Tag: SFATA

  • SFATA Safeguards Production, Sales of Vaping Products

    SFATA Safeguards Production, Sales of Vaping Products

    Credit: SYCprod

    The Smoke-Free Alternatives Trade Association continues to help business owners navigate regulation.

    By Timothy S. Donahue

    In 2012, the Smoke-Free Alternatives Trade Association (SFATA), a trade association representing small and large vaping businesses, began when the industry was still in its infancy. The trade group has been a staple in the tobacco harm reduction circle for more than a decade fighting for balanced regulations in the United States. It hasn’t been easy. The U.S. Food and Drug Administration has nearly decimated the numerous small business owners who once made up most of the vaping industry.

    While the industry has had to evolve, so have the trade industry groups that support it. The SFATA began as an advocacy group for states in its early stages. As federal regulation began to come into reality in 2016, the SFATA altered course and focused on getting balanced regulations on the federal level. In 2021, however, after the FDA either denied or failed to review over 8 million premarket tobacco product applications (PMTAs), it sent the industry scrambling, explains SFATA Board President and CEO April L. Meyers.

    “In the winter of that year, it also sent the states scrambling, so we had to shift our focus from federal to state so that we could save as many small businesses as we could,” she says. “There were several battlefronts and issues, most notably, flavor bans.” The organization had success at the state level. The SFATA had stopped several flavor bans. It was around this time that the organization also introduced its Responsible Industry Network (RIN) program.

    The RIN program helps retailers combat the problem of youth use. It’s a program that provides a postmarket surveillance pathway through data, training, accountability and corrective measures for vapor manufacturers, distributors and retailers as well as a method for law enforcement and regulatory authorities to ensure that significantly fewer vapor products end up in the hands of youth. The RIN program serves the interest of business owners navigating the complexity of a highly regulated market while also assisting enforcement agencies.

    Additionally, authorities can confiscate products that do find their way into the hands of youth and conduct enforcement actions against the parties who are responsible, whether they are manufacturers, distributors, retailers or straw buyers, such as family members or friends. An added value for the industry is that curtailing youth access will lower the biased media attacks that the vapor industry targets children, creating a more stable regulatory environment that allows businesses to grow.

    April Meyers, SFATA

    “If you’re a small [-sized] to mid-sized manufacturer and you received a marketing order, you’d have to either hire somebody full-time to collect the data for postmarket surveillance or spend a lot of valuable time trying to do it yourself,” said Meyers. “That’s where we came up with a program that streamlines the process. Everybody’s got the same due dates and the same forms. And then the agency is looking at the same form coming in at the same time.”

    To receive a marketing order, the FDA states that it “intends to consider how an applicant will target the marketing of its new tobacco product to reach its intended consumers of legal age and to assess the potential effect on nonusers.” The FDA will also consider how the applicant intends to minimize the extent to which youth can access the product and are exposed to its marketing.

    “If the PMTA does not address youth access to the product, youth exposure to the product’s labeling, advertising, marketing and promotion, and youth initiation, such as describing how it proposes to restrict the sale or distribution of its product to limit potential youth access to the product, it’s going to be impossible to get a marketing order,” said Meyers. “[The] FDA may be unable to determine that the applicant has made a showing that permitting the marketing of the new tobacco product would be appropriate for the protection of public health. RIN can help provide that data. And that data can be useful in several meaningful ways.”

    The RIN program will create a rich database that will expose useful sales and marketing insights for participants, according to Meyers. She said that the data can show aggregate buying and selling behaviors of vapor products, data that can also be useful when faced with federal and state flavor bans and taxation bills.

    In order to further help its members, Meyers said the SFATA recently entered a “strategic alignment” with the United States Vaping Association (USVA). She said that teamwork is an important aspect of vapor advocacy and that businesses need to support each other. The partnership creates a more unified voice and prevents wasting valuable industry resources by multiple organizations doing the same work.

    “You’d have to be a dual member to realize the full benefits of advocacy. We’re also trying to make it reasonably priced where a store that’s on its feet and planning to move forward can participate,” she explains. “And we wanted to keep it even across the board because we don’t want to tell a big company that you must pay more just because you’re bigger. Nor a small company [that] you have to pay so much, and then they get costed out.”

