The US Food and Drug Administration (FDA) has approved the cannabidiol (CBD) drug Epidiolex oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older, according to press release from GW Pharma.
TSC is a rare genetic disease that causes non-cancerous tumors to grow in the brain and other parts of the body like the eyes, heart, kidneys, lungs, and skin. TSC affects about 1 in 6,000 people, according to the release.
Epidiolex was previously approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). This is the only FDA-approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with TSC.
Epidiolex’s effectiveness for TSC-associated seizures was established in a randomized, double-blind, placebo-controlled trial where 148 patients out of 224 received Epidiolex. Patients treated with Epidiolex had a significantly greater reduction in the frequency of seizures during the 16-week treatment period than patients who received placebo.
The most common side effects in Epidiolex-treated patients were: diarrhea, elevated liver enzymes, decreased appetite, sleepiness, fever, and vomiting. The FDA had granted Priority Review designation for this application.
The U.S. Food and Drug Administration (FDA) has issued warning letters to 10 companies, including Puff Bar parent Cool Clouds Distribution, asking for the removal of flavored disposable e-cigarettes from the market. The FDA cites youth-appeal and a lack of a required premarket authorization.
“These new actions are part of the FDA’s ongoing, aggressive effort to act against illegally marketed tobacco products amid the public health crisis of youth e-cigarette use in America,” said FDA Commissioner Stephen Hahn. “The agency is particularly concerned about the appeal of flavored, disposable e-cigarettes to youth and continues to monitor all available data.”
Three firms are receiving warning letters for illegally marketing disposable e-cigarettes—Puff Bar, HQD Tech USA LLC and Myle Vape Inc. The FDA’s review of the companies’ websites revealed that each firm is selling or distributing unauthorized tobacco products that were first introduced or modified after Aug. 8, 2016—the effective date of the deeming rule that extended the FDA’s authority to all tobacco products.
“Despite suspending in-person inspection activities—such as retail compliance checks and vape shop inspections—due to the COVID-19 pandemic, our enforcement against unauthorized e-cigarette products has endured,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “These warning letters are the result of ongoing internet monitoring for violations of tobacco laws and regulations.”
Any new tobacco product not in compliance with the premarket requirements of the Federal Food, Drug and Cosmetic Act (FD&C Act) is adulterated and misbranded and may not be marketed without FDA authorization, according to the FDA. Puff Bar and HQD Tech USA LLC were also cited for an additional violation for marketing their products as modified risk tobacco products without an FDA order in effect that permits such marketing.
Additionally, the FDA issued seven other warning letters to the following firms: Eleaf USA, Vape Deal LLC, Majestic Vapor LLC, E Cigarette Empire LLC, Ohm City Vapes Inc., Breazy Inc. and Hina Singh Enterprises (doing business as Just Eliquids Distro Inc.), who “sell or distribute unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth. These firms were cited for marketing unauthorized e-liquids that imitate packaging for food products that often are marketed and appeal to youth, such as Cinnamon Toast Crunch cereal, Twinkies, Cherry Coke and popcorn, or feature cartoon characters.”
The FDA has requested responses from each firm within 15 working days detailing how each company intends to address the agency’s concerns, including the dates on which each firm discontinued the sale and/or distribution of these tobacco products, and its plans for maintaining compliance. Failure to correct violations may result in further action such as a civil money penalty complaint, seizure or injunction. In addition, misbranded or adulterated products imported into the U.S. are subject to detention and refusal of admission, according to the FDA.
The FDA’s actions during the COVID-19 pandemic also include a recent warning letter to e-liquid manufacturer StemStix Inc. for violations of the FD&C Act, including marketing new tobacco products without authorization, marketing tobacco products with false and misleading advertising and marketing unauthorized modified risk tobacco products.
Additionally, last month the agency issued letters to seven tobacco product manufacturers requesting information to help the FDA examine whether certain tobacco products were first marketed after the deeming rule’s effective date and therefore not subject to FDA’s policy on deferred enforcement of the premarket requirements for certain deemed products. Over the past four months, the agency has also refused admission into the U.S. of at least 74 entries of disposable ENDS products for violations of the FD&C Act.
The U.S. Food and Drug Administration (FDA) has issued Acceptance and Filing letters for E-Alternative Solutions (EAS), an independent, family-owned innovator of consumer-centric brands for its Leap and Leap Go vapor products. This notification moves the EAS products to the Substantive Review phase of the Premarket Tobacco Product Application (PMTA) process.
“This milestone represents an important step forward for EAS as we support our mission of producing high-quality vapor products that serve as an alternative to combustible cigarettes with our Leap and Leap Go vapor products,” said Jacopo D’Alessandris, president and CEO of EAS. “FDA Acceptance and Filing Letters are a testament to the strength and thoroughness of our applications, which we believe will meet FDA’s requirements. We want to thank FDA for the prompt turnaround on these materials given the challenging circumstances, and we look forward to partnering with the Agency as we move forward in the process.”
Jacopo D’Alessandris
The Acceptance letters follow the administrative review of EAS’s filings to ensure that the submissions met the baseline criteria for review. The Filing Letters are the result of a preliminary scientific review that ensures that the applications include the necessary ingredients and health analyses. FDA will now conduct a Substantive Review to assess whether the Leap and Leap Go products are appropriate for the protection of public health. If successful, this phase will result in Marketing Orders from FDA authorizing the continued marketing and sale of these products.
