Synthetic Nicotine in the Spotlight

Regulation looms as manufacturers, retailers and consumers embrace lab-derived nicotine

By Renée M. Covino

IN THE TOBACCO WORLD, man-made options are rising to the top. Synthetic nicotine, also known as tobacco-free nicotine, is one of the options gaining traction.

“Scientifically manufactured in state-of-the-art laboratories, synthetic nicotine doesn’t contain any part of the tobacco leaf, stem or waste,” explained Lee Probst, vice president of sales at synthetic nicotine product manufacturer Ignite. “This means that it doesn’t have the tar and other unhealthy components of tobacco. The value to the tobacco industry is that it now gives a cleaner alternative to traditional tobacco.”

The use of synthetically made nicotine in vapor, oral and other alternative tobacco products is a direct result of consumer demand, according to the Consumer Advocates for Smoke-Free Alternatives Association (CASAA), which maintains that more than 23 million Americans currently use vapor and modern oral products.

With this consumer demand, however, comes the threat of regulation.

CASAA was founded in 2009 to raise awareness and protect consumer access to reduced harm alternatives to smoking. The nonprofit organization promotes the availability and protection of smoke-free alternatives to combustible tobacco.

“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,” the association states.

The Push to Regulate

In December, U.S. Food and Drug Administration (FDA) Center for Tobacco Products Director Mitch Zeller spoke about the regulatory challenges regarding the use of synthetic nicotine in electronic cigarettes and vapor products.

These challenges are behind the effort to bring synthetic nicotine under the regulatory authority of the FDA, according to Thomas Briant, executive director of the National Association of Tobacco Outlets (NATO). He outlined three main regulatory challenges around synthetic nicotine: definitional, differentiation and claims.

The definitional challenge refers to the Family Smoking Prevention and Tobacco Control Act, the federal law that authorized the FDA to regulate tobacco products, which defines a tobacco product as “any product made or derived from tobacco, including a component, part, or accessory of a tobacco product.” Synthetic nicotine is not made or derived from tobacco. The differentiation challenge revolves around the increasing difficulty in testing and differentiating tobacco-derived nicotine from synthetic nicotine. The difficulty arises because nicotine itself has two isomer forms (an R-nicotine isomer and a S-nicotine isomer), according to Briant. An isomer is two or more compounds with the exact same chemical formula, but the atoms are arranged differently.

Nicotine derived from tobacco has an isomer that is made up of 99 percent S-nicotine. Previous synthetic nicotine compounds were made up of approximately 50 percent R-nicotine and 50 percent S-nicotine. However, newer synthetic nicotine compounds can consist of more than 99 percent S-nicotine, making it harder to distinguish synthetic nicotine from tobacco-derived nicotine, Briant explained.

“Consumers, by way of supporting the smoking alternatives industry, are demanding responsible and balanced regulations that optimize the transition away from combustion.”

— Consumer Advocates for Smoke-Free Alternatives Association

The final challenge — the claims challenge — revolves around the increasing number of electronic nicotine products using, or claiming to use, synthetic nicotine instead of nicotine derived from tobacco. “As a part of these claims, several manufacturers that were issued Marketing Denial Orders by the FDA for their electronic cigarette products have made public statements that they are using or switching to synthetic nicotine to keep their products on the market,” the NATO director noted.

Closing the Loophole

On March 15, President Joe Biden signed a new federal spending bill that includes a section granting the FDA authority to regulate tobacco products that contain nicotine not made or derived from tobacco (e.g., synthetic nicotine).

The bill amends the definition of the term “tobacco product” under the Family Smoking Prevention and Tobacco Control Act to define a tobacco product as “any product made or derived from tobacco or containing nicotine from any source, that is intended for human consumption.”

The new authority closes the loophole that allowed some vapor companies to remain on the market despite the FDA's focus on removing flavored electronic cigarettes and vapor cartridges in early 2020.

The new legislation sets the effective date as 30 days after the bill is enacted, April 14. Manufacturers marketing a tobacco product that contains lab-made nicotine must file a Premarket Tobacco Application (PMTA) with the FDA within 30 days after the effective date — by May 14 — for its product to remain on the market.

The manufacturer can continue selling its product for an additional 90 days after the effective date. Once that period ends, the product would need to be removed from the market if the FDA has not approved the PMTA.

CASAA’s position is that 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,” the association stated, noting that the FDA and state and local governments have thus far proved incapable of regulating nicotine in a way that is appropriate for the protection of public health.

A new federal bill granted the FDA authority to regulate tobacco products that contain nicotine not made or derived from tobacco.

Business as Usual

By now, the convenience channel is used to regulation looming in all corners of the tobacco category, and most c-stores are operating “business as usual” until a definitive change is put in place.

Ignite’s Probst sees the channel as “the best fit for synthetic nicotine” because of its core business in traditional tobacco products. Synthetic nicotine products offer c-store operators the opportunity to offset the decline in revenue from traditional products, he noted.

The company currently offers five different vape devices with puff counts ranging from 300 to 4,000. Ignite plans to launch two additional synthetic nicotine products this year.

Other vocal players marketing synthetic nicotine include Bidi Vapor, NIIN, Pacha Mama, Rush and Puff Bar, which pivoted to synthetic nicotine in early 2021 after the FDA ordered it to stop selling its tobacco-derived flavored products.

“Government restrictions on advertising certainly limits the ability to educate consumers, which leaves employee education, in-store demos, social media and tradeshows as the most effective ways to educate the synthetic nicotine consumer,” Probst advised. CSN