Last week ECCR covered the fact that the FDA has submitted its final proposal for ecigarette regulation to the Office of Budget Management. TVECA, Tobacco Vapor Electronic Cigarette Association, has shared with us a leaked copy of the proposed FDA ecig regulations. The news is not good. The ENDS may be near for the overwhelming majority of vape shops and American ecig brands.
This sounds extreme but it is real. Here is how it works. The proposed FDA ecig regulations actually apply to any new tobacco product. A new tobacco product is defined as any tobacco related product, including ecigs and eliquid, introduced to market after February 2007. This establishes a grandfather date. New tobacco products will be required to submit notification and seek FDA approval to remain in the market. Even if a new product meets or exceeds every standard it does not matter. Each product still has to submit and pay for the entire process, a process that will cost millions.
If an ecigarette was marketed and sold in the US prior to February 2007, it would still have to meet FDA standards but it would not have to submit and pay for the FDA rubber stamp. The problem is that the ecig industry really did not take off on a large scale until well after February 2007. As a result, pretty much every product and ejuice on the market today would be forced to pay for the FDAs rubber stamp.
While vaping critics commonly attack ecigs as an off-shoot of Big Tobacco, they are promoting a perspective that is completely ignorant of reality. The reality is that the majority of best vaping products are offered by small, independent American businesses like Halo, Apollo, or VaporFi. The reality is also that many quality imported ecig products are distributed by independent vape shops all over the country. If you walk into a vape shop anywhere it is highly unlikely that you will find one single product that has anything whatsoever to do with Big Tobacco.
These businesses do not have the resources to pay for the FDA rubber stamp process. Companies like Halo, VaporFi and Apollo eCig have invested in offering the best possible products and eliquids. They have invested in state of the art lab facilities and are currently producing products that will far exceed any standard that the FDA wishes to impose. Despite this fact, each of these American businesses will be forced into a realm of legal hoops and regulation that will strangle their businesses. They do not have the millions and millions of dollars it will cost to get the FDAs rubber stamp.
Guess who does have the money to get the FDAs rubber stamp? That would be Big Tobacco. For tobacco companies, a few million can probably be found in their couch cushions. Companies like Altria and RJ Reynolds have billions. The ecigs that they currently sell in gas stations and convenience stores do not compare in quality or effectiveness but that will not matter at all.
Big Tobacco will have as easy a path to monopoly as any American industry has ever enjoyed with a big assist to the FDA and to the special interests that have been attacking vaping for the last several years. How ironic that the public health groups who claim to be standing up to Big Tobacco are actually doing more to help Big Tobacco than they could possibly imagine.
FDA eCig Regulation
The FDA says that it does not have the authority to change the February 2007 grandfather date that Congress established in the Family Smoking and Tobacco Prevention Control Act. As such, as of right now, the date remains in effect.
While the FDA does claim not to have the authority to change the date, they certainly are claiming a lot of authority overall.
The FDA is going to extremes to define tobacco products and their obvious target is electronic cigarettes.
The FDA says that nicotine is a tobacco product because the nicotine in eliquid comes from tobacco plants and therefore falls under FDA jurisdiction. That’s not all. They also assert that even non-nicotine eliquid is a tobacco product because the intention exists to add liquid nicotine. So they FDA cannot change the grandfather date but apparently they can read minds.
So while propylene glycol, flavors and vegetable glycerin are suddenly tobacco products the FDA has decided to extend its overreach even further. They are also considering vaping devices and their components to be an aerosolizing apparatus and an ENDS so that it also falls under their jurisdiction. That means the vaping hardware, including ecig batteries, will be considered to be a tobacco product.
The FDA may not enforce the pre-market submission requirement on all products from the outset but they have set the groundwork to give themselves that right should they choose to do so. They are basically writing themselves a blank check to undertake enforcement action against US ecig companies as they see fit.
The FDA is categorizing ENDS products into three categories. Those are e-liquids, aerosolizing products and aerosolizing devices and eliquids that are sold together in the same package. This will cover the overwhelming majority of vaping products that are currently available to adult consumers today.
The FDA also specifies vape shops that currently blend eliquid for customers will be required to submit any product that they manufacture. That means that vape shops will be required to spend millions to offer a few varieties of ejuice with varying nicotine levels.
The FDA ENDS Of Vaping Strategy
One of the other things that the FDA is going to be doing is attempting to re-write the terminology of vaping. Instead of referring to vaping devices as electronic cigarettes, they will be referring to them as electronic nicotine delivery systems, or ENDS. There is an end game for re-defining terminology.
Cigarettes are widely available and in the history of smoking there has never been this type of effort to impede and vilify tobacco. Look at the facts. There are endless stories about ecigs leading to teen smoking but when you look at the data those findings are ridiculous. In fact, Yale University says that banning ecigs will increase teen smoking.
Making cigarettes easier to get than ecigs has to be one of the most misguided decisions in the history of public health interests.
