The Association of Convenience Stores (ACS), a U.K.-based retailers group with more than 33,500 members, has launched a new guide to help retailers with the sale and supply of e-cigarettes and other vaping products.
The guide, which is part of a wider group of Assured Advice guides, covers the regulations that govern the sale and supply of e-cigarettes, retailers’ responsibilities when selling these products, how to ensure packaging and labelling are compliant with the regulations, and advice on how to make sure underage sales do not take place.
Within the guide, ACS recommends retailers use the Challenge25 policy when selling e-cigarettes and vaping products. Challenge 25 is a retailing strategy that encourages anyone who is over 18 but looks under 25 to carry acceptable ID.
As part of an update to Challenge25 materials launched in January, there are new posters, badges and other downloadable materials which refer specifically to e-cigarettes. The new guide is available to download from the ACS website. The Assured Advice guides have the backing of Surrey and Buckinghamshire trading standards departments.
Australian retail representative groups say an overhaul of vaping rules and regulations, alongside a crackdown on the supply of such products to minors, is necessary. The Australian Association of Convenience Stores (AACS), the Master Grocers Association (MGA), and the Australian Lottery and Newsagents Association (ALNA), released a joint statement criticizing the Commonwealth Government’s policy on vapes, claiming it is misguided, poorly designed, and failing the community.
Theo Foukkare, CEO AACS, said although the representative groups disagree with the current prescription model, they do not condone outlets disregarding the law and selling nicotine vaping products to anyone, especially children, according to a story in Convenience and Impulse Retailing.
“We are urging the federal government to consider an overhaul of vaping regulations as a matter of urgency, bringing us into line with the UK and New Zealand where adults – and only adults – can access vapes to help them quit smoking. But in the meantime, urgent enforcement action is needed against those supplying vapes to children,” he said.
The call for a crackdown on the supply of vapes to children comes following widespread reports of use of vapes in Queensland schools. “We would welcome a crackdown on those that are supplying vaping products to children, whether that’s online platforms like Facebook Marketplace or rogue bricks and mortar traders.
“It is clear that not enough is being done to prevent unscrupulous store owners and dodgy online retailers from selling all kinds of vaping products containing mysterious cocktails of ingredients to teens,” he said. The associations also noted an influx of ‘pop-up shops’ selling illicit tobacco products across south east Queensland over the last 18 months, with the majority also selling nicotine vapes. “These are clearly irresponsible retailers who should not be permitted to sell any tobacco of vaping products.”
A proposed solution could be the introduction of a low-cost licensing scheme in Queensland allowing only responsible retailers to deal in tobacco products and would provide a mechanism to shut down and punish those operating outside the law.
E-liquid manufacturers and retailers are still figuring out how to survive the FDA’s erratic regulatory rules.
By Maria Verven
The vaping industry has been in a downward spiral ever since the U.S. Food and Drug Administration began issuing marketing denial orders (MDOs) for electronic nicotine-delivery system (ENDS) products. When a product with a premarket tobacco product application (PMTA) receives an MDO, it must immediately be pulled from store shelves and removed from the market.
The FDA has issued MDOs for nearly all the approximately 6.7 million PMTAs it received. At press time, the agency was still reviewing an estimated 80,000 products, according to Mitch Zeller, director of the FDA’s Center for Tobacco Products (see “From Chance to Change,” page ?). To date, only Phillip Morris International’s IQOS device and Heatsticks and R.J. Reynolds Vapor Co.’s Vuse Solo, along with two tobacco-flavored pod cartridges, have received marketing granted orders.
The FDA also rescinded or was ordered by a court to stay at least 10 MDOs. This has caused a massive amount of confusion in the industry, especially for vape shop owners and vapor distributors who are struggling to keep only legal products on their store shelves.
Complicating matters, many manufacturers have started using synthetic nicotine in their flavored vaping products and products that had otherwise received an MDO. Synthetic nicotine is in a regulatory void as it isn’t yet being regulated at the federal level, although the FDA has stated it may be considered a component of an e-cigarette, which would put synthetic nicotine under its purview.
Many ENDS business owners say that the industry is also still suffering from the 2019 e-cigarette or vaping use-associated lung injury (EVALI) crisis that was wrongly blamed on nicotine vaping products by the FDA and the U.S. Centers for Disease Control and Prevention. It took more than a year for both government entities to state publicly that the true culprits behind EVALI were illegal THC-based vaping products. Vapor business owners must also combat the never-ending amount of misinformation that is broadcast by anti-vaping groups and the mass media.
