In a new op-ed published in the HPHR Journal, The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) Director Brian King writes about what the FDA is calling “health equity.” However, missing from the editorial is any response to either the recent Reagan-Udall Review or the findings of a recent investigation into the CTP by the U.S. Office of Special Counsel (OSC).
In the editorial, King writes that “there is no safe tobacco product; however, products do exist on a continuum of risk, with combustible products being responsible for the overwhelming burden of disease and death from tobacco use.”
He also states that “science is central to informing tobacco regulatory decision making,” noting that he is “a scientist by training” and is “particularly attuned to the vital importance of ensuring we gather and use the best scientific evidence available.”
In writing about his “vision” for the CTP, King does not address memos recently submitted to the U.S. Court of Appeals for the Third Circuit that show King reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers.
King also failed to address the conclusion a recent investigation conducted by the OSC that found the CTP had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns. The OSC sent a letter to the U.S. President and Congress outlining the findings.
In the op-ed, King claims that the CTP “strive[s] to engage with a wide array of stakeholders, including those that work with and represent individuals and communities who are disproportionately impacted by tobacco use, to facilitate an open exchange of opinion from diverse groups.”
However, when the Reagan-Udall Foundation submitted its recommendations to Robert Califf , commissioner of the FDA, in December, the report concluded that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the CTP, particularly with respect to tobacco harm reduction and the requirements needed to navigate the premarket tobacco product application (PMTA) process.
King then goes on to state that in the 13 years since the landmark Tobacco Control Act (TCA) was signed into law, CTP has done “significant work to effectively research, regulate, and educate in a complex and rapidly changing tobacco product landscape.”
However, the Reagan-Udall report stated that the CTP needs to make “process improvements and identify and address the policy and scientific questions” that underpin its regulatory framework. The review concluded that CTP’s implementation of its PMTA program also has been affected by “changes in leadership and administrations.”
Since the implementation of the TCA, CTP has operated under seven different commissioners in three different administrations, and recently hired its third CTP director, King. In October, numerous comments from staffers of the CTP for the Reagan-Udall assessment of the performance of the FDA’s tobacco center claimed the regulatory agency is in a state of disarray and being influenced by outside forces, not scientific research.
One comment stated that reviewers of PMTAs in the CTP’s Office of Science (OS) lack the autonomy to exercise “best scientific practices” in their reviews of PMTAs.
“Scientific disagreement is frowned upon, if not entirely suppressed, and punished through various backhanded methods (e.g., lack of assignments, projects, and other opportunities that are needed for career development/promotion),” the comment states. “In some divisions (e.g., Division of Nonclinical Science [DNCS]), leadership pushes a ‘gotta get em’ mentality onto staff, which is unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.”
The Netherlands banned flavored e-cigarettes effective Jan. 1, reports The Brussels Times. Companies have until Oct. 1 to remove the flavored products from shelves; retailers can sell their current stock until that date, but new flavors may not be marketed.
Belgium plans to tighten vaping regulation as well, according to Federal Health Minister Frank Vandenbroucke.
“E-cigarettes contain some 1,800 different products of which we are far from knowing all the health consequences,” he said. “Maybe some people will switch from regular cigarettes to e-cigarettes, but maybe by using e-cigarettes, people will just end up smoking regular cigarettes.”
A ban on flavors is not currently planned in Belgium, but a royal decree will soon be published imposing more restrictions on the sale of flavored e-cigarettes. “No more trendy names will be allowed to be given to those flavors, and lights will no longer be allowed on e-cigarettes either,” said Vandenbroucke.
There will be a six-month transition period for the industry to adapt to the new rules and another six-month period to sell current stock.
The open-system vaping system manufacturer Vaporesso announced that it has been registered as an authorized e-cigarette brand by the Ministry of Industry and Advanced Technology (MoIAT) of the United Arab Emirates (UAE).
