What happened
Original notice title
Abbott Laboratories MARCS-CMS 669353, October 24, 2023
From the archived source record
The marketing materials FDA reviewed include one handout that bears the heading “Probiotics and Preterm Infants: Clinical Evidence” and another that bears the heading “The Promise of Similac Another Innovation Only From Similac,” which your sales representatives provided together to hospital staff. Based on the statements on your website and your marketing materials, your product is an unapproved new drug and unlicensed biological product that you introduced or delivered for introduction into interstate commerce in violation of 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)]. Your Similac Probiotic Supplement is also adulterated under section 402(a)(2)(C)(i) and (f)(1)(B) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i) and (f)(1)(B)] because it contains B. infantis (Bb-02), an unsafe food additive within the meaning of sections 201(s) and 409(a) of the FD&C Act [21 U.S.C. §§321(s) and 348]; and S. thermophilus (TH-4®), a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury, when used in preterm infants. These violations are described in more detail below. Adulterated Dietary Supplement In addition to your Similac Probiotic Supplement being an unapproved new drug and unlicensed biological product, your product is adulterated within the meaning of section 402(a)(2)(C)(i) and (f)(1)(B) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i) and (f)(1)(B)]. Unsafe Food Additive: Bifidobacterium infantis (Bb-02) Your Similac Probiotic Supplement is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)] because, when used in food for preterm infants, B. infantis (BB-02) is an unsafe food additive within the meaning of sections 201(s) and 409(a) of the FD&C Act [21 U.S.C. §§321(s) and 348(a)].
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- FDA closeout listed
- Source checked
- Jul 16, 2026
- Record revision
- 92cf47a3386e
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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