    Currently, the USVA is focused on winning its lawsuit against the FDA. The USVA believes the regulatory agency didn’t consider the economic impact on small businesses that the PMTA process and subsequent denial orders would have. The USVA suit claims that the FDA acted as if vapor applicants would be able to substantially rely on public data or on 70 studies that the FDA itself was conducting at that time. However, the FDA instead wrote an impossibly burdensome PMTA rule that began putting people out of business.

    The suit is hoping the courts declare the PMTA final rule in violation of the Regulatory Flexibility Act, an effort by the U.S. federal government to balance the social goals of federal regulations with the needs and capabilities of small businesses and other small entities. The USVA also hopes the judges remand the PMTA final rule to the FDA and enjoin the agency from enforcing the final rule against any members of the USVA. This would also include joint SFATA members.

    The suit also criticizes the FDA for prioritizing manufacturers with the greatest market share, companies that were more well funded to tackle the PMTA process. Some of the larger companies were also allowed to make changes to issues with their PMTA submissions whereas smaller companies with the same issues received marketing denial orders for those issues.

    Credit: Rafel

    “If the courts hand down an emergency injunction for relief, it would mean that every member of the USVA, SFATA joint members and the named plaintiffs on the case go back into review. Where we found synergy between the organizations is if you go back into review, what happens? Are you better off? No. Do you have more time? Yes. Can you make more money in the extra time you’ve been given? Yes. But then what? If you don’t address the broken process, that is the PMTA, you have nothing,” said Meyers. “It affects every state, every business, every vapor product retailer.”

    Meyers explained that joining the SFATA helps to safeguard that manufacturers are able to produce products and businesses are able to sell lifesaving vapor devices. The organization is currently laser-focused on the U.S. House of Representatives and is dedicated to trying to do its part to stamp out overzealous and overreaching legislation.

    “We focus on the House because that’s where the oversight is of FDA, and that’s where most bills also get introduced. So that’s where we’ve put our focus and where most of our meetings will be concentrated on at the federal level for this year’s session,” she said. “The FDA’s rules are the problem. The members of the House we have spoken to understand that the process is broken. We are presenting science-based solutions and innovation to show that it can be fixed.” While legal action safeguards against the lack of guidance and transparency from the FDA, the SFATA is working with lawmakers to ensure that its “commonsense solutions for American smokers” are understood and communicated to the FDA and Congress, which oversees the agency, according to Meyers.

    “The recent report from the Reagan-Udall Foundation found numerous wide-ranging problems at CTP,” she said. “Now Congress is asking the FDA to answer those same questions the Reagan-Udall report asked … SFATA is asking those questions too. What is your strategy? What is your plan? What are you going to do? There’s a lot of pressure on FDA to do something and be clear about it. [The] FDA can’t come up with that plan by themselves. They need industry insight and support. Our goal is to come up with that input. That’s why you would support SFATA. You want to be a part of that conversation and get that information. We are here to help.”

  • Vaping Industry Advocates ‘Not Surprised’ by Logic Approval

    Vaping Industry Advocates ‘Not Surprised’ by Logic Approval

    When U.S Food and Drug Administration authorized several tobacco-flavored products from Logic Technology Development for sale in the U.S. the vapor industry wasn’t surprised. Vaping advocacy groups have long expected the FDA to approve many of the brands that had premarket tobacco product applications (PMTAs) submitted and are owned by major tobacco companies.

    SFATA logo“Although we are not surprised to learn that Japan Tobacco Inc., brand owner of Logic, is now among the Big Tobacco companies with FDA market authorization, we certainly aren’t pleased with FDA’s consistent rejection of flavored products and will continue to apply pressure in that regard, as well as in the enforcement discretion arena – particularly for the manufacturers with products still in review that participate in our Responsible Industry Network program,” said April Meyers, CEO of the Smoke-Free Alternatives Trade Association (SFATA). “As the nation’s leading regulatory body, the agency appears to be cherry-picking what science it utilizes for decision making. That FDA cited the recent NYTS data but failed to acknowledge the steep decline in youth use while coining the low rates an “epidemic”, makes its rejection of flavored products today seem more an act of fear over what might happen than a decision based on scientific evidence. This is disappointing, at best, but again, not surprising.”

    Logic, based in Teaneck, New Jersey, is a part of the JT Group of companies. JTI is a international tobacco and vaping company headquartered in Geneva, Switzerland, with operations in more than 130 countries. JTI employs over 50,000 people. In a release, Logic stated that it submitted PMTAs for its Logic Pro, Logic Power, and Vapeleaf products on August 19, 2019, well before the Sept. 9, 2020, PMTA deadline.

