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FDA permits another e-cigarette, pledges decisions soon on big brands

The Food and Drug Administration, kicking off what is expected to be a period of intensified activity on the contentious issue of e-cigarettes, on Thursday authorized several tobacco-flavored vaping products made by the company Logic, and signaled it would soon announce whether other big-name brands will be allowed to keep selling their wares in the United States.

The FDA said Logic can continue marketing certain e-cigarette devices and prefilled cartridges because the benefits — in helping adult smokers move away from traditional cigarettes — outweigh the risk of young people starting to use e-cigarettes. The agency noted that tobacco is not a popular vaping flavor among young people. The FDA has not yet decided on Logic’s request to sell menthol-flavored cartridges.

Logic, owned by Japan Tobacco International, accounts for just about 1 percent of e-cigarette sales in the United States, according to some estimates. But the FDA decision seems likely to presage rulings on companies with the biggest market shares, including Juul, blu, Vuse and NJoy. Mitch Zeller, director of the FDA’s Center for Tobacco Products, is retiring in early April, and speculation is widespread that he wants to issue decisions on the big companies before he leaves.

The agency, in a statement, said continued marketing by these major players “has the potential to have a substantial public health impact — either positively or negatively — as they hold an overall large market share and are used by a lot of people.”

The FDA in October issued its first authorization for an e-cigarette — the Vuse Solo vaping device and its tobacco-flavored e-liquid pods, both produced by R.J. Reynolds. But, like the Logic products cited Thursday, Vuse Solo is not a big seller and is not popular among young people.

In announcing the decision on Logic, FDA Commissioner Robert M. Califf said in a statement that the agency’s career scientists balanced the risks and benefits of the e-cigarettes. He said he was confident the FDA staff was using “the best available evidence with the most robust methods to ensure that products that continue to be marketed are appropriate for the protection of the public health.”

In a statement, Logic said it was excited about the authorizations and that it has always supported “effective, proportionate and evidence-based regulation” of e-cigarettes.

Clifford E. Douglas, director of the University of Michigan Tobacco Research Network, said he hoped the FDA’s vaping efforts were approaching a point “where we transition from the polarized war over these complex issues to a regulated marketplace that carefully provides more support and alternatives for addicted adult smokers” while protecting young people.

But differences of opinion surfaced immediately after Thursday’s announcement. While Douglas found the FDA’s move encouraging, Erika Sward, assistant vice president of national advocacy for the American Lung Association, said she was frustrated the FDA has not made decisions on some big manufacturers and on whether menthol-flavored vapes, which her organization opposes, will be permitted.

She noted that the FDA missed a September 2021 court-imposed deadline for issuing decisions on whether all e-cigarettes could continue to be sold.

The FDA said it has taken action on about 99 percent of the nearly 6.7 million products submitted for its review, including issuing marketing denial orders for more than 1 million vaping products. But those products represent a small fraction of total sales.

Gregory Conley, president of the American Vaping Association, a nonprofit pro-vaping advocacy organization, called the FDA decision on Logic “thoroughly unimportant and unremarkable.” He said few people use the products. Conley has been highly critical of efforts by anti-tobacco advocates and the FDA to ban sweet and fruity flavored e-cigarettes, saying such flavors are key to helping adults switch from traditional cigarettes to vapes.

In summing up its review of the Logic products, the FDA said data showed that smokers who used the tobacco-flavored items “were more likely to significantly decrease their use of combusted cigarettes and that those who don’t smoke are unlikely to start using these products.” Data also showed that the products produced fewer or lower levels of toxins such as carbon monoxide than traditional cigarettes, the agency said. The FDA also imposed marketing restrictions on Logic to discourage youth use.

The agency said it denied applications by Logic for other vaping products but declined to identify them. Those product must be removed from the market immediately or face possible enforcement action, the agency said.

The authorizations do not constitute “approvals” in the way the agency approves drugs as safe and effective. Rather, they mean that the products have passed a risk-benefit analysis — helping adult smokers switch to vapes while not encouraging young people to begin vaping — and thus are in the interest of public health.

The reviews are part of a sweeping, years’ long effort by the FDA to expand its regulation of tobacco products beyond cigarettes. For many years, e-cigarette sales in the United States were relatively small. But the 2015 introduction of Juul Labs’ sleek vaping device and its easy-to-use pre-filled pods, which included sweet and fruity flavors, upended the industry, attracting flocks of teenage users and igniting a battle over vaping that continues, though transformed in many ways, to this day.

Amid the uproar over youth use, Juul pulled its sweet and fruity flavors from the market a few years ago and promised to work more closely with the FDA. Juul, like other cartridge-based vaping companies, is permitted to sell only tobacco- and menthol-flavored pods.

In the most recent National Youth Tobacco Survey, conducted by the FDA and the Centers for Disease Control and Prevention, Puff Bar, which makes disposable e-cigarettes, was by far the most popular vape among high school and middle school students defined as “current users,” followed by Vuse, Smok and Juul. Puff Bar, which sells vapes in a wide range of flavors, had eluded FDA regulation by using synthetic nicotine. But Congress recently gave the FDA authority to regulate laboratory-made nicotine.

Banning menthol e-cigarettes remains a priority for many public health groups. Though menthol is not as popular among young people as fruit flavors, it is far more popular than tobacco-flavored vaping products. But vaping proponents say menthol e-cigarettes can help people who smoke menthol cigarettes switch to less harmful products. So far, the FDA has been mum on menthol-flavored e-cigarettes.

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FDA authorizes very-low-nicotine cigarettes. The only manufacturer has a plant in Mocksville

Tobacco consumers have been given another Food and Drug Administration-authorized modified-risk option in two very-low-nicotine traditional cigarette brands.

The FDA approved Thursday the designation for the “VLN King” and “VLN Menthol King” brands of 22nd Century Group Inc., which has its manufacturing plant in Mocksville with 56 employees.

It’s a controversial authorization for the FDA, given a modified-risk tobacco product designation allows for the advertising of products as reduced harm or reduced risk compared with traditional cigarettes.

22nd Century can now market the two products as having the capability to “help reduce exposure to and consumption of nicotine for smokers who use them” — products that the company touts “that smokes, tastes and smells like a conventional cigarette.”

