The FDA and MDO’s: Hypocrisy and Backlash

The FDA is facing growing backlash as it adds more vaping manufacturers and retailers to its list of marketing denial orders. 

Following a string of tweets made by the FDA, the responses have been interesting, strongly worded, and often pretty factual.

If this was really for the protection of public health I feel the FDA would have left the flavored products on the market vs taking them off and keeping cigarettes on… adult smokers NEED options. Adult Vapers need options!!

— Kyle Adolph (@adolph_kyle) August 31, 2021

The FDA’s latest push to disable vaping has been met with understandable frustration. Today we’ll take a look at a few of the claims made by the FDA, explain the story so far, and take a look at the growing hypocrisy surrounding their decisions.

The FDA and MDO’s: The Story So Far…

Regular readers will already be aware of the FDA’s latest push. In a move that will ultimately harm public health, the Food and Drug Administration rejected 55,000 eliquid pre-market tobacco product applications, effectively causing retailers to remove these products from their shelves immediately. These market denial orders prohibit the sale, distribution, and marketing of any product on the list.

The harm?

Aside from the fact that these products don’t contain any tobacco and share more in common with FDA-approved nicotine replacement therapies than cigarettes, there is a fear that this move will push vapers back to smoking. 

What Does the FDA Say?

The FDA’s cited reason is that the manufacturers failed to provide sufficient evidence that the products listed would provide enough benefit to adult smokers to negate the harms caused to the youth.

Sounds crazy? That’s because it is.

But don’t take our word for it. Here is a selection of recent tweets, straight from the FDA, in order…

Cigarettes are responsible for the vast majority of all tobacco-related disease and death in the U.S. Learn more about the health effects of tobacco use here: https://t.co/oiCEl5jyPc via @FDATobacco https://t.co/rwCaezmaI0

— U.S. FDA (@US_FDA) August 31, 2021

“Cigarettes are responsible for the vast majority of all tobacco-related disease and death in the U.S”.

A fair claim. 

Yet recent studies have shown that restrictions in vaping could lead to a push back towards smoking. Particularly when restrictions are aimed at flavored vaping products. Yes, that does include the youth too.

Several were keen to point out the hypocrisy.

What if we had a product that was developed that wasn’t controlled or invented by big tobacco that could help with this? Oh wait we do! But you are handing it over to them with your policy😡. Why should we listen to anything you say? #vapingsaveslives period!

— Adam G (@adam_g_Boomer) August 31, 2021

It would appear that irony isn’t a word in the FDA’s dictionary because on Sept 2nd, they tweeted the following. 

In August, FDA issued an additional 29 warning letters to firms who manufacture and sell unauthorized ENDS products which lack premarket authorization. The firms did not submit a premarket tobacco product application by the 9/9/2020 deadline. https://t.co/oOeaOZDli1 pic.twitter.com/Yfe3qImoKm

— FDA Tobacco (@FDATobacco) September 2, 2021

Only to add this to it the next day…

September is National Recovery Month. Quitting smoking isn’t easy, but it can be done, and will benefit your health at any age. The sooner you quit, the sooner your body will begin to heal. Find tips to help you quit at https://t.co/MVYqA4eGsF via @FDATobacco. pic.twitter.com/Fr5ZpeUKpi

— U.S. FDA (@US_FDA) September 3, 2021

It is worth noting that vaping products themselves haven’t changed — only the hoops that must be jumped through to sell them. 

Vaping has been proven as one of the most effective strategies to quit smoking. In fact, in certain parts of the world, it is actually prescribed by physicians as an effective way to quit! News articles aside, one only has to look at the figures to understand the positive effect of vaping on the number of smokers.

A report in the Washington Post reported that in 2015 smoking had fallen to the lowest levels ever. This was attributed to the use of e-cigarettes, not by the author, but by the CDC. The numbers quoted state that the percentage of smokers in 2015 was 16.8%… By 2019 it had dropped to 14%.

