WARNING LETTER

Ammonia Sport Inc. MARCS-CMS 672196 — March 19, 2024

Product:: Drugs

Recipient:: Recipient Name

Justin Rapoport; Recipient Title

Owner; Ammonia Sport Inc.; 2045 Cordero Rd.
Del Mar, CA 92014
United States; support@ammoniasport.com

Issuing Office:: Center for Drug Evaluation and Research | CDER; United States

Secondary Issuing Offices

United States

WARNING LETTER

March 19, 2024

RE: FEI # 3017370207

Dear Mr. Rapoport:

This letter concerns your firm’s distribution of over-the-counter (OTC) stimulant drug products. The U.S. Food and Drug Administration (FDA) reviewed your website on November 2023 and March 2024 at the Internet address https://www.ammoniasport.com where your "AMMONIA SPORT AQUA," "AMMONIA SPORT RAW," and "AMMONIA SPORT SQUEEZE" drug products are available for purchase in the United States. Based on our review, your "AMMONIA SPORT AQUA," "AMMONIA SPORT RAW," and "AMMONIA SPORT SQUEEZE" drug products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food Drug & Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), and are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.

Unapproved New Drug and Misbranded Drug Violations

"AMMONIA SPORT AQUA," "AMMONIA SPORT RAW," and "AMMONIA SPORT SQUEEZE" are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body. Specifically, these products are intended for use as stimulant drug products.

Examples of the claims from the products’ labeling that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products include, but may not be limited to, the following:

AMMONIA SPORT AQUA

“Smelling Salts Twist and Sniff!...Ammonia inhalants, also known as smelling salts, are chemical compounds used for arousing consciousness…This ammonia inhalant is designed to boost performance in sports!...The ammonia irritates the blood vessels in the nasal passages providing an instantaneous boost of strength, energy, and focus…” [from your product label]

“AQUA Twist and Sniff >Energy >Focus >Strength.” “What is Ammonia Sport? Our premium smelling salts boost focus, energy, and strength, allowing you to reach your peak performance and get in the game!”… “The Most Energy You Will Get From A Smelling Salt” “Our Smelling Salts boost focus, energy, and strength allowing you to reach your peak performance.”… “That capsule they hold under their nose are smelling salts, and this pregame/in-game ritual of athletes using them to get their head in the game is becoming synonymous with elite level performance.“ “-Supports Explosive Energy -Sharp Focus – Maximum Strength – Instant Sensation – Prevents and Treats Fainting” “Made in a FDA registered facility…in FDA approved facilities that meet all cGMP (Current Good Manufacturing Practices) standards.” [from your products’ website https://www.ammoniasport.com/]

“(Video showing athletes professional taking product) “You may have seen many League players using smelling salts…they wanna get themselves going…you’re wired. ...try to give him a bit of a boost on the bench…smelling salts makes sure that head is cleared and ready to go…this is my secret weapon…you will go absolutely bizerk” [from your products’ website https://www.ammoniasport.com/]

“Voted #1 Smelling Salts for Athletes! Athletic Smelling Salts boost strength, energy and focus!” [from your Facebook social media account https://www.facebook.com/AmmoniaSport/ ]

AMMONIA SPORT RAW

“Smelling Salts Twist and Sniff!...Ammonia inhalants, also known as smelling salts, are chemical compounds used for arousing consciousness…The ammonia irritates the blood vessels in the nasal passages providing an instantaneous boost of strength, energy, and focus…Uncap, sniff, perform…. ” [from your product label]

“RAW Splash and Sniff >Energy >Focus >Strength.” “What is Ammonia Sport? Our premium smelling salts boost focus, energy, and strength, allowing you to reach your peak performance and get in the game!” “The Most Energy You Will Get From A Smelling Salt” “Our Smelling Salts boost focus, energy, and strength allowing you to reach your peak performance.” “That capsule they hold under their nose are smelling salts, and this pregame/in-game ritual of athletes using them to get their head in the game is becoming synonymous with elite level performance.“ “-Supports Explosive Energy -Sharp Focus – Maximum Strength – Instant Sensation – Prevents and Treats Fainting” “Made in a FDA registered facility…in FDA approved facilities that meet all cGMP (Current Good Manufacturing Practices) standards.” [from your products’ website https://www.ammoniasport.com/raw/]

“Voted #1 Smelling Salts for Athletes! Athletic Smelling Salts boost strength, energy and focus!” [from your Facebook social media account https://www.facebook.com/AmmoniaSport/ ]

(Video advertising Ammonia Sport Raw) “Benefits of “Ammonia Sport” Strength Power Easy Energy boost Focus” [from your Instagram social media account https://www.instagram.com/ammoniasport/?hl=enh]

AMMONIA SPORT SQUEEZE

“Smelling Salts Twist and Sniff!...Ammonia inhalants, also known as smelling salts, are chemical compounds used for arousing consciousness…This ammonia inhalant is designed to boost performance in sports!...The ammonia irritates the blood vessels in the nasal passages providing an instantaneous boos of strength, energy, and focus…” [from your product label]