Investors responded to the FDA authorization by sending 22nd Century’s share price up nearly 50% in morning trading to $3.52 a share. Its 52-week share price range is $1.86 to $6.07.

22nd Century has been attempting for several years to persuade the FDA to approve allowing the company to market and sell very-low-nicotine traditional cigarettes.

More specifically, 22nd Century has been waiting since Feb. 14, 2020, on the FDA to rule on its application.

James Mish, the company’s chief executive, said in a statement the authorization “places the FDA and 22nd Century together at the vanguard of transforming the tobacco industry.”

“With 60% of adult smokers in our U.S. market research telling us they are likely to try VLN, this is a complete game-changer for 22nd Century, the tobacco industry, public health and adult smokers looking to change their relationship with nicotine — the addictive chemical found in all tobacco products,” Mish said.

The company said it plans to begin shipping the very-low-nicotine cigarettes within 90 days to several test markets in the U.S. and globally.

Controversial

The burning of tobacco leaves is the cause of most carcinogens associated with traditional cigarettes.

Nicotine, while addictive and potentially harmful to the brain, heart and lungs, is not considered as a carcinogen.

“There is a grave danger that this will reinforce inaccurate beliefs that it is the nicotine, rather than the inhalation of smoke, that is the cause of the harm from cigarette smoking,” said David Sweanor, an adjunct law professor at the University of Ottawa and the author of several e-cigarette and health studies.

“Science has shown for decades that people smoke to get nicotine, but die from the smoke.”

Other anti-smoking advocates say an FDA emphasis on very-low-nicotine traditional cigarettes could steer tobacco consumers away from potentially less harmful products, such as electronic cigarettes, heat-not-burn cigarettes and moist snuff.

“I have taken the position for many years that VLN products are only truly effective as a harm-reduction strategy if there are lower-risk harm-reduction tobacco and nicotine products on the market,” said Scott Ballin, past chairman of the anti-smoking alliance Coalition of Science or Health.

Ballin said that strategy needs to be accompanied by “an aggressive educational campaign that would give consumers truthful accurate and non-misleading information about the risks and relative risk of the spectrum of products.”

“Approval of the 22nd Century product comes up way short in accomplishing that goal.”

22nd Century’s plans

22nd Century said it “plans to position VLN in the premium pricing segment of the cigarette market.”

“We are also in discussions with additional retail trade, marketing and strategic partners to scale VLN sales in the U.S. and internationally, including through potential licensing of our technology to facilitate the broader industry transition to (reduced nicotine content) products,” Mish said.

Cowen analyst Vivian Azer wrote Thursday that “we are leaving our estimates unchanged ($5 share price) as we had already been modeling for more than a doubling of quarterly tobacco revenue in fourth quarter 2022, having assumed that an (modified-risk) designation would ultimately be granted.”

“Initial market share data out of the pilot markets will be necessary to better assess potential upside to our estimates.”

The FDA has placed limitations on how the two brands can be marketed. It allows 22nd Century to make the following claims: 95% less nicotine than most traditional cigarettes; “helps reduce your nicotine consumption;” and “greatly reduces your nicotine consumption.”

“When using any of the reduced exposure claims in the product label, labeling or advertising, the company must include ‘helps you smoke less,” according to the FDA news release.

“The FDA also recommends that the labeling and advertising include the statement: ‘Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death.’ ”

FDA previously authorized these products without the reduced exposure claims or disclaimer in December 2019 through what is known as the premarket tobacco product application pathway.

FDA reasoning

The FDA authorization of the modified-risk marketing is part “of our mission is to find ways to stop tobacco-related disease and death,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a statement.

“We know that three out of four adult smokers want to quit, and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes.

“If adult smokers were less addicted to combusted cigarettes, they would likely smoke less and may be exposed to fewer harmful chemicals that cause tobacco-related disease and death,” Zeller said.

The FDA authorization requires the company to conduct postmarket surveillance and studies to determine whether the authorization criteria for these exposure modification orders continue to be met, including assessing use among youth.

The FDA stressed that “importantly, even with today’s action, these products are not safe nor ‘FDA approved’ — there are no safe tobacco products.”

The company must request and receive authorization from the FDA to continue marketing the products with the same modified exposure information after the initial exposure modification orders expire in five years.

The FDA also may withdraw the initial, and any potential subsequent, exposure modification orders “if the agency determines that, among other things, the orders are no longer expected to benefit the health of the population as a whole.”

Sole provider?

22nd Century’s ultimate goal is for the FDA to mandate that tobacco manufacturers only sell very-low-nicotine traditional cigarettes.

If very-low-nicotine traditional cigarettes prove attractive to tobacco consumers, the end result could be 22nd Century having a sharp increase in revenue and a potential buyout by a global tobacco manufacturer.

‘This is the first, and most likely will be the only, combustible cigarette to ever carry the FDA’s (modified risk) designation,” Mish said.

In September 2017, British American Tobacco Plc — owner of Reynolds American Inc. — ended a low-nicotine traditional-cigarette development partnership with 22nd Century that had been worth $14 million over four years.

According to 22nd Century, annual royalties from BAT were capped at $25 million.

BAT said at that time “we told the FDA it would take 20 years to comply with such a standard” of 95% less nicotine than a traditional cigarette.

Revenue hit?

Anti-smoking advocates say that if the FDA mandates very-low-nicotine traditional cigarettes, some smokers may go to a black market to buy cigarettes made outside the U.S. with current nicotine levels.

A June 2019 report Morgan Stanley analysts predicted that a dramatic decline in revenue — up to 50% by 2034 — could face tobacco manufacturers if the FDA succeeds in establishing significantly lower nicotine levels, particularly in traditional cigarettes.

The analysts said that with the lower nicotine levels, the tobacco industry could lose up to $165 billion in combined profits over a 15-year period even if manufacturers gain revenue from innovation nicotine products, such as electronic cigarettes, heat-not-burn cigarettes and oral nicotine products.

The analysts project BAT could see up to a 13% decline to its market capitalization, partially limited because just 40% of BAT’s profits come from the U.S.