    “We take the quality of our products extremely seriously, along with the way they are marketed and sold, and we are proud that we have received marketing orders from FDA for our Logic products to remain on retailers’ shelves,” said Corrado Mautone, president of Logic. “By receiving FDA marketing orders now, Logic can remain a reliable partner for retailers going forward.”

    Amanda Wheeler, owner of Jvapes and the president of American Vapor Manufacturers, said that it is good to see that the FDA is acknowledging that vaping is safer than combustible cigarettes, but the fight for small business owners continues.

    “People forget that in the story, Dr. Jekyll was a benevolent physician in a lab coat who only wanted to help people. But tomorrow morning, (FDA Commissioner) Robert Califf and (director of the FDA’s Center of Tobacco Products) Mitch Zeller will transform back into their Mr. Hyde alter-egos and resume their hellbent mission to sabotage the single-most effective smoking cessation device ever devised,” said Wheeler. “Well, the American people are watching and I for one am not going to stand by and let them get away with it. So, here’s my own announcement for today: FDA and CDC have my approval to stop deceiving the American public about the safety and efficacy of nicotine vaping.”

    The agency also issued marketing denial orders to Logic for multiple other electronic nicotine-delivery systems (ENDS) products, mostly non-tobacco flavors.

    “While Logic received marketing orders for its tobacco-flavored products, it is still awaiting a determination from the FDA on its menthol products. At the FDAs discretion, products like Logic’s menthol capsules can continue to be marketed while under review,” Logic stated in the release. “Additionally, Logic received marketing denial orders (MDOs) for flavored products that are not currently on retailers’ shelves. Logic is reviewing the FDAs determination and rationale before taking further action.”

    The FDA also indicated that it was moving closer to issuing decisions on other applications that account for “a large part” of the marketplace, which based on Nielsen ratings, are mostly owned by large tobacco companies.

    Logic is only the second company to have vaping products approved for marketing by the FDA. In Oct. of 2021, the agency authorized the marketing approval of three outdated vapor products to the RJ Reynolds (RJR) Vapor Company for its Vuse Solo device and two tobacco-flavored pods. The agency also denied Vuse PMTAs for flavored products other than tobacco.

  • Biden Signs Budget, Gives All Nicotine Authority to FDA

    Biden Signs Budget, Gives All Nicotine Authority to FDA

    Credit: White House

    President Joe Biden on Tuesday signed a bill that gives the U.S. Food and Drug Administration powers over over any nicotine, not just tobacco-derived nicotine. Part of a $1.5 trillion government spending measure, the rider was slipped into the bill with no debate or notification to the vaping industry.

    The language of the Tobacco Control Act will now change to define a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.”

    “You know, in a moment, I’m going to sign this bipartisan government funding bill,” Biden said. “But with this bill, we’re going to send a message to the American people – a strong message – that Democrats and Republicans can actually come together and get something done.”

    Bryan Haynes, a partner with Troutman Pepper, said that the amendment has an effective date 30 days after the bill is enacted (April 14) and gives a manufacturer of a tobacco product with synthetic nicotine (or nicotine derived from a source other than tobacco) 30 days after the effective date to file a premarket tobacco product application (PMTA) with FDA.

    “If FDA has not authorized the product within 90 days after the effective date, the product must be removed from the market. This is likely to amount to an effective ban on synthetic nicotine products,” he wrote in the firm’s Tobacco Law Blog. “FDA is highly unlikely to authorize a PMTA in 90 days when other PMTAs for electronic nicotine delivery systems have been pending for more than two years.”

    April Meyers, board president for the Smoke-Free Alternatives Trade Association (SFATA), told Vapor Voice that the bill will have little effect on youth vaping, which is already down significantly since highs in 2015. “Although the sponsors of the bill claim the intent was to close the loophole on synthetic nicotine-derived products from large companies now popular among youth, the reality is that this bill – and others like it – aren’t likely to have the intended effect,” she said. “Instead, consumers using these products as a harm reduction option will suffer, as will licensed small businesses in full compliance with federal, state, and local laws.

    “The FDA created a problem by overregulating a product used by millions of adults who find vaping a safer alternative to smoking. When a market in high demand is overregulated, grey and black markets emerge where there are no regulations requiring safe products or ID checks.”

