You don’t have to be a doctor, or even play one on TV, to see the conflict: American healthcare policy that promotes taxpayer-funded needle exchanges for drug addicts, but opposes vaping as an alternative for smokers.
The Biden administration recently announced a robust plan to address the nation’s crippling opioid epidemic, which was responsible for 500,000 American deaths between 1999 and 2019. That harm reduction includes needle exchanges, long a controversial policy. In 1988, Congress barred the use of federal funding for needle exchange programs. In 2015, amid the growing opioid crisis, then-President Barack Obama signed the Consolidated Appropriations Act, “which modified the restriction on use of federal funds for distributing sterile needles or syringes,” and allowed for funding to be used for other services, but not syringes.
The Biden administration plan mentions “harm reduction” a total of 12 times and hopes to “enhance” and “support” emerging harm reduction efforts. Although attempting to tackle the opioid epidemic is an admirable goal, the administration is doing an about-face in terms of adult access to all harm reduction products, and they’re not the only ones.
Rhode Island lawmakers recently held hearings on a series of bills that would ban flavored tobacco substitutes like vaping products. But those same Ocean State legislators held a floor session for the final vote on a bill that would establish “harm reduction centers.” A spirited debate took place for nearly an hour. Ultimately the measure passed by a vote of 62-9.
Harm reduction centers for opioid users are a worthwhile goal, but it is overwhelmingly hypocritical for lawmakers to support government funding those, while simultaneously blocking adult access to tobacco harm reduction products including e-cigarettes, heat-not-burn, and smokeless tobacco.
It is the smoke in combustible cigarettes that is responsible for the damage wrought by tobacco. Tobacco harm reduction products eliminate that smoke while allowing adult users to access nicotine, which in itself is not the harmful component of cigarettes. The U.S. Food and Drug Administration (FDA) has noted that it is the “mix of chemicals – not nicotine – that causes serious disease and death in tobacco users.”
The FDA currently regulates vapor products. But the agency, which fought so hard to regulate these products, has yet to approve a single premarket tobacco product application for any e-cigarette product. During a U.S. House oversight subcommittee meeting last month, lawmakers urged the agency to not approve any flavored e-cigarette product to “protect youth.”
In the Rhode Island House hearing, a spokesman for Campaign for Tobacco-Free Kids (CTFK) urged lawmakers to ban flavored tobacco and vapor products while supporting lawmakers’ efforts in increasing access to clean syringes and opioid antagonist medications, including methadone.
This makes no sense.
Is anyone arguing that more Americans should smoke? Or that health policy should promote smoking? Of course not, just as needle exchange advocates aren’t hoping more people will get hooked on heroin. It’s simply an acknowledgment of human nature, and an effort to reduce harm.
The infamous anti-tobacco and vaping crusader Michael Bloomberg similarly supports opioid harm reduction, but not tobacco harm reduction. A recent New York Times article interviewed the director of drug use initiatives at Vital Strategies, a Bloomberg-backed “philanthropic group.” The director noted that harm reduction programs help persons “stay safe and healthy and alive first and foremost.” Since 2016, Vital Strategies has worked in tandem with the World Health Organization to ban adult access to tobacco harm reduction products. In 2019, the organization highlighted India’s ban on e-cigarettes as a victory. Bloomberg himself has donated $160 million over a three-year period to “fight flavored e-cigarettes.”
In Rhode Island, the CTFK spokesperson noted that opioid harm reduction programs don’t create new users. That may be true, but e-cigarettes create former smokers by helping adults quit smoking. Moreover, they don’t cost taxpayers a dime, and as a harm reduction product, they help to reduce health care and other smoking-related costs.
The FDA has the ability to save millions of lives by approving tobacco harm reduction products. They shouldn’t let misinformed entities and people like CTFK and Michael Bloomberg stand in the way of science and common sense.
Many small vapor manufacturers are attempting to overcome the FDA’s rigorous PMTA requirements.
By Maria Verven
A process that was built for billion-dollar tobacco manufacturers has posed onerous challenges for small e-liquid manufacturers. With the enormous work of pulling together premarket tobacco product applications (PMTAs) for the U.S. Food and Drug Administration behind them, vapor manufacturers are now gearing up for the formal substantive review phase when the regulatory agency will conduct in-depth evaluations of the applications’ requisite scientific studies.
