BPI Labs, LLC Warning Letter Details

Summary

BPI Labs, LLC distributed Epinephrine Chloride Nasal Solution 1 mg/mL without FDA approval, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act by introducing an unapproved new drug into interstate commerce. The product was also misbranded under section 502(i) of the FD&C Act, as it lacked required regulatory authorization despite being labeled with claims indicating use as a nasal decongestant and vasoconstrictor. The FDA determined the product did not meet the "generally recognized as safe and effective" (GRASE) standard required for marketing without an approved new drug application.