The move makes the subsidiary of Smoore International, the world’s largest vaping manufacturer, the first open-system vaping device brand to obtain the ability to market and sell its e-cigarettes in the UAE.
“We are thrilled by the MoIAT’s decision to grant our flagship products the marketing and sales authorization, this has boosted our confidence in obtaining the approval for other seven premium products, including Luxe X and GEN PT SERIES, that are in the process of application,” said a spokeperson for Vaporesso’s Middle East team.
The UAE has enforced laws that aim to regulate all nicotine-containing components used in e-cigarettes, refill packages, e-liquids, and tobacco products sold in the country.
The regulations demand that the manufacturers and companies of vaping devices must meet Emirates Authority for Standardization & Metrology (ESMA) standards, which set out strict quality and safety requirements for e-cigarettes and related products, before placing them on the market.
“The initial approval by the MoIAT, which allows the company to establish legal sales channels, both online and offline, for Vaporesso’s Xros Nano, Xros Mini, Xros 2, and ZERO S across the UAE, is the testimony to the company’s commitment to offering market-leading vaping products with unmatched quality and functionality, allowing the global vapers to enjoy the fun and flavors unique in Vaporesso’s products,” a press release states. “The market authorization also marks a significant step forward in its effort to further expand its presence in the Middle East.”
The CBD brand Lifted Made, a subsidiary of LFTD Partners, has entered into an agreement with its third party disposable vape device manufacturer that will allow Lifted Made to recoup just over $1 million of the losses associated with clogged disposable vape devices.
The defective devices were recognized by Lifted Made during Q3 2022.
The unnamed overseas disposable vape device manufacturer has agreed to write-off $630,000 currently owed to it by Lifted Made for previously delivered disposable vape devices, and to give credits to Lifted Made against future purchases totaling $370,047 at the rate of $185,023 for each of years 2023 and 2024, according to a press release.
Nick Warrender, CEO of Lifted Made, and vice chairman and COO of LFTD Partners, said that the company had an excellent relationship with the manufacturer of its disposable vape devices.
“Their willingness to share the losses we experienced during Q3 due to the discontinued clogged 2mL vape devices has really demonstrated to us what a good partner they are. We look forward to a very bright future with them,” Warrender said. “The new, award-winning 3mL disposable vape devices have been really well received by our customers. We are extremely excited about 2023 and all the things we have in the pipeline going into the new year.”
A new Philip Morris Limited (PML) funded study has found that UK retailers can expect “affordability” to be the deciding factor for adult smokers trying to make the switch to vaping products in 2023.
In its third consecutive year of running the survey for PML, KAM Media asked 250 UK convenience stores what factors they believe will be important for adult smokers switching to smoke-free alternatives at the start of the new year and throughout 2023, according to Better Retailing.
When asked what customers will look for when choosing a smoke-free alternative, retailers prioritized price with over half (57 percent) agreeing that customers would select the cheapest products available, followed by those products offering the best overall value for money (18 percent).
Smoke-free alternatives that offered the widest taste range available (10 percent) and those offering convenience and ease (5 percent) ranked third and fourth, respectively.
Asked what may prevent smokers from choosing a smoke-free product this year, price again was a factor with six in 10 retailers concerned that alternatives may be too expensive.
Additionally, 56 percent said that they stock heat-not-burn products.
Kate O’Dowd, head of commercial planning at PML in the UK and Ireland, said that the average price of combustible cigarettes now £12.73 per pack and data shows that retailers are stocking a range of smoke-free alternatives that are affordable.
“2023 will be the year of the multi-category, whereby retailers should offer affordable smoke-free choices that don’t compromise on taste, quality, or satisfaction for the user,” she said.
ALD’s Boom Max is a disposable e-cigarette that offers performance, reliability, convenience and value.
By Mike Huml
The Boom Max from ALD is an oversized, lightweight, disposable e-cigarette that offers performance, reliability, convenience and value. It’s the perfect vaping companion for longer outings without the added heft of similar devices.
