A new bus tour to promote vaping in the U.S. began on Oct. 8. The event kicked off at American Vapor Manufacturers (AVM) president Amanda Wheeler’s vape shop, Jvapes Vape & Smoke Shop in Prescott, Arizona.
“Every American should have the right to use vaping to quit cigarettes. Critical health decisions should be up to the individual. Not the [U.S. Food and Drug Administration]. Not the [U.S. Centers for Disease Control and Prevention]. And certainly not nanny-state politicians in Congress,” the We Vape, We vote website states. “This fundamental belief underlies our entire effort. That’s why we need leaders who recognize vaping as a powerful harm reduction tool and the single most effective smoking cessation device ever created.”
The tour is designed to coincide with the midterm elections, and is intended to “amplify the voices of vapers in the 2022 elections,” according to Americans for Tax Reform (ATR), the Washington, D.C.-based organization sponsoring the tour. Events will include “rallies at vape shops, voter registration drives, discussions with lawmakers” and more, says ATR.
“Events will be covered by local media and promoted on our social media accounts, sending a clear message to lawmakers in state and federal legislatures that vaping saves lives and America’s vapers vote accordingly,” says ATR.
The tour will make 13 stops in 13 states, including Colorado, Iowa, Wisconsin, Illinois, Ohio, Pennsylvania, Washington, D.C. and, North Carolina, South Carolina, Georgia and Florida.
Advocacy organization’s roots are based in giving consumer’s access to lower-risk nicotine products
By VV Staff
In the early days of e-cigarettes, the U.S. Food and Drug Administration (FDA) began seizing the next-generation products. In response to the federal action, a group of enthusiasts and dedicated vapers became concerned that consumers would lose access to the potentially life-saving technology. That led to the creation of the Consumer Advocates for Smoke-Free Alternatives Association (CASAA). Alex Clark, CEO of CASAA, said the organization soon started building an army of consumers dedicated to keeping vapor products on the market.
“We truly are a grassroots consumer organization,” explains Clark. “We speak from the heart. And it is our needs as consumers, as people who are choosing a better path in the way that we consume nicotine and tobacco products; that’s where we’re speaking from, and that’s what sets our policy agenda.”
Speaking during the Global Tobacco & Nicotine Forum (GTNF) in late Sept., Clark disclosed that CASAA does accept donations from a variety of stakeholders, including industry stakeholders, but the organization does not have any policy, legislative messaging or financial agreements with any of its supporters. Clark says that the conversation surrounding vaping is centered in harm reduction and that is the mission of CASAA.
Alex Clark / Credit: CASAA
“Vaping … has become this conversation about tobacco harm reduction, [it] is a consumer-driven movement. I don’t think there’s anything groundbreaking in that statement,” he said. “But I bring it up because I believe—and I think many of us believe—that the industry and policymakers need to be reminded of that, that as people who used to smoke, we have endured years of other people telling our story.”
CASAA grew as a community organization through its “tight feedback loop” between consumers and independent manufacturers. Clark likened the early days of the not-for-profit organization to the local food movement, where “if you wanted to know where your cheeseburger came from, you could drive down the road” and visit the farm.
“I think we can all come to embrace that spirit and that side of the industry as an asset, not necessarily something that needs to be regulated to within inches of its life,” Clark said. “As consumers, we are very deeply afraid that is what’s going to happen. That as larger firms are able to make it through the [premarket tobacco product application (PMTA)] process, that we [will] lose that very important retail experience to be able to walk into a vapor shop and learn about the products, but also discuss the challenges that we’re facing in transitioning away from smoking.”
Clark says that a major concern for CASAA and its supporters is that the U.S. Food and Drug Administration (FDA) PMTA process is too expensive and arduous for small business owners. He says the organization worries that if only large tobacco companies can sell vapor products, consumers will lose the ability to have a place to learn and understand the choices available, through different types of products, to help them stop smoking.
Clark mentioned a study that evaluated the long-term success rates of quitting smoking for people who visited specialty vape shops versus people who bought their products at convenience stores. That study found that consumers that visited vape shops were more successful at stopping smoking. “They were more likely to transition completely and they were more likely to stick with the products for longer,” said Clark.
