After the US FDA regulates synthetic nicotine, what will be the impact on the e-cigarette industry?

In mid-March 2022, the U.S. Congress took action to close loopholes in the use of synthetic nicotine in U.S. electronic nicotine delivery systems (ENDS), aligning them with tobacco-derived nicotine products. In this article, Nveed Chaudhary, Chief Scientific and Regulatory Officer at Broughton, an independent life science research organization, explains the impact of this regulatory change on the U.S. vaping industry.

What has changed in America? When will these changes take effect?

Congress expanded FDA authority over tobacco products to include synthetic nicotine in regulation. The new rules are part of a longstanding spending bill by U.S. lawmakers that was signed into law by President Joe Biden on March 15. From March 15, manufacturers of synthetic nicotine e-cigarettes and oral nicotine pouches must keep their products on the U.S. market for 60 days.

Is the industry expecting this regulatory change?

The end-device industry has been watching for some time whether U.S. regulators are interested in the issue, and synthetic nicotine is expected to receive the attention of regulators, but the speed with which it has been brought into regulation has surprised the industry as a whole.

What is synthetic nicotine?

Synthetic nicotine, also known as tobacco-free nicotine, is chemically synthesized nicotine, not nicotine extracted from tobacco. Recent improvements in manufacturing processes have allowed manufacturers to simulate the enantiomeric ratios of tobacco-derived nicotine. Synthetic nicotine is not new, it was first synthesized in 1904, but mass production has not occurred until recently. Most e-cigarette makers do not use synthetic nicotine because it tends to be more expensive than tobacco-derived nicotine. There is also far less infrastructure to manufacture synthetic nicotine from scratch than the established facilities for obtaining nicotine from tobacco plant material.

Why are US regulators now choosing to close the synthetic nicotine loophole?

Previously, the U.S. Food and Drug Administration defined “any product manufactured or derived from tobacco for human consumption, including any component, part, or accessory of a tobacco product” as a tobacco product. According to this description, e-cigarettes containing tobacco-derived nicotine e-liquids are subject to the Premarket Tobacco Product Application (PMTA) regulatory framework, while e-cigarettes containing smokeless nicotine are not.

However, some U.S. lawmakers and nonprofit lobbyists have long debated how to close the loophole, as it enables manufacturers to bring tobacco-free nicotine products to market without regulation.

Concerns about teen use of single-use synthetic nicotine vaping products, e-liquid flavors, and marketing are particularly acute with the release of recent National Youth Tobacco Survey (NYTS) data, an issue the FDA has no authority to question. As we’ve seen with tobacco-derived nicotine end products, intense scrutiny of those found to appeal to young people has become an important area of political concern in the United States. The fact that some manufacturers appear to be taking advantage of the loophole to circumvent regulatory controls may hasten the pace at which lawmakers feel they must act.

What can synthetic nicotine manufacturers do now?

Manufacturers have 60 days to submit a PMTA application if the product is already available in the U.S. If a manufacturer commercializes a new synthetic nicotine product in the U.S., they have 30 days to launch the product and then 30 days to submit their PMTA. The 60-day data submission period is challenging, but not impossible, for most manufacturers of smoke-free nicotine ENDS.

What are the long-term effects of the FDA on synthetic nicotine products?

The tobacco industry has been discussing how the government will regulate synthetic nicotine products for some time. It’s not made from tobacco, but how else can lawmakers regulate it? This is a typical dilemma for regulators who need to respond quickly to technological innovation with less information than the regulated industry, and then rely on existing regulation to act quickly to fill the gap.

We believe that all products containing nicotine, whether tobacco-derived or synthetic, should be handled in the same way. Regardless of where nicotine comes from, its impact on the health of the population needs to be measured in a consistent manner. The production cost of synthetic nicotine is still high, and only a few companies currently produce synthetic nicotine because its production process is patented. Synthetic nicotine is estimated to cost 13 times more to manufacture than tobacco-derived nicotine.

It will be interesting to see whether e-cigarette makers will now move away from synthetic nicotine due to regulatory changes, or continue to use it. Much depends on how FDA evaluates PMTA applications.