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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; email@example.com
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.
Lawmakers reject science in e-cigarette debate
– Adam Sullivan, 8/2/19
Last week, members of Congress held a hearing about one of the greatest misinformation campaigns in contemporary politics.
No, I’m not referring to former Special Counsel Robert Mueller’s testimony to the House Judiciary Committee about Russian election interference, although that certainly was important as well.
You probably didn’t hear much about another meeting that took place on the same day as the widely covered Mueller spectacle. Democrats on the U.S. House Oversight Committee led a hearing examining e-cigarettes and the “youth nicotine epidemic.”
“We don’t need more studies. We already know the truth here.” – U.S. Rep. Rashida Tlaib, D-Mich.
Unfortunately, the event was dominated by gross misinterpretations of the facts and plainly anti-scientific rhetoric.
Vaping is an important public policy topic here in Iowa, where some policymakers have proposed restricting access to vapor products in response to the popularity of Juul brand e-cigarettes. Last year, Iowa lawmakers introduced bills that would increase taxes on e-cigarettes, and increase the age to purchase all nicotine products from 18 to 21.
Those bills did not pass, but restrictionists vow to try again next year, and the federal government is in the process of imposing new rules on e-cigarette sellers.
Many of the claims made by anti-vaping advocates cannot be traced back to scientific research, and many that can have been distorted or overstated.
The main points of the arguments presented at the Capitol last week are that e-cigarettes are just as harmful as combustible tobacco, and that e-cigarettes have no value as smoking cessation tools. Neither claim appears to be true.
“I’m not going to sit here and allow this committee to be used by anybody, even from the other side, to say that e-cigarettes, vaping, Juul is not killing our people. They are,” said U.S. Rep. Rashida Tlaib, D-Mich.
Does vaping kill people? There are two known cases of vape devices exploding and killing users in the United States. To compare, estimates for the number of Americans killed by lightning strikes each year range from 30 to 100.
The critics’ underlying insinuation — that inhaling flavored nicotine vapor is closely linked to human mortality — is not supported by evidence.
England’s national public health agency reports e-cigarette use is 95 percent safer than smoking cigarettes.
Similarly, the National Academies of the Sciences wrote in a report last year, “There is conclusive evidence that completely substituting e-cigarettes for combustible tobacco cigarettes reduces users’ exposure to numerous toxicants and carcinogens present in combustible tobacco cigarettes.”
Since we know vaping is significantly less hazardous than smoking, we should celebrate the prospect of nicotine addicts switching over. Politicians disagree.
“There is no credible medical evidence of Juul’s most fundamental marketing claim. None,” U.S. Sen. Dick Durbin, D-Ill., said last week, referring to marketing of Juul e-cigarettes as smoking alternatives.
The literature is somewhat less clear on this question, but the evidence certainly is greater than “none.” The National Academies of the Sciences reports there is “moderate evidence” that e-cigarettes are an effective smoking cessation tool.
Since the current body of research is inconclusive, it was especially troubling to hear Tlaib say, “We don’t need more studies. We already know the truth here.”
That is the exact opposite of the truth. Even researchers who are concerned about e-cigarettes’ health hazards consistently emphasize the need to continue researching the long-term effects of a practice that has been common for less than a decade.
The new generation of drug warriors is particularly alarmed at the “teen vaping epidemic,” pointing to research that shows an uptick in nicotine consumption by middle school and high school students. However, a closer look at the data shows little evidence e-cigarette use by young Americans represents an epidemic.
About 21 percent of high school students used vaporizer products in 2018, according to the Centers for Disease Control and Prevention’s National Youth Tobacco Survey. Journalists and politicians consistently neglect to mention that figure includes teens who have tried e-cigarettes just one time in the 30 days preceding the survey.
To put that in context, 20 percent of high school juniors said they had at least one drink of alcohol — which everyone agrees poses significant health risks — in the past 30 days, according to the 2018 Iowa Youth Survey.
It turns out only about 5 percent of American high school students are regular vape users, according to federal research. Any substance dependency among minors unequivocally is a bad thing, but it is not an epidemic.