Because of the success vape shops have had at helping people quit smoking, they began to move away from the stigma they carried in local communities early on as being businesses where “potentially unsavory elements go to get their drugs,” according to Clark. He says that, today, vape shops are seen for what they are: a contact point for public health messaging and people who smoke. “People who are looking for a way to move away from combustible tobacco visit vape shops, and it’s a very casual setting,” he says. “It’s a place where people can feel safe, and welcome, and being able to just share our stories with one another. It is very helpful, and it really looks a lot like a community support [group for smokers].”
Clark said this distinction is important for regulators and anti-vaping groups to understand. Smokers began making the decision to quit using cigarettes by switching to vapor products of their own accord. There was not a government agency telling them that e-cigarettes had the potential to help them quit deadly smoking and small, family-owned vape shops is where the conversations and mass conversions began.
“We have made this decision on our own, which is a bit challenging to the dominant narrative painting people who smoke as victims. I, honestly, don’t feel like a victim,” he says. “I started smoking in the mid-90s. Certainly, I was subject to all kinds of messaging about why I shouldn’t smoke. Not only why it would be negatively affecting my health, but why it was essentially a character flaw and I was a bad person.”
Clark says vape shop owners need to help keep vape shops available to smokers by taking steps to continue to change people’s perceptions of them. Owners need to keep their shops clean and sanitary. Don’t have such a thick cloud of vapor when opening the door that potential customers are driven away. Vape shops should have an open and welcoming environment.
“You need to have a place for your customers to talk with one another. People behind the counter need to be very knowledgeable about the products that they are selling. Regulations [need to allow] people [to] have candid conversations about these products. As it stands now, I think even sharing your personal story about making the switch while standing behind the cash register could get people into a lot of trouble,” he says emphatically. “There’s a lot of room for regulations to improve in terms of allowing people to receive important information and also the education that needs to happen among people working in vape shops.”
People often internalize messages that are intended to encourage them to change their lives for the better, according to Clark. He says people also internalize messages about being deficient. Some of the rhetoric surrounding vaping and the misinformation about its harms is detrimental to public health. Vape shops create an environment where people feel comfortable discussing their goal of quitting cigarettes. Anti-vape groups, however, are putting these “safe zones” for smokers in jeopardy.
“We have already seen the legislative agenda of the anti-vaping, anti-nicotine campaigns which is to go after flavors, which very obviously shuts down vape shops and takes away that very important element of providing a space for people to come together and support one another,” Clark told attendees. “We must be prepared to take on these fights at the local and state level.”
Fighting the types of legislative challenges that the vapor industry is facing is complicated. Clark says that when attempting to tackle many legislative issues in the United States, it is like dealing with 50 different countries. “Certainly, you can see this in our patchwork of responses to the [Covid-19 pandemic],” he says. “Within those 50 countries, we have 39,000 local governments and all of these are potential pressure points where anti-nicotine activists will promote anti-harm reduction policies. If we don’t stand up for ourselves, we can’t rely on other people to do it for us and we cannot surrender our voice to either anti-tobacco activists or the tobacco and nicotine industry.”
Following the PMTA deadline, vape shops are unsure what vapor products are legal to sell in the U.S.
By Timothy S. Donahue
On Sept. 10, vape shop owners in the United States faced a dilemma. Numerous hardware and e-liquid manufacturers in the electronic nicotine-delivery system (ENDS) industry were required to pull their products from store shelves. Any product for which the manufacturer failed to file a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA) by Sept. 9 is now illegal to market in the U.S.
Tim Scarborough, general manager for Tennessee Vapor Factory, with several stores in Tennessee, said that after talking with distributors, he removed thousands of dollars in product from his store shelves. “It was a straight-up loss. We estimate it to be probably upwards of $10,000,” he said. “We haven’t gotten final figures, but it was [a] large sum.”
