The Jones Labs announced it has received filing letters from the U.S. Food and Drug Administration (FDA) for both its premarket tobacco product application (PMTA) and its modified-risk tobacco product application (MRTP).
Credit: The Jones Labs
“The Jones product family is being evaluated for safety and efficacy as alternatives to combustible cigarettes and their comparable safety to smoking the Harmful or Potential Harmful Constituents (HPHCs) of combustible cigarettes,” a press release states. “As a leader of pre-August 8 [the FDA’s deadline for a product to be on the market to be eligible to remain on the market while going through the PMTA process] compliance, The Jones Labs registered with the FDA in July 2016 in preparation for Electronic Nicotine Delivery System regulations.”
The Jones Labs states that the potential of electronic drug-delivery systems remains at the core of its technology. “Due to our record of compliance with the Center for Tobacco Products (CTP), our products are eligible for enforcement discretion until our application process has been completed,” the release states.
The core technology of The Jones Labs submissions are based in “Buffered Aerosol Drug Delivery,” a review article published in the inaugural edition of the United Journal of Drug Development and Industrial Pharmacy. “The technology submitted for review is being further developed in parallel to address other cessation and medicine-assisted therapeutic needs in the market,” the review states. “With this unique drug-delivery platform technology they stand to disrupt the established order of all smoking and smokeless products, cannabis or tobacco.”
The Jones Labs offers universally compatible tobacco vapables as an alternative to smoking combustible cigarettes, the release states. “With multiple present and future product offerings similar to The Jones Pods (www.thejonespod.com), we are developing Rise, by The Jones (www.risebythejones.com), a state-of-the-art smoking cessation platform that utilizes the core technology for replacement and cessation therapies across the board.”
The U.S. Food and Drug Administration (FDA) has sent its first set of warnings letters to manufacturers of electronic nicotine delivery devices (ENDS) that did not submit premarket tobacco product applications (PMTA) by the Sept. 9 deadline.
On Jan. 15, the agency issued warning letters to 10 firms who manufacture and operate websites selling ENDS products, specifically e-liquids, advising them that selling these products, which lack premarket authorization, is illegal, and therefore they cannot be sold or distributed in the U.S.
Per court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to the FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, the FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by the FDA on the application.
The FDA plans to post a list of products for which the agency has received applications; however, before making such a list available, the FDA is verifying certain information about these products so that publication of a list complies with federal disclosure laws.
Stephen Hahn
“The premarket application process ensures that new tobacco products, including many already on the market, will undergo a robust scientific evaluation by the FDA,” said FDA Commissioner Stephen M. Hahn in a statement. “Scientific review of new products is a critical part of how we carry out our mission to protect the public—especially kids—from the harms associated with tobacco use. In addition to the important premarket scientific review, prioritizing enforcement against those who violate the law by selling unauthorized products is how we help protect public health.”
The 10 firms receiving warning letters are Little House Vapes; Castle Rock Vapor; Dropsmoke; Perfection Vapes; CLS Trading; Session Supply Co.; Coastal E-Liquid Laboratory/GC Vapors; Dr. Crimmy; CMM Capital LLC; and E-Cig Barn.
Mitch Zeller
“These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations,” said Mitch Zeller, director of FDA’s Center for Tobacco Products. “We want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace and will hold companies accountable for breaking the law.”
The FDA has requested responses from each firm within 15 working days of receiving the letter detailing how each company intends to address the agency’s concerns.
The Missoula County Commissioners in Montana has provisionally voted to expand the city’s vape ban five miles beyond city limits in what commissioner’s say is an effort to reduce youth access to vape products.
Credit: Antonin Fels
The ordinance restricts self-service display of all vaping and tobacco products and prohibits the sale of flavored e-liquids and other tobacco products, according to an article on khq.com. The approval is provisional, meaning it will be discussed again on Jan. 28 before there is a final vote of approval.
Public comment is available online, via mail or at the county commissioners meeting on Jan. 28.
In late November, the City of Missoula, Montana banned flavored vaping products and not flavored combustible tobacco products. Now, Missoula County is considering using its extraterritorial powers to extend the city’s ban on the sale of flavored vapes and their display five miles outside city limits next week.
Following the recent enactment of smoke-free laws in Paraguay, every South American country has now banned vaping and smoking in most public places.