Many relied on help from the PMTA Sharing Group on Facebook to meet the challenge of submitting a separate application for every flavor in every nicotine level in every size bottle, sending literally millions of pages to the FDA. In addition, every PMTA had to contain a plethora of research into the product’s relative health risks for current users and nonusers as well as whether marketing the new product would be appropriate for the protection of public health (APPH).
A full assessment of how users consume their products over time as well as the potential for addictiveness, abuse and misuse was also required. And for those who missed the Sept. 9 deadline and/or failed to meet these requirements? In January 2021, the FDA issued warning letters to 10 e-liquid manufacturers that failed to submit PMTAs by the deadline, advising them that it is now illegal for them to sell their products in the U.S.
Vapor Voice took on the task of asking several vapor industry experts and business owners for their perspectives on the current situation.
A daunting process
Lindsey Stroud, policy analyst with the Taxpayers Protection Alliance, a Washington, D.C.-based nonprofit think tank dedicated to educating the public on the government’s effects on the economy, said many of her clients are still in the thick of the testing process.
Lindsey Stroud
“The process was daunting—among my clients and the folks I assisted, I probably worked on 100,000 to 200,000 individual products. Several of my clients made it past the first step, but there are many more to come,” she said. “AVM (the newly formed American Vapor Manufacturers) is really a genius idea when it comes to these small e-liquid companies. In getting more small businesses involved, the price of testing can slowly come down.
“In the aftermath of the vaping-related lung illnesses (EVALI) in late 2019, it’s imperative that regulatory agencies know what’s in the products and their effects on the U.S. population. The FDA is bound by law to apply the PMTA equally to all manufacturers, regardless of size. Still, the testing requirements for each and every liquid is unduly burdensome for small e-liquid manufacturers that offer hundreds of flavors, often with many flavor components found in numerous companies’ flavorings.
“Currently, if a manufacturer sells a strawberry e-liquid in 20 different nicotine strengths and three different bottle sizes, the FDA requires them to test all those products (20 products times three bottle sizes would mean 60 tests for just one flavor), which is inefficient, daunting and expensive. The FDA has shifted and made the PMTA requirements less burdensome; for example, [the] FDA now allows companies to submit a single PMTA instead of individual applications for each of their products
“Ideally, I would prefer the FDA to allow a flavor manufacturer to have only three tests per flavor—their zero nicotine option, their lowest nicotine option and their highest nicotine option.”
Phase 3: Substantive review
The team at North Carolina-based Bantam Vape worked with highly qualified labs to conduct the in-depth, product-specific and non-product-specific testing needed for their PMTAs, according to Bantam Vape spokesperson Anthony Dillon.
Anthony Dillon
Offering 21 “uniquely crafted flavors” created by chemists and flavorists in different nicotine levels and sizes, Bantam conducted storage and stability testing, toxicity testing and pharmacokinetic and topography studies as well as submitting an extensive review of available literature on its products. After hearing that the PMTAs for Bantam’s products were initially accepted and filed by the FDA last fall (indicating that the FDA had finished its preliminary review) the Bantam team is now waiting for the formal substantive review phase to commence.
“We invested significant resources into the foundation of our PMTA submissions, and we continue to invest resources in the PMTA process and post-market surveillance,” Dillon said. “We worked with reputable, like-minded industry players to share key costs to significantly improve efficiencies, which can help us continue selling our high-quality vape at an attractive price point.
“The PMTA process has certainly impacted the entire e-liquid industry—from manufacturers to retailers to consumers. We believe the PMTA process, though complex and resource-intensive, provides a benchmark for all e-liquid manufacturers, something that the industry, up until now, was lacking. E-liquid companies undergoing the PMTA process must evolve to remain on the market long term. Bantam is, and has always been, committed to developing and manufacturing high-quality, adult-use e-liquid products consistent with FDA guidance and applicable laws. That goal has not changed.
“With any new process, there are kinks to be ironed out. The PMTA is no different. Wherever possible, we are committed to working with the FDA to streamline and improve the process, and we will also work with our retailers and consumers to help them better understand this complex but necessary process. Currently, our biggest challenges are not due to the regulations but the need for transparency in the process and for enforcement against those that are not in compliance with FDA guidance and applicable laws.
