The US Food and Drug Administration has suggested a multi-state outbreak of infant botulism could be linked to a supplier to formula business ByHeart.
The outbreak, spanning 19 states, has been traced to contamination of ByHeart formula with Clostridium botulinum (toxin), Type A.
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In an update issued on Friday (23 January), the FDA said two collected samples tested positive for Clostridium botulinum (toxin), Type A.
One was a closed product sample of the ByHeart formula and the other was organic whole-milk powder obtained from a third-party supplier.
Whole genome sequencing revealed the bacteria found in the formula matched samples taken from an affected infant.
The agencies have not identified the supplier.
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By GlobalData“While these results advance FDA’s understanding of the outbreak, FDA’s investigation is ongoing to determine the source of contamination,” the regulator said in a statement.
A total of 51 infant botulism cases have been identified so far, with the last case occurring in December. No deaths have been reported.
In November, ByHeart recalled all its infant formula products, including all cans and single-serve “anywhere pack” sticks, nationwide.
According to FDA, the company’s products account for roughly 1% of all infant formula sold in the US.
ByHeart said it continues to “cooperate fully” with regulators.
In an online statement, ByHeart co-founders Mia Funt and Ron Belldegrun said: “We take our responsibility to ByHeart families incredibly seriously and we are deeply sorry for the impact this outbreak has had on our community. While we await the conclusions of FDA’s root cause investigation, we are moving forward with that same sense of responsibility and taking action to regain your trust.”
The company said it is working with its laboratory testing partner IEH to develop new testing protocols for Clostridium botulinum “from farms to our factories.”
“Even though testing on the whole milk powder we received from suppliers exceeded industry and regulatory standards, we now know that the existing safeguards are insufficient,” it said.
ByHeart added the FDA’s findings are “consistent” with whole genome sequencing analysis carried out by the company and IEH Laboratories.
The firm said it will introduce new testing protocols and third-party testing for Clostridium botulinum on every batch of finished infant formula and at multiple points in the supply chain.
The company is also evaluating a “comprehensive set” of additional controls across its supply chain and manufacturing processes.
Besides, it plans to establish a food safety advisory board of “leading third-party experts” to validate safety measures and identify emerging risks.
The firm also announced a full refund for all products purchased on ByHeart.com on or after August.
Founded in 2016, ByHeart broke into the US infant-formula market during the 2022 supply crisis that severely disrupted the sector.