By comparison, Altria Group Inc. could experience up to a 20% decline of its $92 billion market capitalization.

Analysts said the FDA is likely to face multiple lawsuits from tobacco manufacturers and anti-smoking groups on the tighter regulations.

The Morgan Stanley analysts say that any maximum nicotine regulation “is unlikely to come into force within the next 10-plus years … far enough away to allow tobacco manufacturers to de-level their balance sheets, protect their dividends and pivot their businesses away from traditional cigarettes.”

Regardless of nicotine levels, the analysts project the number of U.S. adult smokers will drop from 34 million to 14 million by 2030.

BAT’s stance covered the very-low-nicotine standards the FDA is pushing to achieve, as well as a proposed FDA ban or severe limitation on menthol traditional cigarettes that could be attempted in 2022.

BAT said it “believes the FDA does not have the (congressional) authority to ban a category of product (in traditional markets) … or reduce nicotine (levels) in tobacco products to zero.”

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What we lost when vaping got political

It is easy to forget now, given the speed with which we grew accustomed to the sight of our fellow citizens noisily dragging on devices that wouldn’t have been out of place on the set of Dune, but it was only in 2015 that Juul cracked the code on the unembarrassing electronic cigarette. Juul’s sleek, USB-like design swiped away memories of earlier vapes, which were often clumsy metal representations of the real thing. The Juul was charged via computer port, giving it the feel of a well-polished Apple product appearing in your life to alleviate your anxiety (anxiety being the issue many smokers know is at the heart of their addiction). It was the gadget of smokers’ dreams, and for creating it, cofounders James Monsees and Adam Bowen were handsomely rewarded: Juul reached “decacorn status”—a $10 billion valuation—quicker than any company in Silicon Valley history.

But Juul’s rapid ubiquity and rise to such tech-sector heights belied the small matter of its status with federal regulators. As it turns out, the devices have never been officially approved for use in the United States. For more than a decade, the FDA has punted the decision about whether e-cigarettes are a public health boon, leaving Americans to decide for themselves if vapes are a godsend with the potential to save the lives of millions of smokers—or the worst newfangled tech product to come along since the Zune (with the unfortunate side effect of potentially killing you). The FDA said it would weigh in when it had more information. Finally, in October, the agency granted word from on high that one favored e-cigarette could be sold in the U.S. It wasn’t a Juul.

Few who observed this fight were surprised by this outcome. For the past few years, Juul has been locked in a vicious battle with regulators, school districts, and states. To these antagonists, Juul is an immoral company that prized making billions over deep attention to the moral question at the heart of its controversial product: Is it worth saving the lives of some number of adult smokers by having Juul on the market if the price is nicotine addiction in young people, some number of whom will inevitably move on to combustible cigarettes and hasten their death? As the early leader in the space, Juul has traveled a bumpy path, drawing as much scrutiny as the Trump White House could muster and becoming yet another Silicon Valley cautionary tale along the way. (An FX–New York Times docuseries about the company’s rise last fall was titled Move Fast & Vape Things.)

Juul once had 75 percent of the vaping market share in the U.S. and was down to 42 percent last year, but the FDA-approved e-cigarette, R.J. Reynolds’s Vuse Solo Power Unit, is far less popular. The agency, it would appear, would never give Juul the satisfaction of being the first vape in America to attain authorization to market—it would rather let Juul twist a bit longer in the wind. So what exactly happened to the onetime darling? How did we go from “Dude, Where’s My Juul” and scrambling for lost Juul pods under the seats of our cars to regarding the company as the evil empire? And will we ever go back to a time when Juuling was a verb, like googling, or will it be forever thought of as an unfortunate cultural moment on par with the Tide Pod challenge?

Vaping works by extracting nicotine from tobacco and turning it into a smokable liquid without setting it on fire. It’s not nicotine that is toxic but the tar and chemicals that come from combusting tobacco by lighting a cigarette. Half of the world’s 1 billion smokers will die of smoking-related illnesses, making cigarettes arguably the most dangerous consumer product on the globe. But only Juul figured out how to make vapes so potent that they would satisfy smokers; earlier rivals had exponentially less powerful blends of nicotine.

The company had an elite pedigree: Monsees and Bowen created an early version of Juul as their product design master thesis at Stanford. They had a recombinant vision of marrying the tech and tobacco worlds, making both more humane and ethical, and spoke often about how Juul and its crème brûlée–flavored vapor would save lives by satisfying nicotine cravings, yet not hastening one’s demise. Identifying a big, sweeping idea during our late age of tech, when VCs are more likely to be inundated with investment requests from companies delivering hamburgers than a humanity-saving piece of machinery, was a big deal. Three years after they founded the company, Monsees and Bowen sold 35 percent of Juul to Altria, the company formerly known as Philip Morris Companies, for nearly $13 billion.

But there was one large, potentially humanity-destroying problem: In order to make Juul as appealing to smokers as possible, and by that I mean delivering a nice buzz and head rush, Juul upped the percentage of nicotine in each vape over the potency of e-cigarettes authorized for sale in Europe, not a continent known for its lack of devotion to smoking. This head-buzzy Juul was pleasurable but also insanely addictive. And it proved to be a hit not only with smokers, the group of people Juul claimed it was trying to save, but also with a group of people known for chasing head buzzes, namely teenagers.

Youth smoking has been on the decline since the 1990s (that was its peak in the U.S., with 36.4 percent of teens reporting they smoked the previous month in 1997). This victory is one of the few bright spots in America’s otherwise sad public health regimen (obesity and alcoholism come to mind). Most of the country’s 34 million smokers are Gen X or older. Today the habit doesn’t only stain teeth, wrinkle lips, and age the face; now you look older just because you do it.

But Juul destabilized this progress, turning an estimated 6 million American youths into nicotine fiends, according to Robert Jackler, a Stanford professor and key anti-vaping advocate. “Left on the bedside table of a teenager, a parent wouldn’t recognize it as a smoking device, and they became a thing for kids, like Beanie Babies, Hula-Hoops, or fidget spinners,” says Jackler. “Juul could never have designed such a big fad, because no company could engineer that, but once it happened, they knew about it, and here’s the rub—they went after it. And it succeeded beyond their wildest dreams.”

