WARNING LETTER

Spirochaete Research Labs, LLC aka Scitus Laboratory Products MARCS-CMS 674278 — March 08, 2024

Product:: Drugs

Recipient:: Recipient Name

Eric C. Ritter; Spirochaete Research Labs, LLC aka Scitus Laboratory Products; 822 Terry Rd.
Hauppauge, NY 11788
United States; eric.ritter@spirochaetelabs.com

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

Secondary Issuing Offices

United States

WARNING LETTER

March 8, 2024

RE: 3023254292

Dear Mr. Ritter:

This letter concerns your firm’s distribution of over-the-counter (OTC) stimulant drug products. “ATOMIC RHINO -(SMELLING SALTS)-,” “RED LINE ATOMIC RHINO -(SMELLING SALTS)-,” “MEGATON ATOMIC RHINO -(SMELLING SALTS)-,” and “MEGATON RED LINE ATOMIC RHINO -(SMELLING SALTS)-” 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

“ATOMIC RHINO -(SMELLING SALTS)-,” “RED LINE ATOMIC RHINO -(SMELLING SALTS)-,” “MEGATON ATOMIC RHINO -(SMELLING SALTS)-,” and “MEGATON RED LINE ATOMIC RHINO -(SMELLING SALTS)-” 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 observed on the products’ labeling, including your product labels, product website (https://atomicrhino.com/), where products are available for purchase, and social media websites, such as Instagram, 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:

“…DESIGNED WITH PROFESSIONAL ATHLETES IN MIND - Atomic Rhino ammonia smelling salts are perfect for giving you that extra boost while lifting and powerlifting but also ideal for athletes involved in high intensity sports like hockey, football, and basketball, where the fast adrenaline rush action can sometimes result in injuries or exhaustion…” [from your website under Buy Now/Original Smelling Salts/Description
https://atomicrhino.com/]

“EXPLOSIVE ENERGY AND FOCUS
Massive Boost in psychological athleticism, get the grip you need to excel.”
[from your website under Buy Now/Original Smelling Salts https://atomicrhino.com/]

“BENEFITS YOU CAN FEEL
MAXIMUM STRENGTH EXPLOSIVE ENERGY RAZOR-SHARP FOCUS”
[from your website under Buy Now/Original Smelling Salts https://atomicrhino.com/]

“I needed something to help me make it through the afternoons work. I was skeptical but I didn’t want to put more caffeine in my diet. This product really works and helps wake me up when tired.” [from your website under Buy Now/Red Line https://atomicrhino.com/]

“These smelling salts are very very strong and will ensure you get the big rep you need and even another one due to the product lasting once you use it.” [from a post on your Instagram webpage, dated 12/23/2020, at https://www.instagram.com/p/CmiaaYoModq/]

Based on the above labeling claims, your “ATOMIC RHINO -(SMELLING SALTS)-,” “RED LINE ATOMIC RHINO -(SMELLING SALTS)-,” “MEGATON ATOMIC RHINO -(SMELLING SALTS)-,” and “MEGATON RED LINE ATOMIC RHINO -(SMELLING SALTS)-” drug products, containing the ingredients ammonium chloride, ammonium hydroxide, sodium polyacrylate and/or sodium carbonate 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 four products identified above.

“ATOMIC RHINO -(SMELLING SALTS)-,” “RED LINE ATOMIC RHINO -(SMELLING SALTS)-,” “MEGATON ATOMIC RHINO -(SMELLING SALTS)-,” and “MEGATON RED LINE ATOMIC RHINO -(SMELLING SALTS)-” 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 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, these reflex stimulant drug products 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 “ATOMIC RHINO -(SMELLING SALTS)-,” “RED LINE ATOMIC RHINO -(SMELLING SALTS)-,” “MEGATON ATOMIC RHINO -(SMELLING SALTS)-,” and “MEGATON RED LINE ATOMIC RHINO -(SMELLING SALTS)-” 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 “ATOMIC RHINO -(SMELLING SALTS)-,” “RED LINE ATOMIC RHINO -(SMELLING SALTS)-,” “MEGATON ATOMIC RHINO -(SMELLING SALTS)-,” and “MEGATON RED LINE ATOMIC RHINO -(SMELLING SALTS)-” 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 hydroxide or ammonium chloride,⁵ and are labeled with directions for intranasal administration, neither of which are covered under the deemed final order. Therefore, even if your “ATOMIC RHINO -(SMELLING SALTS)-,” “RED LINE ATOMIC RHINO -(SMELLING SALTS)-,” “MEGATON ATOMIC RHINO -(SMELLING SALTS)-,” and “MEGATON RED LINE ATOMIC RHINO -(SMELLING SALTS)-” 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 “ATOMIC RHINO -(SMELLING SALTS)-,” “RED LINE ATOMIC RHINO -(SMELLING SALTS)-,” “MEGATON ATOMIC RHINO -(SMELLING SALTS)-,” and “MEGATON RED LINE ATOMIC RHINO -(SMELLING SALTS)-” 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, “ATOMIC RHINO -(SMELLING SALTS)-,” “RED LINE ATOMIC RHINO -(SMELLING SALTS)-,” “MEGATON ATOMIC RHINO -(SMELLING SALTS)-,” and “MEGATON RED LINE ATOMIC RHINO -(SMELLING SALTS)-” 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/

CAPT Tina Smith
Office Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
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.