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VTA Responds to CDC FDA Statements on Illicit THC Vape
“VTA has previously said public health departments should fully investigate and release all information about these cases. Either there’s a legitimate basis to tell people to stop using e-cigarettes or they are feeding the hysteria around a different product to conflate the issues by failing to distinguish e-cigarettes. The Vapor Technology Association applauds FDA’s statement clearly advising consumers to avoid THC-containing vapor products. Even former FDA Commissioner Scott Gottlieb, no friend to the vapor industry, has assigned blame to illegal vapor products containing THC and cannabis. By contrast, CDC’s fear mongering statement is misguided and will only cause further harm to overall public health.” – Tony Abboud, Executive Director of the Vapor Technology Association.
Just yesterday New York’s own DOH said these cases were clearly marijuana related. We issued a statement to that point: https://bit.ly/2k5cDht
Additionally, we’ve previously called on public health departments to release this information: https://bit.ly/2lXUcvH
VTA strongly encourages all media outlets to promote the clear statement made by the FDA which fully understands the dangers posed by illicit products and the THC products at issue. VTA also reminds the media that nicotine-containing vapor products already are heavily regulated by the FDA.
New York Department Of Health Says Cannabis – Not Nicotine – Cause Of Recent Outbreak
The New York State Department of Health today released one of the few first statements by officials at the state or federal level that gives a fair and accurate representation of what may have led to recent cases of lung illness. VTA applauds NYDOH for identifying unregulated black-market cannabis-containing products as the likely culprit and for warning consumers to the dangers of these products so that they are fully informed about what products to avoid.
Specifically, NYDOH explained that:
“Laboratory test results showed very high levels of vitamin E acetate in nearly all cannabis-containing samples analyzed by the Wadsworth Center as part of this investigation. At least one vitamin E acetate containing vape product has been linked to each patient who submitted a product for testing. Vitamin E acetate is not an approved additive for New York State Medical Marijuana Program-authorized vape products and was not seen in the nicotine-based products that were tested. As a result, vitamin E acetate is now a key focus of the Department’s investigation of potential causes of vaping-associated pulmonary illnesses.”
In addition, the NYDOH made the following statement, which echoes precisely the same warnings that VTA issued in a statement last week:
“Anyone using vape products should never use unregulated products purchased ‘off the street.’ Cannabis-containing products are not legally available in New York State for recreational use. These unregulated products are not tested and may contain harmful substances. Users of vape products should never modify vape products or add any substances to these products that are not intended by the manufacturer.”
To reiterate, VTA in no way supports the manipulation or adulteration of vapor products to consume THC, THC oil, marijuana, or synthetic products like K2.
E-cigarettes and other nicotine-containing vapor products are designed for the consumption of nicotine to provide adult smokers an alternative to cigarettes; they are not intended to be used to consume illicit substances. Also, the NYDOH finding underscores the fact that while nicotine-containing vapor products are heavily regulated by the Food & Drug Administration, cannabis-vaping products are entirely “unregulated.”
According to Public Health England and the Royal College of Physicians, after a complete review of all the peer-reviewed science on vapor products, nicotine-containing e-cigarettes and vapor products are at least 95% safer than smoking cigarettes.
VTA Asks Health Officials to Speak Responsibly
In light of the seriousness of reports regarding lung disease in youth, the Vapor Technology Association (VTA) strongly urges public officials to thoroughly investigate the circumstances which might have led to each reported hospitalization before making statements to the public as to whether certain products are implicated in these incidents. To date, several public health agencies have failed to provide clear information and, instead, are unnecessarily frightening consumers by failing to distinguish between e-cigarettes and non-nicotine vaporizers.
Recent reports increasingly indicate that these adverse events are linked to illicit substances such as THC and cannabis, not e-cigarettes. For example, the New Mexico Department of Health has clearly determined that products containing THC are likely responsible for the cases highlighted in New Mexico. Despite this, virtually every other public health official continues with their generalized and repeated references to “e-cigarettes.” Such inaccurate warnings will result in either (1) people continuing to use the risky products actually causing the harm about which they have not been specifically warned; or (2) many smokers using e-cigarettes becoming ‘scared’ by these reports and moving back to deadly combustible cigarettes.
VTA condemns in the strongest possible terms the sale or use of black-market products and does not endorse the manipulation or adulteration of vapor products to consume THC, THC oil, marijuana, or synthetic products like K2. E-cigarettes and other nicotine-containing vapor products are designed for the consumption of nicotine to provide adult smokers an alternative to cigarettes; they are not intended to be used to consume illicit substances.
E-cigarettes and nicotine-containing vapor products are used by millions of adults as an alternative to combustible cigarettes, and most vapor products on the market are of high-quality. Nonetheless, no person should:
- misuse or alter a vapor device designed for vaping nicotine-containing products by attempting to vape anything other than an e-liquid designed to be used with that device;
- use any products other than those purchased from a reputable establishment; and
- use a vapor product offered to them by someone else without knowing precisely what they are consuming.
FDA has imposed regulatory requirements on nicotine-containing vapor products for more than three years, since August 8, 2016, including strict labeling and packaging restrictions that require vapor companies to, among other requirements, disclose all of the ingredients in the products sold.
In stark contrast, none of the products designed for THC, cannabis and any other non-nicotine substances are regulated by the FDA.
Importantly, major medical groups and governments have conclusively determined that vapor products are 95% safer than combustible cigarettes, and studies have shown that they are nearly twice as effective at helping adults quit smoking than traditional methods.
