The commercial tobacco industry is no stranger to innovation and controversy, especially when it comes to the composition of substances inhaled through electronic delivery devices, also known as vapes or e-cigarettes. A new trend has emerged with the introduction of products like Spree Bar that claim to be nicotine-free. These products have sparked discussions in the public health community about the legal frameworks and regulatory systems that define what substances fall under their purview.


Spree Bar markets products that contain Metatine, which is a synthetic nicotine analogue.  This is a proprietary compound that mimics the effects of nicotine but with a twist in its chemical structure. Spree Bar products are distributed by an overseas supplier and have made their way onto shelves in California and New York.

The claim that Metatine is not nicotine because of an altered molecule is central to their argument that it should not be regulated in the same way as tobacco products. However, even the manufacturer's website suggests that Metatine “may be addictive” and "is expected to have a toxicity profile similar to nicotine." This raises questions about its safety and the responsibility of regulatory agencies like the U.S. Food and Drug Administration to intervene in the interest of public health.

The Legal and Regulatory Maze

Similar substances, and the way they are regulated, is helpful to understand.  If these compounds are indeed biochemically like nicotine and produce comparable effects, they may fall within the scope of existing federal tobacco regulations. The FDA does regulate synthetic nicotine.  Arguably, substances claiming to provide similar effects should undergo the same premarket tobacco application (PMTA) review process that other nicotine products undergo. However, businesses selling Metatine and related products claim that they contain entirely new compounds and should not be subject to these regulations.

This situation resembles other contexts where analogous substances are regulated, as with the Analogue Act within the Controlled Substances Act, which targets chemical structures that produce similar effects to controlled substances. Similarly, the Environmental Protection Agency identifies and regulates analogues of pesticides. Likewise, the Drug Enforcement Administration has a role in regulating analogues of substances that can be abused.

Under the Family Smoking Prevention and Tobacco Control Act, the FDA has authority over “any other tobacco products that the Secretary by regulation deems to be subject to this chapter,” which could potentially include nicotine analogues like Metatine. However, applying these laws to new substances is often a complicated and drawn-out process, as has been seen with the 2016 Deeming Rule.

Regulation and Enforcement of Non-Tobacco Nicotine (NTN) Products

Another emerging issue is the presence of “no-nicotine” vapes, such as those marketed by Füm. “NTN” is the term used to describe nicotine that did not come from a tobacco plant. NTN includes synthetic nicotine, which is made in a lab and has a similar molecular makeup as naturally occurring nicotine. These products have not triggered marketing alerts, although the FDA does have the authority to regulate them.

Investigations in the United Kingdom, however, show that -- despite their labels – a significant number of these products actually do contain nicotine.  To our knowledge, comparable studies in the United States have not been conducted.  Nevertheless, the results of the existing studies highlight the challenge of taking manufacturers at their word and underscore the importance of regulatory oversight. Moreover, if a product is marketed with claims of providing calming effects, it could be regulated as a drug, depending on the nature of those claims. An example of this is the FDA’s warning letter issued to the company MONQ for claiming its essential oil inhaler product could be used to help with opioid addiction, a claim that crossed the line into drug territory.

Public Health Law Center: A Resource for Clarity

In response to the rise of these new products, the Public Health Law Center has several resources on its website, including webinars and commentaries, covering emerging products and their allure to youth, as well as the tobacco industry’s evasive tactics concerning synthetic nicotine.

States with narrow definitions of tobacco products should feel free to reach out to the Public Health Law Center for model language that could cover these new substances. Comprehensive regulation is essential to ensure that all products on the U.S. market undergo review for the sake of public health and safety.


By introducing Metatine and NTN products, the tobacco industry is trying to create a regulatory conundrum. While manufacturers claim these products are new compounds and thus exempt from existing regulations, their potential for addiction and similarity to nicotine suggest otherwise. Regulatory bodies like the FDA need to assert their authority on nicotine analogues and NTN products to ensure that all products on the market are appropriately regulated.

Willow Anderson, Staff Attorney
February 2, 2024