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Banning flavors for vapor products will send consumers to the black market. Even worse, a ban could send some vapers back to deadly combustible cigarettes. This was the consensus of several vapor organizations and tobacco harm-reduction health groups after President Donald Trump announced his intent to ban all flavored vapor products except for tobacco on Wednesday.

Katherine Mangu-Ward, the editor-in-chief of Reason magazine, probably stated it best when she tweeted “My god. The intense stupidity of this logic: 1) Black market vape cartridges made people sick, so, 2) let’s pass a bunch of regulations to push more popular types of vape cartridges into that same black market; 3) Lives will be saved! Wait, no. THAT WON’T WORK AT ALL. Argh.”

Alex Clark, CEO of The Consumer Advocates for Smoke-free Alternatives Association (CASAA), a vapor industry advocacy group, said in a statement that removing vapor products from the market and prohibiting the sale of nicotine vapor products in flavors other than tobacco will “inevitably lead to the creation of a massive, unregulated underground market” that exposes consumers to dangerous and unnecessary risks.

“Flavored vapor products were developed by consumers who wanted better quality and more effective alternatives to smoking,” Clark wrote. “That grassroots entrepreneurship and innovation is at the core of the vaping community and the industry it supports.”

Tony Abboud, head of the Vapor Technology Association (VTA), a vapor advocacy group, wrote in an email that flavored vaping products are one of the most effective smoking cessation tools on the market.

“A study by the New England Journal of Medicine found that vapor products are nearly twice as effective at helping adults quit smoking than any other nicotine replacement methods like the patch or pill,” Abboud wrote. “Not only that, but the Royal College of Physicians and Public Health England have reviewed all the peer-reviewed research and concluded that nicotine-vapor products are at least 95% safer than cigarettes. There has been no indication that industry standard nicotine-containing vapor products are to blame for recent cases of lung illness. In fact, FDA investigators found that cannabis or THC products were likely the cause.”

Other countries are weighing in as well. Doug Mutter, compliance director at VPZ, the largest vapor retailer in the UK, wrote in an email that Trump’s plans “do not make any sense and will mean that millions of Americans will be forced to choose between smoking again and turning to products on the black market.”

Mutter states that while Trump has rightly called for tighter controls and regulation of the US vapor industry, because there is no strict testing and regulation landscape in the US, “vaping is already proving to be a key weapon in the UK’s stop smoking strategy and is bringing momentum to the country’s ambition of becoming smoke-free by 2030.”

On Sept. 11, President Trump, Health and Human Services Secretary Alex Azar, and Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless announced the intention of the Trump Administration/FDA to take additional action against flavored e-products. The FDA has had the authority to ban vaping flavors since 2016, however, the regulatory agency has previously resisted calls to take that step.

In a separate announcement, Acting Commissioner Sharpless announced that in the coming weeks the FDA’s Center for Tobacco Products would look to clear the market of flavored e-liquid via market authorization requirements based on preliminary results from the National Youth Tobacco Survey showing continued utilization of flavored e-products by youth.

Trump’s first public comments on vaping come as health authorities investigate hundreds of breathing illnesses reported in people who have used e-cigarettes and other vaping devices. No single device, ingredient or additive has been identified, though many cases involve marijuana vaping. The restrictions announced by Trump officials would only apply to nicotine vaping products, which are regulated by the FDA.

Several vapor retailers have expressed frustration over the flavor ban and place the culpability for the rise in youth vaping on small, easily concealed vaporizers and at least one former federal regulator agrees, going as far as to blame a specific product.

Scott Gottlieb, who stepped down as FDA commissioner in April, wrote in a tweet that one company, Juul Labs, bore particular responsibility for forcing the administration’s hand. “Unfortunately, the entire category of e-cigs was put at risk largely as a result of the youth abuse of mostly one manufacturer’s products,” Gottlieb wrote.

On Monday, the FDA issued a warning letter to Juul Labs for marketing unauthorized modified risk tobacco products by “engaging in labeling, advertising, and/or other activities directed to consumers, including a presentation given to youth at a school.”

The agency also sent a letter to the company expressing concern, and requesting more information, about several issues raised in a recent Congressional hearing regarding Juul Labs’ “outreach and marketing practices, including those targeted at students, tribes, health insurers and employers.”