Business owners, additionally, have major concerns about the current nicotine tax in President Joe Biden’s Build Back Better Act (as of this writing, the bill was still in the Senate). The current version of the nicotine tax applies only to vaping products and nicotine pouches. The government would tax nicotine bought by manufacturers at the rate of $50.33 per 1,810 mg of nicotine—or 2.8 cents/mg if the bill passes with the tax included.
To get a better understanding of what is happening at the street level in the ENDS industry,Vapor Voice asked a group of manufacturers, retailers and industry leaders about their experience with the FDA and how the agency’s regulatory actions have impacted their businesses.
Vapor Voice: How have the FDA’s marketing denial orders affected your business?
Char Owen
Char Owen, vice president of American Vapor Manufacturer:I think the negative PR around vaping has caused sales to stagnate for most manufacturers and vapor shops. It has also increased the smoking rates for the first time in many years. It’s heartbreaking for us to watch people revert to smoking again.
Unfortunately, most of the industry has changed to synthetic. Over 95 percent of our sales are flavored e-liquid, and with others switching, there was no choice but to switch. We only manufacture open system e-liquids in many flavors, all created from nontobacco-derived nicotine. Our biggest selling products have always been fruit flavors.
We are trying to bring in new products, such as botanicals, that can help our customers with cravings but remove nicotine from the equation. For us, it has always been about harm reduction, nothing more.
Schell Hamel, president of The Vapor Bar:Sales were affected long before the MDO was received. This down spiral began with the media attacking all vapor products as killing people when they clearly knew it was illegal THC products and the entire vapor industry handcuffed to Juul’s reputation.
According to the MDO, all products made in our lab were denied. It seemed as if they used a rubber stamp to deny anything submitted, all without review. I heard them doing similarly across the industry, then approving Vuse.
Schell Hamel
Jay Oku, business development at Five Pawns:Hundreds if not thousands of customers have been adversely affected from these misguided PMTA, sale and shipping regulations.
We had been developing products to maximize harm reduction for years and were always fascinated with the cleanliness (free of nitrosamines) and the molecular merits of synthetic nicotine. We switched all of our domestic products to synthetic nicotine mid-2020. We are grateful to have maintained our sales volume through 2021.
We saw an increase in overall sales since making the switch to nontobacco-derived nicotine, yet we’ve also seen a longer sales cycle with new accounts due to the number of MDO products that companies are selling through to make room on their shelves. Despite a slight increase in gross sales, net numbers are relatively flat due to the increase in manufacturing and shipping costs in 2021.
Trent Bohl, owner of EZJ Rolling Equipment and Smokey Joes West:It’s logistically added challenges, and the horizon looks like a tough road ahead. While many Juice manufacturers have shifted gears to get into compliance, the shift toward disposables and the future ban of them will be tough for Vape as a whole.
From recent headlines, it seems the FDA doesn’t seem to play well unless you are Big Tobacco.
Do you think there’s a growing black market of products that are no longer legal?
Owen: I absolutely know there is a growing black market. A quick Twitter or Instagram search proves that. So far, those black market dealers have not been targeted by the FDA. Only registered manufacturers have been on their radar.
We need to support and grow the harm reduction industry instead of growing a black market. For harm reduction to be successful, it must be regulated and supported by our federal bodies. Without their support, we risk creating a dangerous environment for consumers. I have a great amount of respect for the U.K. in recognizing this.
Oku: Every day the black market continues to grow. The attrition of retailers, manufacturers and distributors is being caused by excessive rogue state taxation, the PACT Act that complicates accounting and reporting, and misguided government overreach that results in flavor bans.
Jay Oku
Numerous disposable manufacturers are selling mass quantities of vapor products through back doors. Some of these black market brands push immature non-lab-produced concoctions with cartoons on their labels. These regulations push people who benefit from tobacco harm reduction technology to inferior products and even worse, back to cigarettes.
Bohl: I have stores in New Mexico, and in Mexico, which outright banned vapes. The black market is huge in Mexico; any low-dollar mercado or corner OXXO seems to have them. The USA will follow suit I suspect, given the demand for vape. When one reflects on how the black market vape cannabis carts disrupted the industry and damaged lives and harmed the reputation of the industry, it’s just going to be that times 10.
What has been your experience with FDA inspections?
Owen: Personally, I had a good inspector, but it truly is the luck of the draw, and it hasn’t been the case for everyone. In my case, he was only there to find proof of manufacturing of any MDO products, and his paperwork was written to support that. My batching logs were not reviewed nor my manufacturing practices.
