WARNING LETTER

Innovative Formulations, LLC dba Insane Labz MARCS-CMS 672952 — February 22, 2024

Product:: Drugs

Recipient:: Recipient Name

John T Rozkiewicz, Owner; Recipient Title

Dustin LeBleau, Owner; Innovative Formulations, LLC dba Insane Labz; 675 E Highway 43
Harrison, AR 72601
United States; Jtr120271@yahoo.com; dustin@insanelabz.com

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

Secondary Issuing Offices

United States

WARNING LETTER

February 22, 2024

RE: 3010382813

Dear Mr. Rozkiewicz and Mr. LeBleau:

This letter concerns your firm’s distribution of an over-the-counter (OTC) stimulant drug product. The U.S. Food and Drug Administration (FDA) reviewed your website on November 14, 2023 at the Internet address https://www.insanelabz.com, and your Amazon storefront on February 14, 2024 at https://www.amazon.com/s?me=A2D3NRSOL1T2HF&marketplaceID=ATVPDKIKX0DER where your “WAKE THE DEAD SMELLING SALTS” drug product is available for purchase in the United States.

“WAKE THE DEAD SMELLING SALTS” drug product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) of the Federal Food Drug & Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and is misbranded under section 502 (ee) of the FD&C Act, 21 U.S.C. 352 (ee). Introduction or delivery for introduction of such a product 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

“WAKE THE DEAD SMELLING SALTS” is a drug as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is 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 it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as a stimulant drug product.

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

“INSANE LABZ® WAKE THE DEAD™ EXTREMELY POTENT SMELLNG SALTS . . . Certified cGMP . . . WARNING: THIS SMELLLING SALT RELEASES AMMONIA GAS.” [from the “WAKE THE DEAD SMELLING SALTS” label]

“Wake the Dead smelling salts is a POTENT smelling salt . . . Our smelling salts, when hydrated in accordance with the label, release ammonia gas – triggering a strong inhalation reflex. This reflex causes the muscles that control breathing to work faster, while also activating the sympathetic nervous system – increasing the heart rate, blood pressure, and brain activity. . . . Used as an aid by power lifters, strongmen, weightlifters and strength athletes looking for increased focus for PR lifts” [from your website at https://www.insanelabz.com/products/wake-the-dead-smelling-salts]

“Our smelling salts, when hydrated in accordance with the label, release ammonia gas - triggering a strong inhalation reflex. This reflex causes the muscles that control breathing to work faster, while also activating the sympathetic nervous system - increasing the heart rate, blood pressure, and brain activity . . . Ingredients. . . Ammonium Chloride” [from your Amazon listing at https://www.amazon.com/Insane-Labz-Smelling-Boosting-Power-Lifting/dp/B08GQCY6KN/ref=sr_1_1_sspa crid=3PECM2U00Z28H&keywords=wake+the+dead&qid=1707939176&sprefix=wake+the+dead%2Caps%2C64&sr=8-1-spons&sp_csd=d2lkZ2V0TmFtZT1zcF9hdGY&psc=1]

Based on the above labeling claims, “WAKE THE DEAD SMELLING SALTS” drug product containing the ingredient ammonium chloride is intended for use as a stimulant drug product. Specifically, this product is intended for use as a reflex stimulant (i.e., smelling salts, ammonia inhalants) and, more generally, as a stimulant to help restore mental alertness or wakefulness. As described below, this stimulant drug product is an unapproved new drug 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 application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for the product identified above.

“WAKE THE DEAD SMELLING SALTS” is a reflex stimulant drug product subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, this reflex stimulant drug product falls under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), because it is 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, “WAKE THE DEAD SMELLING SALTS” is deemed to be a new drug 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 “WAKE THE DEAD SMELLING SALTS” was not marketed as a reflex stimulant drug product and was only marketed as a more general stimulant drug product, your product would still not meet the requirements under section 505G, under which it 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, nonprescription stimulant drug products are 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 orders.⁴ However, your “WAKE THE DEAD SMELLING SALTS” stimulant drug product does not conform to the conditions of use specified in Monograph M011 because your product is formulated with ammonium chloride⁵ and is labeled with directions for intranasal administration, which is not covered under the final administrative order. Therefore, even if “WAKE THE DEAD SMELLING SALTS” was marketed only as a general stimulant drug product, it would not meet requirements under section 505G, under which it would be deemed to be GRASE and not a new drug.

FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “WAKE THE DEAD SMELLING SALTS” is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling. Moreover, there is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Accordingly, this product is an unapproved new drug 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 a product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).

Lastly, “WAKE THE DEAD SMELLING SALTS” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application 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 exist in connection with your product. Please be aware that 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 adequately address these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

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 product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Please direct your email response to the U.S. Food and Drug Administration, Center for Drug Evaluation and Research - 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/

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 OTC stimulant drug products are subject to Over-the-Counter Monograph M011: Stimulant Drug Products for Over-the-Counter Human Use, as set forth in a final administrative order established under section 505G of the FD&C Act. (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.