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FDA Publishes Final Rules for PMTA's A Month After Submission Deadline

FDA Publishes Final Rules for PMTA’s A Month After Submission Deadline

Have you ever watched a televised sporting event only for the rules to change halfway through, and the team playing by the rules in the first half goes on to lose in the second? How about a courtroom drama where the protagonist is about to be found innocent, only for the judge to change the law part way through his verdict? No, neither have we. Yet on October 4th, 2021, the FDA published its “Final” rules for Premarket Tobacco Applications (PMTA’s). 

What’s the big deal? 

The deadline for PMTA submissions, which has led to over 1 million life-saving vaping products being removed in marketing denial orders (MDO’), was on September 9, 2021. What does the FDA’s latest edict state? Well, read on as you are about to find out.


Back to the Future? The FDA and the Impossible Time Machine

It doesn’t take a genius to work out that October is after September. The fact that the FDA finalized its rules after imposing draconian (and highly misguided) MDO’s, based on what was thought to be the rules, shows that the plan has more holes than a second-hand dartboard.

The sad part?

The application process certainly wasn’t free; the cost of putting together a PMTA can cost $100,000 to upwards of $500,000. Understandably, there were hundreds who invested significant time and money to ensure that they could carry on trading (with some even investing their life savings).

Users on social media were both strong and accurate in their responses. 

This latest poorly thought-out move by the FDA only adds to the ever-growing pile of bad decisions that has plagued the administration since it passed its ‘deeming rule’ that gave them authority over vaping products in 2016. They have effectively hit vape suppliers (many of whom are small, family-run businesses) three times:

  • The first time by making them submit and then rejecting their costly application.
  • The second time by also removing the ability for them to even recoup their lost ‘investment’.
  • And the third time in this ‘final’ move, by effectively demonstrating the game was never winnable in the first place, as it seems everyone was playing the ‘beta version’. 

What Does the FDA’s ‘New’ Rules State?

This new list of requirements for PMTAs is long and extensive. However, it covers two areas. The Premarket tobacco application (the ‘admin’ side of the process) and the Substantial Equivalence (SE) report

According to the FDA Twitter feed, the final rule about PMTAs: –

  • Describes the information an applicant must include for the FDA to complete a substantive review of the PMTA
  • Formalizes the general procedures the FDA follows when evaluating PMTAs

The SE final rule: –

  • Gives additional information on content and format requirements
  • Gives applicants a better understanding of the level of detail required in an SE report

Does it succeed in the above aims?

Not really. To date, the guidance issued by FDA to the industry remains woefully out of date. It does serve a useful purpose, though. It acts as evidence that the FDA has been both ‘arbitrary’ and ‘capricious’ in its subsequent application of the rules. This is probably the reason why it is currently being sued.

Furthermore, it emphasizes the FDA’s complete ignorance (or corruptness, take your pick) regarding vaping. 

Why?

Several reasons. Even the latest news release is littered with doublethink, paradoxes, and contradictions. Let’s take a look at a few examples:-

  • “The FDA is committed to protecting Americans from tobacco-related disease and death by ensuring that new tobacco products undergo appropriate regulatory review.

Tobacco-related disease? 

Other health authorities have promoted vaping as a way to keep clear of cigarettes for years. When vaping declines, smoking goes up. Thankfully we aren’t the only ones who are aware of this.

  • A PMTA is a type of application for any new tobacco product.”

Except, e-juice doesn’t contain any tobacco. And even if it did, some alternatives have literally nothing to do with a tobacco plant.

  • “The agency’s evaluation includes such things as reviewing a tobacco product’s components, ingredients, additives, constituents, toxicological profile, and health impact….”

The main ingredient of e-cigarettes is glycerin, or to be more precise, vegetable or propylene glycol. A substance that has been approved by the FDA for use in everything from food to beauty products.

  • “That statutory standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.”

Wait, what? How can a manufacturer prove that something is safe for someone who doesn’t use it? Passive smoking has long since been proven to be a known carcinogen. The same isn’t true for vaping. 

Want proof? 

Anywhere that utilized smoke machines, such as rock concerts, theatrical productions, and nightclubs, would have known about it by now. Their ‘smoke’ uses exactly the same technology liquid found in e-cigs (without nicotine or flavor). 

  • “The final rule describes the information an applicant must include in a PMTA for the FDA to complete a substantive review of an application.”

This last excerpt is really jarring. So far, it would appear, as proven by the FDAs substantial backlog, that a ‘substantive review’ is the last thing that the FDA has been doing. A blanket ban would be a better term to describe the current process. 

What’s more, if the new ‘final’ rule now allows the FDA to complete such a review, exactly what is it that they were doing before?


Apples and Oranges: An FDA Comparison

While many could see the FDAs current revision as a glimmer of hope as it at least clarifies what has to be done to gain approval, the light at the tunnel still is somewhat dim.

Substantial equivalence paints the vaping industry into a bit of a corner. Substantial equivalence only applies to ‘new tobacco products’. These being products that were only available after 2011. Those that existed before get a ‘grandfather’ pass.

The problem?

The FDA press release gives details that show a significant lack of understanding:

“Some of these reports include very little information on the comparison of the new tobacco product with a predicate tobacco product while other reports include much more.”

If this is the reason that so many PMTAs were rejected, it is hardly surprising. Why would you compare two things that are entirely and utterly different?

Put simply, vaping and smoking are not the same thing. What is it the FDA wants to know? 

One is a known carcinogen that kills millions of people worldwide each year. In contrast, the other is a healthy alternative that has helped millions of people to quit. Talking to vapers about what is ‘appropriate for the protection of public health’ while withdrawing, literally, millions of products that have been proven to do just that smacks of incompetence at best, maliciousness at worst.


The bottom line

The FDA continues to publish rules that make little to no sense. The only good things to come from this are that their incompetence and hypocrisy are now written in black and white for all to see. 

On the plus side, manufacturers and vape suppliers now have something to ‘hang their hat on’ regarding the requirements. Now that the rules are laid out, it is up to them whether they feel they can comply with the rules and, if not, have documents that prove that their application was unfairly rejected. Or at least until the rules change, again.

Jamie G.

After being a smoker for several years, I discovered vaping when a friend bought me a disposable e-cigarette. Since then, I've worked my way up through various devices, becoming an expert in rebuildable tanks, atomizers, and all things to do with vaping. I even make my own e-juice! You’ll find me on the weekend, toolkit in hand, surrounded by box mods, wicks, and wires, trying to get the perfect cloud.

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