What’s a warning letter?
A warning letter is a way for the FDA to communicate to a company that the agency has identified issues it would like the company to correct. Some warning letters are sent after inspections, like FDA did here. The warning letters that were recently provided to infant formula manufacturers are focused on the FDA’s ongoing commitment to enhanced oversight of infant formula manufacturing. As noted by the agency, “Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.” Said simply: the warning letter identifies issues from an inspection that ended earlier this year that we have already worked diligently to address.
Which brands were impacted?
Warning letters were issued to ByHeart, Reckitt, and Perrigo. These companies manufacture the majority of the US-made infant formula brands that you find on shelves today.
Does this have to do with your recall?
No, the warning letter is a result of an inspection of our Reading, PA facility that occurred after our recall and was focused on the facility and how we make infant formula. ByHeart has already submitted comprehensive responses to FDA’s observations from that inspection. The warning letter also references our prior recall involving product that was packaged by our old contract manufacturer that we no longer work with.
As a reminder, in December ‘22 ByHeart issued a voluntary recall as a precautionary measure because one test sample collected from one day of manufacturing at our then third-party packaging facility tested positive for Cronobacter. All formula packaged on the day the sample was collected, as well as the first production on the next day, was isolated for destruction and never distributed. Out of an abundance of caution, we subsequently recalled all formula produced during the entire production run even though it tested negative for Cronobacter prior to release.
At that time, ByHeart owned its manufacturing supply chain with the exception of final packaging (which involves blending and packaging into our cans), which was conducted by a reputable third-party packager. Following the recall, however, we decided not to move forward with our third-party packager because we could not get the level of transparency and confidence we needed from them—and as a result, paused our operations. We have since purchased two new facilities to ensure we can meet our commitments to quality for parents and their babies.
Is this a new/another recall?
This is not a recall. No product that ByHeart has distributed is being recalled and no product that ByHeart has distributed has tested positive for contaminants. All ByHeart formula is safe and nutritious. As noted by the FDA, “the agency is not aware of any distributed product where contamination was confirmed and believes that the [prior] recalls were effective in removing the potentially contaminated batches of product from the market. Additionally, these warning letters are not associated with any current recalls and therefore the FDA does not anticipate any impact to the availability of infant formula on the market.” (link)
Should I be concerned about my formula?
No. All ByHeart formula has met all FDA requirements and is safe and nutritious. As noted by the FDA, the agency “does not advise parents and caregivers to discard or avoid purchasing any particular infant formula at this time.” (link)