  • Biden Expected to Sign De Facto Synthetic Ban Tuesday

    Biden Expected to Sign De Facto Synthetic Ban Tuesday

    President Biden on Tuesday is expected to sign a $1.5 trillion spending bill that funds the government through September and includes a rider that places synthetic nicotine products under the authority of the U.S. Food and Drug Administration. The Senate passed it late Thursday night by a 68-31 margin. Biden signed a stopgap measure Friday that averts a partial government shutdown that would otherwise have occurred midnight Friday.

    The rule will become law 30 days after the bill’s signing date. Manufacturers of currently marketed synthetic products would have an additional 60 days to file a premarket tobacco product application (PMTA) without being subject to FDA enforcement—unless the FDA has already denied a non-synthetic version of the same product (meaning those manufacturers would be subject to enforcement 30 days after the passage of the bill).

    Azim Chowdhury, a partner with the law firm Keller and Heckman said that the way he interprets the rule is that all synthetic products already on the market or newly marketed within 30 days after the enactment date can continue to be marketed during the 60-day period following the enactment date.

    The language of the Tobacco Control Act would change to define a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption,” when Biden signs the bill into law.

    Products subject to timely submitted PMTAs can remain on the market for 90 days after the effective date, which is 120 days after enactment. Any product not authorized by FDA within 120 days of enactment must come off the market, according to Chowdhury.

    “We do not anticipate FDA authorizing any synthetic nicotine products by the end of the 90-day period, though they may take another fatal flaw approach to quickly deny applications,” said Chowdhury. “Significantly, the rider in its current form indicates that a synthetic nicotine version of a product that already went through the PMTA process and is subject to a Refuse-to-Accept (RTA), Refuse-to-File (RTF), Marketing Denial Order (MDO), or withdrawal of a marketing order would have to come off the market as of the effective date – i.e., after 30 days of the law’s enactment.

    “In simpler terms, for products that were previously formulated with tobacco-derived nicotine (and the only change was a switch to synthetic nicotine) and whose PMTAs have already been refused or denied, those products will effectively be banned on the effective date (30 days after enactment) with no opportunity to submit a new PMTA. (This is Congress’ way of punishing companies whose PMTAs were denied and then, in their view, sought to circumvent the law by switching to synthetic nicotine).”

    Beyond the PMTA conditions, manufacturers of synthetic nicotine products would be subject to ‘all requirements of the regulations for tobacco products. Chowdhury said he and his team interpret this to include all additional Tobacco Control Act requirements, including tobacco product establishment registration and product listing, ingredient listing, ensuring that labeling is compliant including required warning statements, and health document submissions, among other.

    April Meyers, board president for the Smoke-Free Alternatives Trade Association (SFATA), wrote in a release that her organization is disappointed by the Biden administration’s use of earmarks in a omnibus appropriations bill without giving an adequate amount of time for interested parties to review and discuss the rule.

    She stated that the vaping industry has helped millions of American adult consumers that have relied on flavored vapor products for over a decade to successfully remain combustible tobacco-free.

    “Sadly, it is those consumers who will pay the ultimate price of this legislation,” she said. “Over the last decade of SFATA’s existence, we have fought diligently to keep flavored products accessible to smokers. Any battle lost means consumers are potentially driven back to deadly combustible cigarettes, and therein lies the real tragedy.

    “It is shameful that public health officials prefer to carve legislation with a butcher’s knife, rather than with the skill and precision of a scalpel better served to ensure the nation’s public health.”

  • Predicting Policy Position

    Predicting Policy Position

    white house
    Credit: Rene Deanda

    Policy experts weigh in on the vaping industry’s future under the Biden administration.

    By Maria Verven

    Within days of assuming office, U.S. President Joe Biden issued executive orders to respond to Covid-19, by far the biggest global health threat in over 100 years. It may be months or even years before anyone knows how the new administration and the U.S. Centers for Disease Control and Prevention (CDC) and its new director, Rochelle Walensky, will respond to another major health threat: the 480,000 annual deaths caused by combustible cigarettes.

    Vapor Voice interviewed vapor industry leaders and legislative experts for their opinions on how the vapor industry might fare under the new administration. The panel includes:

    Mark Anton, executive director, Smoke-Free Alternatives Trade Association (SFATA)

    “Let’s get the junk science funded by big pharma and the tobacco Master Settlement Agreement out of the narrative of harm reduction. The federal government must be guided by the best science to ensure responsible decision-making.”

