E-cigarette companies found a loophole in synthetic nicotine — it won’t stop the FDA

Packed with nicotine and sold in a myriad of kid-appealing flavors, e-cigarettes, or vapes, remain the tobacco products most commonly used by young people. The U.S. Food and Drug Administration has made it one of our top priorities to reduce youth use of these products. But in recent years, some in the e-cigarette industry have responded to our efforts by trying to skirt federal regulation.

In one instance, after receiving a warning letter from the FDA, the maker of the e-cigarette brand most popular with kids removed its products from the market, only to then resume selling its products by claiming to now be using a chemical form of nicotine not derived from tobacco.   

More recently, after FDA notified multiple e-cigarette companies that they were legally required to remove their products from the market, they too announced their intention to switch to so-called synthetic nicotine. One company that marketed flavored products, with names such as Twinkie and Apple Pie, publicly explained its aim was “to be outside of the FDA’s regulations.”

Why proclaim a shift to synthetic nicotine?

This industry behavior was driven by companies who saw a loophole in the current law, which defined a tobacco product as being made or derived from tobacco. Using non-tobacco-derived nicotine emboldened these companies to publicly announce they intended to operate outside of FDA’s tobacco authorities.

However, thanks to the efforts of Congress, policymakers and public health advocates, the critical need to clarify the FDA’s authority over these products has been met: A new federal law that will take effect April 14 makes clear that we can use our tobacco authorities to regulate products containing nicotine from any source, which includes e-cigarettes made with synthetic nicotine.

Now manufacturers of products using synthetic (or other non-tobacco-sourced) nicotine will be held to the same public health standards we’ve worked so hard to implement for other tobacco products. In the coming weeks, manufacturers of these products will need to submit a premarket application and be required to undergo a science-based review and obtain authorization from the FDA to sell their products to consumers. This change also gives us the ability to use other important authorities to ensure they don’t sell to minors or market misleadingly labeled products that appeal to youth, and require them to submit important information to examine their marketing practices and the youth appeal of their products.

Exercising our authority to regulate tobacco products regardless of the source of their nicotine is vitally important because research has shown that nicotine is extremely addictive, especially when used by children. Use of tobacco products is almost always started and established during adolescence, when the developing brain is most susceptible to nicotine addiction. And we now know that popular e-cigarettes can contain as much as or more nicotine than traditional cigarettes.

At the same time, the FDA recognizes there is a demand among adult smokers to use e-cigarette products to try to switch from more harmful combusted cigarettes. When reviewing an application for a new tobacco product, the FDA is required by law to determine the risks and benefits of a product to the population as a whole. Recently, several manufacturers of tobacco-flavored e-cigarettes provided sufficient evidence that for those specific products, the benefits to adult smokers who switched outweighed the lower likelihood that youth would start using, provided the company follows postmarketing requirements to reduce youth access and exposure to their marketing.

As we prepare to implement this critical new law and continue review of new tobacco products, we are also poised to advance two proposed tobacco product standards this spring: one prohibiting menthol in cigarettes and another prohibiting all flavors in cigars. Specific populations have been targeted and disproportionately impacted by tobacco use over many decades. Use of menthol cigarettes, for example, is substantially higher among African American smokers, and menthol cigarettes can be more addictive, and harder to quit, than non-menthol cigarettes by enhancing the effects of nicotine. These new product standards will save lives and improve public health, while also advancing health equity.

The FDA will continue to make decisions and develop policies based on the best available science, with the goal of continuing to reduce preventable disease and death caused by tobacco product use, regardless of the source of nicotine.

Andi Lipstein Fristedt is the deputy commissioner for Policy, Legislation, and International Affairs of the Food and Drug Administration. Mitch Zeller is the center director of the Food and Drug Administration’s Center for Tobacco Products.