Under Decree No. 4624, approved by Paraguay’s presidency on Dec. 29, consuming lit, heated, or electronic tobacco products is permitted only in uncrowded open air public spaces that are not transit areas for nonsmokers.
“This is a great achievement for the people of Paraguay,” said Carissa F. Etienne, director of the Pan American Health Organization, in a statement. “The country has taken an enormous step toward protecting its citizens from the devastating health, social, environmental and economic consequences of smoking and exposure to tobacco smoke.”
Credit: Ye Jinghan
Following Paraguay’s recent ban on public smoking, all South American countries have comprehensive smoke-free laws.
“This is a great moment not only for the health of Paraguayans, but for the entire region of South America,” said Adriana Blanco, head of World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) Secretariat. “Paraguay’s decree creates a subregion of the Americas that is totally free of tobacco smoke.”
According to the Campaign for Tobacco-Free Kids, some 430 million people are now protected by laws requiring smoke-free public places and workplaces. These laws also ban designated vaping or smoking areas.
This progress is the result of years of commitment and action from political leaders and civil society groups in South America working to fulfill their obligations under the FCTC.
When the FCTC came into force more than 15 years ago, only one country in South America, Uruguay, provided its citizens with broad protection against secondhand smoke and vapor.
Vaping products are going to be much harder to sell in Connecticut under bills that are being introduced in the General Assembly, including a ban on the sale of all nicotine products in pharmacies, and e-cigarettes within five miles of schools.
Credit: Haiberliu
Lawmakers are also expected to reintroduce legislation from Gov. Lamont that failed in the closure of the General Assembly last March, to ban flavored vaping devices, in attempt to prevent teenagers and young adults from starting what data show can become lifetime habits, according to an article in the Middletown Press.
Several of the bills, including the outright ban on refillable e-cigarettes and vaping products in the state, have been introduced by state Sen. Saud Anwar, a physician from South Windsor who serves as vice chairman of the Public Health Committee.
“Many of the children are facing life-long addictions and we must do something,” Anwar, a Democrat, said in a Friday interview. He said that it is hypocritical for pharmacies on the one hand to be places where health aids, drugs and vaccines are available, while the nicotine-based e-cigarettes and vaping materials are in the same place.
The five-mile zone around schools would also include neighborhood variety stores and gas stations. Another bill would require Connecticut buyers of online nicotine-delivery products to produce proof of their age before transactions can be completed.
Kevin O’Flaherty, regional director of advocacy for the Campaign for Tobacco-Free Kids, said Friday said the organization’s main goal this year is to eliminate all flavored tobacco products, including cigarettes, mirroring a law that took effect last year in Massachusetts.
“We’ve got to protect kids from these flavors,” O’Flaherty said. “We really want all flavors off the market. You just have to do it that way. Smoking overall is going down. If we are serious about ending the cycle of addiction, we have to nip it in the bud. All of Connecticut’s neighbors have banned all flavored e-cigarettes, but only Massachusetts has banned flavored tobacco too.”
A spokesman for the vapor company Juul Labs, said Friday that with a customer base of one billion adults, it is committed to keeping children away from using its products, while helping grown-ups wean themselves from smoking. In September of 2019, the company ceased all marketing and advertising.
“We will continue to reset the vapor category in the U.S. and seek to earn the trust of society by working cooperatively with attorneys general, legislators, regulators, public health officials, and other stakeholders to combat underage use and transition adult smokers from combustible cigarettes,” the spokesman said.
At Puff City on River Road in Shelton, Matt Genc, a partner in the three-year-old smoke shop, says any state laws are part of the cost of doing business. He said that banning flavored vapes would hurt sales, but that the store obeys all rules. “Whatever is legal, we’re selling and whatever is not legal, we’re not selling,” Genc said in a Friday phone interview.
A suburb of Chicago is considering a temporary ban on the sale of vaping products. The board for the Village of Vernon Hills voted Monday to draft a moratorium that, depending on the formal language approved, could limit the types of flavored tobacco and vape products businesses can apply to sell for in town.
Credit: Vaporesso
The decision was part of a broader discussion to possibly ban the sale of such products within the village, according to a story in the Chicago Tribune. Board members opted to put that discussion on the back burner until the board and residents can meet in person to hear out both sides of the issue, choosing a moratorium as a stopgap until the discussion could take place.