This is what is currently known about the planned vapor flavor ban:

• Preliminary numbers from the National Youth Tobacco Survey show increases in the number of youth reporting use of e-cigarettes overall (based on reported use in the last 30 days): climbing from 21% in 2018 to 27.5% in 2019. Additionally, the survey indicates an increase in youth use of mint/menthol flavored e-cigarettes, rising from 51% in 2018 to 63.9% in 2019.
• CTP will, in the coming weeks, issue revised compliance policies concerning enforcement of the August 8, 2016 deeming regulations regarding all ENDS products except non-flavored and tobacco-flavored products.
• If CTP follows through with the policy revision outlined in Commissioner Sharpless’s statement, in the coming weeks, CTP is likely to rescind enforcement discretion for ENDS products concerning provisional Premarket Tobacco Product Applications (PMTA) that have a characterizing flavor other than tobacco. This will effectively ban flavored ENDS products unless there is a product on the market that has a PMTA authorization.
• Commissioner Sharpless’s statement contained a further warning for tobacco-flavored ENDS products: if future survey data indicates a migration of youth consumption patterns to tobacco flavored products, CTP will take additional action.
• Action threatened by CTP follows a warning delivered by FDA’s previous commissioner, Scott Gottlieb, following 2018’s announcement of a revised enforcement policy for flavored ENDS products sold in unrestricted retail establishments. In that announcement, Gottlieb indicated that FDA will take further action should the survey data show continued increases in youth consumption.
• In recent weeks FDA has faced mounting pressure from civil society and Congress (on a bi-partisan basis) to take action to address vaping issues. This pressure comes on the heels of media reports concerning young people falling ill or passing away due do complications experienced following vaping. Administration officials outside of FDA have expressly linked the Administration’s focus on this issue to these deaths and illnesses.

U.S. Senator Mitt Romney has urged federal health authorities to consider recalling e-cigarettes in the wake of recent hospitalizations and deaths associated with vaping, report The Hill.

In a letter sent Wednesday to Health and Human Services Secretary Alex Azar, Romney expressed concern that experts don’t know what’s been causing people to become ill, other than the fact that they had used e-cigarettes.

For the Food and Drug Administration to consider recall, a product must be dangerous and defective to the extent that it “predictably could cause serious health problems or death.”

In his letter, Romney said Azar should consider whether e-cigarettes meet this threshold.

Federal officials have not identified a single vape product or substance linking all the cases.

Most patients reported using e-cigarette products containing elements of marijuana, including THC, but some patients also reported using nicotine-based products as well.

U.S. President Donald Trump’s administration says it will release new rules banning flavors for vapor products in the next several weeks, officials said Wednesday.

“We are looking at vaping very strongly,” Trump said during a meeting in the Oval Office. “It’s very dangerous. Children have died, people have died. … We’re going to have some very strong rules, regulations, and more important I think we’re going to have some very important information come out very shortly. And we’ll be reporting that over the next couple of weeks.”

The U.S. Food and Drug Administration (FDA) says it will prioritize the agency’s enforcement of the premarket authorization requirements for non-tobacco-flavored e-cigarettes, including mint and menthol, clearing the market of unauthorized, non-tobacco-flavored e-cigarette products.

“The Trump Administration is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools and communities,” said Health and Human Services Secretary Alex Azar. “We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth.”

Azar’s statements seem contradictory to Trump’s claims that his actions are due to recent deaths from what the FDA has said is most likely attributed to vapable THC products.

“We appreciate President Trump and Secretary Azar’s continued support of the agency’s efforts to prevent youth use of e-cigarettes, including the bold approach we’re announcing today,” said acting FDA Commissioner Ned Sharpless.

“Once finalized, this compliance policy will serve as a powerful tool that the FDA can use to combat the troubling trend of youth e-cigarette use. We must act swiftly against flavored e-cigarette products that are especially attractive to children. Moreover, if we see a migration to tobacco-flavored products by kids, we will take additional steps to address youth use of these products.”

Azar and Sharpless said the FDA would consider mint and menthol as “flavored” products and would be subject to any flavor ban.

Vapor Voice will continue to cover this story more in-depth in the coming days and in its next issue.

Following the death of a third person related to a mystery respiratory illness linked to vaping, U.S. Senator Dick Durbin today called on U.S. Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless to take decisive action within the next 10 days to regulate e-cigarettes and the accompanying flavors and products.

In a letter to the acting commissioner, Durbin said that should Sharpless fail to act within ten days, Durbin will call for his resignation.

“As Acting Commissioner of the FDA, you alone have the power to stop this vaping epidemic, which has now reached the point where children and young adults are getting sick and dying,” Durbin wrote. “It is my strong belief that, if you do not take decisive action within the next ten days, you should resign your post. If you continue to refuse to do your job—which is to protect the public health—then it is time to allow someone else to take the helm.”

Durbin also called for Acting Commissioner Sharpless to send a letter to all schools in America warning of the health consequences associated with vaping, and asking each school to ensure this message is conveyed to parents and students alike; immediately ban all e-cigarette flavors other than tobacco; and immediately ban all e-cigarette devices that have not been approved for sale by the FDA, and ensure their immediate removal from stores nationwide.