The Boom Max has a lot going for it despite its simplicity. For starters, it’s diameter is slightly larger than that of a U.S. quarter coin, but it remains lightweight due to a smaller battery. It holds 8 mL of e-liquid but is only equipped with a 400 mAh battery. However, it is rechargeable via a USB-C cable, and this is actually a better scenario than having a larger battery with a smaller e-liquid reserve.
Consider this: Most disposable vapor devices end up sitting on a shelf for a good amount of time and most battery-operated devices don’t ship with a fully charged battery. That means whether by design or by happenstance, the battery in a disposable will deplete faster than the e-liquid, and many disposables are not rechargeable. As a battery sits uncharged and unused, its remaining capacity depletes. So, many unlucky customers end up buying a disposable with a nearly dead battery that cannot be charged. With a USB-C charging port and a modest battery, the Boom Max can be recharged in about 15 minutes, ensuring that the liquid can be fully used up with no wasted juice or money.
A smaller battery is also lighter, and despite the size of the Boom Max, it remains extremely lightweight and manageable with a large e-liquid reservoir. That makes the Boom Max the perfect portable vape, and in this day and age, many people have access to a charger for their mobile devices. With such chargers almost always available at a moment’s notice, the pros of a smaller battery far outweigh the cons and demonstrate good judgment on the part of ALD’s designers.
The performance of the Boom Max is fantastic all around. With a draw-activated switch and a tapered mouthpiece, the Boom Max feels comfortable and easy to use. It never feels like you’re pulling and pulling for anemic vapor production. The built-in 1 ohm heating element fires at 11 watts, and that’s just about perfect for mouth-to-lung vaping. The vapor is warm but not overbearing or harsh, and the flavor is clean and refreshing. There’s no spitback, gurgling or leaking at all, and the entire experience is satisfying and effortless.
Each flavor from ALD, while simple, is infused with a touch of menthol, which really adds to the crisp and refreshing sensation in each drag. While some vapers may not be a fan of menthol, keep in mind that menthol is not mint. Mint has several varieties of specific flavors, but menthol in itself is flavorless. It only provides a cooling sensation, much like capsaicin adds the heat to spicy foods but has no distinct flavor on its own.
As such, menthol pairs perfectly with fruit and beverage flavors as these are generally consumed cold. As you’re vaping Blueberry Ice, for example, you’re not tasting minty blueberries. Instead, you’re tasting crisp, fresh blueberries. Out of all the flavors sampled from ALD, none of them missed the mark. Naturally, each person has their own flavor preferences, but each flavor is accurate to the description.
Many fans of disposable vapes, particularly the large disposables advertising 3,000 puffs or more, have complained of these devices only lasting a day or two before the “massive” battery dies while they were expecting to get a week of use. Sometimes a simple solution is the best solution, as demonstrated by the Boom Max. Why offer a battery that can provide 3,000 puffs that never comes fully charged when you can cut the weight almost in half with a smaller battery and make it rechargeable? This is the main advantage of the Boom Max over the competition.
The Boom Max looks simple and unassuming, performs great and holds a lot of liquid—but so do many other devices. Many of those devices fall short in the convenience department, however, since customers pay a premium, expecting to use their device for a week but only getting a day or two. As the playing field levels out in terms of vape quality, convenience will become the deciding factor for many vapers, and the Boom Max is the epitome of convenience.
The lightweight nature and foolproof operation of the Boom Max make it an easy sell for anyone just wanting to pick up a disposable, crack open the box and start vaping. It’s weightless in a pocket or pocketbook, comes with 8 mL of great-tasting liquid and can be recharged as many times as necessary. Overall, the Boom Max is exactly what most disposable vapers are looking for as a daily driver.
It was more adversity for the vapor industry as many companies are still waiting on PMTA results.
