FDA Stunning Reversal Extends Vaping PMTA Regulations to 2022!

churnmag.com: We brought you the shocking news over the weekend now here is the full story! Late Friday Food and Drug (FDA) Commissioner Scott Gottlieb announced in a press release on the agency’s website the good news. This push is hailed by many as the lifeline needed to save the vaping industry from collapse in the US.

The Premarket Tobacco Applications (PMTA) delay is part of an anti-smoking plan which also includes the decreased nicotine of combustible cigarettes that is expected to start in 2022. The agency also goes on to distinguish the difference between smoking and vaping. This is great news for vapers who have been hammered with local regulations and feared the PMTA going into play in 2018.

“Nicotine is by no means a completely safe and benign compound. As far as nicotine is concerned, the problem isn’t just the nicotine. The bigger problem is the delivery mechanism — how the nicotine gets delivered. Attach it to smoke particles created by burning cigarettes and the mechanism is deadly.” said FDA Commissioner Scott Gottlieb

The agency will issue a guidance explaining this policy in detail shortly, but the cut off date of applications for non-combustible products like vaping has been extended and won’t go into effect in 2018. This is great news and brings the clarity many have been asking the agency to give on this Obama era mandates. This announcement also includes some other big news.

The FDA is wanting to have a dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards.  This news stunned tobacco makers and is something the FDA has never proposed before. These sweeping changes would be phased in but many claims it would push users to find other ways to obtain nicotine.

The best smoking alternative is vaping. Unlike nicotine gum or patches, vaping offers an experience much like smoking while substantially mitigating the risks associated with traditional cigarettes. Former smokers still crave hand and mouth sensations. Therefore gums and patches simply fall well short. This is also the reason why such alternative products are not necessarily effective.

FDA’s New Plan and Vaping Extension

Nicotine levels in cigarettes could be reduced to non-addictive levels, according to this new plan. The FDA announced a specific roadmap to reduce deaths from tobacco, and tobacco-related disease. This was in response to the more than 480,000 deaths in the US are caused by tobacco every year. However, FDA Commissioner Scott Gottlieb warns that to be successful in this, a new approach must be taken.

“Our approach to nicotine must be accompanied by a firm foundation of rules and standards for newly-regulated products,” he added. “To be successful all of these steps must be done in concert and not in isolation.” -FDA Commissioner Scott Gottlieb

The agency extended the deadline by up to four years for the vaping industry to comply with the FDA guidelines. It is expected to take effect August 8, 2022. Best of all right there on the website is a plan to issue a larger policy. A large complaint by many has been the veil of secrecy by the former FDA administration on the process. There were risk and cost with no guarantees for the manufacturers.

The new FDA stance is a fresh direction. They aim to make the product review process more efficient, predictable, and transparent for manufacturers while upholding the agency’s public health mission. This is great news and opens the doors for many possibilities.

Financial Markets React

While the FDA cannot reduce nicotine levels to zero, nor can it ban cigarettes it does have the power to regulate nicotine levels. This declaration stirs up an ongoing debate among public health advocates as to whether e-cigarettes represent a health risk or potential benefit. With the FDA’s goal to render cigarettes minimally addictive or non-addictive the world markets responded sharply late Friday.

• British American Tobacco shares, trading close to all-time highs, fell 6.8 percent to post their biggest one-day loss in nine 9 years.
• Altria, which makes the Marlboro brand of cigarettes, closed down 9.5 percent.

Another Win for Vaping

The plans also push back deadlines by which e-cigarette manufacturers have to provide information on current and future products to gain FDA approval, shifting it from 2018 to 2022. An open acknowledgment by FDA Commissioner Scott Gottlieb is certainly welcomed. Hopefully, this will start to clear up the misinformation from other public agencies.

We want to hope this will trickle down to other health agencies. Furthermore, unfair policies on local levels should scrutiny and repeal in light of the federal direction to improve public health by all means possible. This includes vaping as a real option for cancer and other known health issues related to smoking.

What Happens Now

The FDA’s announcement sets in motion a lengthy rulemaking process that will involve public comment and input from multiple agencies.

“To complement these larger policy considerations, the FDA plans to issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers, while upholding the agency’s public health mission.”

This week will sure to bring reactions and hopefully a warmer reaction to those who vape. This news is going to make some waves and stir up some debates. However, it is very hard to argue with the science based facts the FDA is leaning on. The director is also a cancer survivor with the will to take on big tobacco!

Check back often for updates on this fast changing story.

As a licensed agent with HealthMarkets, I (Robert Morgen) am sharing this article with my LinkedIn community. I serve Nevada, California, Arizona, Texas, & South Carolina as a Health Benefits Adviser.