At the meeting, village staff presented information that broke down what businesses would be impacted if such an ordinance were passed. Village Manager Mark Fleischhauer reported that 15 businesses within town are licensed to sell tobacco and vaping products.
About half those businesses sell flavored products, with one business in particular, Artisan’s Vaping, selling it as their main focal point, Fleischhauer said. While nothing is formal on any ban, trustees kicked around the idea of a grandfather clause if such a thing materialized.
As for the moratorium, officials said there are a few potential ways the ordinance can be written. The range of potential products that could be impacted includes flavored tobacco, flavored vaping or e-cigarettes, to vaping products as a whole, officials at the meeting said.
Trustees will discuss the options at their next committee of the whole meeting, with an eye on passing the moratorium at the board meeting that follows.
The discussion to potentially ban flavored tobacco products was sparked at the village’s last meeting in December, where they received a presentation from a resident that cited the harms and risks associated with using said products, particularly with youth.
During the meeting Monday, Trustee James Schultz took issue with the possibility of a ban, saying the product is legal in the state. He added that the village has done a good job of not allowing flavored and vaping products to be sold to minors.
“Does that mean we shouldn’t be issuing liquor licenses because more people die and start drinking at a young age?” Schultz said. “This is a bridge too far for me.”
The board also received a comment on the matter from a resident. The comment stated it was unfair for a discussion of a potential ban to be taking place without those who sell vape products knowing or having a chance to give their thoughts.
The City of Chicago attempted to ban all flavors of vaping products except tobacco and menthol. It has been sent back to committee. The cities of Beverly Hills and Manhattan Beach, California were the first two cities in the U.S. to ban the sale of vapor products.
VDX Distro announced today the launch of its e-liquid brand, Four Seasons Fine Tobacco. The brand was founded to give smokers a more authentic and pleasing replacement for traditional cigarettes, according to a press release.
Credit: Four Seasons
“Four Seasons’ e-liquids are designed to withstand flavor bans by being what they are and no more – pure, authentic tobacco flavors. Its flavors are all made from naturally extracted tobacco, with no artificial flavors, colors, additives, or sweeteners, giving consumers that pure tobacco taste,” the release states. “Each flavor is carefully crafted to emulate those of the most widely appreciated cigarette brands, resulting in a vaping experience that most closely resembles the mouth feel, throat hit, and taste.”
Four Seasons’ products have received an acceptance letter from the U.S. Food and Drug Administartion (FDA) for its premarket tobacco product application (PMTA) accepted, according to the release.
“At Four Seasons we seek to bring you a satisfying vaping experience that will give you the tools you need to make the switch away from combustible tobacco for good,” said Four Seasons CEO and Founder Ryan Chalmé. “Our mission from day one remains the same as it does today, helping adults discover an alternative to traditional tobacco.”
The FDA requires a product to have been on the market prior to Aug. 8, 2016 and have filed a PMTA in order to remain on the market after Sept. 9, 2020. There was no mention if Four Seasons was on the market prior to Aug. 8, 2016.
Two California cities have become the only jurisdictions in the U.S. to eliminate the sale of all vaping and traditional tobacco products. On January 1st, Beverly Hills and Manhattan Beach, both in the Los Angeles area, began to enforce the strictest vaping rules in the country. The law also included a phase-out period for retailers to empty their shelves of e-cigarettes. Other cities are considering enacting similar bans.
The Beverly Hills City Council, the first to pass its ordinance, proposed the rule nearly three years ago during a meeting discussing the potential ban of flavored vaping products. Ultimately, the council settled on a total ban of all vaping and traditional tobacco products.
Credit: Haiberliu
“Somebody’s got to be first, so let it be us,” said then-Mayor, current Councilmember John Mirisch, who first proposed the concept in 2017, according to a press release. Mirisch recently joined the Board of Trustees of the advocacy group Action on Smoking & Health (ASH), which coordinates Project Sunset, an effort to phase out tobacco sales worldwide.
“Cigarettes have become so normalized that to some this might seem like a drastic step,” said Chris Bostic, ASH Policy Director. “But if another product emerged tomorrow that was highly addictive and killed when used as intended, of course we’d ban its sale. We’d probably charge the people who marketed it with manslaughter too.”