“The PMTA process provides a benchmark for all e-liquid manufacturers—something that the industry was lacking. We are proud of and confident in the e-liquid products that are going through the PMTA process, and we look forward to Bantam’s products being enjoyed by adult consumers for years to come.”
Exceptions for artisan cigars
Established in February 2014, 906 Vapor is located in a small community in Michigan. While at one time, they had about $250,000 in annual revenues, sales plummeted to about $180,000 last year due to a state flavor ban and the EVALI scare. One of 906 Vapor’s first customers, Mark Slis bought the store in October 2015. They currently carry over 100 e-liquid flavors using freebase and salt nicotine, along with kits, tanks and mods, a line of disposables and miscellaneous batteries and accessories.
Mark Slis
Since 906 Vapor does not manufacture e-liquids, Slis didn’t have to submit any PMTAs; however, he helped the small Michigan juice manufacturers whose e-liquids he carries submit their PMTAs. Slis lobbied in Michigan, suing the state, health and human services and Governor Whitmer to stop last year’s flavor ban. He also organized a state trade organization and lobbied against flavor bans and other anti-vaping bills in the state’s house and senate, assisting various national organizations in their efforts.
“The required testing places a massive and completely unnecessary burden on all manufacturers,” Slis said. “The proper regulatory response is to set standards, since all e-liquids utilize the exact same four ingredients with variation only in the specific flavoring(s) used. The ingredients have already been thoroughly studied and tested and found to be safe for human consumption. Only product standards should now be required.
“Requiring duplicate testing for each of the 419 million flavors registered with the FDA and duplicate testing for each and every nicotine level for the same flavor is a transparent attempt by the FDA to eliminate the electronic cigarette industry—not regulate it. The FDA has already made it abundantly clear where they stand on independent, small vapor manufacturers. They refused to talk to vapor manufacturers and denied them any relief. Yet when artisan cigar manufacturers lobbied the FDA for a realistic approval pathway and assistance, the FDA not only granted them an indefinite exemption from the PMTA; they offered to spend taxpayers’ money to conduct the prohibitively expensive testing on their cigars.
“In effect, [the FDA] will bend over backward to ensure deadly combustible products remain on the market while regulating smoking cessation out of existence.”
Concerning job losses
A member and vice president of the American Vaping Manufacturers (AVM) Association, a member of the Smoke-Free Alternatives Trade Association (SFATA) and the U.S. Vaping Association (USVA), Char Owen owns a small line of wholesale e-liquids called Unchained as well as two brick-and-mortar stores in Texas called Cloud 9 Vapor Shop that opened in December 2013.
Char Owen
“Absolutely no consideration has been given to small business owners except a short PMTA extension during this pandemic,” Owen said, adding that although she contracted Covid-19 in December, she continued to help small businesses while combatting the illness. “There’s no process for notifying the FDA to request an extension when your family has been affected by Covid[-19]. A large company doesn’t need this, but most small companies are one-person shops or only have a few employees.”
With over 800 e-liquid recipes, Owen ended up submitting PMTAs for over 332,000 SKUs to the FDA. As of this writing, all her PMTAs had been received but had not yet been accepted. They held a listening session with the FDA to obtain feedback on a testing protocol that Owen said could significantly cut the cost of testing.
“The FDA said they will not be creating a simplified pathway for small business,” Owen said. “Testing requirements will put an unnecessary burden on them. These businesses have been selling the same product for many years. I’ve been selling the same product for eight years with zero complaints that our products have caused harm.
“Using standard testing methods and one of the handfuls of testing labs, the testing requirements would cost me over $9 billion dollars. The market, however, will narrow to only those owned by large tobacco, which sells closed pod systems extremely high in nicotine sold in grocery stores and convenience stores. They are the only ones that can afford the PMTA process.
“The problem is SKU inflation. In the FDA’s definition, my 800 products equal 332,000 products, or a 41,400 percent inflation of product SKUs. Something as simple as offering a different bottle size—common in our industry—is a major factor in testing costs, even though the original recipe is still the same. In vitro and in vivo studies could be withdrawn since these products have been on the market for almost 10 years. Just the high range of nicotine could be tested, and if those tests are acceptable, then obviously any lower nicotine levels would be acceptable.