One member had their inspector show up at 7 p.m. on Halloween. Another member had the FDA come to her home and photograph her home office instead of her manufacturing establishment. He then took photographs of her neighbor’s home. There were instances where the inspector pressured staff when owners or managers were not present to make MDO’d products and then sent warning letters.
The American Vapor Manufacturer is usually involved in a warning letter meeting every couple of weeks. We even help nonmembers with those. It’s a very tricky process, and it’s good to have someone there who can be objective and help both the FDA and the manufacturer resolve the matter.
Trent Bohl
Bohl: I haven’t seen them from this industry perspective, but from the agricultural side and medical marijuana side, one thought comes to mind: brutal for some, not bad for others.
What ultimately will result from these MDOs?
Owen: What the FDA did was extremely arbitrary and capricious. I feel that anyone who can afford to challenge them in court will be able to prove that. My concern is for all the small businesses that cannot afford to do that.
If something doesn’t change, you will see manufacturers close and smoking rates rise. In almost all industries except vaping, small business is celebrated. This is a shame because those small shops are the ones with the hearts for harm reduction.
To lose those small businesses would be a devastating blow to the effort in moving this country to becoming smoke-free.
Oku: I am optimistic that the FDA will reconsider or rescind MDOs and revise their outdated ambiguous and debilitatingly cost-prohibitive PMTA process.
Since 2016, FDA action against the industry has resulted in warning letters and fines to those breaking the rules, yet there’s little to no enforcement. Many MDO products are being sold since there was an enormous glut of inventory in preparation for the September 2021 ruling.
There will invariably be an increase in synthetic nicotine products until those, too, are regulated out of the market.
Congress has been slipping anti-vaping bills into much larger spending packages, such as during the 2019 holiday break deep in the Omnibus Spending Bill. These bills implement devastating regulations that put our industry and the health of our customers in jeopardy.
Bohl: The goal stated by the FDA 15 years back was the end of combustibles. Vape could have helped that. I am buying a decent stock, fearing the day one more freedom is taken away in the name of safety.
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.
The vapor industry has experienced growth after Covid-19 lockdowns sent many back to cigarettes.
By Timothy S. Donahue
After declines in 2019 and 2020, the vapor industry has grown 10-15 percent in 2021. Don Burke, senior vice president of Management Science Associates, speaking on a panel during the first day of TMA’s “From Chance to Change” webinar on No. 17, said that he expects the industry to continue its growth into 2022.
“Vapor cartridges were up by 18.5 percent. Over … 2019 going into 2020, we were seeing some declines in vapor. One of the things to keep in mind is at the end of 2019 was that illegal THC vaping [EVALI] crisis,” said Burke. “That turned a lot of people off of vapor, even though it was only an illegal product that caused the issues. No legitimate product caused any problems. It’s about a year-and-a-half now since that occurred … because of that, consumers are starting to forget, vapor is coming back.”
Burke said disposables, because they’re allowed to have flavors, were up 28.9 percent and all-in-one kit volumes are growing (up 2.9 percent). He said vape shop and tobacco outlet sales are also on the rise after many closed or limited hours due to the Covid pandemic. He said his research includes approximately 300,000 stores. It does not include vape shop sales.
“We’re looking at distributor to shipment retail data. In many cases, that’s important because a lot of the convenience stores and some tobacco outlets do not collect their data and, therefore it’s very difficult to get a clean read,” he said. “The convenience channel – because they were considered essential businesses in most parts of the US – managed to survive the pandemic and in fact, now are a larger percentage of stores in the US. Also, 71 percent of tobacco volume goes through convenience stores.”
Burke said pods for closed-pod systems (cartridges) are up 6 percent in the most recent quarter. He said that during the third quarter of 2021 disposables continue to have strong sales, rising by 21 percent and he expects those trends to continue. E-liquid distribution fell by 49.6 percent through 2020 and into current 2021 and sales fell nearly 15 percent, mostly due to recent regulatory action in the US.
Burke also said cannabis sales grew significantly during 2020 and into 2021, but he didn’t elaborate.
For more on this session from TMA 2021 read the next issue of Vapor Voice coming in mid-December.
The parent company behind the 88Vape brand, Supreme, announced revenues rose 36 percent as U.K. smokers attempted to quit smoking combustible cigarettes during Covid-19 lockdowns. The company’s total revenue was up 33 per cent at £122.3 million ($166 million) as of March 31, 2021. This is up from £92.3 million in same period of 2020.
Gross profits jumped to £33 million, which helped the company to slash its debt by 64 percent, ending the financial year with a just £7.6 million burden compared with £21.3 million in 2020, according to City A.M. The strongest sales growth was found in vaping and its sports nutrition and wellness branch, the company said in a statement.
