Nose Slap LLC

Warning LetterOpen

Daniel Schofield Nose Slap LLC 7115 S Culbertson Way Boise , ID 83709 United States contact@noseslap.comIssued Apr 24, 2023Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Letter Details

Firm: Nose Slap LLC
Location: Daniel Schofield Nose Slap LLC 7115 S Culbertson Way Boise , ID 83709 United States contact@noseslap.com
FEI Number: N/A
Country: United States
Issue Date: April 24, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Nose Slap LLC distributed unapproved new drug products called "NOSE SLAP" and "SOUL SLAP" in violation of section 505(a) of the FD&C Act, which requires FDA approval before marketing new drugs. The products were marketed as stimulant inhalants containing ammonia and essential oils, with claims on labeling and the company website that they provided "immediate energy" and served as a "caffeine alternative," thereby establishing them as drugs intended to affect body function without the required FDA approval. The products were further found to be misbranded under section 502(ee) of the FD&C Act and their introduction into interstate commerce violated sections 301(d) and (a) of the FD&C Act.