Juul violated a sacrosanct principle—do not market vices to American kids, or at least don’t be so obvious about it. Around 2018, when some Americans started acquiring lung diseases from vaping, journalists and politicians pointed the finger at Juul, even though the people who fell sick were actually smoking marijuana that had been laced with a chemical that black market purveyors use as a thickening agent. During the Trump administration, Juul’s most popular vapes, the ones with flavors, were pulled off the market. Juul hadn’t created mango-tasting vapes expressly to attract teenagers—an industry survey showed more than 90 percent of vape users prefer flavors to tobacco-flavored nicotine, which is right up there with durian on the list of world’s worst tastes—but the fact that adults also favor flavored vapes was considered beside the point.

Even if the company was dumb and greedy—and I think there is evidence to this effect—it paid a high price for being the prime mover in the e-cigarette revolution. By 2020, Altria was massively writing down its investment in Juul, because the company could not function in the current U.S. regulatory environment. But if you think about smoking as a larger public health problem, it’s also possible that Juul kick-started the important process of moving Americans to e-cigarettes—one that now needs to be finished.

The Biden administration seems to be thinking about how to move more smokers to vapes. They’re working on a plan to decrease the potency of nicotine in smokable cigarettes, to push Americans toward every type of e-cigarette. Vaping isn’t completely without risks, at least we don’t think it is; addiction to nicotine can warp adolescent brains in a state of plasticity, and some data suggests a link between vaping and asthma, chronic lung disease, and an increased risk of cardiovascular disease in “dual users” (people who vape and also smoke cigarettes).

In the rest of the world, many nations may have less incentive to help citizens get off cigarettes, because they gather high taxes for their coffers from the products. China has effectively outlawed e-cigarettes. Indonesia is weighing a ban. In the Philippines, you can be arrested for vaping in public. America has a second chance, with the FDA’s new approval of at least one e-cigarette, to do vaping right—and this time focus more deeply on the best way to truly save lives in the process.

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The FDA Exhales a Vape Approval

After years of debate, research, and data accumulation, the FDA finally approved a vape for commercial use. With the debate continuing, children are becoming the new battlefield. 

On Oct. 12, the Federal Drug Administration (FDA) announced the first vape authorized for mass marketing and distribution in the United States.

In a press release, the federal agency declared they “granted orders to R.J. Reynolds (RJR) Vapor Company for its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods.”

The authorization comes after several vape companies handed over samples to the FDA for testing and potential regulation. Only the Vuse product from the Reynolds Company met the requirements that the FDA demanded.

Not all of the flavors were approved — only the nicotine flavor which lacks the other additives that provide an extra taste.

The main reason for approving the product is the potential assistance it can provide for people who are addicted to nicotine products. Other alternatives like nicotine gum do not provide the same physiological connection of inhaling and exhaling.

“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, said in the press release. “The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products — either completely or with a significant reduction in cigarette consumption — by reducing their exposure to harmful chemicals.”

The Vuse vape is available at various gas stations, smoke shops, and other convenience stores. Their large availability plays an important role in the Reynolds Company’s overall success.

Like many traditional vapes, the Vuse has a refillable cartridge that relies on a liquid, commonly referred to as “juice,” to provide the inhalable vapor. This liquid is found in replaceable pods. The device features a battery that allows for greater portability as well.

The three flavors offered by the company are menthol, golden tobacco, and rich tobacco. The pods are placed magnetically into the device. All of the flavors offer a contrast from the fruity flavors other companies use to market towards  younger audiences.

Currently, Vuse owns 33 percent of the market share while Juul owns 40 percent. With a shift towards flavorless pods, the market share that Vuse acquired without appealing to a younger audience played a role in the product becoming authorized.

“For these products, the FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products,” the FDA stated in a press release. 

While the FDA felt the device would not lead to the youth gravitating towards the Vuse product, certain health experts are concerned with the adverse consequences of authorizing a vape product.

Ryan Barrlett of Utah’s Department of Health, felt as if a “green light” was given to people to consume and use vape products. Young adults, one group of concern for the FDA, may misinterpret the authorization.

“When it comes to e-cigarettes, we’re most concerned about youth, people who are in high school, middle school and even into the young adult range,” Bartlett said to Deseret News. “Because that’s the age where if you start using this, there’s a fairly good chance you’re going to use for the rest of your life.”

Apart from the confusion caused by the authorization, the Vuse device is only authorized for people who are attempting to quit smoking, not someone who is starting to vape. There is still the likelihood that a person who uses Vuse will emerge addicted to nicotine and could then start smoking cigarettes.

Eric Lindlom, a former official at the FDA, mentioned the specific use for the device is the only one tolerated. Any other uses pose risk for the user.

“The only way Vuse [products] could be used to reduce health harms relating to tobacco are if smokers switch entirely or near-completely from smoking to using the Vuse e-cigarette instead,” Eric Lindblom, a former official at FDA’s Center for Tobacco Products who is now a senior scholar at the Georgetown University Law Center, wrote in an email to POLITICO. “Any other use will increase the health harms and risks to the users.”

Compliance with the FDA requires multiple checks on a product to make sure it is consistently meeting the requirements. For the Vuse device, the amount of aerosols the device produces is the key aspect. As long as the amount is low enough to warrant the use for addicts, the regulation could continue.

“These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes,” the FDA stated in their press release. 

Going forward, the FDA still needs to rule on other companies’ products. The decision on Juul products was delayed with a ruling that should be executed within the near future.

With the FDA establishing that youth deterrence is a priority, they stated more actions are still needed to fully regulate vaping. After several products were ruled to be removed for marketing and sales, other potential actions loomed on the horizon.

Jody Sindelar, in the New England Journal of Medicine, addressed one of the potential actions which may follow regulation rulings: taxation.

With taxes rising on cigarettes to make them more expensive than vapes, nicotine addicts could transition to vaping rather than smoking cigarettes.

Also, if taxes are high enough, the high price of vaping could result in fewer young people becoming inclined to spend so much money. The next regulation could be higher taxes along with banning flavored vapes.

Young people could end up being deterred from even starting to vape with a higher entry cost and less attractive flavors.