Durbin asked that Senators immediately be briefed on what steps FDA is taking to combat this public health crisis, including what role marijuana-derived products are playing in this epidemic.

To date, the Centers for Disease Control and Prevention has reported 450 cases of severe respiratory illness among people using e-cigarettes in 33 states, as well as three deaths (in Illinois, Oregon, and Indiana).

A fourth death is being currently investigated.

The U.S. Food and Drug Administration has issued a warning letter to Juul Labs for marketing unauthorized modified risk tobacco products by engaging in labeling, advertising and/or other activities directed to consumers, including a presentation given to youth at a school.

The agency also sent a letter to the company expressing concern, and requesting more information, about several issues raised in a recent Congressional hearing regarding Juul’s outreach and marketing practices, including those targeted at students, tribes, health insurers and employers.

“Regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful,” said Acting FDA Commissioner Ned Sharpless.

The FDA has requested that Juul provide a written response within 15 working days describing its corrective actions and its plan for maintaining compliance with the Federal Food, Drug and Cosmetic Act, including its plan to prevent the same or similar violations.

Read the FDA statement announcing the warning.

Even though the chemical emissions from heat-not-burn devices are lower than those produced by cigarettes, they are still high enough to raise concern, according to new research from the Department of Energy’s Lawrence Berkeley Lab.

“These products are engineered so that it looks like hardly anything comes out of them; but just because the emissions are minimal doesn’t mean they don’t exist,” said first author Lucia Cancelada, a former affiliate researcher in Berkeley Lab’s Indoor Environment Group.

The Berkeley Lab team examined mainstream and sidestream emissions of “a product authorized for sale in the U.S. by the Food and Drug Administration in April 2019.”

Overall, their experiments demonstrated that the emissions are on par with those of electronic cigarettes.

“When we modeled indoor concentrations of acrolein that could be found in a home with regular heat-not-burn use and in spaces with multiple users, such as bars, we found that in certain conditions levels could exceed what the state of California considers to be a safe level for chronic exposure,” said co-author and chemist Lara Gundel.

Additionally, when predicting the intake of irritants and carcinogens by the user, the team found that consuming 20 heat sticks a day—equivalent to a pack a day of conventional cigarettes—would deliver doses of acrolein, benzene, acetaldehyde, and formaldehyde comparable to or higher than health-based exposure limits set by the state of California.

The authors conclude that while heated tobacco products appear to be a weaker indoor pollution source than conventional cigarettes, the impacts cannot be brushed aside and need to be investigated further.

The study was funded by the University of California’s Tobacco-Related Disease Research Program, which is supported by California state cigarette taxes.

Health experts are reassuring British vapers in the wake of recent vaping-related hospitalizations and deaths in the United States, reports The Guardian.

Martin Dockrell, head of tobacco control at Public Health England, said most cases in the U.S. appeared to be linked to illicit vaping fluid, bought on the streets or homemade, with some containing cannabis products.

“Unlike the U.S., all e-cigarette products in the U.K. are tightly regulated for quality and safety by the Medicines and Healthcare Products Regulatory Agency and they operate the yellow card scheme, encouraging vapers to report any bad experiences,” he was quoted as saying.

“It seems highly unlikely that widely available nicotine-containing vaping products, particularly of the type regulated in Europe, are causing these cases,” said Linda Bauld, a public health expert at Edinburgh University.

“All the evidence to date suggests that illicit marijuana vaping products (THC oils) are the cause. In particular, a compound called tocopherol acetate may be the culprit.”

According to Deborah Arnott, chief executive of Action on Smoking and Health, to date no serious vaping side-effects have been reported in the U.K.

The U.S. Food and Drug Administration (FDA) has advised vapers to avoid inhaling vitamin E acetate in the wake of recent reports of respiratory illnesses and deaths.

Vitamin E acetate is a substance present in topical consumer products or dietary supplements, but data are limited about its effects after inhalation.

While acknowledging that it does not have enough data presently to conclude that vitamin E acetate is the cause of the lung injury in the reported cases, the FDA believes it is prudent to avoid inhaling this substance.

Because consumers cannot be sure whether any THC vapor products may contain vitamin E acetate, the FDA also urges consumers to avoid buying vapor products on the street and to refrain from using THC oil or modifying/adding any substances to products purchased in stores.

British American Tobacco (BAT), one of the world’s largest vapor companies, welcomed the FDA’s recommendation.