Total vaping and tobacco bans have been gaining traction more recently, within the public health community and more broadly. The Danish Institute for Human Rights, after concluding a human rights assessment of Philip Morris International in 2017, concluded that “there can be no doubt that the production and marketing of tobacco is irreconcilable with the human right to health. For the tobacco industry, the UNGPs [United Nations Guiding Principles on Business and Human Rights] therefore require the cessation of the production and marketing of tobacco.”
Vapor industry advocates say that banning e-cigarettes only pushes former combustible cigarettes smokers back to combustibles. They also say that vaping bans increase the size of the black market. Black market THC vaping products were the cause of a lung disease that sickened and killed numerous youth in 2019.
The state of Indiana will again try to ban flavored vaping products in its next legislative session. Senate Bill 45, authored by Sen. Ronald Grooms, will be on the the agenda when the 2021 session begins on January 4, at 1:30 pm.
Credit: Davis Mark
The bill defines “flavored e-liquid” as e-liquid that contains a constituent ingredient that is added for the purpose of imparting a characterizing flavor. The bill would also make it illegal for any manufacturer, distributor, or retailer to manufacture, distribute, or market flavored e-liquid in Indiana.
The bill would prohibit the sale of flavored e-liquid to a person of any age and authorizes the state’s alcohol and tobacco commission to investigate and enforce penalties for certain violations involving flavored e-liquid.
Indiana has previously tried to ban flavored vaping products without success. In early March, the Indiana House of Representatives approved a bill to ban flavored e-liquids 213-195, but it failed to gain approval in the senate.
Photo Credit: Peggy und Marco Lachman / Photo Illustration by Mike McDonald
By Maria Verven
Char Owen and Amanda Wheeler knew the enormous uphill battle other vape business owners would face when pulling together their premarket tobacco product applications (PMTA) for the U.S. Food and Drug Administration (FDA). After all, the PMTA process—which the FDA has foisted on thousands of small business owners—had been built for billion-dollar tobacco manufacturers. Every flavor in every nicotine level—even the smallest differences—needed its own PMTA, and each PMTA cost hundreds of thousands of dollars.
Add it all up, and some manufacturers had to submit PMTAs for more than 2,000 products. The costs will be astronomical—estimated in the hundreds of millions. Aside from the costs, there’s another huge hurdle: Very few vape business owners have information technology experts or paid scientists on staff—the kind of expertise necessary to submit the extensive paperwork required by a PMTA.
And what about the help for small businesses that the FDA promised? It never arrived. So Owen and Wheeler stepped up to help their colleagues. After downloading the complete list of manufacturers from the FDA site, they called each and every one to announce their new group, simply called PMTA Sharing.
Ultimately, the group grew to 1,700 members, including vape businesses all across the country as well as several suppliers that offered to pitch in to help business owners through the PMTA process. The group’s services are completely free; the only fee members pay is for environmental assessments or cover letters and forms created by industry attorneys. Thus far, the PMTA Sharing group has helped more than 200 businesses submit PMTAs for 1.7 million products. But Owen and Wheeler didn’t stop there.
They’re now starting a new nonprofit trade association called American Vapor Manufacturers (AVM) to help small businesses meet the FDA’s onerous scientific testing requirements (see sidebar).
Here’s their story.
Vapor Voice: Tell me more about your vapor businesses. How have your businesses fared over the years?
Owen: I own two brick-and-mortar vapor shops as well as a very small wholesale line. We started in 2013 as a labor of love dedicated to my father whom I lost from lung cancer in 2001. I’ve since gained more friends in my little town of Seguin, Texas, than I can count. We all have one common goal—keep people away from combustible tobacco.
We lost some sales due to the EVALI (e-cigarette or vaping product use-associated lung injury) scare, but thankfully most did not return to smoking, and those who did are slowly returning to vaping. Our retail lobby had to close during the shutdowns in Texas, but I fought extremely hard and was able to at least keep curbside service available. So while we lost a bit of sales, we didn’t have to close. We are grateful, as many others were not so lucky.
Wheeler: I own Jvapes E-liquid, founded in 2011, headquartered in Prescott, Arizona, with stores in Arizona, Colorado and Oklahoma. We also sell online at www.jvapes.com and wholesale at www.wholesalejvapes.com.