The future of vaping regulation remains up in the air, and multiple avenues can develop according to how many more devices are FDA approved.

Depending on how the market develops, other actions like Dr. Sindelar proposed could be instituted as a means of achieving youth deterrence. As more research is done, increasingly strict or loose regulation could be coming soon.

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FDA OKs first e-cigarette, Vuse, a vaping device from RJ Reynolds, citing benefit to smokers

Story Highlights

  • Tuesday’s decision only applies to Vuse’s Solo e-cigarette and its tobacco-flavored nicotine cartridges.
  • Launched in 2013, Vuse Solo is a rechargeable metallic device that’s shaped like a traditional cigarette.
  • Vuse is the No. 2 vaping brand in the U.S. behind Juul, accounting for about a third of all retail sales.

WASHINGTON — For the first time, the Food and Drug Administration on Tuesday authorized an electronic cigarette, saying the vaping device from R.J. Reynolds can help smokers cut back on conventional cigarettes.

E-cigarettes have been sold in the U.S. for more than a decade with minimal government oversight or research. Facing a court deadline, the FDA has been conducting a sweeping review of vaping products to determine which ones should be allowed to remain on the market.

The agency said in September it had rejected applications for more than a million e-cigarettes and related products, mainly due to their potential appeal to underage teens. But regulators delayed making decisions on most of the major vaping companies, including market leader Juul, which is still pending.

Tuesday’s decision only applies to Vuse’s Solo e-cigarette and its tobacco-flavored nicotine cartridges. The agency said data from the company showed the e-cigarette helped smokers significantly reduce their exposure to the harmful chemicals in traditional cigarettes.

While the products can now be legally sold in the U.S., the FDA stressed they are neither safe nor “FDA approved,” and that people who don’t smoke shouldn’t use them.

Launched in 2013, Vuse Solo is a rechargeable metallic device that’s shaped like a traditional cigarette. The FDA said it rejected 10 other requests from the company for other flavored products. The agency is still reviewing the company’s request to sell a menthol-flavored nicotine formula.

“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” said Mitch Zeller, director of the FDA’s tobacco center, in a statement. “The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption.”

E-cigarettes first appeared in the U.S. around 2007 with the promise of providing smokers with a less harmful alternative to smoking traditional tobacco cigarettes. The devices heat a nicotine solution into a vapor that’s inhaled.

But there has been little rigorous study of whether e-cigarettes truly help smokers quit. And efforts by the FDA to begin vetting vaping products and their claims were repeatedly slowed by industry lobbying and competing political interests.

In recent years, the vaping market grew to include hundreds of companies selling an array of devices and nicotine solutions in various flavors and strengths. But the vast majority of the market is controlled by a few companies including Juul Labs, which is partially owned by Altria, and Vuse.

Vuse is the No. 2 vaping brand in the U.S. behind Juul, accounting for about a third of all retail sales. Its parent company R.J. Reynolds sells Newport, Camel and other leading cigarettes.

A company spokesperson said in a statement that the FDA decision confirms “that Vuse Solo products are appropriate for the protection of the public health, underscoring years of scientific study and research.”

To stay on the market, companies must show that their products benefit public health. In practice, that means proving that adult smokers who use the products are likely to quit or reduce their smoking, while teens are unlikely to get hooked on them.

Kenneth Warner, a tobacco expert at the University of Michigan’s school of public health, said the news was a positive step for reducing the harms of smoking. But he lamented that only a vaping device backed by a Big Tobacco company was able to win the FDA’s endorsement.

“The demands the FDA places on companies filing these applications are so extraordinary difficult to meet that only those with huge resources and personnel – in terms of scientists, lawyers, researchers – are able to file successfully,” said Warner.

He said smaller companies and vape shops should have a separate path to get their products authorized.

The FDA declared underage vaping an “epidemic” in 2018 and has taken a series of measures aimed at the small cartridge-based devices that first sparked the problem, including limiting their flavors to tobacco and menthol. Separately, Congress raised the purchase age for all tobacco and vaping products to 21.

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Youth Vaping Declined Sharply for Second Year, New Data Show

Teen use of electronic cigarettes fell sharply in 2021, the second consecutive year of big declines, according to the government’s annual National Youth Tobacco Survey.

This year, 11.3 percent of high school students reported that they currently vape — down from 19.6 percent in 2020 and strikingly lower than the 27.5 percent reported in 2019, according to a report of the survey issued Thursday by the Centers for Disease Control and Prevention.

Even with the drop, the survey found that more than 2 million high school and middle school students were currently using e-cigarettes. And because the declines came during the pandemic, some public health experts questioned whether the data really signaled a change in youth vaping trends over the long term.

E-cigarettes came on the market in the United States in the early 2000s, devices designed to give smokers the nicotine fix they craved without the carcinogens that come from burning cigarettes. But they began to catch on with teenagers who had never smoked, and in 2018, the Food and Drug Administration warned of an epidemic of vaping among teenagers who were becoming addicted to nicotine through e-cigarettes.

In a statement, Mitch Zeller, the director of the F.D.A.’s Center for Tobacco Products, said that the new data remained concerning, particularly the popularity of flavored e-cigarettes, which were banned by the Trump administration but remain on the market in certain forms through a regulatory loophole. According to the report, nearly 85 percent of youth e-cigarette users said they used flavored products. The most common flavors were fruit flavors, but also included candy, mint and menthol — consistent with prior years.

“We are equally disturbed by the quarter of high school students who use e-cigarettes and say they vape every single day,” Mr. Zeller said, pointing to the data that shows 27 percent of regular users are daily users.

The American Heart Association expressed concern as well.

“The results show that the crisis of e-cigarette use among youth remained very much alive even with kids spending large amounts of time at home during the pandemic,” the heart association said in a published statement. “With millions of children having returned to school this fall, immediate action is needed to prevent the sale of flavored e-cigarettes and other tobacco products, including menthol products.”

Robin Koval, president and chief executive of Truth Initiative, a nonprofit organization focused on ending nicotine addiction, emphasized that the sharp drop in youth vaping may be attributable to a temporary factor, the pandemic restrictions that kept young people at home. “Kids were not in school, they were not seeing friends,” Ms. Koval said.

