The US FDA is one of the most powerful institutions in the field of health in the world. It stands on the same line with WHO if we measure the level of people’s trust. It was recently stated that one is allowed to sell vaping products within the United States only if the FDA Center approves them for Tobacco Products. Product has to go through the Premarket Tobacco Application (henceforth – PMTA). This suggests a special procedure of submission by the FDA.
Such a decision has raised a number of questions. One of the most discussed among them is the issue of possible speculation. However, it should be mentioned that the procedure was announced in 2016, and the official deadline was Sep 9, 2020. Just before the deadline loads of misinformation, superstitions, rumors, and manipulations were highlighted in media space, which was quite expected as people are afraid to accept new and unknown rules of the game.
The fears of the audience are comprehendible. Everyone wants to know that he can continue consuming his dry herb vaporizer pen or his e-cigarette with no change. Stability is what the majority of people are seeking for. However, usual vapers do not risk this much. PMTA is more threatening for business. Especially for small businesses. Owners of small vape shops do not always know what to do to continue selling their goods.
PMTA: the timeline
To begin with, it was 2009, when the bill on Tobacco Control was ratified and, as a result, the Family Smoking Prevention and Tobacco Control Act appeared. Highly skilled politicians, lawyers, and experts in other fields were negotiating the law. Some people from tobacco giants also participated. On the one hand, it helped make it easier to approve some new products, which is a positive point for the tobacco industry.
On the other hand, the outcome was lobbying cigarettes, which is not a positive point for the vaping industry at all. Unfortunately, that is true that bringing brand new products to this market is extremely complicated because the FDA has set a tremendously high bar for getting approved. Also, companies need to prove the relevance of their products for public health care. The issue is if it is at least possible.
It is quite challenging to prove that a vaping device can have any positive health effects, except for the weed pens, which can be used for medical purposes. Probably, this point was added because of the lack of stability on the tobacco market. Young people showed the tendency not to smoke at that time. That was the convincing and compelling reason for congressional representatives to complicate new products’ paths.
Deadlines Becoming Hot Potato
In 2009 nobody thought of vaping devices seriously, claiming that the regulation for vaping devices was not developed properly. However, the list of rules included roll-your-own tobacco and smokeless tobacco apart from cigarettes. It was just 2016 that the FDA Center for Tobacco Products issued the Deeming Rule, which included e-cigarettes, pipe tobacco, hookah products, cigars, and pipes.
Here is where the problem for the vaping industry appeared. The cigars have been on the market for decades before the rule, but there existed no best vape pen for weed on sale at that time. To continue selling their products, all the manufacturers had to go through the vicious circle of red tape to get permission to be sold on the American market. Moreover, all they needed proofs that they are safe and can come in handy in protecting public health. It should have been done until Aug 8, 2018.
Therefore, Aug 8, 2016, is the day when the market was frozen because everyone wanted to apply. Unless you were selling your goods before, you could no enter the market without giving proofs of safety. It does not matter how good your new dry herb vape pen’s quality is, you should have documents to make it possible for retailers to show the device in the shop window. It is worth saying that the exact date has been changed for a couple of times.
Firstly, They decided to push the deadline back for 4 years. The new date sounded like Aug. 8, 2022, which has become a shock for both the vaping community and tobacco control institutions. As anticipated, this behavior has deeply concerned the community and was condemned by the experts’ vast majority. The FDA was sued by the American Academy of Pediatrics. According to the decision of the federal court, May 12, 2020, was set as the new deadline.
This decision has also brought some changes to the rules. For instance, the agency was allowed to stretch a point and leave some of the PMTA requirements out of the scale on a case-by-case basis. However, that was not a happy end. As far as humanity has faced the coronavirus crisis, most countries were locked down, a tremendous number of people died, the court allowed a four-month delay. Overall, Sep 9, 2020, has become the new deadline for those willing to apply.
The problem with PMTA is that if a great manufacturer from another country, who produces vape pens, can set aside a budget for tests of each new weed pen, a small company, which produces e liquids in, say Odessa, Texas cannot afford to do that for each type of e-liquid, for each flavor and taste. Moreover, it seems impossible to provide such testing for each possible combination of an e-liquid with each type of a vaping device, with various wattage, voltage, amperage, and so on.
The most problematic point here is that even if a manufacturer provides all the tests, it is impossible to predict if he or she would get the permission and the product would be approved. This law questions the issue of the access of small business to the markets. Therefore, people get more and more critical about it. They see a kind of discrimination in it. Journalists, experts, and business owners blame the FDA in an attempt to make it impossible for small companies to sell their items.
To sum up, the demand for a vaping product to be “appropriate for the protection of public health” is at least strange. We do not encourage people to get illicit substances, but such a demand gives no choice for a person. Is that a democracy with a free market yet?