Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your firms manufacture, import, and/or distribute “Bebelyn Diarrhea” and “Bebelyn Colic,” and that these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).
Passage 2your “Bebelyn Diarrhea” and “Bebelyn Colic” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.
Passage 3Your “Bebelyn Diarrhea” and “Bebelyn Colic” products are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).
Passage 4There are no FDA-approved applications in effect for “Bebelyn Diarrhea” and “Bebelyn Colic.”