By VV Staff
The year 2022 was tough on the vaping industry. While several countries banned or began heavily regulating vaping products, the United States banning most premarket tobacco product applications (PMTAs) probably had the greatest impact on the industry. Industry analysts estimate that 50 percent to 60 percent of vaping-related businesses in the U.S. had closed by late 2022 after the Food and Drug Administration began issuing mass marketing denial orders (MDOs) for nearly all the 6.5 million PMTAs submitted by 500 companies in 2021.
Companies had until May 14 to submit a PMTA to the FDA to keep their synthetic nicotine products on the market. Companies that failed to secure authorization were supposed to pull their products from the market by July 13. However, the regulatory agency has been using some discretion in its enforcement of synthetic nicotine products as it continues to review both tobacco and nontobacco PMTAs.
One of the biggest stories of the year is the rise of R.J. Reynolds Vapor Co.’s Vuse e-cigarettes, which took over as U.S. market leader from Juul in 2022. Juul’s fall came after the FDA issued an MDO for Juul Labs’ PMTAs on June 23. On July 5, the FDA stayed the MDO, announcing that it would review the decision after determining “there are scientific issues unique to this application that warrant additional review.” By October, Vuse had expanded its market share lead over Juul to 12 percent in the Nielsen analysis of convenience store data.
January
Credit: Selen Geren
Thirty U.S. states plus the District of Columbia kick off the new year on Jan. 1 with taxes on vaping products. Filipino vapers appeal to Duterte to sign a bill that would legalize vaping. The U.S. Congress begins review the Clarifying Authority Over Nicotine Act of 2021—a bipartisan bill designed to give the FDA the authority to regulate synthetic nicotine products just as it regulates nicotine products made or derived from tobacco. South Africa begins considering taxes on hardware and e-liquids, with high-nicotine products getting higher rates. Malaysia postpones implementing a tax that would have more than doubled the retail prices of e-liquid bottles for open systems. FEELM Air launches in the U.K.
February
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Triton Distribution makes opening arguments in its battle with the FDA over how the regulatory agency conducted its PMTA reviews. A court of appeals stays Bidi Vapor’s MDO. Judges grant stays to Diamond Vapor, Johnny Copper and Vapor Unlimited in MDO lawsuits. The U.S. Senate confirms FDA Commissioner Robert Califf. Philip Morris International announces its plans to bypass an import ban by manufacturing IQOS in U.S. The FDA posts its first warning letter for vaping hardware products. The letter is issued to China-based Sigelei Vapor for two coil brands. The U.S. International Trade Commission (ITC) issues a general exclusion order that bans the importation of any unauthorized cartridges compatible with the Juul vaping system that infringe Juul Labs’ patents. The FDA submits its proposal to ban menthol to the Office of Management and Budget for review.
March
Credit: V. Chalup
The Swedish government proposes a ban on nontobacco-flavored vaping devices, including menthol. The National Youth Tobacco Survey (NYTS) 2021 finds youth cigarette smoking rates in the U.S. at historically low levels, with just 1.9 percent of high school students reporting current use of cigarettes. U.S. President Joe Biden signs a bill giving the FDA power over synthetic nicotine. Companies have 60 days to file PMTAs. China announces e-cigarette regulations, including flavor bans and compliance of all products produced for export with the regulations and laws in the destination country. If a country does not regulate e-cigarettes, China’s rules for vaping products would apply to those exports, including bans on flavors and synthetic nicotine. Myth of a gateway from vaping to smoking is debunked … again. FDA issues marketing orders to eight Logic brand vaping products.
