Federal Court Rules Against Nicopure.
Nicopure Labs’ fight for vaping rights suffered a setback in a Washington, DC federal court. This is the first major court loss for the vaping industry in what may very well be just one of many court battles in the long-term fight against FDA overreach. Nicopure had been seeking relief from oppressive regulation.
A level of regulation that many say represents an existential threat to the entire vaping industry. The court case dealt with motions for a summary judgment filed by Nicopure to immediately and permanently deny the FDA any authority to implement and enforce FDA regulations on vapor products.
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The court combined the Nicopure case with similar lawsuits and plaintiffs including the Right 2 B Smoke-Free Coalition, which is a group of e-cig companies and advocacy groups. All eyes in the vaping community were watching and waiting for the decision. When the decision finally came, it was not what we were hoping for.
Judge Amy Berman Jackson upheld the FDA’s deeming regulations in a 93-page decision. The end result is that the FDA’s authority to regulate vapor products under the 2009 Family Smoking Prevention and Tobacco Control Act remains in effect. But the fight is far from over.
Federal court upholds the FDA’s complete authority to regulate vapor products.
What’s Next in the Courts?
Immediately after the court decision, one of the attorneys representing the plaintiffs left the door wide open to an appeal. Azim Chowdhury, known by many as the e-cig attorney, made clear that an appeal is being considered and the fight would continue. In all likelihood, the only reason that an appeal was not immediately announced is that several similar cases are currently making their way through the courts.
There are multiple pending lawsuits challenging FDA deeming regulations for electronic cigarettes. There will be more court decisions to come.
Nicopure and the Right 2 Be Smoke-Free coalition are no doubt watching closely to find out what happens with other cases challenging the FDA. Other courts may very well deliver a different judgment in favor of the e-vapor industry. It will only take one court victory to change everything.
The Fight for Vaping in Congress
Vapers, vape shop owners, and independent American electronic cigarette companies are all hoping for a positive decision from the courts but there is a possibility that the ultimate decision on the future of vaping will not come from the courts. There are multiple bills in Congress that directly challenge the FDA’s e-cig deeming regulations. Senator Ron Johnson of Wisconsin has flat out called for the FDA to butt out of the vaping industry altogether.
Recently, the House Appropriations Committee passed legislation to block the FDA from regulating electronic cigarettes as tobacco products. Will this legislation will make it onto a bill that is passed into law? That has yet to be determined. Vapers are encouraged to get involved and contact their representatives and urge them to support the freedom of adults to access vapor products. Contact your rep by email or better yet, pick up the phone.
In addition to the fight in courts, the fight for vaping rights is playing out in the United States Congress. There is existing legislation that, if enacted, could change or even block the FDA’s authority to regulate vapor products.
When you call your local rep’s office, chances are you will not be able to speak to your Senator or House Representative. That’s okay. Talk to the staffer who takes your call. Ask them their name. Introduce yourself. Keep the dialogue firm but friendly. Simply tell your personal story. Let them know that the e-vapor industry is creating jobs. Tell them you want regulations to ensure quality standards but that the current deeming regulations go too far. Remember, friendly but firm. If you want to protect your right to vape, don’t sit this one out.
What Is Really on the Line With FDA Deeming Regulations?
The term “deeming regulations” is used a lot. But what does it mean? Basically, it means that the FDA is asserting jurisdiction over vaping as part of the authority Congress vested in them in the 2009 Family Smoking Prevention and Tobacco Control Act. The deeming regulations pertaining to vaping require that electronic cigarette products are labeled and all ingredients of e-liquids listed. That sounds good. No one really disagrees with those requirements. Then what’s the problem?
The Act states that any tobacco product introduced to the market after February 2007 is regarded as a “new” tobacco product. Products introduced after February 2007 will be required to submit a PMTA application to the FDA for approval to be sold on the market. That still doesn’t sound so bad. But here is where things go sideways. A PMTA application process is a lengthy, expensive ordeal with more red tape than you can imagine. The costs are staggering.
