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WARNING LETTER

Date: April 24, 2023

To: 880 E Franklin Road, Suite #306
Meridian, ID 83642

Dear Mr. Schofield:

This letter concerns your firm’s distribution of over-the-counter (OTC) stimulant drug products. “NOSE SLAP” and “SOUL SLAP” 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

“NOSE SLAP” and “SOUL SLAP” 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, including your product labels and website (https://www.noseslap.com), where products are available for purchase, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following:

“NOSE SLAP! THE WAKE UP STICK . . . SMELLING SALTS INFUSED W/ ESSENTIAL OILS . . . We are on a mission to wake up the world one slap at a time. . . . CAUTION: Product releases ammonia gas. [from the “NOSE SLAP” label]

“NOSE SLAP! . . . Immediate Energy . . . Caffeine Alternative . . . Nose Slap will give you the energy boost you need to get through your day . . . With Nose Slap by your side, you are always second (sic) away from slapping the tiredness away and tackling whatever the day throws at you. . . . FAST ACTING FOR INSTANT ENERGY. . . With Nose Slap on-hand, you’re always just seconds away from a clear head and feeling prepped to crush whatever it is that’s in front of you . . . Rejuvenate your mind, refresh your senses, and increase your focus… all without sugary energy drinks . . . Nose Slap was created to fill a void of and provide a product that could provide instant alertness . . . We offer a safe alternative to energy drinks and provide a product that can provide instant alertness when waiting for energy isn’t an option. . . .” [from your website at https://www.noseslap.com]

“Nose Slap will give you the energy boost you need to get through your day, without keeping you awake later! . . . Smelling Salts have been a “thing” for years, but have never been combined with the unique properties of essential oils, creating the boldest concoction of instant energy the world has ever seen. . . . Smelling salts have been used thousands of years to provide alertness and an increased flow of oxygen to the brain. [from your website at https://www.noseslap.com/products/nose-slap]

“What is Nose Slap?. . . Nose Slap is Maximum Strength Smelling Salts with Essential Oils…Nose Slap is a mixture of sodium carbonate, ammonium chloride, and peppermint essential oil . . . What do smelling salts do? . . . The stimulant effect of smelling salts is due to the ammonia, which provokes someone’s nasal and lung membranes once they inhale through the nostrils. The end result is that the person involuntarily inhales and begins to respire quicker, which sends extra oxygen to the brain.” [from your website at https://www.noseslap.com/pages/faqs ]

“SOUL SLAP! NOSE SLAP WAKE UP STICKS . . . HARDEST SLAPPING SMELLING SALTS IN THE WORLD . . . We are on a mission to wake up the world one slap at a time. . . . CAUTION: THESE SMELLING SALTS ARE EXTREMELY POWERFUL! Product releases ammonia gas.” [from the “SOUL SLAP” label]

“SIZE MATTERS . . . SOUL SLAP! IS BIGGER AND OVER 10X STRONGER . . . If you like Nose Slap!, you’ll love what Soul Slap! does to wake up your senses and deliver laser-like focus. It’s the meanest blend of smelling salts and essential oils on the planet. . . . The body’s reaction to our unique energy blend will cause increased airflow, created [sic] an instant sense of rejuvenation and feeling of well-being. And unlike caffeine, it won’t keep you up at night.” [from product website at https://www.noseslap.com/products/soul-slap]

Based on the above labeling claims, “NOSE SLAP” and “SOUL SLAP” drug products, containing the ingredients ammonium chloride, sodium carbonate, and essential oil, 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 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 application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for the two products identified above.

“NOSE SLAP” and “SOUL SLAP” 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 fall 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 generally recognized as safe and effective (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, “NOSE SLAP” and “SOUL SLAP” 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 “NOSE SLAP” and “SOUL SLAP” 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 set forth in the Over-the-Counter Monograph, M011: Stimulant Drug Products for Over-the-Counter Human Use (hereinafter M011).⁴ However, your “NOSE SLAP” and “SOUL SLAP” stimulant drug products do not conform to the conditions of use specified in Monograph M011 because your products are formulated with the active ingredient ammonium chloride⁵ and labeled with directions for intranasal administration, neither of which are covered under the deemed final order. Therefore, even if “NOSE SLAP” and “SOUL SLAP” were marketed as only general stimulant drug products, they would not meet requirements under section 505G, under which they would be deemed to be GRASE and not a new drug.

In addition, the FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “NOSE SLAP” and “SOUL SLAP” 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 sections 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 and 301(d) of the FD&C Act, 21 U.S.C. 331(d).

Lastly, “NOSE SLAP” and “SOUL SLAP” 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 regarding your products nor are the stimulant drug products named in this letter intended to be an all-inclusive list of products you have manufactured, registered, and/or listed in FDA’s electronic drug registration and listing system (eDRLS), or introduced into interstate commerce. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence and the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Failure to address violations of the FD&C Act may be cause for FDA to withhold approval of requests for export certificates and approval of pending new drug applications or supplements listing your facility as a supplier or manufacturer.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot completely address the violations within 15 working days, state your reasons for delay and schedule for completion.

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.

Please direct your email response to Office of Unapproved Drugs and Labeling Compliance at the following email address to FDAADVISORY@fda.hhs.gov and include your firm name in the subject line of your email.

Sincerely,
/S/

Tina Smith
Acting Office Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

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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.