Nicotine Caffeine Drink Product Receives Warning Letter

A nicotine and caffeine drink company was cited for making disease claims and for selling a “new tobacco product.” I’ve seen a lot of weird products, but a nicotine caffeine beverage is a first, and for good reason, as this product category is presumably way out of compliance unless there was premarket approval.

I guess it is “possible” to sell a nicotine beverage, but this would require a Premarket Tobacco Product Application, where they must prove to the FDA that the drink is “Appropriate for the Protection of Public Health” (APPH), but since it looks like a nicotine soda, the chances of it passing are small. Alternatively, the new drug application pathway is theoretically possible, but it is burdensome, lengthy, and very expensive, and is unlikely to justify the market demand.  FDA’s warning letters also indicate that a nicotine beverage faces a second, independent problem: if it is a conventional ‘food,’ then added nicotine would be treated as an unapproved/unsafe food additive, rendering the beverage adulterated. That issue would remain even if marketing disease claims were removed and the firm pursued tobacco-product premarket authorization.

The primary issues cited in the warning letter relate to disease claims, which likely tipped the scale to the warning letter. These types of “online disease claims” are the easiest FDA targets for warning letters, as they are less involved than GMP inspections or testing products. A quick plug for Apex Compliance, my software that scans websites, authenticated Instagram/Facebook accounts, and pre-published content for issues. We use agentic AI to help you understand regulatory issues, including net impression, and help you with possible more compliant rewrites. It would have flagged MAJOR ISSUES with this website before it leads to a warning letter. Learn more and free trial.

From warning letter. “On a July 3, 2025 blog post: “The Surprising Truth About Nicotine: Benefits, Risks, and Smarter Use…May ease symptoms of depression and anxiety in some users.”

The company’s website is currently “under construction,” which makes me think this is the kind of situation where a risky company grows without regulatory oversight, then just shuts down when it gets in trouble. This whack-a-mole strategy has got to be difficult for the poorly resourced FDA, but I applaud their effort here.

Read the letter here.