Coincidence? Unlikely…

The FDA states that “the sooner you quit, the sooner your body will begin to heal,”… yet only a day prior had issued 29 warning letters to firms whose products had now become ‘unauthorized’…

If that doesn’t sound like a lot, think again… By the FDA’s own admission, that restricted the sale of over 268,000 products.

While each warning letter announced today cites specific products as examples of tobacco products that lack the required premarket authorization, collectively these 29 firms have listed a combined total of more than 268,000 products with the FDA.

— FDA Tobacco (@FDATobacco) September 2, 2021

Why are restrictions harmful?

From the CDC’s website, one only has to look at the following quote to question the wisdom behind recent decisions…

“Some research suggests that using e-cigarettes containing nicotine is associated with greater smoking cessation than using e-cigarettes that don’t contain nicotine, and more frequent use of e-cigarettes is associated with greater smoking cessation than less frequent use.”

One Twitter user summarized the sentiments of many vapers most effectively.

This seems like a good time to remind everyone that cigarettes are approved for public consumption by the FDA, but #Lenzilumab is not yet deemed safe enough to treat hospitalized covid patients. The bar is set at cigarettes and OxyContin

— Hans_olo (@Hansolo37059705) September 3, 2021

“This seems like a good time to remind everyone that cigarettes are approved for public consumption by the FDA….” 

While they are not ‘approved’, they are, in fact, ‘regulated’ by the FDA, semantics, yet important when you consider that one is in the process of being heavily restricted. At the same time, the other can still be purchased at any corner store.

What’s Wrong with the Latest Rulings?

Before we continue, it is important to understand that the vaping products themselves have not changed. The FDA has created criteria that practically no independent producer or retailer could ever hope to satisfy.

The clue is in the phrase “lacked sufficient evidence”… The FDA has stated that such ‘evidence’ could “be product-specific in randomized controlled trials or longitudinal cohort studies”. Hardly the technology that most firms have access to.

Why is the above bureaucracy and posturing so hypocritical?

Well, there is little to no difference between FDA-approved products such as ‘inhalers’ and electronic cigarettes. They both contain nicotine, so if that’s the enemy, why the double standard? 

When you consider other FDA-approved strategies to quit, such as Chantix, the MDOs make no sense whatsoever. If you were wondering, here is a list of potential side effects with the FDA-approved Chantix…

Seizures, cardiovascular problems, allergic reactions, nausea, sleep problems, vomiting, constipation…

Ask a vaper how many times they experienced the above when they gave up cigarettes using an e-cig.

Aside from hypocrisy, there is a bigger problem waiting in the wings… 

A recent report from the NIH released just over a month ago suggested that around 33% of vapers would actively switch back to cigarettes if they lost access to vaping products. The report also makes several other statements that seem to be at odds with the FDA’s certainty…

Namely…

“Support for sales restrictions and perceived impact on young adult use are unclear”.

‘Protecting the kids’? Hardly.

The conclusion of the report even states that “young adult user subgroups may not experience benefit.”

Bearing in mind that the whole premise behind the FDA’s most recent stance is that they (mistakenly) believe that the benefit to adults doesn’t outweigh the risk to youths, one can only feel exasperated and slightly confused, given all of the above.

In Summary

The FDA continues to deny retailers the opportunity to sell products that have been proven to increase the success rate of quit attempts while consistently tweeting about the harms of smoking. The disconnect in thought is astounding. One only has to look at their tweets and responses to see how glaringly obvious this is. We’ll leave you with some of the responses so that you can judge for yourself how ‘successful’ this move could be.

You really have some balls posting this after you have been denied every single PMTA for vaping products go to hell

— Nicholas Green (@SaberAthena252) September 4, 2021

So what’s the difference between cherry flavoured eliquid and cherry flavoured cigars?? I know which I’d rather inhale 🤙

— Dodgybroinc (@dodgybroinc) August 28, 2021

How about some quick math? 8 mil vapers in the US, let’s say denying flavored vapor products sends 50% back to smoking, actually, scratch that, let’s be conservative and say 25%, that’s 2 mil. Since 50% of smokers die from it, you will effectively have murdered 1,000,000 people.

— James (@jamesdhoy) August 29, 2021