Vapor Technology Association And Vapor Stockroom File Lawsuit Against Fda
Contact: Alex Schriver; firstname.lastname@example.org
WASHINGTON D.C. – August 14, 2019 – Today, the Vapor Technology Association (VTA) and Vapor Stockroom (VSR) filed a lawsuit in federal court against the U.S. Food & Drug Administration (FDA), amongst others, over its unreasonable and arbitrary Pre-Market Tobacco Application (“PMTA”) process and the recently grossly accelerated PMTA filing deadline. Plaintiffs are taking action to require FDA to publish and complete the long-promised “foundational rules” describing the specific requirements for PMTAs. In addition, Plaintiffs are asking the court to enjoin FDA from enforcing the May 2020 PMTA deadline or taking enforcement action against companies that do not have a PMTA on file until a reasonable period of time after the actual foundational rules are finalized.
With over 3 million vapor products registered with FDA, the arbitrary May 2020 PMTA deadline which FDA is currently enforcing is simply impossible to meet for thousands of small and mid-sized vapor businesses, particularly in the absence of a draft or final PMTA Rule. Any final PMTA Rule must allow sufficient time to conduct the many complex and time-consuming tests and studies currently being required by FDA.
Since 2016, FDA has provided five different PMTA submission deadlines: August 8, 2018; November 8, 2018; August 8, 2022; August 8, 2021; and now May 12, 2020. The most recent deadline was only just established on July 12, 2019 – leaving a scant ten months for vapor industry manufacturers to attempt to comply, which is now 27 months earlier than previously set by FDA.
“FDA’s constantly shifting regulatory process is wholly unreasonable, unfair and unlawful. The Agency has failed to provide advance notice or an opportunity for public comment as required by the Administrative Procedure Act. Grossly accelerating the deadlines and then repeatedly changing the already onerous requirements is unacceptable under any regulatory regime, but this is especially true for vapor products when FDA itself warns that ‘it is likely that there would be a mass market exit of ENDS products’ that ‘could adversely affect the public health,’” said Tony Abboud, Executive Director of the Vapor Technology Association.
The PMTA application is by far the most arduous of the many regulatory requirements governing ENDS products, and requires a complex, multi-year, multi-million-dollar process that FDA has still failed to fully articulate despite its repeated promises to do so. “To be clear, no business could rationally have been expected to start conducting complex PMTA testing before FDA finally published its PMTA guidance document on June 11, 2019, the day before it asked the Court to impose a 10-month PMTA deadline,” said Abboud.
The stark facts set forth in the Complaint are that, even with unlimited resources, there are not enough labs, there are not enough subjects, and there are not enough hours in the day to properly conduct the scientific inquiries that FDA only just laid out on June 11, 2019, by the May 2020 deadline.
Our company complied with every regulation imposed by FDA and invested in our business while waiting for FDA to deliver on all of the promised PMTA rules, guidance and standards. We never thought that FDA would wait so long to provide any direction and then immediately shrink the deadline so that we had no chance to stay in business,” said Tony Florence, President of Vapor Stockroom, LLC. “It’s a devastating one-two punch to small businesses all over the country,” he added.
“It is time for FDA to stop moving the goalposts and changing the rules in the middle of the game to the detriment of our manufacturers and small businesses,” said Abboud. “FDA’s actions, if unchecked, will shut down an entire industry that has developed to challenge the combustible cigarette. Whatever FDA calls its ‘rules of the road’ simply cannot be relied upon in the absence of a real PMTA rulemaking process that gives all stakeholders the opportunity for notice and comment, not just those interested parties that file lawsuits,” he added.
The plaintiffs in the case are Vapor Technology Association and Vapor Stockroom, LLC. The plaintiffs are represented by Thompson Hine LLP as counsel. The case, titled Vapor Technology Association, et al. vs. Food & Drug Administration, et al. has been filed in the United States District Court for the Eastern District of Kentucky. The case number is not yet assigned but a link to the filing can be found here.
About the Vapor Technology Association
The Vapor Technology Association is the leading U.S. non-profit industry trade association whose 800+ members are dedicated to innovating and selling high quality vapor products that provide adult consumers with a better alternative to traditional combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, flavorings, and components, as well as the largest wholesalers, distributors, importers, and e-commerce retailers, in addition to hundreds of hard-working American brick-and mortar retail store owners throughout the United States.
Vapor Stockroom is a Lexington, Kentucky manufacturer of nicotine-containing e-liquids and currently manufactures 40 distinct lines. It employs thirteen people and sells its products in local retail stores, online, and through distribution to vape shops and tobacco specialty stores nationwide.
Chicago Tribune: Vaping Helps Ex-Smokers
As a former smoker, I used to be cynical about vaping. I have now experienced firsthand just how effective flavored vapor products can be to help transition smokers away from deadly cigarettes.
I believe it is important that these safer, healthier products remain available to adult smokers throughout Illinois. I also believe action should be taken to further regulate vapor products to make sure minors cannot purchase them.
It’s important that our representatives in Springfield recognize that vapor products can be life-changing tools to help people like me quit smoking. We should set reasonable standards and regulations to protect young people while making it clear to adult smokers that vaping is a much safer and healthier alternative. These products played a crucial role in my journey to kick my smoking habit, and it’s important that other adult smokers have the same opportunity.
VTA Marketing Standards for the Industry
We have aggressively pushed industry and policy makers to adopt marketing standards to eliminate potential appeal to youth.