BPI Labs, LLC

Selected passages from the FDA letter

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

Passage 1

Your Epinephrine Chloride Nasal Solution product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), 331(d).

Passage 2

This product is also misbranded under section 502(i) of the FD&C Act, 21 U.S.C. 352(i).

Passage 3

The Epinephrine Chloride Nasal Solution glass vial and its similarity to the glass vials for your FDA-approved Epinephrine Injection may mislead users into believing the product is intended for injection and thereby, increase the risk of erroneous administration.