Another striking change seen in the new data was the decline in popularity of Juul, the once-dominant e-cigarette maker, whose sleek devices, sometimes dubbed “the iPhone of e-cigarettes,” are considered by many to started the youth vaping trend. Juul now only sells menthol and tobacco flavors, after the F.D.A. banned flavored pods in early 2020.

The latest survey showed that Puff Bars, which sells a variety of flavors, is the most popular brand among youth, with 26 percent of regular high school e-cigarette users reporting Puff as “their usual brand.” Other popular brands include Vuse (10.8 percent) and SMOK (9.6 percent), while just 5.7 percent said their usual brand is Juul.

That change reflects a loophole in federal regulations that allowed flavors to be sold in disposable e-cigarettes while banning them in the pods go in refillable cartridge-based devices that companies like Juul sell. The loophole caused a surge in sales of disposables and in popularity among disposable brands, notably Puff Bars.

In 2021, disposables were most commonly used, by about 53 percent of youth who vape, followed by refillable or prefilled cartridges at 28.7 percent. A year ago, those figures were essentially flipped, with prefilled pods and cartridges leading and disposables taking a distant second.

The new numbers renewed calls to close the loophole and ban flavors for all devices, including disposables.

“Today’s survey results point to clear actions the FDA must take to end the youth e-cigarette epidemic for good: It must eliminate all flavored e-cigarettes, including menthol-flavored products,” said Matthew L. Myers, President for the Campaign for Tobacco-Free Kids, a nonprofit advocacy organization.

The C.D.C. and the F.D.A., which regulates e-cigarettes and tobacco products, emphasized that the year-to-year comparisons are complicated by changes to data collection: In 2021, because of the pandemic, youth responses were gathered entirely electronically, through online questionnaires, whereas the data had previously been conducted in classroom surveys.

Ms. Koval and other public health advocates said the change in methodology could have meant that some youth were answering questionnaires at home — with parents around — which could have caused them to be less truthful then in prior years.

But the data have considerable implications for policy decisions currently in front of the F.D.A. The agency is deciding which e-cigarette companies can be allowed to remain on the market, following a review of whether their products provide more public benefit — by helping smokers quit cigarettes — than harm, by creating a new generation of nicotine addicts.

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The FDA Postpones A Long-Awaited Decision On Juul’s Vaping Products

The Food and Drug Administration said it has ruled on whether some electronic cigarette products can remain on the market, but that it’s also delaying action on products made by Juul, which accounts for 40% of the e-cigarette market.

The FDA said Thursday it has issued marketing denial orders for more than 946,000 flavored vaping products because their applications “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.”

The decisions encompass 93% of the applications companies submitted for approval – but Juul, the largest vape company, was not included in Thursday’s action.

A federal judge had given the FDA one year to act on a flood of applications submitted by vape companies in a decision stemming from a lawsuit brought by anti-tobacco groups. The agency said it’s made progress but needs more time.

“We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” the FDA said.

The news comes after years in which critics have urged tighter federal controls on vaping to combat a new surge of nicotine use by minors.

One in five high school students — and more than 6% of American adults overall — now say they vape. The industry has ballooned to more than $6 billion, led by Juul.

The FDA has long regulated the marketing and sale of traditional tobacco products such as cigarettes. But until now, the agency hasn’t required the same scrutiny for vapes, allowing the market to flourish.

Decisions are pending on many vaping products

E-cigarette companies, including Juul, argue that their products are safer than traditional tobacco products such as cigarettes. But the FDA has been evaluating about 6.5 million products made by more than 500 companies to determine whether they are “appropriate for the protection of public health.”

The products under FDA review range from rechargeable vape pens and the liquids that fill them to disposable e-cigarettes. Each of them requires a Premarket Tobacco Product Application, or PMTA, to be filed with the government — and those applications are what the FDA has been considering.

In the most serious instances, some products would be required to be pulled from the market.

Last month, the FDA issued its first marketing denials for some 55,000 flavored vape products from three companies, ordering them to withdraw their products from stores. It has also denied applications for companies marketing flavors designed to appeal to kids, such as Apple Crumble and Cinnamon Toast Cereal.

Regulators said the applications in the FDA’s first set of denials “lacked sufficient evidence” that any benefit to adult smokers outweighed “the public health threat posed by the well-documented, alarming levels of youth use of such products.”

The FDA weighs vaping’s health effects

Though vaping allows users to avoid some of the harmful carcinogens caused by smoking traditional cigarettes, studies have found that e-cigarettes are still harmful.

Inhaling vapors from the products can introduce harmful chemicals into the lungs, including, in some cases, vitamin E acetate. Dozens of people have died in recent years from vaping complications in the U.S., and thousands more have been hospitalized. Most of those vaping injury cases were linked to products containing THC, not nicotine.

Virtually all e-cigarette products contain nicotine, some in high levels — including Juul’s 5% pods, each of which contains as much nicotine as an entire pack of cigarettes. Nicotine also affects prenatal and adolescent brain development, making it dangerous for both teenagers and pregnant people to vape.

“If any e-cigarette could actually help a smoker quit, they would apply to be a drug through other pathways that the FDA [has], and they would demonstrate that they are safe and effective in helping smokers quit,” said Erika Sward of the American Lung Association, which has advocated for the denial of all applications to the FDA for any flavored tobacco product.

“Instead, what we’ve seen is another generation of kids addicted and a whole situation where we have millions of smokers — who might otherwise try to end their addiction — try to use this product,” she said.

Why the FDA was expected to announce decisions Thursday

In 2019, a federal judge ordered e-cigarette manufacturers to submit applications to the FDA by 2020. Their products would be allowed to remain on the market for one year while the agency reviewed them. That year-long deadline arrived on Thursday.

The agency was not expected to respond to every product application by Thursday’s deadline. It has said it will prioritize companies based on their market share, meaning Juul, along with British American Tobacco and Imperial Brands — which respectively own the brands Vuse (formerly Vype) and blu — would have been expected to be the first to face decisions.