    Gregory Conley, president, American Vaping Association (AVA)

    “Legal nicotine vaping products are far less hazardous than smoking and serve a vital public health role in helping adult smokers quit.” 

    Michael Siegel, professor, Department of Community Health Sciences, Boston University School of Public Health 

    “Vaping is, for many smokers, a life-saving health decision. It is much safer than smoking and is literally saving the lives of smokers who would likely die if they weren’t able to stop smoking.”

    David T. Sweanor, adjunct professor, advisory board chair, Centre for Health Law, Policy & Ethics, University of Ottawa

    “It’s the smoke, stupid.”

    Vapor Voice: What policy changes might the Biden administration make regarding vaping products?

    Anton: During the Biden administration, SFATA is taking the lead in youth prevention with the creation of the Responsible Industry Network, which we presented to HHS and the FDA. This would allow adults to access flavors while protecting small businesses through the FDA’s PMTA (premarket tobacco product application) process.

    Mark Anton SFATA
    Mark Anton / Credit: SFATA

    Adults need access to products that help them transition away from combustible cigarettes, so unfavorable e-cig policies and flavor bans should not be on their agenda. Vaping is truly a good tool for tobacco harm reduction. The industry is made up of former smokers who strive to develop the best manufacturing practices without the FDA’s help. To protect against youth use, SFATA supports the enforcement of T21 [Tobacco 21], passed by Congress and signed by the president. Covid[-19] policies have prevented true enforcement.

    Finally, the CDC should always give true assessments and release reports to the media and medical and public health journals. Last year, the CDC failed to give a full accounting of EVALI (vaping-related lung illnesses), when they should have made a declarative statement that vaping nicotine e-cigs was not the cause.

    Conley: Sadly, there is no use answering this question as there’s no indication whatsoever that the Biden Administration will make favorable decisions with regard to vaping products. I would be thrilled to be wrong, but after a decade of fantasizing about smart policy and regulations and only getting the opposite, it’s time to stop dreaming and work within the broken system we have.

    Siegel: Introduce legislation to ban the sale of tobacco products, including vaping products, with the exception of stores only open to [consumers] 21-plus that only sell these products. And direct health insurance companies to cover electronic cigarettes just as they cover other forms of nicotine-replacement therapy.

    Encourage physicians to promote vaping for smokers who are unable to quit using other means. And direct the CDC, FDA and other national health agencies to endorse the use of vaping products for smoking cessation, especially when traditional medications do not work. Finally, discontinue the requirement for PMTAs for vaping products and, instead, directly regulate these products by forcing the FDA to promulgate safety regulations.

    Sweanor: Follow the science on relative risk and communicate truthfully with the public. And empower those who use nicotine to have control over their health though ready access to a wide range of low-risk alternatives to cigarettes and risk proportionate regulation of the spectrum of products. Access to alternatives to cigarettes should be no less urgent a public health goal than access to Covid[-19] treatments and vaccines. Government policy should reflect this urgency.

    What were the most egregious policies implemented during the Trump administration? 

    Anton: Clearly, CDC misinformation about EVALI, falsely accusing e-cigarettes and seeking to ban flavors without sufficient scientific evidence is high on the list of misguided policies. And despite all the research to the contrary, they created hysteria by calling e-cigarette use by minors an ‘epidemic’ when it was not. The true epidemic is 480,000 smokers dying every year from smoking combustible cigarettes.

    Conley: [Former]President Trump created a wave of issues when he declared that flavored vaping products should be banned because they were killing people. He was undoubtedly being fed bad information from his advisors, but it was ridiculous coming from the supposed pro-business, anti-regulation POTUS. Even Trump’s biggest fans realized that one of his flaws was his inability to hire competent people who shared his worldview. Putting Alex Azar in as Secretary of Health and Human Services assured there would be no positive movement to reform vaping regulations at any of the agencies HHS oversees.

    conley
    Greg Conley / Credit: AVA

    Siegel: The ban on flavored e-cigarettes in pod systems and the requirement that companies must submit PMTAs to stay on the market both need to be reversed. There does need to be regulation of nicotine strengths, especially for nicotine salts, but getting rid of flavors isn’t going to solve the problem of youth vaping, and it is hurting many adult ex-smokers.