April
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Mitch Zeller retires as director of the FDA’s Center for Tobacco Products (CTP). Vuse surpassed Juul to become the No. 1 e-cigarette brand in the U.S., according to Nielsen. Smoore International, the largest vaping company in the world, reports 2021 annual revenue of $2.16 billion. Canada proposes the first federal nicotine-only vape tax. China releases its rules listing the requirements for design, chemical compounds and the mechanics for manufacturing e-cigarettes. New York Stock Exchange rules force RLX Technology co-founder Kate Wang to resign from RLX committees. Fontem Ventures, a subsidiary of Imperial Brands, receives an MDO for its MyBlu products. Judge orders the FDA to give PMTA updates every 90 days for products with at least a 2 percent market share. Juul begins settling marketing lawsuits with several states. Hong Kong’s ban on vaping products makes it illegal to use or carry an activated vaping device in no-smoking areas. The FDA publishes rules for the menthol ban. Several Njoy vaping products receive marketing orders.
May
For the first time, the FDA issues warning letters for marketing products containing delta-8 THC. Several R.J. Reynolds Vapor Co. Vuse branded e-cigarette products receive marketing orders, including six new tobacco products, through the PMTA pathway. The San Diego City Council passes an ordinance for the second time banning vape flavors, and it’s effective Jan. 1, 2023. In its first status report, the FDA states that it expects to have resolved 63 percent of PMTAs set out in its original priority by June 30. Altria Client Services pays $100.5 million for assets and properties used in Poda Holdings’ business of developing, manufacturing and marketing multi-substrate heated capsule technology. FEELM wins four Red Dot Awards, an international competition for product, communication and concept design. Longtime Centers for Disease Control and Prevention alumnus Brian King succeeds Mitch Zeller at the FDA’s Center for Tobacco Products (CTP).
June
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Mexico bans all vaping and heated-tobacco products. Mexican President Andres Manuel Lopez Obrador signs a decree that outlaws the sale of e-cigarettes in line with continuing the government’s ongoing anti-vaping policy. Heated-tobacco products are not exempt from the ban as previously reported that they would. Njoy Daily disposables get marketing orders; however, the FDA issued MDOs to Njoy for multiple other flavored Daily e-cigarette products. A study finds e-cigarette or vaping product use-associated lung injury (EVALI) and Covid-19 boosted misinformation on vaping. A federal court jury finds R.J. Reynolds’ Vuse Solo and Alto devices infringe two Philip Morris patents. Zinwi is among the first to get a green light to produce e-liquids under China’s new regulatory framework. Juul receives an MDO, which is subsequently stayed in court. The FDA places Juul’s application back under review. EU lawmakers propose a flavor ban for heated-tobacco products.
July
PMI opens its flagship IQOS store in South Africa. Confronted with rising prices for batteries, engineers in Ukraine begin using power cells from vapes to power drones. A U.S. administrative tribunal invalidates two claims in an R.J. Reynolds vaping patent. Panama bans the sale and import of vapes, joining more than a dozen Latin American and Caribbean countries with such restrictions. Brazil also maintains its ban on vaping products. The FDA issues first warning letters for synthetic products. Juul Labs begins exploring financing options to avoid bankruptcy. Juul quarterly revenues drop 23 percent. FDA Commissioner Robert Califf says the nonprofit Reagan-Udall Foundation—a nongovernmental research group created by Congress to support the FDA’s work—will convene experts to evaluate the CTP within 60 business days. Matt Holman, the director of the CTP’s Office of Science, announces he is stepping down. Altria reduces the value of its investment in Juul Labs to $1.3 billion, a nearly 70 percent loss of its original $12.8 billion evaluation. The Philippine president allows a bill that legalizes e-cigarettes to lapse into law.
August
Credit: Savvapanf Photo
CTP Director Brian King states that the agency is “making significant progress” in reviewing synthetic nicotine applications. Chinese car maker BYD gets a vape production permit and its stock price soars. Monroe County becomes the first in New York state to accept e-cigarettes and e-liquids for safe disposal. VPR Brands receives an FDA warning letter for its nicotine gummies. FEELM, one of the largest and most influential e-cigarette brands, earns its production license in China. The U.S. Court of Appeals for the Eleventh Circuit grants petitions for review filed by Bidi Vapor, Diamond Vapor and four other companies challenging the FDA’s rejection of their e-cigarette applications in a 2-1 decision. Great Britain reports record levels of vaping in a report that found 2.4 million vapers are ex-smokers. Vuse’s market grows from 37.4 percent to 39 percent, with Juul declining from 30.7 percent to 29.4 percent. A U.S. appeals court denies a petition to review the FDA’s marketing denial order to Illinois-based e-liquid manufacturer Gripum.