“We respect the central role of the FDA and the required thorough science- and evidence-based review of our applications, which is key to advancing harm reduction and earning a license to operate,” a company spokesman for Juul Labs said in a statement. “We remain committed to transitioning adult smokers away from combustible cigarettes while combating underage use.”

Thursday’s deadline left many industry watchers wondering if the FDA might impose a major crackdown on virtually all vape products or if it might take a more targeted approach, such as blocking the sale of flavored products or disposable e-cigarettes — or creating marketing rules similar to those for traditional cigarettes.

Restrictions on marketing and package designs are meant “to reduce youth initiation and use,” said Kathleen Hoke, a professor of public health law at the University of Maryland.

Some worry vaping limits will lead teens to cigarettes

Some researchers worry that a major crackdown on Juul and other manufacturers would simply send teenagers reaching for traditional cigarettes instead.

“I think it would be a public health disaster,” said Dr. Michael Siegel, a researcher at Tufts University who studies youth tobacco and alcohol use. “Vaping is not causing a culture of smoking. It’s actually replacing that culture.”

Youth smoking rates have fallen dramatically in recent years as vaping has exploded in popularity. But other researchers are skeptical the trend would reverse.

“Whether those people chose to choose to go back to a cigarette that tastes like a cigarette or a vape product that tastes like a cigarette, I think is anyone’s guess,” the University of Maryland’s Hoke said.

NPR’s Allison Aubrey and Bobby Allyn contributed to this report.

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Are they banning delta 8 hemp moon rocks in Texas?

Have you been hearing the term moon rocks going around lately? If not, then you’re about to. Moon rocks are a relatively newer product in the world of Cannabis. If you’ve ever come across one, then it is self-explanatory as to how it got its name. The recent years saw speculation about banning delta-8 THC due to its similarity to delta-9. But, these words may only sound similar, but they have a lot of differences between them. Let’s get into detail about delta 8 hemp moon rocks and why it has been around so much buzz.

 

What are delta 8 moonrocks?  

Delta-8 Moonrocks are hemp flower buds sprinkled with Delta-8 distillate and rolled in CBD or CBG kief. In simple language, hemp and marijuana plants are processed into making delta-8 which contains cannabinoids such as CBD, CBG, etc. The combination of delta-8, CBD and CBG, makes consuming it a one-of-a-kind experience.

 

Difference between delta-8 and delta-9

The similarity between these two cannabinoids lies in their chemical structure and their name. But the primary difference is that delta-9 gets you to experience psychotic effects and the ‘high’ associated with marijuana, while delta-8 doesn’t.

 

The extraction process for delta-9 is pretty cheap. That is because that cannabinoid can be found in the cannabis plant in abundance. So, the process is relatively simple. On the other hand, extracting delta-8 is a great deal of effort. It is synthesized entirely from CBD with the help of solvents because there are very few neutral delta-8 present in the Cannabis plant. This process is although expensive but has made the process easier. As a result, delta-8 is derived from hemp instead of marijuana.

 

Talking about its effects, delta-9 is considerably more potent than delta-8. It is also believed to be twice as strong. However, users have also said they experience ‘high’ but not as strong enough to lose motor functioning. The user may experience many side effects such as paranoid delusions, memory loss, and impaired motor functioning skills. On the other hand, delta-8 is said to provide a much soothing experience. People feel very calm and relaxed after consuming it. They feel less stressed and more flexible.

 

Legality in Texas

The current legality of delta-8 THC products was called into question when Stephen Paul from the Department of State Health Services testified during the hemp hearing. He testified that DSHS considers delta-8 THC illegal under current state law.

 

Owing to the 2018 Farm Bill, the consumption of THC, CBD, and delta-8 was legalized by federal law. However, we recommend delta8, it is still something that experts and lawmakers do not universally prefer. The federal and state laws are strictly against recreational and even medical use of high-THC concentrated delta-9. It is illegal to use it for any purpose. But these rules vary from state to state.

 

Delta-8 and other THC products were to be made illegal with the passage of Texas House Bill 2593. Last month, the provision that would make them illegal was stricken from the voted-on legislation. According to the Texas House Bill 1325, an individual can use products with less than 0.3 percent of THC.

 

With the endless efforts from delta-8 vendors and the Texas Hemp Federation, it revoked the bill to make consumption of delta-8 illegal. Hometown Hero, a veteran-owned business, teamed up with various advocacy groups and sellers of the product to prevent it from passing. After there could not be an agreement between the House and the Senate, the bill died.

 

Currently, the Texas Legislature is coming to the end of their 2021 and still working through several bills aiming to do things like the expansion of research into the medicinal properties of the psychedelics, also expand the THC level allowed in recreational use of medical Cannabis, and also decriminalize the possession of marijuana. Each of these bills remains in different stages with the deadline coming closer, but at least one looks at an added agreement during the debate to add laws in the state concerning the levels of delta-8 THC allowed in products and delta-9.

 

The general public considers regulation as a far better approach to move ahead with laws concerning delta-8. At present, the delta-8 market is relatively unchecked and unregulated. Many people demand the institution of reasonable regulation and not simply prohibit the product. It’s a collective effort from people favoring legalization who make sure that people are well-educated about driving under its influence, which would remain illegal, and age requirements to protect children. Similar regulations are in place for alcohol consumption and should be imposed for THC as well.

Benefits

Many people have stated that delta-8 brings them to a state of overall well-being because the cannabinoid receptors are directly involved with homeostasis, which is the body’s natural resting state. Other benefits include people feeling energized, well-rested and clear-headed. They even mentioned getting rid of nausea that was caused by alcohol hangovers.

Are they banning delta 8 hemp moon rocks in Texas?
https://pixabay.com/photos/delta-8-thc-cbd-oil-cannabis-6105641/

According to recent research, delta-8 THC helps produce an element in our body called Acetylcholine, a neurological function responsible for cognition, memory, and arousal.

Moonrocks are very convenient for people who want to get instant relief from their medical problems. It helps you treat issues such as anxiety, depression, chronic pain, etc. People who have been suffering from low libido also tend to look towards delta-8. It may also help to treat menstrual pain and cramping relief.