Both my husband and I are former smokers who quit with vaping. At the time, vapor products were not widely available in our local community. We started out with a tiny 400-square-foot store, but the response to vapor products was so positive, our business quickly grew into what it is today.
With the exception of late 2019 and misinformation surrounding EVALI, our business has fared very well over the years as people have seen for themselves the effectiveness and positive change from vaping. Our target audience are cigarette smokers, age 49 on average, who have not been able to quit by other means. We learned during our PMTA data collection that 83 percent of our customers have quit smoking entirely.
Have you been involved in vape advocacy?
Owen: I have been involved with advocacy in Texas for the last three years through SFATA [the Smoke Free Alternatives Trade Association] and have also been involved with federal advocacy. I am a member of SFATA, USVA [U.S. Vaping Association], a monthly supporter of CASAA [Consumer Advocates for Smoke-Free Alternatives Association] and am now the vice president of our new company, AVM.
Wheeler: I am the president of Rocky Mountain Smoke Free Alliance, our Colorado trade association. I’m also executive director of the Arizona Smoke Free Business Alliance where I’ve worked on everything from vapor taxes to flavor and public vaping bans to licensing. Prior to starting AVM, I was involved in federal advocacy for PMTA reform where we spent over a year lobbying Health and Human Services [HHS] to have small business PMTA applications accepted.
When and why did you start the PMTA Sharing group?
Owen: I was in the process of doing my own PMTAs. As a 20-year computer engineer, I had an extensive history in document replication and information technology, so I knew I could create the documents I needed. But I also knew that most small businesses did not have the same ability. Most could not even use Microsoft Excel.
I started the PMTA Sharing group on Feb. 17, 2020—a significant date for me because it was my son’s birthday. I lost my son in 2013 just a few weeks before we opened our first brick-and-mortar store. I tried many times to help him quit cigarettes but was never successful.
So after filing our own PMTAs, we created applications for other businesses to create and file their documents and then held Excel training classes. We even did computer support when their machines were unable run the applications, implemented a Microsoft OneDrive for data collaboration, and created training videos and step-by-step instructions.
Amanda Wheeler
Wheeler: I began advocating for a streamlined PMTA process for small businesses. I knew that my business as well as my state’s group members and most independent vapor manufacturers would not have the financial resources to complete the full PMTA process. Without significant changes to the process, only large corporations would survive PMTA regulations.
Does the work keep you up at night?
Owen: Helping the group submit PMTAs was a monumental undertaking, requiring 14[-hour] to 16-hour workdays most of the time. It has taken a toll on both my physical and mental health.
We put as much effort as was needed to make sure no one would be left behind. We’ve received tons of feedback [see testimonials] and gratefulness for our group. They now have hope that their small businesses can continue to help people who have quit and those who want to quit smoking.
It’s an amazing feeling when you’re walking in your town and someone who has smoked for 30-plus years recognizes you and gives you a hug because they can finally live a life away from combustibles. We all feel that same joy with each and every person who puts down cigarettes.
I remember one lady who called me to thank me, explaining that if it wasn’t for our group, she would have no means to support herself and her two-year-old daughter. Of course that makes me happy, but also very angry that the FDA put her in that situation and treated her as if she was a big tobacco business with all the resources necessary to meet their requirements.
Char Owen
The FDA has publicly acknowledged that the costs associated with the PMTA process may be challenging to small businesses and that many would go out of business. That is not how our government is supposed to operate.
What else do people in the vapor industry need to know that would help and motivate them?
Owen: We are optimistic that we will complete this process through sheer determination. While we don’t expect help from the FDA, the HHS has been willing and open to listen to our challenges.
We hope to move the group through to the testing phase and move the membership to the AVM. We have accomplished the monumental task of completing the first part of the process. It will be difficult, but we will move as many small businesses through the entire process as soon as we possibly can.
Our colleagues in the vapor industry need to know that we will not stop fighting for them. We understand what they are facing better than anyone. We are them. There is no one better to fight for small manufacturing than small manufacturers. Our hearts are fully invested in this industry.
Wheeler: I am optimistic. We have a very solid plan and approach, and we have the right scientific, legal and lobbying expertise to get the job done. Many passionate and dedicated individuals are on the AVM board, guiding our organization in the best interests of small businesses.
We are unified and moving together toward the same goal, and I believe we have a recipe for success.
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.