    Sweanor: I think the biggest failure was the failure to remove the mounting barriers confronting less hazardous products such as e-cigarettes. After a steep decline in cigarette sales by substituting safer products, particularly vaping, cigarettes started making a comeback as the CDC and other agencies engaged in a massively misleading campaign against vaping.

    Meanwhile, the FDA put vaping at a marketplace disadvantage compared to cigarettes. Research showed those most at risk were misinformed about the relative risks.

    At the end of Biden’s term, what state do you think the vaping industry will be in?

    Anton: The outlook is not very bright for the small vaping industry based on Biden’s cabinet selections; many have anti-vaping outlooks and ignore the multitude of studies in support of the harm reduction potential of vaping products. The focus has been on youth use even though it’s decreasing at record levels. Much of the vapor industry success or demise will hinge on the Biden administration’s willingness to look honestly at the science. Additionally, Congress has pushed to ban flavors despite the fact that flavors are an important tool for the average smoker to quit smoking.

    Politics have clouded the potential of this industry’s ability to reduce harm in the U.S. regarding smoking combustible cigarettes. If the Biden administration follows this path, we will be worse off. But if they choose science and real life, it will be better. Much hinges on the role the FDA will play in issuing marketing authorizations.

    Conley: Right now, most adult vapers can easily access tens of thousands of different vaping products in every flavor you can think of. While there will always be a gray market and internet sales, the legal market will never be as free as it is today.

    Four years from now, there will still be a legal market for tobacco-derived nicotine vaping products authorized by the FDA. It may not be a great market, but it will exist. Companies with authorized products will do everything in their power to disrupt the gray market such as stand-alone devices, nicotine-free or tobacco-free nicotine e-liquids that many vapers rely on.

    Siegel: It will probably be worse off. If the administration enforces the PMTA rules, many vaping products will be taken off the market. Big tobacco companies and a few large independent companies will dominate the market. The growth of the e-cigarette sector will wane. Many ex-smokers will return to smoking, and e-cigarettes will no longer serve as an off-ramp for as many smokers.

    dr michael siegel
    Dr. Michael Siegel

    Sweanor: Ultimately, disruptive technology, science, rationality and human rights will win, and cigarettes will go the way of previous categories of unreasonably hazardous goods and services. The question of whether that happens within four years depends on the way politics unfolds and the emergence of leaders who see the opportunity and relentlessly pursue it.

    Is limiting the level of nicotine a viable solution for users of conventional tobacco?

    Conley: Bloomberg-funded prohibitionists and legislators who can’t differentiate between classes of vaping products are not going to be swayed by nicotine limits. Their goal is prohibition. When you give in to the prohibitionists, all you’re doing is guaranteeing they’ll be back next year to argue that we need flavor bans because nicotine limits didn’t work.

    Siegel: Yes. Limiting nicotine in e-cigarettes will help reduce youth addiction to these products. There is also evidence that very low nicotine cigarettes can result in much lower levels of addiction in cigarette smokers.

    Sweanor: No. It’s a replication of the disastrous Volstead Act that ushered in Prohibition, which forced beer and wine to have no more than a minimum level of alcohol.

    sweanor-web
    David Sweanor

    The total U.S. nicotine market is over $80 billion, and the cigarette market alone is over $60 billion, with tens of millions of consumers. The products are far more dependence-producing than alcoholic beverages. A prohibitionist policy is very unlikely to garner political acceptance and could rapidly lead to the sort of entrepreneurship and criminality long associated with other abstinence-only campaigns.

    Many who are pushing for such a policy also oppose the wide availability of consumer-acceptable low-risk alternatives to cigarettes, demonstrating that this is a flawed moralistic strategy rather than a pragmatic public health one.

    What chance do any of these proposed changes/solutions have at being implemented?

    Anton: The previous FDA leadership has called the millions of smokers who have transitioned from combustible cigarettes to flavored vapor products ‘anecdotal evidence’ without investing any funds into research. The Biden administration and the new FDA leadership now has the opportunity to affect public health on a massive scale by investigating this hypothesis.

    The U.K.’s National Health policy recommends that smokers who want to quit switch to vaping. They recognize vaping is safer than cigarettes. This is from the country that put warning labels on cigarette packs four years before the U.S. The Responsible Industry Network is a framework that will help prevent youth access, limit marketing to age-restricted stores and develop a pathway to prevent the loss of tens of thousands of small businesses. It brings together all the elements of the Tobacco Control Act (TCA)—protecting youth from smoking and tobacco use while assisting millions of adults who are trying to stop smoking.

