An Update On The FDA Warning Letter To Baby Formula Companies

On August 30, 2023 the FDA issued warning letters to three infant formula manufacturers, ByHeart, Mead Johnson Nutrition (Reckitt), and Perrigo, as part of the agency’s ongoing commitment to enhance regulatory oversight to help ensure that the industry is producing infant formula under the safest conditions possible.  

The published warning letter to ByHeart references an inspection of our Reading, PA plant that concluded in February ‘23. Prior to receipt of the warning letter, ByHeart has already submitted comprehensive responses to FDA’s observations from that inspection and there is no disruption to our manufacturing facilities or supply. 

Rest assured that no distributed ByHeart product has ever tested positive for contaminants and our recently relaunched product is manufactured end to end by us, including final packaging. 

We commend the FDA for its efforts to unify the industry’s ongoing work to elevate manufacturing and safety standards to protect babies. We believe the industry should embrace this level of transparency! Our industry has a responsibility to continuously improve and set higher standards for infant formula safety and quality. 

Together, we can continue working toward a common goal of providing safe and high-quality infant formula for all parents and babies.

If you have further questions for us regarding this matter, we’d love to hear from you.
Feel free to contact our Parent Experience team at any point to discuss.