Vaping FDA Regulations

The FDA’s Deeming Regulations Devastate the Vaping Community

On Thursday, May 5th, the U.S. Food and Drug Administration publicized the new FDA regulations on vaping 2016 for the manufacturing, distribution, and sales of e-cigarettes and other tobacco products. While the new regulations ban the sales of these products to minors, they also call for all tobacco and e-cigarette companies to submit products for pre-market review in order to permit continued sales. The only products that are exempt from this pre-market review process are those that arrived on the market before February of 2007.

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New FDA E-Cigarette Regulations to Become Effective Over Two Separate Time Periods

After 90 days following the May 8th publication of these regulations, minors cannot purchase e-cigarette products either online or in person, free samples will be illegal to dispense and vending machine sales are prohibited.

The second time period allows for a current product to be sold two years after the May 8th publication, at which point a Pre-Market Tobacco Application (PMTA) must be submitted for FDA approval. After the PMTA is submitted, another year is allotted for a product to be sold while the application is considered. However, the submission of a PMTA  does not guarantee a green light for the permanent sale of the product. This means that on August 8th, the e-cigarette market will be frozen. At which point, new vaping products are illegal to sell or manufacture without FDA approval.

 

What Does This Mean For E-Cigarette Companies?

In terms of business, this call to action of a premarket approval for all products now listed in the Tobacco Control Act is at the expense of vapor product companies—many of which are still in their initial phases. An estimation by the FDA projects that a PMTA will require about 1,700 hours of labor and cost $1 million dollars to test each product. This means that for e-juice, a separate application must be submitted per flavor and milligram. So, if you have one flavor of e-juice that comes in five different nicotine levels, you will need to spend $5 million dollars for the approval of that one flavor.

This is absolutely heartbreaking and devastating. Many e-cigarette companies will be forced off the market, as submitting applications for each product isn’t, by a long shot, affordable for small businesses. Tobacco companies the only companies who can actually afford the exorbitant amount of money that it will cost to test each product. This will not only demolish many vapor product companies, the impact on vapers will be devastating, with the possibility that many will return to smoking cigarettes.

 

The Established Facts Do Not Support the FDA’s Decision

Although e-cigarettes and regular cigarettes are to be regulated in the same exact way, we know that e-cigarettes do not hold the same amount of health problems that are caused by their deadly alternative. This is fact. The Royal College of Physicians, which back in 1962 published the initial report on the health-associated risks linked to smoking cigarettes, stated the following points in June of 2014:

  • “The RCP recognises that electronic cigarettes and other novel nicotine devices can provide an effective, affordable and readily available retail alternative to conventional cigarettes. These innovations could make harm reduction a reality for smokers, as proposed in our 2007 report.”
  • “The RCP also recognises that these new products present potential risks as well as opportunities for individual and population health, and therefore advocates proportionate regulation to maximise the overall public health benefit.”
  • “Regulation should ensure that products deliver nicotine effectively and safely; that advertising and promotion do not target young people or other non-smokers; and that advertising and use (for example, in public places) do not undermine smoking prevention policies. The RCP therefore supports regulation of electronic cigarettes and other novel nicotine products as medicines.”
  • “Close monitoring of the use of electronic cigarettes in UK society is essential to ensure trends that are counter to public health are identified and acted upon promptly.”
  • “On the basis of available evidence, the RCP believes that e-cigarettes could lead to significant falls in the prevalence of smoking in the UK, prevent many deaths and episodes of serious illness, and help to reduce the social inequalities in health that tobacco smoking currently exacerbates.”

 

HR 2058 and the Cole-Bishop Amendment

There exists two pieces of legislation in Congress that stand to change the new FDA vape laws in regard to the date for products to be grandfathered into approval, rather than removing current products from the market.

The legislative prospects that aim to ease this impending doom are HR 2058 and the Cole-Bishop Amendment. Both are trying to advance the predicate date (grandfathered date) in the Tobacco Control Act (TCA) from February 15th 2007 to August 8th, 2016. Changing the predicate date would permit that the vapor products presently on the market would be exempt from the PMTA.

