In what appear to be the first restrictions of their kind, the state of California and the city and county of Denver have adopted bans on flavored tobacco products that cover not only products containing tobacco and nicotine, but also nicotinic alkaloids and nicotine analogs.

The new restrictions come in the wake of an uptick in the U.S. market of nicotine analog products, which reportedly use compounds that are not nicotine but are closely related to it in structure. For example, Spree Bar purports to use “Metatine^TM,” which is described as “a patented non-nicotine compound that provides adult users with a strong sense of satisfaction that is largely indistinguishable from traditional vape products.” Outlaw Dip Company, Inc. manufactures pouch products that use a compound called “Nic-Safe^TM” that is described as “a NON addictive Nicotine alternative that still gives you a buzz!” but “is 100% TOBACCO FREE AND NICOTINE FREE.” Happy Hippo markets a pouch product containing “Hippotine (Imotine^TM)” that it describes as an “experimental,” “innovative non-nicotine compound.”

So why the growth in nicotine analog products? For the most part, they are not subject to existing tobacco product regulations. FDA’s tobacco product authorities cover “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.” This clearly covers synthetic nicotine but not necessarily nicotine-like compounds that have a different chemical composition. Similarly, although many state and local laws have been amended to regulate nicotine products, such as vapor products and modern oral nicotine pouches, many do not address nicotine analogs.

This means that companies marketing nicotine analog products can often avoid legal requirements, such as FDA premarket review, state and local licensing and excise tax requirements, and state and local restrictions, such as bans on flavored tobacco products. Indeed, Spree Bar’s website boasts that “[m]etatine products are exempt from nicotine excise taxes in many states, which can result in massive savings for retailers and consumers,” and “[m]etatine can be combined with many flavors and is legal to sell in nearly all 50 states.” Similarly, Happy Hippo’s website advertises that Hippotine products are “[a]vailable to Californians (not subject to flavored pouch restrictions).”

Regulators, however, are catching up. Effective January 1 of this year, California law prohibits retailers from selling flavored tobacco products, including flavored products containing “nicotinic alkaloids and nicotine analogs.” Similarly, the city and county of Denver passed an ordinance in December 2024, slated to take effect in March, that prohibits retail tobacco stores from selling flavored tobacco products, including flavored products “containing nicotine alkaloids and nicotine analogs such as metatine.”

In addition, other federal and state regulators can rely upon existing tobacco product definitions that are broad enough to regulate nicotine analog products without any amendments needed. For example, the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) regulates electronic cigarettes used with nicotine analog substances under the federal Prevent All Cigarette Trafficking (PACT) Act — a federal law that imposes requirements on delivery sellers of electronic cigarettes and certain other tobacco products. The PACT Act defines the term “electronic nicotine delivery system” as “any electronic device that, through an aerosolized solution, delivers nicotine, flavor, or any other substance to the user inhaling from the device.” Similar examples can be found at the state level. In Nevada, for example, the Department of Taxation oversees tobacco tax laws that define “vapor product” as “any noncombustible product containing nicotine or any other substance that employs a heating element, power source, electronic circuit or other electronic, chemical or mechanical means, regardless of the shape or size thereof, that can be used to product vapor from nicotine or any other substance in a solution or other form, the use or inhalation of which simulates smoking.”

FDA does not appear to have taken a position on nicotine analog products, but it is worth noting that the agency could use its existing drug authorities to regulate such products. Under federal law, a “drug” includes “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Thus, to the extent nicotine analog products make therapeutic claims, they would fall within the definition of “drug.” Nevertheless, the last time FDA faced a growing, new tobacco product category — synthetic nicotine products — the agency chose not to use its “drug” authorities to regulate the category. Instead, the agency waited until Congress amended the definition of “tobacco product” to include products “containing nicotine from any source.” Therefore, absent the making of therapeutic claims by manufacturers and marketers of analog products, it is reasonable to expect that FDA may again wait for congressional action to regulate nicotine analog products.

In the meantime, if the market for nicotine analog products continues to grow, we expect that states and localities will amend their existing tobacco product laws to capture such products where necessary. For more information or assistance with federal and state regulation of these products, please contact our team.