E-Cigarette Bans Undermine Decades of Anti-Smoking Efforts
By MICHAEL SIEGEL July 26, 2019
Coast to coast, cities are feeding dangerous misperceptions and making it harder for smokers to quit.Today, cigarette smoking remains the No. 1 cause of preventable death in the United States. So why are cities and towns coast to coast taking harm-reduction alternatives off the shelves while allowing Marlboros to remain?
Last month, San Francisco banned the sale, including the online sale, of e-cigarettes. Around the same time, Brookline, a Boston suburb, did the same thing. Livermore, Calif., followed suit. Also moving in this direction are Morristown, N.J., Blufton, S.C., and Seattle.
Perplexingly, these strict regulations essentially ignore traditional cigarettes. Menthol cigarettes are banned in both San Francisco and Brookline, but other flavors — which constitute the vast majority of the cigarette market — are still sold.
With an uptick in teen vaping, parents and residents are understandably worried about our youth picking up a bad habit. But in their eagerness to tackle one problem, these municipalities are revealing a deep misunderstanding of vaping, ignoring the unintended consequences of bad policy, and putting many more lives at risk.
As the FDA acknowledges, nicotine “is most harmful when delivered through combustible tobacco products.” Vaping doesn’t release the toxins that come from burning tobacco and that lead to lung cancer, emphysema, and heart disease. By itself, nicotine is addictive — but not toxic.
As a result, Public Health England considers e-cigarettes 95 percent safer than traditional cigarettes for adult smokers; and in 2015, Britain’s Royal College of Physicians stated that e-cigarettes are “likely to be beneficial to public health.” In fact, the U.K. views e-cigarettes as so much better than traditional smoking that several hospitals there are now providing them as a part of their anti-smoking efforts. What’s more, The New England Journal of Medicine published British research finding that smokers who use e-cigarettes are twice as successful at quitting as those who rely on other approaches. And now a similar American study has arrived at the same result: Daily e-cigarette use “was associated with a 77% increased odds of prolonged cigarette smoking abstinence over the subsequent two years.”
New E-Cigarette Laws Could Drive Some Users to Smoke More Cigarettes
MAKING E-CIGS LESS APPEALING TO YOUTH MAY HAVE UNINTENDED EFFECTS ON EXISTING USERS
Efforts by the FDA and some cities to limit the availability and appeal of e-cigarettes to young users could drive some existing users to smoke more tobacco cigarettes to get their fix, according to new research from Duke Health.
The findings, from a survey of 240 young U.S. adults who use both e-cigarettes and traditional tobacco cigarettes, are scheduled to be published July 15 in the journal Substance Use & Misuse
“The FDA now has regulatory authority over all tobacco products, including e-cigarettes and we know that some communities have taken action to ban flavored e-cigarette products,” said Lauren Pacek, Ph.D., the study’s lead author and an assistant professor in psychiatry and behavioral sciences at Duke.
“We wanted to take a first pass at seeing what users’ anticipated responses to new regulations might be,” Pacek said. “Our findings suggest that while some regulations, such as banning certain flavors to limit appeal to adolescents, might improve outcomes for those young users, the new regulations might have unintended consequences with other portions of the population.”
The online survey asked participants aged 18 to 29 to predict their use of two products they already used — e-cigarettes and traditional tobacco cigarettes — in response to hypothetical regulations to limit e-cigarette flavors, limit the customizability of e-cigarettes or eliminate the nicotine in e-cigarettes.
About 47 percent of respondents said if regulations eliminated the nicotine in e-cigarettes, they wouldn’t use e-cigs as much and would increase their use of traditional cigarettes.
About 22 percent said if regulations limited the customizability of devices, such as features allowing users to adjust nicotine dose or vapor temperature, they would use e-cigs less and smoke more tobacco cigarettes.
About 17 percent said if e-cigarettes were to be limited to tobacco and menthol flavors, they wouldn’t use e-cigs as much and they would smoke more tobacco cigarettes.
According to other research on e-cigarette use, about a third of people who use e-cigarettes also use other tobacco products, Pacek said. For instance, some smokers might use an e-cigarette where tobacco smoking is not allowed, such as at work or a restaurant.
The survey was small and not designed to predict the behavior of e-cigarette users across the U.S., Pacek said. However, the data suggest that when considering changes to e-cigarettes, such as limiting fruity flavors proven to appeal to youth, that regulators also consider the downstream effects of new regulations on other users.
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