 

The Cole-Bishop Amendment Also Includes these Key Points

  • Vapor products are required to list the precise amount of nicotine content on the bottle, as well as the following phrases on the packaging: “Keep Out of Reach of Children,” and “Underage Sale Prohibited.”
  • Vapor product sales are prohibited through vending machines or displays that are not located in age restricted establishments where.
  • Vapor retail establishments are required to register with the Secretary of HHS, except for “any establishment subject to an active registration under any state law relating to tobacco products” or “section 905 of the Federal Food, Drug, and Cosmetic Act.
  • Vapor product advertising is prohibited in all publications with the exception of adult publications.
  • In order to enact a product standard for “vapor product batteries,” the Secretary of HHS must appropriate a Notice of Proposed Rule Making (NPRN) within a 12-month period of the effective date of the deeming regulations in order to establish a “vapor product battery” standard.

 

What if The Cole-Bishop Amendment Passes?

If passed, e-cigarette products will still have to abide by the following requirements itemized in the Tobacco Control Act: the registration of manufacturing facilities, specifying product listings to the FDA, providing all ingredients used to the FDA—including those that are known to be harmful and are possibility harmful, and placing identifiable health warning on packages.

 

Who’s Fighting Back? 

Senator Johnson Demands Answers From The FDA

Senator Johnson, a Republican of Wisconsin, is apprehensive about the outcome of the deeming regulations. He is apprehensive because these new regulations have the potential to put a halt on the development of the e-cigarette industry altogether, resulting in vapers resolving to return to smoking regular cigarettes.

“Unfortunately, the FDA’s attempt to improve the public’s health by scrutinizing the e-cigarette industry could ultimately result in negative unintended health consequences,” writes Senator Johnson. “The costly impact the rule will have on e-cigarette manufacturers will stifle innovation and make it harder for e-cigarette companies to continue to offer products that serve as an alternative to smoking.  It is possible that without a cost-effective alternative, some consumers will resort to traditional cigarettes.”

It’s comforting to know a member of Congress is on our side. According to a press release from the Senate Homeland Security and Governmental Affairs Committee, Senator Johnson has communicated his concerns to the FDA Commissioner. The Senate Homeland Security and Governmental Affairs Committee, which Senator Johnson is Chair of, is evaluating how these regulations will negatively affect, and subsequently demolish, small businesses.

Senator Johnson called upon the FDA Commissioner to answer important questions regarding the regulations, and provide evidence to support his answers. The FDA Commissioner was provided a May 31st deadline to answer the follow questions:

  • “Will the FDA issue a revised rule if there is sufficient data that finds that e-cigarettes are a safer alternative to traditional cigarettes?  Please explain.”
  • “How is the FDA’s regulation of e-cigarettes not a premature restriction on an industry given the FDA’s admission that it does not have ‘sufficient data’ about e-cigarettes to determine the effects on the public’s health?”
  • “Did the FDA determine how many e-cigarette businesses will be affected by the rule?  If not, why? If so, please provide that data.”
  • “Of the e-cigarette businesses that will be affected by the rule, how many of those businesses does the FDA predict will exit the market as a result of the new requirements?”
  • “Has the FDA considered the unintended consequences if decreased access to e-cigarettes leads to increased consumption of traditional cigarette and tobacco products?  Please explain.”

 

Halo Hails Fire: The First E-Liquid Company to Take Action

E-liquid company Nicopure Labs, LLC, parent of Halo, has taken initiative to combat the FDA’s deeming regulations by filing a lawsuit in the US Court for the District of Columbia. This lawsuit describes how the FDA has directly violated the Administrative Procedure Act in the rule making process. Additionally, the lawsuit indicates that the First Amendment to the United States Constitution has also been violated by the deeming regulations.

 

Our Response

The FDA’s deeming regulations will have a ripple effect that will disseminate into the lives of so many. Although this was “supposed to be” implemented as a measure of harm reduction, it’s completely counterintuitive and indicative of either complete “idiocracy” or a total conspiracy—probably both.