As for ordering new products, Scarborough says that many manufacturers and distributors have lists of products for which they have filed PMTAs. Those are the products Scarborough’s shop is trying to keep in stock. “It’s getting harder. We are having to do research to figure out if some of these products filed as well,” he says. “The selection, variety of product, is really minimal right now. We don’t even know for sure the FDA is going to approve a product. I think that, in the long run, this will push people back toward cigarettes.”
During the Global Tobacco & Nicotine Forum (GTNF) held virtually in September, a representative of a large vapor industry distributor told Vapor Voice that his retailers had no way of knowing exactly what products are legal, so they have been selling off the product currently on shelves but have been weary of ordering new product. The distributor did not want to be named due to fears of potential FDA reprisal.
“I’ve had retailers call and say they have lost 50 percent of their juice wall because of the companies they know didn’t file PMTAs. Shop owners have been asking for a letter of acceptance and maybe even a list with all the SKUs for the files we have submitted,” he said. “Retailers don’t want to incur fines for selling illegal products, but how can we even as a distributor know if a company has filed a PMTA? How many products have even been filed? I saw something the other day where the FDA was expecting 2 million PMTAs. A vape shop in Texas had 333 submissions. Beard e-liquids had 72. We submitted 105, but its more than that if you break it down into the different flavors and nicotine strengths. If we broke down our submission like that, it’s about 7,000 PMTAs. It’s really hard to know what exactly the FDA is doing.”
Many manufacturers and retailers have closed their businesses due to the cost of submitting a PMTA and the uncertainty surrounding the industry. NicVape, BlueDot Vapor and Stash E-liquids did not submit PMTAs, for example. A note on Illinois-based e-liquid manufacturer Level Up Vapor’s website reads only, “Closed; We are no longer accepting orders.” In a letter to its customers, VapeWild, explained it would not be submitting PMTAs and was shutting down. The company had been in business for six years and was a favorite of vapers worldwide.
“The PMTA deadline is finally upon us … It’s been a long road, and we did our best, but in the end, we just aren’t able to pull it off,” VapeWild wrote. “These are crazy times we’re living in, and they just keep getting crazier,” the letter states. “Our sincerest hope, though, is that we have somehow made a difference in the world for the better.”
Only a small number of the thousands of vapor companies in the U.S. have announced that they filed PMTAs by the deadline. Complicating matters, most of those companies have not released what devices or e-liquid flavors they have filed. So far, based on Reddit posts, press releases and media reports, just over 100 companies stated they have filed a PMTA or had the intent to file before the deadline. Just over 50 companies announced they had filed an application before the deadline. Even fewer revealed that the PMTA had been accepted by the regulatory agency. All the major tobacco companies in the U.S. have a PMTA currently accepted, filed and under review for a vapor product.
Credit: Smoque Vapor
Once an application is sent to the FDA, manufacturers are permitted to sell their products for a year unless the agency acts. So far, Philip Morris’ heated-tobacco device IQOS and Swedish Match’s General snus are the only two tobacco brands to have survived the PMTA process.
And the process does not end with marketing authorization. After receiving a PMTA, a company must continue to conduct postmarket surveillance and studies to determine the impact the orders have on consumer perception, behavior and health and to enable the FDA to review the accuracy of the determinations upon which the orders were based. These postmarket requirements also include a rigorous toxicity study using computer models to help predict potential adverse effects in users, according to the FDA. The orders also require the company to monitor youth awareness and use of the products to help ensure that the marketing of the products does not have unintended consequences for youth use.
In July, the director of the FDA’s Center for Tobacco Products, Mitch Zeller, said the agency would prioritize policing vapor products aimed at youth. However, the Covid-19 pandemic has put vape shop inspections on hold, according to Zeller, adding that no date has been announced for when in-person inspections would begin again.
“All the entities that we have contracts with have state level for activities like compliance checks and vape shop inspections,” Zeller said in July. “With that stop-work order, we’ve temporarily postponed all in-person inspections of tobacco retail establishments, but we continue to do all of our monitoring and surveillance and websites and publications and social media because we can do that remotely and have always done that, if you will, remotely from offices.”
