FDA WARNING_LETTER - Abbott Laboratories - October 24, 2023

The FDA issued Warning Letter #669353 to Abbott on October 24, 2023, following a review of their websites (www.abbottnutrition.com, www.abbott.com, www.pediatricproconnect.com) and marketing materials for Similac® Probiotic Tri-Blend (Similac Probiotic Supplement) in October 2023.

The FDA identified several violations: 1. **Unapproved New Drug and Unlicensed Biological Product:** Similac Probiotic Supplement, containing *Bifidobacterium infantis* (Bb-02) and *Streptococcus thermophilus* (TH-4®) and marketed for preterm infants, is deemed an unapproved new drug and unlicensed biological product. Marketing materials and website statements claim the product "significantly improve outcomes" for "All-cause mortality," "Necrotizing enterocolitis (NEC)," "Late-onset sepsis," and "Feeding tolerance," indicating intended use for disease mitigation, treatment, or prevention. This violates the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 331(d)] and the Public Health Service Act (PHS Act) [42 U.S.C. § 262(a)(1)]. A valid biologics license application (BLA) or investigational new drug application (IND) is