 

Conclusion 

As a beginner in the Cannabis industry, moonrocks may not be the ideal choice for you, as it is super potent. There are benefits and the presence of multiple cannabinoids in one product. As moonrocks are smoked and vaporized, they enter our lungs within minutes. So, if you are someone who is comfortable with something much stronger than a traditional plant, then moonrocks might be a good option for you. Before consuming any Cannabis product, be it CBD or delta-8, always make sure to consult your doctor to avoid any potential adverse reaction that might happen due to any previous medications.

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400+ Vape Businesses Urge FedEx to Change Shipping Rules

WASHINGTON, D.C. — Today, the American Vaping Association, a pro-vaping advocacy organization, sent a letter to FedEx signed by 428 small business owners urging the carrier to reconsider its recent policy change that prohibits them from shipping or receiving vaping products, otherwise known as e-cigarettes. The letter warns that the refusal of FedEx to update their policy will have unintended consequences, including perpetuating smoking-related deaths, especially in marginalized communities.

Small businesses across the country rely on common carriers like FedEx, UPS and DHL to meet customer demands and to get lifesaving products in the hands of those who need them most. Unfortunately, in the wake of the decision by Congress in December 2020 to prohibit the United States Postal Service from delivering vaping products to consumers, these private carriers responded by prohibiting their customers from shipping vaping products to both businesses and consumers.

Now, small businesses across the country are feeling the brunt of these new policies, which make vaping products harder to ship than firearms. In the letter, the owners write:

“Without the option to order vaping products at wholesale or ship their products to consumers, vape stores have seen their shipping options skyrocket in cost or evaporate entirely. If consumers are not able to access or afford these reduced-risk alternatives to cigarettes, they will be forced to turn back to combustible tobacco, which is far more dangerous and will have life-long consequences on their health.”

The effects of this decision will be felt disproportionately among minority and low-income communities. The letter points out that these communities “smoke cigarettes at higher rates than white and more affluent populations,” and Black Americans are among the most likely demographic to use e-cigarettes as a tool to quit combustible tobacco.

President of American Vaping Association Gregory Conley implores these shipping companies to reconsider this decision and look at the harmful effects it will have on already disadvantaged communities:

“FedEx is doing a great disservice to American small businesses and consumers. They are playing right into the hands of Big Tobacco, which directly benefits from policies that make it more expensive for adult smokers to switch. Not only are vaping products legal and regulated by the Food & Drug Administrations, but they saving lives by keeping people off combustible cigarettes.”

That is why American Vaping Association stands with these businesses and is encouraging FedEx to revisit this disastrous policy.

To read the full letter, please visit: https://vaping.org/wp-content/uploads/2021/07/AVA-Coaltion-Letter-FedEx-7.12.21.pdf

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Ban on flavored vaping may have led teens to cigarettes, study suggests

When San Francisco voters overwhelmingly approved a 2018 ballot measure banning the sale of flavored tobacco products — including menthol cigarettes and flavored vape liquids — public health advocates celebrated. After all, tobacco use poses a significant threat to public health and health equity, and flavors are particularly attractive to youth.

But according to a new study from the Yale School of Public Health (YSPH), that law may have had the opposite effect. Analyses found that, after the ban’s implementation, high school students’ odds of smoking conventional cigarettes doubled in San Francisco’s school district relative to trends in districts without the ban, even when adjusting for individual demographics and other tobacco policies.

The study, published in JAMA Pediatrics on May 24, is believed to be the first to assess how complete flavor bans affect youth smoking habits.

“These findings suggest a need for caution,” said Abigail Friedman, the study’s author and an assistant professor of health policy at YSPH. “While neither smoking cigarettes nor vaping nicotine are safe per se, the bulk of current evidence indicates substantially greater harms from smoking, which is responsible for nearly one in five adult deaths annually. Even if it is well-intentioned, a law that increases youth smoking could pose a threat to public health.”

Friedman used data on high school students under 18 years of age from the Youth Risk Behavior Surveillance System’s 2011-2019 school district surveys. Prior to the ban’s implementation, past-30-day smoking rates in San Francisco and the comparison school districts were similar and declining. Yet once the flavor ban was fully implemented in 2019, San Francisco’s smoking rates diverged from trends observed elsewhere, increasing as the comparison districts’ rates continued to fall.

To explain these results, Friedman noted that electronic nicotine delivery systems have been the most popular tobacco product among U.S. youth since at least 2014, with flavored options largely preferred.

“Think about youth preferences: some kids who vape choose e-cigarettes over combustible tobacco products because of the flavors,” she said. “For these individuals as well as would-be vapers with similar preferences, banning flavors may remove their primary motivation for choosing vaping over smoking, pushing some of them back toward conventional cigarettes.”

These findings have implications for Connecticut, where the state legislature is currently considering two flavor bills: House Bill 6450 would ban sales of flavored electronic nicotine delivery systems, while Senate Bill 326 would ban sales of any flavored tobacco product. As the U.S. Food and Drug Administration recently announced that it will ban flavors in all combustible tobacco products within the next year, both bills could result in a Connecticut policy that is similar to the complete ban enacted in San Francisco.

The San Francisco study does have limitations. Because there has been only a short time since the ban was implemented, the trend may differ in coming years. San Francisco is also just one of several localities and states that have implemented restrictions on flavored tobacco sales, with extensive differences between these laws. Thus, effects may differ in other places, Friedman wrote.

Still, as similar restrictions continue to appear across the country, the findings suggest that policymakers should be careful not to indirectly push minors toward cigarettes in their quest to reduce vaping, she said.

What does she suggest as an alternative? “If Connecticut is determined to make a change before the FDA’s flavor ban for combustible products goes into effect, a good candidate might be restricting all tobacco product sales to adult-only — that is 21-plus — retailers,” she said. “This would substantively reduce children’s incidental exposure to tobacco products at convenience stores and gas stations, and adolescents’ access to them, without increasing incentives to choose more lethal combustible products over non-combustible options like e-cigarettes.”

This work was supported by a grant from the National Institute on Drug Abuse of the National Institutes of Health and FDA Center for Tobacco Products (CTP). The content is solely the responsibility of the author and does not necessarily represent the official views of the National Institutes of Health or the Food and Drug Administration.