Teen smoking, by the way, is at an all-time low. In the 80s and 90s when teen smoking rates were more than double what they are now you never saw this type of negative press thrown at tobacco companies. States were not trying to ban cigarettes. The Senate was not trying to pass an official smoking age law. Now, states have adopted laws and bans against ecigs that Big Tobacco companies never had to deal with.
By putting ecigs into a category with a medical sounding name, the FDA is positioning ecigs as a medical device in order to justify oppressive, job killing regulation. With ecigs now labeled ENDS, they justify creating an environment where it will be a lot easier to buy deadly tobacco cigarettes rather than ecigarettes.
Every credible report tells us resoundingly that vaping is safer than smoking. Even the most ardent, single-minded anti-ecig people like Tom Frieden at the CDC admit that ecigs are safer than cigarettes. Yet in states like California tax dollars are buying billboards by the 10 freeway in Los Angeles to terrify people into thinking that electronic cigarettes are the Devil incarnate.
Public Health England has found that vaping is 95% safer than smoking. The worst of the negative ecig myths have been debunked by credible scientists. Every year in the US 450,000 people die from cigarettes. In response, the FDA is attacking vaping and independent American ecig companies as well as vape shops.
Here’s the spin that the ENDS label will help the FDA sell. One, the new terminology diminishes ecigs as a smoking alternative simply by changing the name. Two, the FDA paints a picture that says they are not be crushing a life-saving product that has been innovated by independent entrepreneurs, no the FDA will simply be appropriately regulating a medical device called ENDS. At least that is the narrative that they will spend your money trying to sell to the American public. Had ecigs been the product of Big Pharma or Big Tobacco, something tells me that an entirely different story would be unfolding at this point.
Can You Protect Your Right To Vape?
You may still be able to protect your right to vape. There is an effort in Congress to change the February 2007 grandfather date but as of yet that piece of legislation has not moved. If you are concerned, you should contact your member of Congress and ask that they support Rep. Tom Cole’s Bill, HR 2058.
You can protect your right to vape by asking that Congress protect an adult’s freedom of choice to opt for a less harmful option of his or her own choosing, not an inferior gas station cigalike marketed by rich tobacco companies.
Call your representative and ask that an adult’s right to access to smoking alternatives is respected and protected. If you have a personal success story, share it. Remember to be calm and rational in your request. Be respectful, present your request and define your position in a dispassionate tone.
The anti-vaping forces have gone to extremes. They lie and scare. Let’s not be like them. We can be better than them and make our case without histrionics. Call or write your representative and simply speak the truth. To help, we have compiled a list of talking points you may choose to include as part of your argument:
- Public Health England has found that vaping is at least 95% safer than smoking. In fact, PHE is upset at the fact that there is so much negative information about ecigs because people are not even trying vaping, rather they are sticking with cigarettes.
- It will cost in the range of $20 million dollars to submit each ENDS product for FDA approval. The FDA has previously said that the estimated cost would be about $300,000 per product. These costs will wipe out small business US ecig companies and ensure that Big Tobacco takes over the industry.
- With these costs, the FDAs proposed regulations will essentially ban the sale of 99% of vapor products to adults. This will put an estimated 10,000 vapor companies (including vape shops) out of business.
- The proposed FDA regulations will put at least 50,000 vaping industry employees out of work.
- Create a monopoly for electronic cigarette products (ENDS) with large tobacco companies enjoying the benefits.
- Create a multibillion dollar black market for totally unregulated vapor products
- Force millions of vapers to go back to smoking cigarettes, switch to an FDA approved ENDS, or buy totally unregulated vapor products from newly created black markets
- Protect cigarettes and threaten the lives of millions of vapers and smokers
If Congress moves to change the date from February 2007 then as long as a product meets FDA standards, it can continue to be made available to adult smokers. No one in the vaping community has a problem with the most of the reasonable requirements imposed by the FDA. Warning labels, childproof packaging and quality control assurances are a good thing.
The dog found a bone. The dog chewed a bone. The dog buried a bone.
We encourage compliance with common sense product safety and quality control measures. The industry needs them. In fact, many of the leading companies are already self-policing and actually exceeding FDA standards. US ecig companies will no doubt fight these oppressive vaping regulations and legal challenges are expected, but these companies do not have the deep pockets of their opposition.
The problem truly is that these proposed regulations will crush the best vaping products, will crush innovative products that are saving smoker’s lives and will crush American business while driving people back to deadly cigarettes because the product that was working for them will suddenly disappear from the market.
The best electronic cigarette products are being made and sold by independent US ecig companies. None of these businesses are huge. None have the capacity to go through the FDA hoops. Big Tobacco does. This is precisely the news that Big Tobacco was hoping for. The ENDS, pardon the pun, of the vaping industry as we know it will benefit tobacco. For the health groups out there who have been calling for these oppressive regulations, your new best friends are Altria and RJ Reynolds. We hope that you realize that before its too late.
Ecigs represent the best ally we have ever had in the fight against smoking. Our sincere hope is that we do not end up regulating vaping into oblivion.