The Congressional Omnibus Budget Act, which is due to be voted on later this week, would introduce a measure that would give the U.S. Food and Drug Administration the authority to regulate synthetic nicotine products as tobacco products.

The current Federal Food, Drug, and Cosmetic Act (FDCA) defines a "tobacco product" as "any product made or derived from tobacco for human consumption, including any ingredient, part, or accessory of a tobacco product." Dec 15 , Congresswoman Mikie Sherrill of New Jersey introduced the Nicotine Clarification Authorization Act of 2021, a bipartisan bill that gives the U.S. Food and Drug Administration (FDA) the authority to regulate synthetic nicotine products in the same way as regulating the manufacture or manufacture of The same way nicotine products are derived from tobacco. The new legislation was enacted on March 15 and went into effect on April 14.

Rep. Cherrill said in a press release that the bill is designed to protect minors. "This bill will ensure that all tobacco products, including those made with synthetic nicotine, are regulated by the FDA to protect children in our community and those who may seek to use these products."

For now, the Federal Food, Drug, and Cosmetic Act (FDCA) defines a "tobacco product" as "any product made or derived from tobacco for human consumption, including any ingredient, part, or accessory of a tobacco product." However, , in addition to regulating synthetic nicotine as an "ingredient" in tobacco products, the FDA can also regulate it as a "drug".

Discussing the measure, Michael Landl, head of the global harm reduction advocacy group World Vaping Users Alliance (WVA), explained how the regulation will harm current smokers and vapers.

“This bill threatens the availability of less harmful alternatives to smoking, such as e-cigarettes. A public health disaster is imminent. By closing thousands of vaping stores, many e-cigarette users will be forced to return to smoking. The exact product they quit smoking makes no sense. Synthetic nicotine is an innovative way to reduce the harmful effects of smoking and provide people with an alternative to traditional cigarettes," Randall said.

"The goal of harm reduction is to reduce the adverse outcomes for those who are unable to quit. It has proven effective in many countries around the world and has helped millions to quit. The land of freedom should follow these countries and not become a nanny state."

Many brands have turned to synthetic nicotine due to strict PMTA restrictions

Meanwhile, given the millions of premarket tobacco product application (PMTA) rejections vaping product makers have faced in recent months, many have turned to synthetic nicotine in hopes of avoiding the strict, expensive, and in most cases futile Premarket application review process.

“Many companies do not have the resources required to submit premarket tobacco applications, which are required by FDA regulations for tobacco products. This bill will have many negative impacts on tobacco harm reduction efforts, potentially limiting the use of vaping products, and forcing ex-smokers to return to cigarettes," Landl added.