Many experts, such as Bill Godshall of Smoke-Free Pennsylvania, claim that if current FDA e-cig regulations are fully implemented it will cause 99% of existing products to be gone. It will put most independent e-cig companies and vape shops out of business.
The FDA estimates that one PMTA application for one product will cost $300,000. Experts say that number is not even close. The real costs for one single PMTA application may be closer to $1 million. Think of your favorite e-liquid. Let’s make one up. How about Sara’s Apple E-Juice. If Sara’s Apple E-Juice comes in four different nicotine levels in both a VG and PG blend, that is a total of eight PMTAs that Sara’s Apple E-Juice will have to submit for one e-liquid flavor. That means Sara may have to come up with $8 million to sell just one of her e-juice flavors. Imagine if she has 10 different flavors. Sara will go out of business.
Meeting FDA E-cig Deeming Regulation Criteria
The idea that products should have labels and meet certain standards is opposed by no one. The clear issue is the costs involved. The vaping industry in the United States is driven by independent American entrepreneurs, not by big corporations. The reality is that these companies cannot afford to pay for the FDA red tape. The only companies that will be able to afford the FDA PMTA process are the Big Tobacco e-cigs that you see sold in convenience stores and gas stations.
Here is another reality. An independent American vape company can exceed every standard the FDA can throw at them. In fact, most of the best-e-cig brands easily exceed any FDA standards. And most of them have long before the FDA did. Just meeting the standards is not the issue. At all. It is the expense that experts say will wipe out 99% of the vapor products currently available to you right now. Unless something changes.
UPDATE: Nicopure Fight For Vaping Rights
When the FDA deeming regulations for electronic cigarettes were announced in the spring of 2016, Nicopure responded immediately. They announced their lawsuit to challenge the FDA. Although the court decision did not go their way, we have an important update to tell you about right now.
When the FDA announced their electronic cigarette deeming regulations in the spring of 2016, they declared that all PMTAs for any product must be submitted by August 2018. The final rule was that any product on the market by August 2016 would have 2 years to submit their paperwork to remain on the market. That date has just changed. Any product that was on the market as of August 2016 will now have until 2022 to file their paperwork. A reprieve.
The FDA postpones PMTA application deadlines until 2022.
Just days after the court decision last week, FDA head Scott Gottlieb held a press conference. The press conference outlined an overall strategy for tobacco harm reduction. Gottlieb seemed to be focused on reducing the nicotine content of tobacco products. In regards to vaping, the major announcement was that the FDA is extending the PTMA submission deadline until 2022.
Nicopure Responds to The FDA Extension Until 2022.
The news from the FDA was a mixed bag. The products currently on the market should be available to you until 2022. That’s the good news but the bigger threats remain unchanged. It remains very difficult to get new products to market. The more bad news is that e-liquid flavors will be coming under FDA review sometime soon. That news represents a possible intrusion into your access to a range of flavors that vapers enjoy. So clearly, the vaping community will take the reprieve and utilize the additional time to strengthen the fight for vaping rights.
We reached out to Nicopure to ask about their strategy moving forward. They responded to us with the following statement:
We are encouraged by Commissioner Gottlieb’s announcement today regarding the extension of PMTA submission deadlines through 2022. This is a wise decision and a much-needed delay. However, the deeming rule as a whole still does not change and it still does not take into consideration the harm reduction potential of e-cigarettes. The grandfather date stays the same, and we still cannot launch new products or improve on existing ones to keep up with advances in technology. So, while grateful, much more needs to be done and the entire regulatory framework needs to be reevaluated and changed. We feel strongly this extension only allows for a window of opportunity to ensure a sustainable future for our industry in the form of appropriate regulation and even a change in legislation. Nicopure Labs will stay at the forefront on the fight and engagement to ensure that our consumers, and smokers in general, have acceptable alternatives to combustible cigarettes that will improve their quality of life and give them a chance to move away from smoking.
Clearly, this is not over. Nicopure makes it clear that the FDA extension is a reprieve, not a victory. The additional time will allow additional cases to work their way through the courts and to perhaps see a breakthrough in Congress.
Vaping Daily is watching all of these events very closely. You can count on us to keep you informed of the latest developments the moment the happen.
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