Abbott Laboratories

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Because these statements indicate that your product is intended for use in the mitigation, treatment, or prevention of disease, your product is a drug under section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)].

Passage 2

Your product is not the subject of an approved BLA nor is there an IND in effect for its use.

Passage 3

There is no food additive regulation that authorizes the use of *B. infantis* (Bb-02).

Passage 4

The ingredient *B. infantis* (Bb-02) does not meet the definition of a dietary ingredient.

Passage 5

We are not aware of a basis to conclude that any use of *B. infantis* (Bb-02) in dietary supplements or food for preterm infants is GRAS.

Passage 6

The available scientific information regarding the safety of S. thermophilus (TH-4®), when intended for consumption by preterm infants, indicates that 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.