Update on FDA Review and Enforcement of Non-Tobacco Nicotine Products

On April 28, 2022, the FDA placed a total ban on all flavored nicotine products in an attempt to reduce the number of nicotine-related diseases and illnesses. Following previous FDA rulings to ban Non-Tobacco Nicotine Products, Brian King, director of the FDA’s Center for Tobacco Products (CTP), provided an update.

The MD Anderson Cancer Center defines menthol as “a flavor additive with a minty taste and smell.” Additionally, the organization states that “in addition to tasting good, it has a cooling and painkilling effect. Cigarette manufacturers add it to cigarette filters to cover up the unpleasant taste of tobacco and make cigarettes more appealing.”

According to the MD Anderson Cancer Center, an estimated 18.5 million people in the United States consume flavored nicotine products. This number composes 37% of the cigarette market. There are evident racial discrepancies in the consumption of these cigarettes.

Over 80% of Black smokers smoke menthols, while the percentage for Hispanic and Asian American smokers is 46% and 39%, respectively.

The April ban and introduction of new regulations have prevented companies from evading the regulation. Many companies have submitted non-tobacco nicotine product premarket applications, which the FDA is reviewing.

According to the press statement, over 88,000 of these applications have been rejected in the previous three weeks, making these products illegal to sell or distribute in the US.

Conversely, 350 applications have been accepted by the FDA. Despite this, King states that these acceptances do not mean that the products are fully authorized for sale and distribution. Instead, these products will enter an additional phase of review to determine if they meet the standards.

“I’m thankful that our authority is now clear, and I will not stand by as illegal products with the potential to cause a new generation of youth to become addicted to nicotine, proliferate in the marketplace. With that commitment made clear, I am fully dedicated to implementing and enforcing this new law, building upon the important progress CTP has already made since its passage,” stated King in the recent press release.