Ammonia Sport Inc. – FDA Warning Letter, Mar 19, 2024

The FDA issued a Warning Letter to Mr. Rapoport regarding the distribution of "AMMONIA SPORT AQUA," "AMMONIA SPORT RAW," and "AMMONIA SPORT SQUEEZE" OTC stimulant drug products, sold via ammoniasport.com. FDA's review in November 2023 and March 2024 found these products to be unapproved new drugs and misbranded.

The products are deemed drugs under sections 201(g)(1)(B) and (C) of the FD&C Act due to claims of stimulating energy, focus, and strength, and preventing/treating fainting. Examples of claims include "boost performance in sports," "instantaneous boost of strength, energy, and focus," and "prevents and treats fainting."

These products are considered unapproved new drugs under section 505(a) and 301(d) of the FD&C Act because they are not generally recognized as safe and effective (GRASE) and lack FDA approval. Specifically, as reflex stimulants, they are subject to a 2008 proposed rule (73 FR 34895) deeming ammonia ingredients not GRASE. Even if considered general stimulants, they do not conform to OTC Monograph M011, which permits only caffeine orally, whereas these products contain ammonium chloride, sodium carbonate, sodium polyacrylate, and ammonium hydroxide, and are administered intranasally.