Is Tobacco-Free Nicotine Also Coming Under Regulation?

Recently, tobacco-free nicotine has come under scrutiny in the United States. The U.S. FDA issued a warning letter to tobacco-free nicotine product company Amarillo Snuff Co. More notably, none of the more than one million smokeless nicotine applications submitted by over 200 manufacturers in the U.S. have been approved so far.

According to the FDA, the warning was issued because the company manufactures, sells, and distributes unauthorized smokeless nicotine products, including products made using corn husks in place of tobacco leaves. These unauthorized products contain tobacco-free nicotine and therefore fall under the FDA’s regulatory authority over tobacco products containing nicotine from any source.

From this perspective, smokeless nicotine is also regulated in the United States and must obtain FDA marketing authorization.

Brian King, director of the FDA’s Center for Tobacco Products, said, “Last year, Congress clarified FDA’s authority to regulate tobacco products containing nicotine from any source, closing a loophole some companies sought to exploit to evade regulation,” adding, “Our jurisdiction over these products is clear, and FDA is committed to holding those responsible for illegal products accountable.” 

As of now, the FDA has not authorized any tobacco-free nicotine products. That means all tobacco-free nicotine products currently on the market are being sold illegally. At present, the FDA is also reviewing roughly one million applications for tobacco-free nicotine products submitted by more than 200 manufacturers before the May 14, 2022 deadline.

Generally, the FDA first issues a warning, followed by a requirement to respond within 15 working days. Otherwise, actions such as injunctions, seizures, and/or civil penalties may follow. In most cases, “Most companies that receive warning letters correct their violations, but if they fail to do so, these products may be subject to enforcement action.” 

This also shows that the move is the FDA’s latest action against the marketing of illegal tobacco-free nicotine products in the tobacco product supply chain. As of July 2023, the FDA had issued nearly 600 warning letters to manufacturers of illegal tobacco products this year, including more than 100 related to illegal tobacco-free nicotine products. On the retail side, as of June 30, 2023, the FDA had issued more than 2,800 warning letters and 825 civil money penalties to retailers for selling e-cigarette products to minors.

This clearly indicates that the U.S. market is now entering a phase of gradually intensified enforcement.

The company that received the warning is in fact a pioneering American snuff business founded in 2013. It once obtained a patent for using corn husks as a substitute for tobacco. All of its flavors are made with 100% food-grade ingredients and contain no tobacco. Its nicotine offerings are limited to full-strength and half-strength versions.

As one of the world’s largest vaping markets, the United States has approved only a little over 20 vaping products through the FDA so far, leaving very few categories legally available for sale while many more have been shut out. Its strict enforcement has drawn close attention from Chinese companies.

Compared with the U.S., the European market is more mature and more accepting of vaping products. As it continues to mature, the strength of the opportunity becomes increasingly clear.