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WARNING LETTER

February 5, 2026

RE: 719715

Dear James Nabors III:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://nicandjetfuel.com/ in November 2025. The FDA has observed that your website offers “Nicotina Energy Citrus Surge Lite 3 MG” and “Nicotina Energy Grapefruit Spark Lite 3 MG” for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Based on a review of your website, your “Nicotina Energy Citrus Surge Lite 3 MG” and “Nicotina Energy Grapefruit Spark Lite 3 MG” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:

On the webpage https://nicandjetfuel.com/https://supplycenterusa.com/:
• “Sparks Focus + Clarity . . . cut through mental clutter . . . help you zone in on what matters.”
• “Boosts Dopamine . . . tap into your brain’s dopamine system, enhancing motivation, drive, and satisfaction.”
• “Heightens Alertness[.] Nicotine activates pathways in the brain that sharpen reaction time and sensory awareness.”
• “Elevates Mood . . . stimulates receptors tied to mood regulation”

On a July 26, 2025 blog post: “Nicotine Energy Drinks: The Bold New Category You’ve Never Tried (But Should)” on the webpage https://nicandjetfuel.com/blogs/nic-and-jet-fuel-journal/nicotine-energy-drinks-the-bold-new-category:
• “What Are Nicotine Energy Drinks? Nicotine energy drinks combine a small, controlled dose of nicotine (typically 3mg or 6mg) with other energizing compounds like caffeine, adaptogens, and clean nootropics. . . . This is clean fuel. Think sharper focus, calmer nerves, and sustained drive — without the crash.”
• “Why Nicotine? . . .[I]solated nicotine . . . acts on the brain’s acetylcholine system, improving memory, attention, and reaction time.”
• “The Benefits of Nicotine Energy Drinks[:] Mental clarity without the jitters[,] Sustained energy without crashes[,] Laser-sharp focus for hours”

On a July 3, 2025 blog post: “The Surprising Truth About Nicotine: Benefits, Risks, and Smarter Use” on the webpage https://nicandjetfuel.com/blogs/nic-and-jet-fuel-journal/the-surprising-truth-about-nicotine-benefits-risks-and-smarter-use:
• “Nicotine triggers the release of dopamine, acetylcholine, norepinephrine, serotonin, and beta-endorphins. The result? Better focus, faster reaction time, improved memory, appetite suppression, and reduced anxiety.”
• “The Benefits. . .
o Brain Boosting: Enhances attention and memory, especially in tired or sleep-deprived states.
o Neuroprotection: May reduce risk or progression of diseases like Parkinson's and Alzheimer's.
o ADHD Support: Works similarly to stimulants like Adderall by increasing dopamine and norepinephrine.
o Mood Regulation: May ease symptoms of depression and anxiety in some users.”

On a July 26, 2025 blog post: “What Is a Nicotine Energy Drink? (And Why It’s Not What You Think)” on the webpage https://nicandjetfuel.com/blogs/nic-and-jet-fuel-journal/what-is-a-nicotine-energy-drink:
• “Nicotine by itself is not tobacco. Not smoke. Not combustion. And when used responsibly in low doses, research shows it may actually support:
o Mental clarity
o Reaction time
o Focus and memory
o Appetite control”
• “How Nicotine Affects Energy and Performance[.] . . . nicotine works on acetylcholine pathways — the neurotransmitter responsible for focus, alertness, and learning.”

On a July 23, 2025 blog post: “Nicotine in Moderation: A Tool, Not Taboo” on the webpage https://nicandjetfuel.com/blogs/nic-and-jet-fuel-journal/nicotine-in-moderation-a-tool-not-taboo:
• “What the Research Says
o When microdosed and used responsibly, nicotine may support several cognitive and functional benefits”
• “Increased Focus & Attention
o Nicotine stimulates the release of acetylcholine and dopamine—two neurotransmitters linked to learning, memory, and focus. Several studies have found improved reaction times, attention span, and short-term memory in test subjects using small doses.”
• “Mood Stabilization
o Low-dose nicotine has been observed to improve mood, particularly under stress. It can enhance the brain’s reward system without the overstimulation seen in traditional energy drinks or synthetic compounds.”

Your “Nicotina Energy Citrus Surge Lite 3 MG” and “Nicotina Energy Grapefruit Spark Lite 3 MG” products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. Subject to certain exceptions not applicable here, a new drug 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 approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Furthermore, please note that if you take corrective actions such that your products are no longer drugs, your products may meet the definition of a tobacco product under section 201(rr)(1) of the FD&C Act and thus would be required to comply with the FD&C Act and its implementing regulations relating to tobacco products.¹ For instance, generally, to be legally marketed in the United States, the FD&C Act requires “new tobacco products” to have a premarket authorization order in effect. A “new tobacco product” is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. § 387j(a)). Generally, a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)) and FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. § 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. § 387e(j)(3)). All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA’s discretion including, but not limited to, civil money penalties, seizure, and/or injunction.

In addition, products that meet the definition of a food under section 201(f) of the FD&C Act must comply with the requirements and prohibitions applicable to foods. Many substances intentionally added to beverages and other conventional foods are food additives. Food additives require premarket approval based on data demonstrating safety. Any unapproved food additive used in a beverage or other conventional food causes the food to be adulterated under section 402(a)(2)(C) of the FD&C Act. Adulterated foods cannot be legally imported or marketed in the United States.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement 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 lead to regulatory or legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct 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 fifteen 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. Please include your firm name and the unique identifier “719715” in the subject line of the email.

Sincerely,
/S/
Jill P. Furman
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

/S/
John E. Verbeten
Director
Office of Compliance and Enforcement
Center for Tobacco Products
Food and Drug Administration

_______________________

1 Note that section 201(rr)(2) of the FD&C Act provides that an article is not a tobacco product if it is a drug under section 201(g)(1).