDA’s warning letters seriously and take steps to ensure that their products are safe.
• Businesses should also have a plan to investigate contamination complaints and take appropriate corrective actions.
• The FDA’s warning letters are a reminder of the importance of ensuring the safety of baby formula. Businesses that manufacture or sell baby formula should comply with the FDA’s regulations and ensure that their products are safe for infants.