Speaking at the virtual GTNF in September, Alex Clark, CEO of the Consumer Advocates for Smoke-Free Alternatives Association (CASAA), said there is a lot of uncertainty right now not just in what types of products will get acceptance letters but also how quickly the FDA will be able to bolster enforcement. This, at a minimum, gives retailers a little leeway. If regulators can’t inspect stores, then retailers can still sell products if the FDA hasn’t previously stated that a product is illegal.
“Because there is this lag in enforcement, there [are] still [illegal] products on store shelves,” said Clark. “[The regulatory environment in the U.S.] is bad … we are concerned that [the U.S. is] exporting our bad policy ideas and our bad science and bad campaigns. In New York, for example, bad science … helped change people’s minds and vote to advance the flavor ban language.”
In a press note on Aug. 31, Zeller wrote that the FDA plans to make publicly available a list of the deemed new tobacco products that are subject to the Sept. 9 deadline and that were on the market as of Aug. 8, 2016 (it had not been released as of this writing). “However, before doing so, we will need to ensure that the publishing of any such information complies with federal disclosure laws and regulations as only certain types of product information from applications can be lawfully disclosed,” Zeller wrote.
This has left retailers in limbo. Shop owners don’t know if a product they are selling could make them a criminal. Zeller stated that the agency knows of more than 400 million deemed products. To date, the FDA has received applications for around 2,000 products, he said, adding that the agency has processed 40 percent of those. Zeller did not specify how many of those applications were for vapor products. Zeller acknowledged that the FDA was unlikely to be able to review that many applications in the year timeline set for their review.
“Even if applications are submitted for only a portion of those products, the likelihood of [the] FDA reviewing all of these applications during the one-year review period is low given that this would be an unprecedented number of applications and several orders of magnitude greater than anything the agency has experienced,” Zeller wrote. “Depending on the number of new applications we receive by the deadline—which could be anywhere from a few hundreds of thousands to millions—as a matter of practicality, we may not be able to fully complete review of all tobacco product applications that we receive by Sept. 9, 2020, within the year.” The FDA has not announced how many products filed PMTAs.
Zeller also stated that the agency was willing to work with manufacturers. The FDA has said it could allow some smaller manufacturers to submit a “deficient” PMTA and keep marketing products until the necessary data is collected. He said the FDA would accept several justifications for such applications, such as the Covid-19 pandemic and a limited amount of lab space for testing. “Although we expect high quality and complete applications to come in by Sept. 9, if we do find deficiencies, it is likely [the] FDA will issue a deficiency letter with a 90-day deadline for companies to respond,” Zeller wrote.
Orion Saith, with Smoque Vapours Electronic Cigarettes in Chicago, says that her store had already destroyed most of their disposable products because of Chicago’s ban on flavored vapor products. The company is still selling mix-in flavors for e-liquids and has its own line of e-juices as well. “We haven’t taken any juices off the shelves yet. We have our own juice line, and those PMTAs were submitted to the FDA, so we are doing OK for now,” said Saith.
Finding hardware, however, has been extremely challenging. Saith says that knowing what products are legal to sell while PMTA submissions go through the process is getting more difficult by the day. “It is very difficult. We have been getting whatever we can that is still in stock from wholesalers who say that the devices are legal,” she said. “It involves a lot of trust. We have been asking to see submission letters from the FDA too. What’s concerning is that as some of these large major brands leave shelves, the consumers are the ones who suffer. If you can’t get a quality device, you probably end up going back to cigarettes. That’s just a horrible thing to force on someone.”
Credit: Thorn Yang
The FDA has been sending notices to companies selling illegal products. In late April, the FDA issued 10 warning letters to retailers and manufacturers who were selling, manufacturing or importing unauthorized ENDS products that “were clearly targeting use, or likely to promote the use, of these products by young people.” The agency sent three more notices on Sept. 9, the same day PMTAs were due. Zeller said the agency will continue to send warnings.
“All told, since our compliance and enforcement program began in 2010, we have completed over 1.2 million retailer inspections. This has resulted in over 97,000 warning letters, over 11,000 of which were for illegal products,” said Zeller. Many experts predicted the vapor industry would come to end after the PMTA deadline. For now, at least, it will continue.