September
Credit: Kristina Blokhin
Juul Labs agrees to pay nearly $440 million to settle a two-year investigation by 33 U.S. states into the marketing of its vaping products, which critics have blamed for sparking a surge in underage vaping. A jury in the U.S. District Court for the Middle District of North Carolina awards Altria Client Services more than $95 million after finding that Reynolds Vapor Co.’s Vuse Alto e-vapor product infringes three Altria patents. The FDA states it sent more than 44 warning letters to manufacturers and over 300 warning letters to retailers for violations relating to nontobacco nicotine. Alaska’s governor vetoes an age-to-vape bill because it also included the implementation of a tax on e-cigarettes. Nicaragua bans the import of e-cigarette products. Altria Group exercises its option to be released from its noncompete deal with Juul Labs. Maine backs out of a Juul settlement claiming it would cancel out school district suits.
October
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The Colorado Supreme Court rules that the Colorado attorney general’s office’s lawsuit against electronic cigarette manufacturer Juul Labs cannot include four of the company’s executives. The FDA announces that as of Oct. 7, it has issued refuse to accept (RTA) letters for more than 889,000 synthetic nicotine product applications that did not meet the criteria for acceptance. Magellan CEO Jon Glauser says the FDA acknowledged in writing that it had “erred in failing to inform the company” about its MDOs before announcing the move publicly. An analysis suggests that over 90 percent of FDA warning letters were sent to small online retailers. For the first time, the U.S. Department of Justice files requests for permanent injunctions in federal district courts against six e-cigarette manufacturers on behalf of the FDA. Charlotte’s Web signs the first CBD licensing deal with Major League Baseball. A health regulatory body for Mexico’s government says its scientists have developed a new methodology to analyze the aerosols in electronic nicotine-delivery systems because “no one else has come up with one.” PMI reaches a deal with Altria Group to pay nearly $2.7 billion for exclusive U.S. commercialization rights to IQOS. FDA staff comments for the Reagan-Udall assessment of the performance of the CTP suggest the regulatory agency is in a state of disarray and being influenced by outside forces not scientific research. The FDA issues its first menthol MDOs for the Logic Pro Menthol E-Liquid Package and the Logic Power Menthol E-Liquid Package.
November
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China’s Ministry of Finance imposes a consumption tax on e-cigarettes sold in China from Nov. 1. China bans celebrities from endorsing vaping products. Logic is granted a temporary stay of the FDA’s menthol MDO. The EU publishes a directive officially banning flavors in heated-tobacco products throughout the union. Magellan sues the FDA and the U.S. Department of Health and Human Services, claiming the agencies violated the Administrative Procedure Act in the PMTA reviews. Maryland and Missouri become the 20th and 21st states to legalize marijuana for adult recreational use, but cannabis reform efforts meet defeat in Arkansas, North Dakota and South Dakota. Vuse’s market share rises from 40 percent in the previous report to 40.4 percent compared with Juul declining from 28 percent to 27.6 percent in Nielson’s four-week period ending Nov. 5. The European Union proposes a bloc-wide vaping tax policy as part of a shake-up of levies on the tobacco industry.