How the Regulations Will Impact Individuals

If you don’t smoke cigarettes, it’s safe to say that you probably don’t know just how hard it is to quit—no matter how many times you tried to kick the habit in the past, the addiction took you over. Finally, a product hits the market that holds a promise of a healthy future—e-cigarettes. At this point, one finally starts to think that maybe there is a way out after all. Not only is it healthier and more hygienic, it provides a smooth transition to quitting altogether.

When a habit as heinous as smoking cigarettes is finally challenged, the last thing you want to do is rock the boat in terms of what is working for the person who took the initiative to quit. If there is a better, happier, healthier alternative, then why in God’s name would you try and poke holes in a higher quality of life? Not only have e-cigarettes saved the lives of so many people who would have otherwise still been smoking cigarettes, they have saved the lives of those who would have been otherwise been exposed to secondhand smoke. This doesn’t only affect e-cigarette companies and vapers—it will affect many people who don’t even know that they will be put in harms way.

How The Regulations Will Impact Businesses

If you are in the vapor products business, the FDA is basically asking you to walk right into the line of fire. Because, in addition to the costliness of the PMTA application, which has no guaranteed approval, the FDA has applied even more severe requirements. E-cigarette businesses are mandated to demonstrate that their products are a beneficial alternative to not only cigarettes, but also other e-cigarette products on the market. Really? How would you even begin to go about that?

With the deeming regulations as they are, this is an almost fruitless and futile process that aims to utterly destroy the vaping market as we know it. Small, and even medium sized companies and manufacturers cannot submit to such a ridiculous request. Vaping as we know and love it will be reduced to extinction, with all current products being wiped off the market in two to three years. Except for vape products made by the tobacco industry. Go figure.

 

The FDA Absolutely IS Waging War Against The Vape Industry

So, basically the FDA wants to turn the vaping industry into…well, vapor. It’s absolutely disgusting that the FDA has actually specified that the nicotine found in pharma gum and patches is neither habit-forming nor dangerous. Yet the nicotine found in e-juice will, in stark contrast, deliver kids into a “lifetime of addiction.” To quote Marilyn Manson, “I wasn’t born with enough middle fingers,” at least in this situation anyway.

It makes absolutely no sense to regulate e-cigarettes the same way as tobacco—the risk associated with vaping is a fraction compared to the danger of smoking. Especially considering the fact that the FDA is implementing and marketing these regulations in the name of “protecting kids,” yet conversely, and knowingly, is leading them to their demise.

The sad truth is that these deeming regulations have absolutely no affect on the tobacco industry. They’ve made billions of dollars each year at the expense of others since the 1920’s. On the other hand, the vapor industry is still budding, and on the contrary, isn’t an industry that aims to thrive regardless of how many lives hang in the balance. Instead, the vaping industry intends to alleviate the harm caused by the tobacco industry.

The Outcome

The results from these regulations will be devastating and deadly, as the only products left on the market will be those from an industry that doesn’t care what you do, whether you smoke or vape or jump out of a window. And as these vapor products from the tobacco industry fail to give vapers the experience they’re used to, they will have no choice but to either resort to illegal and expensive measures to keep vaping, or return to smoking again.

 

What Can I Do To Help?

In the words of Dylan Thomas, “Do not go gentle into that good night.”

Question the FDA’s authority. Don’t just submit to pressures that wish to eradicate you of your right to vape. Speak up and fight back in solidarity with the vaping community.

But, How?

  • Let your lawmakers know that you support the both pieces of legislation by filling out this simple form.
  • Support HR 2058 by petitioning your legislator here.
  • If you do not reside in Representative Cole’s District, send a traditional letter. Although it is urged that you write from your own experience, CASAA has provided this pre-written letter here. Please send to the following address:Rep. Tom Cole2467 Rayburn HOBWashington, D.C. 20515Phone: (202) 225-6165Fax: (202) 225-3512
New FDA Regulations on Vaping 2016
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