Supreme’s partnership with convenience store chain McColl’s to supply shops with vaping products marked the company’s growth in the vaping sphere. The rollout of 88Vape products was completed in March 2021, adding an additional 1,180 retail convenience stores nationwide to Supreme’s portfolio.
“There are clear and very exciting opportunities that exist for our business, particularly in categories like sports nutrition and wellness and vaping, and I look forward to providing further updates in due course as we capitalise on these,” Supreme CEO Sandy Chadha said. “We have made a good start to the current financial year and look to the future with confidence.”
More than 400 owners of independent vape shops are urging FedEx to reverse its rule banning the shipment of vapor products. A letter drafted by Greg Conley, president of the American Vaping Association (AVA), to FedEx Chairman and CEO Fredrick Smith, states that the shipping ban is a “misguided and unnecessary” policy that prevents combustible smokers from access to lower-risk products that could help them quit smoking. The signatories include representatives from every facet of the vaping industry.
Credit: John R Perry
“It also threatens thousands of small businesses like ours, which rely on common carriers like FedEx to ship the lifesaving products we stock every day,” the letter states. “Please reconsider this disastrous decision, which will perpetuate another generation of smoking-related deaths – especially among underprivileged communities.”
The letter also accuses FedEx of continuing to ship vapor products for a select few large vaping industry manufacturers. The letter claims that FedEx is “picking winners and losers” in the vaping industry, calling the practice discriminatory against small businesses and raises serious antitrust concerns.
“In addition to the hypocrisy, antitrust concerns, and blatant negative impact on marginalized communities, we can’t help but also notice an inconsistency in shipment policies of companies like yours. For example, it struck us as ironic that FedEx banned the shipment of our legal, lifesaving, and regulated products, yet they are failing to identify and stop the company’s own shipment of illegal pharmaceuticals – products that have proven to have disastrous consequences on our country,” the letter states. “Also, while we as a group do not express a position on the Second Amendment, it does seem odd that you continue to ship firearms yet are prohibiting us from stocking our store shelves with legal products.”
The U.S. Congress imposed new limitations on the shipment of electronic nicotine delivery systems (ENDS) through the United States Postal Service (USPS) by including ENDS products in an updated provision to the 2009 Prevent All Cigarette Trafficking (PACT) Act. ENDS would now be subject to the same shipping laws as combustible tobacco.
The PACT Act has historically exempted business-to-business deliveries from the USPS ban. Specifically, the USPS ban does not extend to tobacco products mailed only for business purposes between legally operating businesses that have all applicable state and federal government licenses or permits and are engaged in tobacco product manufacturing, distribution, wholesale, export, import, testing, investigation or research.
While the legislation was geared toward nicotine vaping products, the law is so broadly defined that cannabis businesses must also comply. This means marijuana and CBD companies selling, manufacturing or shipping vaporizers or associated parts across state lines are required to comply with the provisions of the PACT Act.
FedEx regulations are harsher than those mandated by Congress. The company has prohibited the shipment of all vaping products to both businesses and adult consumers. The letter states that the FedEx regulations would have a greater impact on small businesses than on large companies who have sophisticated distribution networks.
“Because most vape retailers are small mom-and-pop shops, they do not have the ability to build in-house distribution networks like those utilized by big tobacco companies,” the letter states. “As a result, the consequences of this decision are largely being borne by small, independent vape shops and our customers. We rely on companies like FedEx to stock our store shelves and meet customer demand. These restrictions will inevitably result in unintended, but severe, consequences for us, our businesses, our families, former cigarette smokers, and those trying to quit smoking around the country.”
A central Georgia vape shop is the latest business to be raided by authorities in relation to the sale of delta-8 THC products . Two store employees were charged as part of the crackdown. The proliferation of delta-8-THC products being sold outside dispensaries has prompted a patchwork of enforcement reactions and crackdowns in states with varied policies on cannabis, from South Carolina to Oregon.
Credit: Fotokitas
The Newnan Times-Herald reports that Coweta County authorities were tipped off that the store called Tobacco & Vapor was illegally selling THC products. An undercover officer bought gummies from the store that failed THC testing. A search warrant was later executed and authorities seized 554 suspected delta-8-THC edibles and 616 suspected delta-8-THC products other than edibles.
