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Abbott Laboratories was cited for marketing Similac Probiotic Tri-Blend, a dietary supplement containing Bifidobacterium infantis and Streptococcus thermophilus, as an unapproved new drug and unlicensed biological product intended for use in preterm infants in violation of the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. The product was found to be adulterated because it contained B. infantis (Bb-02), an unsafe food additive, and S. thermophilus (TH-4®), a new dietary ingredient lacking adequate safety data to ensure it does not present significant or unreasonable risk. Abbott promoted the product to healthcare professionals through websites and marketing materials that made clinical claims, thereby introducing it into interstate commerce without required FDA approval.