Why The Ban on Synthetic Nicotine is Counterproductive to Public Health
The upcoming Congressional omnibus budget bill, set to be voted on later, will introduce a measure giving the US Food and Drug Administration 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 that is intended for human consumption, including any component, part, or accessory of a tobacco product.”
On December 15th, New Jersey Congresswoman Mikie Sherrill introduced the Clarifying Authority Over Nicotine Act of 2021, a bipartisan bill that grants the U.S. Food and Drug Administration (FDA) the authority to regulate synthetic nicotine products, in the same way it regulates nicotine products made or derived from tobacco. The new legislation was enacted on March 15th, and took effect on April 14th.
In a press release, Rep. Sherrill said that the bill aims to protect minors. “This bill will ensure all tobacco products, including products made with synthetic nicotine, are regulated by the FDA in order to protect kids in our communities and those who may seek to use these products.”
As it stands, the Federal Food, Drug, and Cosmetic Act (FDCA) defines a “tobacco product” as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” However, besides regulating synthetic nicotine as a “component” of a tobacco product, the FDA could also regulate it as a “drug”
Discussing the measure, director of the global advocacy group for harm reduction, World Vapers’ Alliance (WVA) Michael Landl, explained how this regulation will harm current smokers and vapers alike.
“The bill threatens the availability of less harmful alternatives to smoking such as vaping. There is a disaster for public health looming. By putting thousands of vape shops out of business, many vapers will be pushed back to smoking. Targeting the exact product that allowed them to quit smoking makes no sense. Synthetic nicotine is an innovative way to decrease harmful effects of smoking and provide people with an alternative to traditional cigarettes,” said Landl.
“The goal of harm reduction is to reduce adverse consequences among people who aren’t able to quit smoking. It has proven effective in many countries worldwide and helped millions quit smoking. The land of the free should follow these countries instead of turning into a nanny state.”.
Many brands had turned to synthetic nicotine due to harsh PMTA restrictions
Meanwhile, given the millions of Pre-market Tobacco Product Application (PMTA) rejections faced in recent months by manufacturers of vaping products, many had turned to synthetic nicotine in the hope of avoiding the rigorous, costly and in most cases futile, pre-market review process.
“Many companies do not have the resources needed to file the Premarket Tobacco Application, which is required under the FDA regulation for tobacco products. This bill will bring many negative consequences for tobacco harm reduction efforts, potentially limiting access to vaping products and forcing ex-smokers to return to cigarettes,” added Landl.