FDA – A NEW DAY AND A NEW WAY

August 3, 2017


We all did it!! The FDA has backed down!”
Congrats to all who will now live longer & keep their jobs/businesses.”

A Billion Lives (via Twitter)


July 28, 2017. Less than 90 days after being appointed FDA Commissioner, Scott Gottlieb, MD outlines a new and many would say, long overdue, direction for FDA’s oversight of tobacco product regulation.

For those who have followed the debate since the Tobacco Control Act (TCA) was signed into law in 2009, the scope of the changes outlined in Gottlieb’s speech are nothing short of remarkable. This is a plan of action that not only includes provisions for changes in compliance requirements but, for the first time, positions the FDA squarely in support of evidenced based tobacco harm reduction. A position that has for years been vehemently rejected by ideological “quit or die” public health individuals and organizations. Commissioner Gottlieb:

“Armed with the recognition of the risk continuum, and the reality that all roads lead back to cigarettes as the primary cause of the current problem, we need to envision a world where cigarettes lose their addictive potential through reduced nicotine levels.  And a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them.”

Gottlieb acknowledges the importance of product innovations. Two changes announced in his speech are crucial steps in the right direction. First, he has extended newly regulated products to include all products on the market as of Aug. 8, 2016.

“The FDA is committed to encouraging innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes. To make this effort successful, the agency intends to extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016.”

Second, compliance requirements under the former FDA regime would have eliminated 99% of vaping businesses in the U.S. in 2018. The cost and complexity of the requisite Pre-Market Tobacco Applications (PMTA) were simply beyond the reach of all but Big Tobacco. Gottlieb has pushed the compliance date back by four years to Aug. 8, 2022. But he didn’t stop there. Under the previous FDA rules, any products not approved by 2019 would be taken off the market. Under the new rules, those products will remain on the market pending the outcome of the approval process.

“The agency plans to issue this guidance describing a new enforcement policy shortly. 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 addition, Gottlieb is suggesting streamlining and increased transparency for product reviews:

“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. Among other things, the FDA intends to issue regulations outlining what information the agency expects to be included in Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications and reports to demonstrate Substantial Equivalence (SE).”

David Sweanor, Adjunct Law Professor at the University of Ottawa, emphasizes the importance of Gottlieb’s focus:

“…continuum of risk, encouraging innovation, backing off from onerous requirements on alternatives to cigarettes.”

“This is a huge switch from the tobacco-free world/abstinence-only/quit or die approach to tobacco and nicotine by U.S. government agencies. It will now be very hard for instance, for the Centers for Disease Control and Prevention, to continue engaging in misinformation campaigns on relative risks.”

So what is the response from public health organizations to this very significant change in the FDA’s approach to tobacco regulation?

The Campaign for Tobacco-Free Kids

A spokesman for CTFK, Vince Willmore stated – “To Dr. Gottlieb’s credit, when he looked at the issue, he realized that to be effective, the promotion of less-harmful tobacco products must be paired with reduction in the use of the most harmful products.”

Matthew Myers, President of CTFK – the FDA’s proposal “represents a bold and comprehensive vision with the potential to accelerate progress in reducing tobacco use and death.”

Myers then went on to say – the extension of e-cigarette deadlines “will allow egregious, kid-friendly e-cigarettes and cigars, in flavors like gummy bear, cherry crush and banana smash, to stay on the market with little public health oversight.”

American Lung Association

“We are concerned about how long a product standard on reducing the addictiveness of cigarettes is going to take based on the process outlined on Friday.”

American Heart Association

“FDA’s move today to lower nicotine levels and take a harder look at how flavored tobacco products attract the young is to be commended. However, the association is disappointed with the agency’s decision to delay certain e-cigarette and cigar compliance deadlines. Altering the deadline for FDA review of e-cigarettes and cigars is a troubling step and one that we will closely monitor.”

There are many questions still to be answered. Much work to be done. And no doubt lawsuits to be litigated. But these things will take place in a dramatically different landscape. A landscape where public health is the driving force. A landscape where harm reduction and evidence based science is the focus for saving lives. A landscape that has no tolerance for combustible tobacco cigarettes.

It is a new day and a new way. Harm reduction. Science and evidence based policy. Consumer choice. Lives saved. Aaron Biebert and “A Billion Lives” has my sincere and utmost respect. But they got this one wrong. The FDA has not backed down. The FDA has stepped up.


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Dave Coggin has a Master’s Degree in business and spent 35 years in corporate America. He is a co-founder and partner in DIYELS. He has spent the last ten years actively researching and following the evolution of the e-cigarette industry. He is a strong proponent of e-cigarettes as the most promising option currently known for tobacco harm reduction. He may be contacted directly at dave@diyels.com .

The opinions presented here are exclusively those of the author. Vaper’s Vortex is offered as a service to our customers and followers. Anyone considering e-cigarettes as an alternative to tobacco cigarettes should seek qualified advice from a medical professional.

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