When the modern e-cigarette was created, no one could have anticipated its rapid growth and unprecedented popularity. With the first models hitting the shelves in America around 2008 the growth of the product has skyrocketed at rates no one could have anticipated. Especially not regulators, who have been struggling to catch up with e-cigarette growth in America and impose regulation on the products.
In general this should be a good thing. Regulation is designed to keep consumers safe– something that is designed to keep the manufacturers in check and ensure that the best and safest product will get to the market. However, regulation stands to do a lot more harm than good. The FDA has sent their proposed rules to the United States government, and some of what is included in the initial deeming seems less like a benefit to the industry, and more like a deathblow to the booming businesses that have grown up around electronic cigarettes.
History of FDA Regulation
When the country began to notice the new product, regulation efforts began to look like the next logical idea. In April of 2011 the FDA announced they would consider e-cigarettes as if they were a new tobacco product. After a failed attempt to block e-cigarette sales, the FDA acquiesced to the fact that electronic cigarettes and their components would need to be officially considered on their own, before they were restricted. In order to do this, the FDA is adding them to the list of other items that are covered in the Tobacco Control Act. This process is called, “deeming regulations” and when approved e-cigarettes will be added to the list of other FDA regulated items, likes cigarettes, rolling tobacco, chew and snuff. Other items in addition to e-cigarettes – cigars, pipe tobacco, as well as e-liquids, will also be added to the FDA control list.
Several years passed as people speculated over what the FDA would do to impose regulation. In that time, the vaping industry only grew. In April 2014, we finally saw the proposed deeming regulations, which were followed by a period designated for open public comment. After reviewing the public comments the FDA drafted their final proposed regulations and sent them to the Office of Management and Budget at the White House in Washington D.C.
Now that the proposed rules are in Washington D.C.’s court, we are beginning to understand some of what the FDA is expecting to accomplish if they enact the regulations proposed as is. The FDA’s proposal has been called “The Cigarette Protection Act of 2015” a name that is already exceedingly misleading. While they have not released their full proposal rules to the public, they have made available the proposed deeming available to the Tobacco Vapor Electronic Cigarette Association (TVECA). The association did not release the full proposal, at the request of the FDA, but they did make the Premarket Tobacco Application approval guidance available on their web site. The Premarket Tobacco Product Application, known as the PMTA, is the document e-cigarette and e-liquid manufacturers will have to produce in order for their products to remain on the market. TVECA just released a guidance of the PMTA procedure, and that guidance document itself was over 40 pages long. The guidance gives us a glimpse of the long and arduous pathway that e-cigarette and e-liquid manufacturers will have to traverse in order to stay on the market with FDA approval.
If these proposed rules are accepted as it, it paints a pretty grim picture for the future of the electronic cigarette industry. Thousands have called, written and proclaimed their concern about these potentially destructive rules to the FDA and now to the legislators in Washington, which will hopefully lessen these cumbersome regulation hurdles and keep the smaller companies in the industry alive.
The PMTA is bar-none the thing that scares everyone in the e-cigarette industry the most. In basic terms, it means that all products sold that have been introduced to the market after February, 15th 2007 must be approved by the FDA before they can be marketed to the public. There are two ways to meet this authorization. The first is the Substantial Equivalence Report and the second is by using the Premarket Tobacco Product Application. The Substantial Equivalence basically means if a new product introduced is basically equivalent to one that was on the market before the grandfathering date of February 2007 then it can be approved. The problem? There weren’t really any e-cigarettes on the market in February of 2007. That means that almost all products are going to have to go through the PMTA to get market approval and that burdensome undertaking has many people worried.
The PMTA is a pretty hefty piece of paperwork. The companies will be required to provide a massive amount of data to the FDA in order for their products to be available on the market. Part of the PMTA will include, full reports of investigations of potential health risks, full statement of all pieces and parts, components, ingredients and physical properties, principles of operations, full description of methods of all manufacturing processes, a thorough explanation of how the product meets all the requirement and standards, samples of products and product components, proposed labeling, and basically anything else that the FDA requires at their discretion. It’s not too much to ask for a lot of these things really, but the levels at which the FDA is requiring for a qualifying PMTA may be a bit too stringent. The guidance document for the PMTA provided by TVECA details the kind of clinical and non-clinical studies that may be needed to meet the approval requirements. This may require consumer opinion studies, statistical analysis, mathematical modeling, and significantly scientific processes. Let’s face it, some of these levels of scientific analysis may be beyond the reach of a lot of your basic mom and pop e-cigarette or e-liquid companies, as well as the small vape stores that will also be effected by regulation.
However, the PMTA it isn’t as immediately damning as one might think. The FDA knows full well that very few, if any, products would be approved with the grandfathering date set to February 15, 2007. Therefore, in the proposed regulations, the FDA has allowed for what is called a “compliance policy.” This would give e-cigarette and e-liquid companies two years from the effective date of the regulation to remain on the market as long as the product and company meets the following qualification. Firstly, a PMTA for the product on the market must be submitted no later than the two year anniversary of the effective date of regulation. Secondly, if a new product is going to be introduced into the market at the end of this two year period, the manufacturers will need to obtain the PMTA before they can sell their new products.
What’s also encouraging to know is that PMTA is not impossible to obtain. Just recently the FDA announced that they approved several products using the premarket tobacco application authorization pathway. The FDA approved for sale, several Swedish Match North America SNUs, which are smokeless tobacco products. While the sale is approved, the FDA will not deem the product “safe” and will require a package warning label. The FDA also determined that the approved products would provide less toxic options if they were used as replacements for other tobacco products.