“SQUEEZE: Squeeze and Sniff >Energy >Focus >Strength.” “What is Ammonia Sport? Our premium smelling salts boost focus, energy, and strength, allowing you to reach your peak performance and get in the game!” “The Most Energy You Will Get From A Smelling Salt” “Our Smelling Salts boost focus, energy, and strength allowing you to reach your peak performance.” “That capsule they hold under their nose are smelling salts, and this pregame/in-game ritual of athletes using them to get their head in the game is becoming synonymous with elite level performance.“ “-Supports Explosive Energy -Sharp Focus – Maximum Strength – Instant Sensation – Prevents and Treats Fainting” “Made in a FDA registered facility…in FDA approved facilities that meet all cGMP (Current Good Manufacturing Practices) standards.” [from your products’ website https://www.ammoniasport.com/squeeze/]

“(Video showing athletes professional taking product) “You may have seen many League players using smelling salts…they wanna get themselves going…you’re wired. ...try to give him a bit of a boost on the bench…smelling salts makes sure that head is cleared and ready to go…this is my secret weapon…you will go absolutely bizerk” [from your products’ website https://www.ammoniasport.com/]

“Voted #1 Smelling Salts for Athletes! Athletic Smelling Salts boost strength, energy and focus!” [from your Facebook social media account https://www.facebook.com/AmmoniaSport/ ]

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).

In general, a drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling; and in general, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for the products identified above.

"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. The term “smelling salt” typically is used to refer to an ammonia aromatic preparation used as a reflex stimulant.¹ On June 19, 2008, FDA issued a proposed rule (73 FR 34895)² setting forth a determination that ammonia and any other ammonia ingredient in a drug product that is labeled with claims or directions for use as a reflex stimulant are not GRASE or are misbranded. This June 19, 2008 proposed rule is the most recent applicable FDA proposal issued under 21 CFR part 330 with respect to ammonia as a reflex stimulant in OTC drug products. Thus, "AMMONIA SPORT AQUA," "AMMONIA SPORT RAW," and "AMMONIA SPORT SQUEEZE" are deemed to be new drugs under section 201(p)(1) of the FD&C Act and subject to the requirement to have an approved new drug application under section 505 of the FD&C Act, 21 U.S.C. 355, beginning on September 23, 2020.³

Even if "AMMONIA SPORT AQUA," "AMMONIA SPORT RAW," and "AMMONIA SPORT SQUEEZE" were not marketed as reflex stimulant drug products and were only marketed as more general stimulant drug products, your products would still not meet the requirements under section 505G, under which they would be deemed to be GRASE and not a new drug.

Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as "OTC monograph drugs"—may be legally marketed if they meet applicable requirements. In particular, stimulant drug products are deemed to be GRASE and not a new drug if, among other things, they conform to the conditions of use in the Over-the-Counter Monograph, M011: Stimulant Drug Products for Over-the-Counter Human Use (hereinafter M011), as set forth in the applicable final administrative order.⁴ 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"),⁵ and are labeled with directions for intranasal administration, neither of which are permitted conditions of use under the deemed final order. Therefore, even if "AMMONIA SPORT AQUA," "AMMONIA SPORT RAW," and "AMMONIA SPORT SQUEEZE" were marketed only as general stimulant drug products, they would not meet requirements under section 505G, under which they would be deemed to be GRASE and not new drugs.

In addition, the FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that "AMMONIA SPORT AQUA," "AMMONIA SPORT RAW," and "AMMONIA SPORT SQUEEZE" are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling. Moreover, there is no evident basis under the FD&C Act under which these products would be legally marketed without an approved application. Accordingly, these products are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).

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.

The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov and include your firm name in the subject line of your email.

Sincerely,
/S/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

______________________

1 Merriam Webster’s dictionary defines “smelling salts” as “a usually scented aromatic preparation of ammonium carbonate and ammonia water used as a stimulant and restorative.”

2 On June 19, 2008, FDA issued a proposed rule (73 FR 34895) setting forth a determination that ammonia and any other ammonia ingredient in a drug product that is labeled with claims or directions for use as a reflex stimulant are not generally recognized as safe and effective (GRASE) or are misbranded.

3 FDA did not determine that it was in the interest of public health to extend the period during which any drug subject to section 505G(a)(4) may be marketed without an approved new drug application.

4 Section 505G(a)(1) of the FD&C Act specifies criteria under which certain nonprescription drugs without an approved application are deemed GRASE and not "new drugs," notably, conformance with conditions detailed in applicable OTC monograph documents issued by FDA under 21 C.F.R. part 330 prior to enactment of the CARES Act. In the case of OTC stimulant drug products, relevant documents were deemed under section 505G to be a final administrative order, Over-the-Counter Monograph M011: Stimulant Drug Products for Over-the-Counter Human Use. (Over-the-Counter Monograph M011 Final Administrative Order (OTC000025))

5 M011 specifies that caffeine, in a form suitable for oral administration, is the only acceptable active ingredient for use as a stimulant under the order.