FDA WARNING_LETTER - Nose Slap LLC - April 25, 2023

The FDA issued a Warning Letter on April 24, 2023, to 880 E Franklin Road, Suite #306, Meridian, ID 83642, concerning the distribution of over-the-counter (OTC) stimulant drug products, "NOSE SLAP" and "SOUL SLAP." The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act, and are misbranded under section 502(ee). Consequently, their introduction into interstate commerce is prohibited under sections 301(d) and 301(a) of the FD&C Act. The products are considered drugs due to claims on their labels and website indicating their intended use as stimulants to restore mental alertness or wakefulness. They are deemed unapproved new drugs because they contain ammonia ingredients intended as reflex stimulants, which were determined not Generally Recognized As Safe and Effective (GRASE) in a June 2008 proposed rule (73 FR 34895) under 21 CFR part 330. Furthermore, even as general stimulant drug products, they do not conform to OTC Monograph M011, as they use ammonium chloride as an active ingredient and are administered intranasally, neither of which is covered by the monograph. There are no approved applications or adequate clinical trials supporting their GRASE status. The firm is required to take prompt action to correct these violations, investigate their causes, and prevent recurrence. A written response detailing corrective actions or reasons for delay must be submitted within 15 working days. Failure to comply may lead to legal actions, including seizure and injunction, and could impact approvals for export certificates or new drug applications.