“Vapor shops cater to an over-21 clientele and mainly offer open system e-liquids. They employ a more hands-on approach to helping adults off-ramp from combustibles. We support, educate and help smokers convert to noncombustibles. Because of this support, we see a much higher rate of success than is reported by the FDA, which includes consumers who purchase at convenience stores and big chains. Mainly, we are just trying to help people stay off combustible cigarettes in our local communities.
“It’s important to realize that this industry was founded by small business. The FDA’s requirements, together with a lack of a streamlined process, could cost over 100,000 people their jobs. We already have a huge job loss in the U.S. It’s the last thing we need.”
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a P.R. and marketing firm specializing in the vapor industry.
A new year and new resolutions. In 2021, many Americans will attempt to lose the weight gained after weeks – and months – of stay-at-home orders. Some may have been inclined to reduce their Zoom time, but for many smokers the beginning of a new year marks a resolution to quit smoking.
Credit: Marko Tomic
This particular resolution is difficult. A 2016 study from the UK’s Royal Society for Public Health (RSPH) reported that “quitting smoking is the most difficult resolution to keep,” and that among Brits who reported making a resolution to quit smoking, “41% kept this for a month, [and] 13% [stuck] with it after a year.” A study from the University of Scranton found “only 8 percent of people who make resolutions [to quit smoking] meet their goal.”
Regardless if one is choosing to quit smoking as a New Year’s resolution, giving up cigarettes is difficult any time of the year. According to the Centers for Disease Control and Prevention, less “than one in 10 adult cigarette smokers succeed in quitting each year,” and in 2018, only 7.5 percent of smokers had successfully quit smoking.
There are many options for smokers to use to help aid their smoke-free journey, including traditional nicotine replacement therapies (NRT) like gum and patches, medication, and switching to electronic cigarettes and vapor products. In the aforementioned RSPH report, the agency noted vapor products “are becoming increasingly popular, and RSPH [recognizes] the growing body of evidence that for many they can be an effective smoking cessation tool.”
A landmark October 2020 review published in the Cochrane Library Database of Systematic Reviews examined 50 completed studies on e-cigarette use, which represented more than 12,400 e-cigarette users. The authors found that there was “moderate-certainty evidence, limited by imprecision, that quit rates were higher in people randomized to nicotine [e-cigarettes] than in those randomized to nicotine replacement therapy.” Indeed, the authors found that of “every 100 people using nicotine e-cigarettes to stop smoking, 10 might successfully stop, compared with only six of 100 people” using NRT or “nicotine-free e-cigarettes.”
Despite the science presented, many lawmakers are disregarding the evidence and seeking to limit and/or prohibit adult access to vapor products. Currently, New Jersey, New York and Rhode Island have banned the sale of flavored vapor products. Massachusetts has a current ban on both flavored combustible cigarettes and e-cigarettes, and California’s own flavored tobacco and vapor ban is currently delayed as officials verify signatures for a referendum that would create a ballot measure to repeal the flavor ban in 2022.
Worse, politicians have used the novel coronavirus to push through legislation that bans the United States Postal Service (USPS) from delivering vapor products. Literally “buried” in the thousands of pages in the December COVID-19 relief package is the “Preventing Online Sales of E-Cigarettes to Children Act” which orders the USPS to “promulgate regulations” to apply the Jenkins Act – which currently forbids the shipment of cigarettes by the USPS – to vapor products. The legislation also imposes greater tax reporting requirements on business sales of vapor products that are shipped by the USPS.
Although addressing youth use of e-cigarettes is laudable, essentially preventing online sales of vapor products will harm consumers of those products as retailers are forced to rely on an even limited number of delivery services to ship their products. FedEx recently announced that beginning on March 1, 2021 the delivery service “will begin prohibiting electronic cigarettes, vaping liquids, and other vaping products in the FedEx global network.”
New Year’s resolutions shouldn’t be broken because of government regulations. Former smokers should not be fearful of a possible return to cigarettes because policymakers are preventing access to tobacco harm reduction products. Perhaps the only good thing is that this year, unlike other New Year’s resolutions, smokers can blame the government on their broken resolution to quit smoking.
The views expressed in the above opinion are those of the authors’ and do not necessarily represent or reflect the views of Vapor Voice or its parent organization.
Lindsey Stroud is the creator and manager of Tobacco Harm Reduction 101 (www.thr101.org), a website that provides analysis and insight on tobacco and vapor products. She wrote this for InsideSources.com.