December
Credit: Sharaf Maksumov
Macau’s blanket ban on vaping products goes into effect. The rules prevent people from carrying e-cigarettes across the border with fines up to mop20,000 ($2,505). The Netherlands bans all e-cigarette flavors except tobacco effective Oct. 1, 2023. U.S. President Joe Biden officially signs the first piece of standalone federal cannabis reform. The Marijuana and Cannabidiol Research Expansion Act is aimed at providing federal support to facilitate research of cannabis and its potential health benefits. Juul Labs settles more than 5,000 lawsuits covering more than 10,000 individual plaintiffs. Financial terms of the deal were not disclosed. Costa Rica for the first time gives a company authorization to grow and process hemp. Canada’s Minister of Mental Health and Addictions and Associate Minister of Health released a report finding that vaping products offer the 3.8 million Canadians who smoke a less harmful source of nicotine than tobacco products, and do help people to stop smoking. The Reagan-Udall Foundation submitted its recommendations to the commissioner of the FDA. The report concludes that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the Center for Tobacco Products (CTP), particularly with respect to tobacco harm reduction and the requirements needed to navigate the PMTA process. A separate investigation, conducted by the U.S. Office of Special Counsel (OSC) after a whistleblower complaint, found the CTP had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns.
Looking ahead
It’s impossible to predict what the vaping industry will look like by the end of 2023. The U.S. will probably see a decline in product variety because the FDA is unlikely to approve many devices. However, globally, especially in the EU and the U.K., the industry should continue to thrive and expand, according to industry analysts. More importantly, innovation should continue to thrive outside the U.S.
Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, said the global fight for fair and sensible regulation of vaping products will continue throughout 2023. “Regrettably, just like years prior, some battles will be lost, and the end result will be fewer adults who smoke fully switching to vaping,” he said. “However, the silver lining is that—as we see today in Australia and Thailand—even prohibitions with criminal sanctions are not enough to stop illicit markets from popping up. This industry will never be able to stop every attempt at prohibition, but it can continue to document and expose how black markets follow whenever these bans are implemented.”
On the U.S. state level, Conley said his major concern is PMTA registry bills being put forth by the tobacco industry. He explained that these bills would devastate law-abiding vape shops and smoke shops by banning any vaping product that does not have a PMTA granted or explicit enforcement discretion from the FDA. “This means that synthetic nicotine, nicotine-free [products] and CBD/delta products would all become illegal to sell,” said Conley.
Nationally in the U.S., Conley said the FDA’s policy on vaping products in 2023 is likely to still be characterized by regulatory paralysis and the eternal search for the least politically controversial regulatory option. “Despite declines in youth vaping and the admonishment of federal judges, leadership at FDA remains steadfastly committed to having more combustible cigarettes on the market than vaping products,” he said. “On the plus side, the pace of FDA review has been slow to say the least, so we won’t hear rulings on many applications until 2024 or later.”
The U.S. Food and Drug Administration is planning to make recommendations on how to regulate the use of the popular cannabis compound cannabidiol (CBD) in food and supplements, the Wall Street Journal reported, citing agency officials.
After weighing the evidence on the compound’s safety, the FDA will decide within months how to regulate legal cannabis and whether that will require new agency rules or new legislation from Congress, according to the report.
In an interview, Janet Woodcock, the FDA’s Deputy Commissioner and leader of the agency’s cannabis regulation efforts, expressed concern about the safety of CBD and whether current regulatory pathways for food and dietary supplements are suitable for this substance.
However, the agency is interested in determining whether it is safe to consume CBD on a daily basis for extended periods of time or during pregnancy.
Woodcock mentioned concerns about potential effects on fertility in the future, but, at the same time, her comment signaled that the agency is working to establish regulatory frameworks for the legal sale of appropriate cannabis and cannabis-derived products.
CBD is a chemical compound found in cannabis plants. It is one of the main ingredients in cannabis, but unlike THC, it does not cause a high or have psychoactive effects.
The 2018 Farm Bill legalized hemp cultivation in the U.S., which led to significant growth in the market for CBD products. These products, sold as dietary supplements, are believed to have health benefits. As a result, many businesses in the cannabis industry are now selling CBD products across the country.