It should be noted that SNUs have been around a lot longer than e-cigarettes and while it is uncertain what scientific information was included in the PMTA for these products, it is highly likely that they have greater access to the types of scientific research the FDA is looking for. With e-cigarettes, the studies are less frequently found. While more research is being conducted every day, the results of what is out there now are so all over the board it’s hard to imagine how the e-cigarette companies are going to be able to make these kind of essentially nonexistent reports materialize in order to come into compliance with regulations and keep their products on the market.
In addition, the PMTA that the Swedish company turned into the FDA was over 100,000 pages long. It included scientific disciplines everywhere from toxicology, pharmacology, microbiology, statistics, engineering and chemistry to name a few. While this shows that authorization is possible, it also shows that it is in fact heavily burdensome, and like most experts agree, something that smaller e-cigarette companies will simply not have the time or resources to complete. So while obtaining PMTA approval is not impossible, it still presents a near impossibility to many businesses who are prevalent in the e-cigarette world today.
With these problems relating to the PMTA, it’s hard to see if there is regulation out there that can be a good thing. However, clearly with exploding e-cigarettes and harmful e-liquids there is a need out there. Is there a middle ground somewhere where people can agree the simply basic regulations, but without alienating the companies that have given vaping the popularity it now enjoys?
Despite the danger of the PMTA approval process, regulation is presenting many positives, something that must be considered before it is said that writing of regulation completely is a the best thing to do. There are many potential benefits that regulation could bring about for the industry and for overall public safety.
Potential Benefits of Regulations
Just because there is so much at stake with the PMTA approval process, does not mean that regulation may not result in some benefits to the user and the public health community.
The immediate benefit that would come as a result of FDA regulation for consumers would be exclusive access to a safer variety of e-cigarette devices and e-liquids. With the implementation of basic manufacturing standards we can hope to curtail the occurrence of exploding cigarettes and faulty devices that come when production standards are not taken into consideration.
Ingredient Lists and E-Liquid Chemical Testing
Another major benefit from regulation could help encourage a lot more safety overall in your e-liquids. Recently, there have been several unsettling reports about e-cigarette liquids containing harmful flavoring chemicals that are safe to consume, but not necessarily safe to inhale. The FDA will ensure that approved products will not contain the hazardous flavorings, and that ingredient lists will be included on the final product packaging.
Warning Labels & Child Resistant Packaging
E-liquid poisoning has become a real concern for parents of young children, who mistaken the small bottles of e-liquid for something safe to consume. While these cases have been down lately, the advent of required warning labels and child proof packaging will help ensure that unfortunate poisoning occurrences remain even lower.
Restricting Teenage Sales
Another benefit will be overall regulation that covers the concern of youth use. Even now, there are still a few states that do not outlaw the sale of e-cigarettes to minors, though many businesses opt to restrict sales to youth regardless. FDA regulation will ensure that no state, no business will be able to lawfully sell e-cigarettes or their components to a minor.
The truth is, electronic cigarette regulation is coming and no matter how you slice it, it will change things in this industry. Does this mean you should go out and buy up all of your favorite products now? Not necessarily. These are simply the initial deeming and while it is unsure how much input the White House will take, they have fielded thousands of calls on why these proposed restrictions would be overkill and virtually a knife in the back of the e-cigarette industry. There is still the possibility for change in the final rulings. In addition, even if the regulations don’t change, remember that the products you know now will have a two year window of opportunity once regulation takes effect, where they can still be on the market, even if they don’t meet the PMTA approval from the FDA.
Many critics of the approval process, however, don’t believe even two years is enough to complete the process of PMTA approval. That is why so many people aren’t fighting for change of the process, but rather for the change of the grandfathering date. Since there are virtually no products on the market that would qualify under this grandfathering date of February 15th 2007, many people are hoping the regulators will determine a different date, one effective once regulation takes place.
This simple change would allow consumer to continue buying the brands and flavors they know and love, meanwhile the companies won’t buckle from the incredible weight of regulation paperwork that would now be at their feet. Companies would still have to adhere to new standards, such as packaging and labeling requirements, but the products would remain available as long as the company continued to produce it.
Even though it’s easy to say that overall regulation is a bad thing, there are still many reason why it is ever so important to the future and safety of the industry. It’s hard to admit, but regulation is actually needed. From exploding e-cigarettes to potentially dangerous e-liquids, regulation could stand to make the necessary changes to the e-cigarette manufacturing world to truly have a safe product to offer people. The initial deeming however seem less interested in the safe and helpful regulation, and more aligned to the idea of e-cigarette prohibition.
While the larger companies, ones like Altria Group Inc., who back e-cigarettes like MarkTen or Lorillard who is behind the popular Blu e-cig, won’t have any problem hiring the researchers and man power needed to keep their products on the market, the smaller companies, the brands you know well and love, may struggle to adhere to the standards and be unable to keep their products on the shelves. Especially e-liquid companies who have hundreds of products, each of which would require their own PMTA, creating literally thousands of man hours, that could cost these small companies their business. Many are preparing, but what the majority of people are hoping for are a lessening of the proposed rules as the stand. That is why even now people are still calling White House regulators even now.
It is yet uncertain what the White House will do with the information they have received, but most vaping companies and enthusiasts are hoping that the regulators take their words of concern to heart. If regulation can move away from being a thinly disguised attempt at banning the devices, toward becoming a regulatory system of checks and balances then we have a chance. A shift of the grandfathering date would be an excellent way to accomplish this, without cutting consumers off from a product that could stand to improve the general health of thousands, if not millions of people.