Abbott blasted in warning letter for unapproved claims on infant probiotic

The US Food and Drug Administration (FDA) on Wednesday issued a warning letter to Abbott Laboratories for making unapproved claims about its infant probiotic, Similac Probiotic Tri-Blend for infants. The agency said there are safety risks in administering this product as a probiotic to treat preterm infants.

The agency followed up with a wider notification to healthcare providers noting the dangers of administering probiotics to preterm infants.

The warning letter went to the company’s site in Abbott Park, IL. It states that “you refer to your product as a probiotic and offer it for sale to health care professionals in the United States. Your product is labeled as containing, among other ingredients, Bifidobacterium infantis (Bb-02) and Streptococcus thermophilus (TH-4®), otherwise known as B. infantis (Bb-02) and S. thermophilus (TH-4®), and you sell it for use in preterm infants.”

The company’s promotional materials claim that “probiotics have shown to significantly improve outcomes” for mortality, necrotizing enterocolitis (NEC), and late-onset sepsis were not supported by safety data, according to the warning letter.

FDA stated, “There is inadequate information to provide reasonable assurance that S. thermophilus (TH-4®) does not present a significant or unreasonable risk of illness or injury.” It further noted that “available information on the use of microorganisms in products intended for preterm infants raises serious safety concerns.”

FDA’s concerns echo those of the American Academy of Pediatrics, which “does not endorse the routine use of living microorganisms in preterm infants, finding conflicting data on its safety and efficacy in this vulnerable population, particularly those with birth weight <1000 grams,” according to a wider safety notification issued by the agency to healthcare providers on 26 October.

Abbott has 15 days to respond to the warning letter.

Abbott spokesperson John Koval told Focus that the action does not affect other infant formula products and that its Similac Probiotic Tri-Blend product is used by fewer than 200 hospitals. Koval said the company has “been in conversations with FDA about discontinuing the product.” This product has about $1 million in sales.

The 26 October notfication included stronger language warning of the dangers of administering probiotic products to preterm infants.

FDA is aware of one infant death this year and more than 24 reported adverse events since 2018 associated with probiotics in infant formula. FDA has not approved any probiotic product for use as a drug or biological product in infants.

The agency also warned another company, Infinant, about its probiotic product, Evivo with MCT Oil, which was also being marketed as a treatment for preterm infants. The product has since been voluntarily recalled.

“Adverse events in any infant following the use of a probiotic are a concern to the FDA. We especially want to make clear that products containing live microorganisms may present serious risks to preterm infants in hospital settings,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER).

The warning letter follows previous formula problems for Abbott. In February 2022, the company voluntarily shut down production of its infant formula at its Sturgis manufacturing plant after discovering that the infant formula was contaminated and sickened infants who consumed the formula. The shutdown spurred a nationwide infant formula shortage.

The infant formula crisis, in part, sparked a reorganization at FDA (RELATED: FDA updates on proposed foods reorganization, shifting some of ORA’s functions, Regulatory Focus 23 August).

In September 2023, FDA issued a warning letter to Abbott regarding its Digene antacid product made in India, which was spurred by customer complaints about odors associated with the tablets (RELATED: Asia-Pacific Roundup: Goa warns Abbott India over production plant involved in recall, Regulatory Focus 18 September 2023).

In April, an Abbott subsidiary received a warning letter for failing to seek approval for changing a device intended to measure troponin in the blood to detect myocardial infarction, (RELATED: FDA warns diagnostic maker for failing to seek approval for changes, OTC firm for lax investigations, Regulatory Focus 20 April 2023).

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Abbott blasted in warning letter for unapproved claims on infant probiotic

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