“We fully support the FDA’s view that vapers should always source their devices and liquids from reputable manufacturers, should avoid modifying or adding substances to the products they purchase and should only ever use the devices as the manufacturer intended,” said David O’Reilly, BAT’s director of scientific research in a statement.

The FDA is currently analyzing samples submitted by a number of states for the presence of a broad range of chemicals, including nicotine, THC and other cannabinoids along with cutting agents/diluents and other additives, pesticides, opioids, poisons, heavy metals and toxins.

According to the FDA, no one substance has been identified in all of the samples tested.

Pyxus International, Inc., a global value-added agricultural company, has signed an agreement with Cornell University’s College of Agriculture and Life Sciences (CALS) to fund research designed to identify and address knowledge gaps surrounding hemp production through the evaluation of cannabidiol (CBD) hemp cultivars and cannabinoid production.

The partnership between the premier agricultural research university and the global agricultural company is rooted in the partners’ shared commitment to provide growers and processors in the rapidly expanding hemp industry with unbiased data and valuable insight on cultivation as the organizations work to reduce the risks associated with cultivation of this new crop through science and education.

This research is intended as an important step in developing hemp as a profitable crop for farmers in New York and across the United States. Beyond providing growers and processors with valuable data and insight, the research coming out of this partnership may also be used by consumers to help them understand hemp and CBD. “Pyxus is dedicated to advancing the cultivation of hemp,” said Bryan Mazur, Executive Vice President of Global Specialty Products at Pyxus International. “We are eager to learn from Cornell’s expertise and research in the field and are excited that this partnership will eventually be part of an even larger Pyxus initiative with additional partners and resources.”

According to the National Conference of State Legislatures, at least 47 states have enacted legislation to establish industrial hemp cultivation and production programs. Additionally, the Brightfield Group, a leading predictive analytics and market research firm for the legal CBD and cannabis industries, has stated that the demand for hemp-derived products, like CBD, will continue to increase, with the market expected to experience a compound annual growth rate of 147 percent.

“Hemp production manuals already exist for grain and fiber; however, equivalent science-based information on hemp production for natural, plant-based cannabinoids and CBD is entirely lacking,” said Cornell University’s Professor of Plant Breeding and Genetics Larry Smart. “Through our partnership with Pyxus, we will build the knowledge base to help the industry make informed decisions that are backed by research to ensure a stable supply of hemp to U.S. processors, and improve the livelihoods of our farmers.”

The Pyxus and Cornell University research project will last multiple years with the first year of research focusing on accomplishing four objectives meant to educate both growers and landowners.

The objectives include: 1) Evaluating and comparing commercially-available cultivars of hemp grown for CBD; 2) Conducting a detailed study of cannabinoid production over the course of the plant’s floral development; 3) Observing the effects of controlled stress treatments on cannabinoid levels; and 4) Extending knowledge of CBD hemp cultivars and cannabinoid accumulation to growers.

Federal health officials are facing scrutiny for their vague public warnings after one death and nearly 200 cases of vaping-related lung illnesses, which some say are related to the far riskier practice of vaping marijuana oil rather than nicotine. 

Some state health department and news reports suggest many of the cases of lung problems involve tetrahydrocannabinol, known as THC, the chemical in marijuana that causes psychological effects, according to an article in USA Today.

Boston University public health professor Michael Siegel said the Centers for Disease Control and Prevention is being “unnecessarily vague” about describing the injuries as simply vaping-related when many people might have been injured by vaping THC oil, according to the article.

“Based on what we know now, I think there’s enough to tell people: Don’t vape THC oils – especially products that are bought off the street,” Siegel said. “There are certain things the agency could be recommending right now that could potentially save lives and prevent this from happening by being much more specific.”

The CDC, the US Food and Drug Administration and state health agencies say they are completing the painstaking work of tracing common factors that may have triggered the spate of vaping-related lung illnesses mainly harming young adults, according to the article.

Siegel acknowledged he is not privy to all the information the CDC has gathered. The agency probably does not know whether THC is the only culprit, he said, but the public would likely benefit if the agency warned vapers to avoid THC oil, according to the article. 

“There are millions of people vaping out there,” said Siegel, who supports vaping as a way for adults to quit smoking. “When they get this advice ‘Well, we don’t know what it is; it’s vaping,’ that doesn’t help anyone. So I think they need to try to be specific.”

Marijuana oil vaping was cited in at least 21 cases of severe lung illness reported by the San Francisco Chronicle last week. In Utah, officials said marijuana oil was a likely culprit in most cases of lung illnesses in teens. A Wisconsin man had so much trouble breathing after he vaped nicotine and THC oil that doctors put Dylan Nelson into a medically induced coma and hooked him up to a ventilator, according to the article.