In a shocking but long-overdue announcement last Friday, FDA Commissioner Scott Gottlieb singlehandedly rolled back the implementation of FDA e-cig regulations by another five years. Thanks to the revised timelines, the American vaping industry can now delay applying for the Pre-Market Tobacco Application (PMTA) until 2022.
This is considered a huge windfall for retailers and manufacturers of electronic cigarettes, e-liquids and other related accessories. According to the FDA deeming regulations, a PMTA is required to be filed and approved by the FDA for each and every product offered to market after February 2007 – some ten years ago.
The original deadline was supposed to be this month, August 2018, but it was previously extended to November 2018 immediately after Trump won the presidency. Now, the extension drops back to August of 2022, according to the Friday morning FDA news release.
“Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022. Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.”
In a single press release, Gottlieb may have just save the American vaping industry. Had retailers been forced to adhere to the previous deadlines, thousands of vape shops were expected to either close up shop permanently or enter bankruptcy within the next tear.
Related Article: NEW FDA E-CIG REGULATIONS AND THE MILLION-DOLLAR PMTA PROCESS
An individual PMTA is estimated to cost somewhere between $300,000 to over $1 million per product, depending on the amount of scientific research and documentation required. Furthermore, the FDA guidelines do not clarify how long the PMTA approval process takes, or even if FDA approval is guaranteed.
Gottlieb also gives Big Tobacco a smackdown
In the very same press release, Gottlieb and the FDA also take aim at Big Tobacco. In a bold move, the agency announced that it is also considering the implementation of new regulations which could potentially result in the legal lowering of nicotine levels in combustible cigarettes.
Immediately after the FDA announcement, The Verge ran a news story suggesting that the “FDA's plans for low nicotine cigarettes could drive more people to vape.” Science Alert also published a similar report entitled, “The FDA Changes Its Mind on Vaping, Cracks Down on Nicotine Instead.”
Considering that scientists from around the world have been screaming for years that vaping is 95% healthier than smoking, the updated FDA stance is largely viewed as a positive step forward in the war against smoking addiction.
“The FDA plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards. The agency intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes. Because almost 90 percent of adult smokers started smoking before the age of 18 and nearly 2,500 youth smoke their first cigarette every day in the U.S., lowering nicotine levels could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit.”
But why the sudden change of heart? The Trump Administration has long proclaimed its disgust with excessive government regulation of almost any sort. From the attempted repeals of Obamacare to the rollback of government regulations involving the Environmental Protection Agency (EPA) and the controversial Paris Agreement, the GOP largely views vaping far more favorably than the Democrats. And the Gottlieb announcement is just further proof of this political point of view.
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Vaping enthusiasts have a great many people to thank for the recent postponement of the FDA deeming regulations. Advocacy groups like the Consumer Advocates for Smoke-free Alternatives Association (CASAA), the Smoke-Free Alternatives Trade Association (SFATA), and NOTBlowingSmoke.org have played a very important roll.
Sen. Ron Johnson (R-Wisconsin) from the Committee on Homeland Security and Governmental Affairs has also been a staunch and vocal supporter of the American vaping industry. Johnson has written multiple letters to both Gottlieb and his predecessor, Robert Califf of the Obama Administration, questioning the constitutionality of the FDA deeming regulations regarding e-cigs as “tobacco products.”
Rep. Duncan Hunter (R-California) has also been working hard to promote an alternative to the FDA deeming regulations which is currently under review in the House. Hunter is also affectionately known as “The Vaping Congressman” after his public vaping incident during a congressional meeting in 2016. To each of these politicians, advocacy groups, and countless others who are unnamed in this article, the vaping industry owes a huge debt of gratitude.
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