Ammonia Sport Inc.

Selected passages from the FDA letter

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

Passage 1

Based on the above labeling claims, "AMMONIA SPORT AQUA," "AMMONIA SPORT RAW," and "AMMONIA SPORT SQUEEZE" drug products, containing the ingredients ammonium chloride and sodium carbonate ("AMMONIA SPORT RAW") and sodium polyacrylate and ammonium hydroxide ("AMMONIA SPORT AQUA" and "AMMONIA SPORT SQUEEZE"), are intended for use as stimulant drug products. Specifically, these products are intended for use as both reflex stimulants (i.e., smelling salts, ammonia inhalants) and, more generally, as stimulants to help restore mental alertness or wakefulness. As described below, these stimulant drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).

Passage 2

"AMMONIA SPORT AQUA," "AMMONIA SPORT RAW," and "AMMONIA SPORT SQUEEZE" are reflex stimulant drug products subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, these reflex stimulant drug products are deemed to be new drugs under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), because they are subject to a determination to be not GRASE in a proposed rule that is the most recently applicable proposal issued under 21 CFR part 330.

Passage 3

However, your "AMMONIA SPORT AQUA," "AMMONIA SPORT RAW," and "AMMONIA SPORT SQUEEZE" stimulant drug products do not conform to the conditions of use specified in Monograph M011 because your products are formulated with the active ingredients ammonium chloride and sodium carbonate ("AMMONIA SPORT RAW") and sodium polyacrylate and ammonium hydroxide ("AMMONIA SPORT AQUA" and "AMMONIA SPORT SQUEEZE")

Passage 4

Lastly, "AMMONIA SPORT AQUA," "AMMONIA SPORT RAW," and "AMMONIA SPORT SQUEEZE" are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because they are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of applications approved under section 505 of the FD&C Act, 21 U.S.C. 355.