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New synthetic nicotine for Vaping e-liquids

US: New Bill Sets in Place Regulations For Synthetic Nicotine in 2022

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.

Diane Caruana

January 5, 2022

Given the millions of PMTA rejections faced in recent months by manufacturers, many had turned to synthetic nicotine in the hope of avoiding the costly and in most cases futile pre-market review process.

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.

Another obstacle for the vaping industry

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.

In fact, due to these harsh and in some cases unattainable standards, Avail Vapor, a massive vape company based in the US, has dismantled its business which was founded way back in 2013. AVAIL Vapor LLC’s specialized brick-and-mortar shops and website, were started by James Xu in 2013 and grew to over 100 retail stores in 12 states, 400 employees and a manufacturing facility in Chesterfield County. However, given the current hostile regulatory environment, Xu sai the brand is entering 2022 with essentially “zero” business. “Right now, we are unwinding everything,” said Xu as quoted by The News and Advance.

The founder explained that in line with other vape businesses the brand is finding it impossible to meet the FDA’s unrealistic regulatory requirements. “Under this environment, we cannot operate a legitimate business,” Xu said. “Our biggest problem was we tried to believe in the FDA – that one day it would regulate this market with common sense.”

Of course this sentiment is echoed throughout the industry. In fact, while the FDA has rejected PMTAs for small to medium-sized businesses by the thousands. And to the shock of many, new documents have recently revealed that PMTA reviewers have created a method to get through a backlog of millions of PMTAs, enabling them to quickly dismiss many of them without reviewing their submitted documents.

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