In recent months, the FDA posted warning letters to at least nine companies for illegally selling products containing CBD. The companies are accused of selling products containing CBD that the FDA states some people may confuse for traditional foods or beverages that do not contain CBD or were making medical claims about their CBD products.
In 2021, The FDA told Charlotte’s Web Holdings Inc., one of the world’s largest CBD companies, that its cannabidiol product cannot be sold as a dietary supplement, signaling that CBD reform may have to wait for congressional action.
The FDA has not approved any CBD-based products for use as dietary supplements. The only CBD-based product the FDA has approved is Epidiolex, a prescription medication used to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in children two years of age and older.
A bill has been submitted in the legislature of the U.S. state of Maine that would ban flavored vaping and other tobacco products in the state if passed.
Maine State Senator Jill Duson filed the bill on Friday. Maine has served as a centerpiece for bans on the sale of flavored tobacco recently, as three of the state’s four most populated cities have passed their own bans.
Most recently, South Portland passed legislation banning the sale of flavored tobacco products.
The owner of Portland Smoke and Vape South Portland says there has been overwhelming support from the vape community who have signed a petition against the ban.
South Portland joins Portland, Brunswick, and Bangor as communities where flavored tobacco products are no longer sold.
The Maine State Legislature has already begun its session, but the bill has not yet been assigned to a committee, according to media reports.
The upscale U.K.-based grocer Waitrose has halted sales of single-use vaping products due to the impact on the environment and the “health of young people.”
Two types of single-use e-cigarettes have now been removed from sale as a result, Waitrose said.
Waitrose said it has de-listed vaping products containing lithium, which it has historically sold under the Ten Motives label, according to the Daily Mail.
Waitrose commercial director Charlotte Di Cello said the company is “driven by doing the right thing,” and selling single-use vapes is not something Waitrose could justify given the impact on “the environment and the health of young people.”
“We had already decided it wasn’t right to stock the fashionable bright-colored devices, which are seeing rapid growth – so this decision is the final jigsaw piece in our clear decision not to be part of the single-use vaping market,” she said.
For the first time, the FDA issues warning letters for marketing products containing delta-8 THC. Several R.J. Reynolds Vapor Co. Vuse branded e-cigarette products receive marketing orders, including six new tobacco products, through the PMTA pathway. The San Diego City Council passes an ordinance for the second time banning vape flavors, and it’s effective Jan. 1, 2023. In its first status report, the FDA states that it expects to have resolved 63 percent of PMTAs set out in its original priority by June 30. Altria Client Services pays $100.5 million for assets and properties used in Poda Holdings’ business of developing, manufacturing and marketing multi-substrate heated capsule technology. FEELM wins four Red Dot Awards, an international competition for product, communication and concept design. Longtime Centers for Disease Control and Prevention alumnus Brian King succeeds Mitch Zeller at the FDA’s Center for Tobacco Products (CTP).
PMI opens its flagship IQOS store in South Africa. Confronted with rising prices for batteries, engineers in Ukraine begin using power cells from vapes to power drones. A U.S. administrative tribunal invalidates two claims in an R.J. Reynolds vaping patent. Panama bans the sale and import of vapes, joining more than a dozen Latin American and Caribbean countries with such restrictions. Brazil also maintains its ban on vaping products. The FDA issues first warning letters for synthetic products. Juul Labs begins exploring financing options to avoid bankruptcy. Juul quarterly revenues drop 23 percent. FDA Commissioner Robert Califf says the nonprofit Reagan-Udall Foundation—a nongovernmental research group created by Congress to support the FDA’s work—will convene experts to evaluate the CTP within 60 business days. Matt Holman, the director of the CTP’s Office of Science, announces he is stepping down. Altria reduces the value of its investment in Juul Labs to $1.3 billion, a nearly 70 percent loss of its original $12.8 billion evaluation. The Philippine president allows a bill that legalizes e-cigarettes to lapse into law.
