FDA Vapor regulations announcement
If you haven’t heard, the largest announcement in what has saved a new multi billion dollar and growing industry from absolute prohibition was announced on July 28th, 2017. The “E-cig” industry, otherwise known as “vaping industry”, provides an alternative to traditional smoking and has gained serious popularity over the past 5 years but underwent a series of regulatory provisions under the FDA Deeming rule that consequently would have snuffed out a new industry in just over a year, diminishing an industry that provides a successful alternative to combustible cigarettes to millions of smokers.
FDA Vapor regulations before announcement
In 2009 congress extended authority to the FDA under the “Family smoking prevention and tobacco act”. This authority was in order for the FDA to govern the tobacco industry and reduce smoking related deaths from tobacco related illnesses while providing awareness of the dangers of tobacco to minors. At that time, ecigs/ vapor products were not largely known or used, little was known about them and most thought it was nothing more than a “Fad” which clearly turned out to be false. To understand the magnitude of this recent decision by the FDA, it’s important to explain how it all came to be. The ecig industry rose from merely nothing, to a multi billion dollar industry with millions of users converting in just a few short years. There is an estimated 10 million ecig/ vapor product users in the USA alone and are widely popular in countries around the world. Users are steadfast that Vapor products have aided them in a smoke free life for the first time ever or drastically reduced their smoking habit altogether, both which are great outcomes. Or is it?
The FDA vapor regulations plans (before this latest announcement) deemed vapor products as tobacco and moved to govern them as such despite evidence to the contrary that supports ZERO tobacco contents contained in vapor products and are non combustible. Vaping Advocacy groups, businesses and consumers worked relentlessly to fight these claims. Despite the outcry, science based studies and the Public Health England (PHE) stating that ecigs are at least 95% less harmful than traditional cigarettes, the FDA announced a swift paralyzing blow on August 8th, 2016 in the form of the “Deeming regulations” that essentially would have wiped 99% of all vapor products off the market and consequently closed thousands of small businesses across the country. The FDA vapor regulations required manufacturers to submit what is called “PMTA” (Pre-market tobacco applications) which is an application to obtain FDA approval which cost millions of dollars for every sku with little promise that they would even be approved at all, considering there was no clear guidance from the FDA on the PMTA submissions process which inherently made matters much more complexed. This was nothing short of a jump to conclusion that would have ended in the prohibition of vapor products.
Misconceptions about FDA Vapor regulations and the industry
There is a significant misconception in regards to where or how the “vapor industry” was founded. many believe that it was created by none other than Big tobacco and that they were marketing their products undercover. The truth is, the vaping industry was not founded by big tobacco at all and small business fueled the way forward in every aspect and still do. Although big tobacco has there hands in the industry, their products have proven to be ineffective and unsuccessful in converting smokers. It has always been, and still is the small manufactures and brands having nothing to do with big tobacco that cater to the millions of ecig/vapor products users. Statistics prove that millions of smokers find success in vapor products that small businesses provide and not the cig-a-likes that big tobacco sell in gas stations and convenience stores worldwide. Big tobacco did not get the added word “Big” in front of their industry’s name for no reason. They are now a trillion dollar industry with astronomical reach to the masses. It is no wonder there is such a large misconception that big tobacco controls the vaping industry. They have deep enough pockets to market their product on a level that far surpasses the small manufactures who sell the vaping products that have proven to be effective in providing a successful alternative.
Distinguishing the 2 industry sectors are vital in understanding the misconceptions that would had resulted in limited access to vapor products if the FDA vapor regulations were not extended to 2022. The misconception is that the vaping industry and the ecig industry are the exact same industry marketed and fueled by big tobacco. Yes, this may seem confusing, but the truth is the vapor products that are mostly used by those who “Vape” are in fact purchased from the smaller manufacturers who provide products to thousands of smaller retailers. Many still associate ecigs and vapor products as exactly the same product simply because their characteristics are similar and that they are marketed to the same demographic. The Vaping Products that would have been seriously affected by this rule come in a wide variety of devices such as mods, tanks and accessories that have many customizable sizes, settings and features such as the degree of heat, the amount of power, battery life and many additional significant differences. Whereas a typical “Ecig” from Big tobacco has no customization and produces very little vapor and an extremely limited amount of flavor choices. Comparing the 2 products is like comparing a traditional watch to a smart watch, similarities, but nevertheless vastly different.
New Commissioner announces FDA Vapor regulations changes
The new FDA director’s comments regarding the overall FDA vapor regulations speak volumes on his perspective of the vaping industry and the tobacco industry. Doctor Scott Gottlieb announcement has now given renewed life to the vaping industry stating “envisioning a world where cigarettes could no longer sustain addiction, and adults who still need or want nicotine could get it from alternative and less harmful sources needs to be the cornerstone of our efforts” has made it clear where he stands. The FDA vapor regulations “PMTA” (Pre-market Tobacco applications) gave strict deadlines to manufactures whereby the costly applications needed to obtain FDA approval needed to be submitted no later than August 8th of 2018. This strict dealine gave the vapor industry only 12 months before they would no longer be able to comply with the FDA vapor regulations due to the costly process, extremely tough provisions that only big tobacco would have had the resources to comply with. Due to the New commissioner’s approach on regulating Vapor products, the industry will not be ousted without a chance.
Many are praising the new FDA commissioner Scott Gottlieb who took swift and decisive action before the vapor industry was regulated out of existence. It is clear from the commissioner Scott Gottlieb’s address, a common sense approach towards properly governing these new products and industry will be taken. Amending the deeming rule and amending many areas of FDA vapor regulations has undoubtedly saved this industry from what would have been outright prohibition. But the commissioner did not stop there as he raised awareness that nicotine itself is not the cause of death and disease and that cigarettes are the most harmful form of nicotine delivery. Further stating that switching to a lower risk products, such as vapor products, can provide actual public health benefits!
FDA Vapor regulations Moving forward
The deeming rule still has many of its original provisions that must be abided by in order to comply with the FDA vapor regulations. But the most burdensome provision that the industry escaped was the costly application process that most businesses in the industry say would have been to much money and resources needed to even submit the application by the 2018 deadline. Some of the rules in FDA vapor regulations that will go into effect and enforcement on September 30th, 2017 are rules having to do with manufacturing standards such as; Manufacturers listing proper warning labels, prohibiting sales to minors, child proof safety caps and other packaging requirements, listing ingredients, registering the labs the e-liquids are being manufactured, amongst many other provisions manufactures will have to comply with. It is also important to note that the FDA considers it to be a violation for any company to tamper with any products once the sale from the manufacture to the wholesaler, distributor or retailer has been transacted. The FDA considers a business to be a manufacture if that business sells anything to the public other than a sealed bottle of E-liquid that has come from a manufacture that has complied with all provisions under the rule. If any business, whether a wholesaler, distributor or a retailer tampers with any E-liquids or vapor products in a whole, they would then be subjected to the FDA vapor regulations in the same capacity as a manufacture and those regulations would be enforced. However, due to this singular extension of the PMTA deadline and the new common sense approach that the new FDA commissioner has chosen to take, those who comply will be able to now offer these alternatives and consumers will continue to have access to vapor products as an alternative to cigarettes.
Although these FDA vapor regulations may seem strict, it is to ensure product standards and safety for those who want to make the switch and for those who currently use vapor products. This alone should raise consumer confidence and peace of mind in knowing what they are purchasing has complied with product quality safety standards and is being regulated for the betterment of the products. In any event, this announcement was none other than a victory for the vaping industry and there will be much to look forward to in watching the evolution of an industry that was born to provide an alternative to traditional tobacco products.
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