As the list of marketing denial orders issued by the FDA grows, the future of vaping as we know it is uncertain. But all is not lost. While the Food and Drug Administration has been most zealous and myopic in its outlook, there might be a solution. It all boils down to semantics.
Laws, by their very nature, are written to be unambiguous. Yet, any lawyer will tell you that the devil is in the details and there is one ‘detail’ that could offer vapers, vaping vendors, and manufacturers a ‘get out of jail free card’. At least, for now. Today, we are looking at how synthetic nicotine could be used to circumvent the continuing issue of MDO’s and allow vendors to keep on vending.
The FDA and its Edicts: How Did We Get Here?
The road to what can only be described as prohibition has been a long and fairly convoluted one.
In 2009, the Obama administration enacted the Family Smoking Prevention and Tobacco Control Act. Without going overboard on legalese, this Act gave the FDA the authority to control and regulate tobacco products’ manufacture, distribution, and marketing. Around this time, vaping was a relatively new phenomenon. The Act was aimed primarily at cigarettes — already widely known to have severe health implications.
In May 2016, the FDA passed a rule requiring all vaping manufacturers to follow the same practices and processes that tobacco product manufacturers had to comply with when releasing new products.
These practices were commonly known as PMTA’s (Pre-Market Tobacco Applications). You’ll have heard about them a lot recently.
These processes allowed the FDA to review tobacco products and assess how safe they are before being made available for sale. The original deadline for PMTA applications, after being extended, was August 8th, 2022. That is until a collective of fundamental lobbyists, often with vested interests, sued the FDA, leading to the deadline being brought forward to September 9th, 2020.
And here we are now.
How were the products reviewed?
Well, read the general criteria and witness the hypocrisy.
Manufacturers must provide explicit details of; product marketing, ingredients, public risk and benefit, and whether the product affects the use of other tobacco products.
In order of the above criteria, vaping:
- Isn’t heavily marketed, and those who have previously marketed have faced significant penalties.
- Contains no known cancer-causing ingredients.
- Has been proven to reduce smoking rates and improve long-term quit goals.
- Has reduced the number of smokers worldwide.
Yet, to date, the FDA has issued a total of 295 MDO’s leading to the withdrawal of over a million life saving products.
Bleak and illogical, most definitely. The responses prove it.
When are you going to tell Bloomberg funded anti-vaping groups to go away, and start following true science? 2016, Royal College Of Physicians concluded, #vaping is AT LEAST 95% safer than smoking. Since then, several other health organizations have came to similar conclusions!
— Jerry Pruitt (@NC_horseshoe) September 18, 2021
When @yale research published in @JAMA_current shows that banning flavors doubles teen smoking, what does @FDATobacco do? Ban flavors https://t.co/57m7vvIqT9
— SET NIC FREE (@SetNicFree) September 17, 2021
FDA is proud to announce their commitment and support for the continued deaths of 1,300+ Americans every day from SMOKING. This abritrary & capricious denial of ENDS products will have deadly results, including an increase in teen smoking. FDA is killing jobs & people. #Resist
— David P Forsyth (@DavidPForsyth) September 17, 2021
But there could be a solution.
A Legal Loophole | A ‘Grey Area’ or Light at the End of the Tunnel?
Read the above again (and if you have the time, read the Act and the associated developments). There will be a word that crops up often; “Tobacco Products”.
You’ll find it in section 101 of the Family Smoking Prevention and Tobacco Control Act. You know, the one that the rabid anti-vape groups cited as a source to sue the FDA. It states:
“The term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption.”
While e-juice does not contain any tobacco, the nicotine within it is tobacco-derived.
However, there is an alternative, which escapes this definition.
We are talking about synthetic nicotine.
As the name suggests, synthetic nicotine is lab-produced and doesn’t (currently) come under the definition of a ‘tobacco product’. As a result, it could allow manufacturers to continue to manufacture and distribute vape products without having to go through arbitrary (and quite frankly, ridiculous) PMTA’s.
What is Synthetic Nicotine | How It’s Made and the Advantages
Synthetic nicotine, or tobacco-free nicotine (TFN), if you prefer, is developed in a lab. Consider it an identical yet artificial replica of plant-based nicotine. Without a tobacco plant being anywhere near!
The science of how it is produced is complex, but what you need to know is this. Synthetic nicotine is identical in its composition to tobacco-derived nicotine. Still, the effect it has on the body is identical.
Without getting too deep into ‘the science’, think of it a little like a diamond. ‘Natural’ diamonds are made from compressing carbon under high heat and pressure. Lab-created diamonds are made by compressing carbon under high heat and pressure. The only difference? Chemically? None whatsoever, just the process and the raw materials differ slightly. It’s the same with synthetic nicotine.
The advantages of synthetic nicotine? Plenty:
- It is consistently better quality! – As with all organic matter, tobacco plants contain impurities and imperfections. Lab-created nicotine is about as pure as it gets.
- It works! Because it is chemically identical to tobacco derived nicotine, synthetic nicotine provides the same level of satisfaction.
- It isn’t tobacco-derived – Synthetic nicotine is created using a chemical process; there is no need for tobacco plants!
- Nicotine Doesn’t Cause Cancer – It is the other compounds released by the burning of tobacco that causes cancer in cigarettes
- It isn’t currently covered by the FDA definition of a ‘tobacco product’ – This is a great advantage at present and could offer a viable alternative for vaping manufacturers.
Are there Downsides to Tobacco-Free Nicotine?
It isn’t a perfect world. There are a few downsides.
It is thought that due to the complexity required to make it, synthetic nicotine may be more expensive than its ‘organic’ counterpart.
Also, it wouldn’t take much to change or amend a few words in the current legislation. The FDA has already ignored that vaping products contain no tobacco, and it hasn’t been particularly astute in understanding the differences between vaping and smoking. The FDA has already begun to cover itself, stating it will make determinations on a case-by-case basis. But that said, referencing that section of the website only mentions “disposable, closed system devices”.
The Bottom Line
While anti-vaping groups have accused suppliers of ‘exploitation’ of the rules by proposing to use synthetic nicotine in their products, the truth is that it may just provide a lifeline for those struggling for survival.
Many vaping product manufacturers willfully followed the rules. They invested thousands, or sometimes hundreds of thousands of dollars, trying to ‘play by the rules’ and appease the FDA. In the blink of an eye and the posting of an MDO, that money, along with livelihoods and public health, has been lost.
The saddest part is that vaping is a better alternative to smoking, whether with synthetic nicotine or organically produced nicotine. The widespread adoption of this loophole will hopefully buy the industry more time and allow common sense to prevail.