    While these are foundational items of the TCA and the FDA, politicians are missing the opportunity to help millions of current smokers because vaping is so politicized and youth use and access to vapor products has been blown out of proportion.

    Siegel: The likelihood [that] these policies will be implemented is very low. I just don’t think the mainstream tobacco control and health organizations support the idea of harm reduction in tobacco control.

    Sweanor: I have little ability to discern the likelihood of rational policies, in part because the current politics around nicotine seem to favor a War on Drugs mentality where the pursuit of total abstinence takes precedence over a public health orientation. Much will depend on Americans who use nicotine, a demographic Biden appears to care very much about.

    The original “Vaping Vamp,” Maria Verven owns Verve Communications, a P.R. and marketing firm specializing in the vapor industry.

  • USPS Mail Ban of ENDS Could Also Include Hemp Products

    USPS Mail Ban of ENDS Could Also Include Hemp Products

    Words say a lot. It’s especially true in the rule of law. When Congress approved the recent appropriations bill to keep the government running, lawmakers also passed the “Preventing Online Sales of E-Cigarettes to Children Act,” which prohibits the United States Post Office (USPS) from shipping vaping products.

    mailbox
    Credit Anne Onyme

    While the legislation was geared towards nicotine vaping products, the law is so broadly defined that hemp businesses must also prepare to comply, according to Patricia Kovacevic, founder and president of PK Regulatory Strategy. The legislation takes effect in late March – 90 days after its published in the Federal Register. The USPS then has 120 days to issue its rules.

    Speaking during a Smoke-Free Alternatives Trade Association (SFATA) webinar, Kovacevic said that the legislation states that an electronic nicotine delivery system (ENDS) is defined as any device that “delivers nicotine, flavor, or any other substance to the user inhaling from the device.”

    “It’s very broadly defined. It really is any other substance. So even if you inhale, I’m being ridiculous, the air [if inhaled from] a device is still covered,” she said. “So, unfortunately, it’s very broad. That’s actually what makes it worrisome. But that also could be its flaw. [The definition being too inclusive] could be an opportunity to challenge the rule.”

    According to the legislation, anyone selling vaping products must:

    • Register with the U.S. Attorney General
    • Verify age of customers using a commercially available database
    • Use private shipping services that collect an adult signature at the point of delivery
    • If selling in states that tax vaping products, sellers must register with the federal government and with the tobacco tax administrators of the states
    • Collect all applicable local and state taxes, and affix any required tax stamps to the products sold
    • Send each taxing state’s tax administrator a list of all transactions with customers in their state, including the names and addresses of each customer sold to, and the quantities and type of each product sold
    • Maintain records for five years of any “delivery interrupted because the carrier or service determines or has reason to believe that the person ordering the delivery is in violation of the [PACT Act]”

    Both UPS and FedEx have rules against shipping traditional cigarettes and say they will extend those rules to include ENDS products. Violators can receive up to three years in prison, face steep fines and potentially lose their business.

  • SFATA Elects New Board Members Cage,Casey

    SFATA Elects New Board Members Cage,Casey

    The Smoke-Free Alternatives Trade Association (SFATA) announce the results of its recent elections. In a press release, the vapor industry organization said Robert Arnold (Saffire Vapor) will return as board treasurer. Also returning are board president and CEO April L. Meyers (Northeast Vapor Supplies), board vice president Dave Morris (Vape Gravy) and acting board secretary Lindsey Stroud (Taxpayers Protection Alliance).SFATA logo

    New to the board this year are Taylor Cage (Trace/Verify) and Shaun Casey (FlavourArt, N.A).

    “Our Board of Directors is comprised of a diverse team of leaders committed to providing strength, longevity, and stability to the vapor business community,” said Meyers. “We are excited to channel Taylor and Shaun’s skills, expertise, and energy into furthering SFATA’s mission. We are delighted they are participating at SFATA’s board level.”

    Cage and Casey join SFATA as the association readies to roll-out the Trace/Verify segment of its flagship Responsible Industry Network (RIN) Program. The program’s goals are keeping its member businesses viable and flavored vapor products in the hands of adult consumers, according to the release.

    Now seated, the 2021 SFATA Board will begin its work, planning strategy alongside Executive Director, Mark Anton.  The board will decide on the association’s annual budget and select its officers during a two-day meeting before March.