Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for the four products identified above.
Passage 2On June 19, 2008, FDA issued a proposed rule (73 FR 34895) setting forth a determination that ammonia and any other ammonia ingredient in a drug product that is labeled with claims or directions for use as a reflex stimulant are not
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.128
- 21 CFR 330