Two of the store’s employees were charged with drug crimes including narcotics possession. Delta-8-THC is a molecule that exists rarely in the cannabis plant but can be easily synthesized from cannabinoids extracted from legal hemp, prompting confusion over its legality. Delta-8 is not specifically banned in Georgia. Delta-8 will also provide a positive result in testing as current tests used by law enforcement cannot differentiate between delta-8-THC and delta-9-THC (which is illegal federally and in Georgia).
While hemp itself is federally legal (at or less than 0.3 percent THC), each state has different laws and restrictions regarding byproducts derived from hemp, including Delta-8. No products containing Delta-8 have been tested by the U.S. Food and Drug Administration or are FDA-approved. The 2018 Farm Bill, which legalized hemp and its byproducts, explicitly excluded delta-9-THC, also known as simply THC, the compound that produces the typical marijuana “high.” But because of the bill’s loophole, delta-8 seemingly remains legal.
Twelve states have completely banned delta-8 sales specifically. Those states include Alaska, Arkansas, Arizona, Colorado, Delaware, Kentucky, Idaho, Iowa, Mississippi, Montana, Rhode Island and Utah. New York has a proposed rule to ban Delta-8 products, which is under a comment period until July 19. California, Oregon, Vermont and Washington are in the process of enacting regulations for delta-8 products. Several other states are also considering bans. Florida’s language concerning delta-8, however, allows for the legal sale of delta-8 in that state.
In order to prosecute a business or individual for selling or possessing delta-8 products, the government has to prove that you knowingly possessed or distributed a schedule I controlled substance, specifically THC or marijuana. Georgia officials have been cracking down on delta-8 sales over the last year. In May, local law enforcement in the metro-Atlanta area executed search warrants at several stores and a warehouse belonging to a small business owner who operates a chain of vape shops. Police seized several products that allegedly contain delta-8.
The U.S. Food and Drug Administration (FDA) continues to be adamant about removing illegal e-liquids from the market. On Tuesday, the regulatory agency issued two more warning letters for companies selling e-liquids without having filed a premarket tobacco product application (PMTA). The total now stands at 115 companies that have received notice since Jan.1 of this year.
Credit: Hurricane Hank
Adirondack Juice d/b/a Adirondack Vapor & Co. and Blue Eyed Vapor (BEV) received the letters from the FDA on May 14, however the agency didn’t post the letters to its website until May 25. Adirondack and BEV both were accused of selling or marketing multiple e-liquid flavors. The companies have 5,800 and 20 products registered with the FDA, respectively.
Last week, the FDA released its list of products that are legal for sale in the U.S. A total of 360 companies filed more than 6 million PMTAs. The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed.
The FDA often only lists a few products that a company is selling as illegal in the letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
In an email to subscribers, My Freedom Smokes (MFS) announced Monday that it would be closing its doors due to the current regulatory climate of the vaping industry. In business since 2008, MFS has been a longtime staple in the business of vaping.
Credit: MFS
“Due to ongoing compliance requirements and new regulations of the e-cig industry, it has become nearly impossible for a shop like MFS to function without turning into something completely different,” the email states. “This was never the goal for MFS as we always prided ourselves on being able to offer customized products and service at great prices. So unfortunately, we will be shutting our doors at the end of the month.”
The MFS website states that the company is run by vapers, for vapers and is a one-stop website for everything from e-cig starter kits and cheap e-liquids to the most advanced cloud competition ready box mods and RDAs available. Based out of Charlotte, North Carolina, MFS was founded by Chris Yelton.
The U.S. Food and Drug Administration (FDA) issued seven more warning letters to vapor companies for selling illegal products. The total now stands at 111 for the number of warning letters the regulatory agency has issued to vapor companies in 2021. The FDA accuses the companies of selling vapor products without having submitted a premarket tobacco product application (PMTA) by Sept. 9, 2020.
Credit: Trend Objects
The companies all received their letters on May 7, however the FDA didn’t post the letters on its website until May 18. The companies receiving letters include:
Nicotine Nirvana, which has over 50 products registered with the FDA;
FF Vapors, which has over 257,000 registered products with the FDA;
JP & SN Enterprises Inc. d/b/a eCigs International, which has over 4,500 products listed with the FDA;
The Iron Crow, which has 400 products listed with the FDA;
Sema International, which has over 500 products listed with the FDA;
Central Iowa Electronic Cigarettes, which has over 3,400 products listed with the FDA;
High Voltage Vaporz, which has over 600 products registered with the FDA.
The FDA often only lists a few products that a company is selling as illegal in the letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
The Association of Convenience Stores (ACS), a U.K.-based retailers group with more than 33,500 members, has launched a new guide to help retailers with the sale and supply of e-cigarettes and other vaping products.
