Outbreak of infant botulism linked to ByHeart Infant Formula – CDPH reports

USA – Infant nutrition brand ByHeart has recalled two batches of its Whole Nutrition Infant Formula following notification from the FDA about an ongoing investigation into the recent outbreak of infant botulism in the USA.

A statement released by California’s Department of Public Health (CDPH) said that preliminary testing of one sample of the formula, carried out at its laboratory, suggested the presence of Clostridium botulinum, the bacterium that causes botulism.

Erica Pan, CDPH director and State Public Health Officer, said: “Infant botulism is a very rare disease that occurs when babies inhale or swallow spores of the toxin-producing bacteria that cause infant botulism, which leads to progressive muscle weakness including trouble breathing if not treated in time”.

Pan added: “We have tested a sample of the specific powdered infant formula linked with these cases and preliminary tests are positive. We are urging parents to stop using ByHeart formula immediately.”

According to the FDA, 83 cases of infant botulism have been reported nationwide since August, with 13 infants having received ByHeart formula at some point.

There has been no historical precedent of infant formula causing infant botulism, which is extremely rare and originates from environmental sources such as soil, dust or certain vegetables.

A statement shared by ByHeart co-founders Mia Funt and Ron Belldegrun, said ByHeart is treating the CDPH’s preliminary result “with the utmost seriousness,” and is now conducting testing, with a third party independent testing laboratory, of the two recalled batches of its formula.

However, the co-founders said the positive sample tested by the CDPH came from a previously-opened can. As a result, they stated that the testing “lacks scientific basis to establish causation between the product and illness”.

“We know that Clostridium botulinum is a bacteria that exists naturally in the environment – in places like soil, dust, and even vegetables – meaning that an opened can can be contaminated in multiple ways,” the statement added.

About the disease

Infant botulism is caused by colonization with Clostridium botulinum spores, whch germinate and produce botulinum neurotoxin in the intenstine.

The immature gut microbiota and reduced bile acid levels in infants create a permissive environment for spore germination and toxin production.

Infant botulism occurs when swallowed spores for Clostridium botulinum or related species temporarily colonize a baby’s large intestine and produce toxin. 

The toxin is then absorbed and carried in the baby’s bloodstream to the neuromuscular junction where it cleaves key intracellular proteins needed for the release of the neurotransmitter acetylcholine. 

Treatment should not be delayed while awaiting laboratory confirmation. BabyBIG® (Human Botulism Immune Globulin Intravenous) is the treatment of choice and should be administered as soon as infant botulism is suspected.

BabyBIG® is only available through the CDPH IBTPP program. Meticulous supportive care, including respiratory and nutritional support, is often required.

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