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Synthetic Nicotine: CASAA Position Statement

Why Synthetic Nicotine?

Recently, various e-liquid manufacturers announced they are switching from tobacco-derived nicotine to synthetically made nicotine. You may be wondering why companies are shifting to synthetic and what this will mean for vapor or other nicotine products you use.

Synthetic nicotine falls into a regulatory grey area at the federal level and across most states. This makes it an attractive alternative to tobacco-derived nicotine for some vapor companies that have recently received marketing denial orders (MDOs) from the FDA, but who wish to continue serving customers who rely on their smoke-free products. Some manufacturers concluded prior to the court ordered September 9, 2020 PMTA deadline that receiving market authorization through FDA was improbable. Switching to synthetically made nicotine avoids (at least temporarily) being subject to FDA’s strict and, at times, opaque and unpredictable tobacco regulations.

There may be other advantages to using synthetically made nicotine due to the fact that manufacturing does not leave nearly the same environmental footprint as tobacco-derived nicotine because it does not require growing, harvesting, and processing leaf tobacco.

What is Synthetic Nicotine?

Synthetic nicotine is not a new idea or product, but it is made in a lab. Tobacco companies considered a few applications for it in the 1960s, but issues with cost and product quality at the time made using it unattractive. Today, the cost of making high-quality synthetic nicotine is lower than in the 1960s, but it is still more expensive than nicotine derived from tobacco. While people who enjoy synthetically made nicotine may pay more for these products, it still costs less than cigarettes and is safer than smoking.

Appropriate Regulation

Given the similarities between synthetic nicotine and nicotine derived from tobacco, we already know a considerable amount about reasons why people may choose to consume it, toxicology, as well as short-term and some long-term risks. There is no reason to believe that synthetically made nicotine poses any greater risks to consumers than tobacco-derived nicotine. 

Because synthetic nicotine is not currently regulated by FDA as a tobacco product, there have been some demands from the usual suspects that it be folded into tobacco regulations. Still others are demanding that it be regulated as a drug (and for therapeutic uses only). They claim that if synthetically made nicotine is not treated as a tobacco product or as a pharmaceutical, there will be an unruly free-for-all at check-out counters across the country.

CASAA does not agree with assertions that the only alternatives to regulating synthetic nicotine as a tobacco product are either regulating it as a drug or allowing a completely unregulated environment where consumers have no assurance of the quality of the products they purchase. Consumers will benefit the most from regulations that establish clear standards for purity, safe supply chains, manufacturing, marketing, and sales. Consumers by way of supporting the smoking alternatives industry are demanding responsible and balanced regulations that optimize the transition away from combustion. 

Regulatory Threats to Consumer Access

Several states have already amended their tobacco laws to include synthetic nicotine. These regulations include, but are not limited to, taxation, place bans, minimum sales age, and flavor bans. CASAA expects anti-nicotine activists (formerly concerned with the harm to people’s health from smoking) will continue lobbying for federal and state regulations that treat synthetically made nicotine just like tobacco products or a therapeutic drug. In turn, synthetic nicotine may soon face the same regulatory hurdles and barriers to use that are currently restricting access to nicotine derived from tobacco.

CASAA’s Position on Regulating Synthetic Nicotine

The FDA and state and local governments are proving incapable of regulating nicotine in a way that is appropriate for the protection of public health.

The use of synthetically made nicotine in vapor, oral, and other alternatives to tobacco products is a direct result of consumer demand to preserve access to these life-saving options. With more than 23 million Americans who use vapor and modern oral products1, it is clear that both synthetic and tobacco-derived nicotine are filling a dire need which is not being met by current regulations.

Synthetic nicotine presents regulators with an opportunity to optimize the public health benefits of nicotine from smoke-free sources. Namely, allowing the use of synthetic nicotine in products that are attracting and diverting people away from smoking.

1Herzog, Bonnie. “Current Trends and What’s Ahead in Tobacco/Nicotine.” NATO Webinar, September 29, 2021.