Abbott Laboratories
FDA issued a warning letter to Abbott Laboratories (CEO Robert B. Ford) regarding its Similac® Probiotic Tri-Blend dietary supplement marketed for use in preterm infants. FDA found that marketing claims on Abbott's websites and sales handouts — stating the product reduces necrotizing enterocolitis (NEC), mortality, and sepsis — rendered the product an unapproved new drug and unlicensed biological product under the FD&C Act and PHS Act. The product was also found adulterated because it contains B. infantis (Bb-02), an unsafe food additive for preterm infant use, and S. thermophilus (TH-4®), a new dietary ingredient lacking adequate safety assurance for this population. FDA demanded corrective action within 15 working days and warned that failure to comply could result in seizure and/or injunction.
Flagged claims (5)
Probiotics have shown to significantly improve outcomes
ensure the probiotic is ready for hospital use
probiotics increase the number of good bacteria in the gut, promoting a healthy microbiome
Benefits of probiotics on NEC: significantly reduc[ing] incidence of NEC in clinical studies
Importantly, giving probiotics to preterm infants can reduce the incidence of NEC.
Required actions (3)
Within fifteen working days of receipt of this letter, please notify FDA in writing of the specific steps that you have taken to correct any violations.
We advise you to comprehensively review your website, product labels, and other labeling and marketing materials to ensure that you are lawfully marketing your product in full compliance with the FD&C Act, the PHS Act, and their implementing regulations.
Failure to adequately address this matter may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.
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