FDA Rejects 55,000 Eliquid PMTA’s: The Thin End of a Dangerous Wedge

While you’d expect the US Food and Drug Administration to actively support products that reduce the number of people smoking, a recent news release by the organization has shown that they are interested in anything but. As of August 26th, the administration has issued its first marketing denial orders (or MDO’s) to three vape liquid manufacturers: JD NOVA Group LLC (Vapolocity), Great American Vapes, and Vapor Salon. All of the denied products were flavored eliquids.

While this might not sound like a lot, it actively prohibits the sale of 55,000 vape-related products, or to put it in real terms, the rejection of 2% of the remaining 2 million PMTA applications out of the 6.5 million originally submitted applications. The move represents a dangerous precedent and indicates that the FDA may reject further e-liquid PMTA applications. 

Nonsensical and counterproductive, given that vaping helps people to quit? Definitely. Today we are going to look at why and what this denial could mean going forward…

What is an FDA MDO?

In simple terms, when the FDA issues an MDO it effectively removes the right for manufacturers to sell, market, or distribute their products. This doesn’t only apply to new products either. Existing products must be removed as well.

It is also important to consider that the MDO only addresses applications that were accepted. The FDA mentions in the announcement that other products “did not meet the filing requirements”.

Vaping Product Applications Denied | Why? (According to the FDA)

The FDA announced that the rejected manufacturer’s products “…lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.”

Earlier in the report, it states:

“We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making… This action represents a significant step toward making progress on the unprecedented number of applications.”

“Progress”? 

Hardly. In real terms, this is most definitely a retrograde step. Vaping represents a healthier alternative to smoking. It has been proven in several studies that when electronic cigarettes and their associated products are restricted, the number of smokers increases… This actually includes the youth too.

Throwing the baby out with the bathwater? More like “destroying the village to save it”.

While the restrictions will undoubtedly stop some people from vaping, it has also been found that those who vape may have otherwise been cigarette smokers. Again, this includes the nation’s youth.

The Burden of Impossible Proof | The FDA’s Double Standard

The FDA has created a situation where it could be practically impossible for any small vape manufacturer to satisfy the required criteria. 

Suppose this ruling represents a precedent and a similar standard is applied to all applications. In that case, it could be the case that no manufacturer of flavored vaping products can succeed. 

The report itself states:

“The burden is on the applicant to provide evidence to demonstrate that the marketing of their product meets the statutory standard of ‘appropriate for the protection of the public health.”

The evidence? Oh, it only has to be product-specific in randomized controlled trials or longitudinal cohort studies. The budget and means to provide such evidence aren’t available to most manufacturers who have submitted an application to the FDA. 

But we’ll tell you who does have access to the process described above — big tobacco and industrialized conglomerates.

The snag with the above is that the burden of proof has been placed on the manufacturers to show that their product is safe instead of the administration proving that it isn’t. 

Public health?

Why not look at the fact that in 2018 (a year when vaping was relatively free of punitive restrictions), cigarette smoking was at an all-time low of 14%… This figure is taken directly from the CDC website.

When you consider that only a few days ago, the American Public Health Association published an article calling for the public and policymakers to recognize the benefits of vaping, along with the dangers of citing ‘the risk to youth’ as the only criteria in the debate, the FDA’s decision goes against the grain.

So, where’s the double standard?

There are quite a few.

The report states that, even if a manufacturer were to submit scientific evidence, the FDA would conduct a further in-depth scientific evaluation of whether it satisfies the standard. So, if ‘the science’ doesn’t match the required agenda, it too can be rejected? Or only then does the FDA have the means to find out whether a product is safe?

Another jarring line is the following: 

“…All ENDS products available for sale have [to have] demonstrated that they are ‘appropriate for the protection of the public health’”…

This is the sole reason why electronic cigarettes exist. To benefit public health and to provide a means to quit smoking. 

Already some manufacturers have suggested that they will be forced to market their products on the black market. This is not good news either. By pushing vape sales underground, the FDA will lose all supervisory power regarding quality control… An area that vapors do focus on when it comes to protecting their health. 

Arguments Against the FDA MDO

There are a few arguments worthy of consideration, which admirably demonstrate why these latest MDO’s are a bad decision.

The first is that they seek to apply heavy-handed regulation (and for that matter, downright rejection) of non-tobacco flavored vaping products. You have to read between the lines here. The same criteria are not being pushed on those flavors that do emulate tobacco. 

Fruit loops bad, Marlboro good… Got it. 

Vaping is, by design, supposed to be different from smoking. Why approve something that tastes like the very thing you are trying to stop? It’s like a government health organization giving out beer-flavored gum at an AA meeting.

Tobacco flavored e-juice and all of the other flavors have only one distinct difference. 

The flavoring itself. 

The nicotine content is the same. The liquid in which the ingredients are suspended is identical. Even those whose products may gain approval from large companies like Juul contain exactly the same solution as you’ll find in a bottle in a vape store.

And it should be noted that many of the flavors used to create the various eliquids are already approved for use in commercial catering.

Another key point, again alluded to by the previous week’s report, cautions against damaging the health of all to protect the few. In this case, of-age vapers are penalized to prevent the youth from vaping. 

By protecting ‘the few,’ the FDA is actually putting the health of ‘the many’ at risk.

However, there may be a ‘loophole’ that will allow manufacturers to continue selling flavored e-liquids. The current ruling focuses on tobacco-derived nicotine products, so there could be the option to utilize synthetic nicotine in vape liquids instead. This doesn’t use any plant matter and is created entirely in a lab. 

But, and it’s a big, there are already plans in place for synthetic nicotine to fall under the FDA’s control as a drug. Furthermore, it is expensive to produce. When all of this is viewed as a whole, it represents a large challenge for the vaping industry.

Conclusion

Sadly, it seems that the FDA, in line with many governmental bodies, has missed the mark with the current ruling. By setting an impossibly high bar and effectively closing down manufacturers who fail to attain it, they are, in fact, damaging the wider public health. While it may create a warm and fuzzy feeling to say you are ‘protecting the youth’, young users represent a minority, and youth use, as with alcohol and regular cigarettes, could be dealt with differently. Note that neither of these has been outright banned.

The biggest losers in this battle are the multitude of small businesses who rely on providing a diverse range of products, as well as the majority of vapers themselves.

The fact that a record number of vape manufacturers applied in good faith, and with thousands of products, to the FDA should indicate the popularity and effectiveness of vaping as a technology that saves lives by reducing smoking. If the FDA wants to reduce public harm, it should look at the drop in the number of smokers over the last 10 years and stop drawing equivalences with vaping and cigarettes.