“The Substantive Review is where our months of hard work assembling more than 100,000 pages of evidence will pay off in supporting our proposition that the Leap and Leap Go products are appropriate for the protection of public health,” said Chris Howard, Vice President, General Counsel and Chief Compliance Officer at EAS. “We are looking forward to continued collaboration with FDA in the weeks and months to come and remain optimistic that the PMTA process will result in Marketing Orders.”
The U.S. Food and Drug Administration (FDA) on July 7 issued exposure modification orders to Philip Morris Products’ (PMP) IQOS heat-not-burn device system (holder and charger) and three Marlboro Heatstick variants.
The FDA previously authorized the marketing of IQOS without modified risk information in April 2019 via the premarket tobacco application pathway.
In its most recent ruling. the FDA determined that IQOS does not currently meet the standard for marketing with reduced-risk claims but can be marketed with a reduced-exposure claim.
Specifically, the FDA is allowing the company to claim:
The IQOS system heats tobacco but does not burn it.
This significantly reduces the production of harmful and potentially harmful chemicals.
Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.
“Through the modified risk tobacco product application process, the FDA aims to ensure that information directed at consumers about reduced risk or reduced exposure from using a tobacco product is supported by scientific evidence and understandable,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.
“Data submitted by the company shows that marketing these particular products with the authorized information could help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals, but only if they completely switch.”
In its announcement, the FDA stressed that is marketing authorization doesn’t mean the reviewed products are safe or “FDA approved.”
The FDA’s marketing order requires PMP to conduct post-market surveillance and studies to determine the impact of these orders on consumer perception, behavior and health, and to enable the FDA to review the accuracy of the determinations upon which the orders were based.
These post-market requirements include a rigorous toxicity study using computer models to help predict potential adverse effects in users. The orders also require the company to monitor youth awareness and use of the products to help ensure that the marketing of the MRTPs does not have unintended consequences for youth use.
“The FDA’s decision is a historic public health milestone,” said Andre Calantzopoulos, CEO of Philip Morris International. “Many of the tens of millions of American men and women who smoke today will quit—but many won’t. Today’s decision makes it possible to inform these adults that switching completely to IQOS is a better choice than continuing to smoke. FDA determined that scientific studies show that switching completely from conventional cigarettes to IQOS reduces exposure to harmful or potentially harmful chemicals.”
“The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health.”
“We’re delighted that the FDA authorized IQOS to be marketed as a modified-risk tobacco product,” said Billy Gifford, CEO of Philip Morris USA’s parent company, Altria Group, which will be marketing the product in the U.S. “This authorization gives PM USA an opportunity to communicate additional benefits of switching to IQOS and this decision is an important step for adult smokers.”
In a note to investors, Morgan Stanley described the FDA’s order as a positive development because it provides greater flexibility for IQOS to be marketed as relatively less harmful than cigarettes.
“The inability to make relative lower harm claims is a constraint to broader IQOS adoption in the U.S.,” wrote Morgan Stanley analyst Pamela Kaufman.
“Over time, PM can continue to submit additional information towards a full MRTP approval. The modified exposure designation combined with pending PMTA approval for IQOS 3 should accelerate MO’s [Altria’s] U.S. expansion strategy for IQOS. The FDA’s recognition of IQOS’s benefits relative to cigarettes may also enhance IQOS’ perception with international health agencies, helping its growth prospects,” Kaufman said.
Anti-smoking activists were less enthusiastic. In a joint statement, the Campaign for Tobacco-Free Kids, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association and the Truth Initiative, said the FDA marketing order would put consumers at risk.
“With today’s action, the FDA has created a real danger that kids and adults will falsely believe IQOS has been proven to present a lower health risk and that kids will be exposed to marketing that portrays IQOS, a highly addictive tobacco product, as an appealing, cool alternative to cigarettes, in much the same way as e-cigarettes,” the anti-tobacco groups wrote in their statement.
The 5th U.S. Circuit Court of Appeals has upheld the U.S. Food and Drug Administration (FDA)’s authority to regulate e-cigarettes as tobacco products, reports Reuters.
A unanimous panel ruled Thursday that Congress’ decision to delegate vaping regulation to the FDA was constitutional under the non-delegation doctrine because Congress had articulated an “intelligible principle” in delegating authority to determine what qualified as a tobacco product to the FDA.
The 5th Circuit’s ruling is the latest rejection of a series of legal challenges from the vapor industry.
The U.S. Food & Drug Administration (FDA) does not intend to delay the current Sept. 9, 2020 deadline for the vapor industry to submit applications for marketing authorization before a hearing is scheduled for the plaintiffs in the case.
In a status report filed Wednesday to the U.S. District Court for the District of Columbia, the regulatory agency told the court that it does “not currently plan to seek an extension of the September 9, 2020 premarket application deadline.”
Any extension requested by the plaintiffs could be complicated because the request would have to be approved by the Maryland-based federal court that forced the agency to move the deadline to May 12, 2020 due to a separate lawsuit.
The FDA has already delayed the PMTA deadline due to the Covid-19 pandemic. The deadline was previously scheduled for May 12, 2020 but was moved to Sept. 9. According to the FDA’s status report, the plaintiffs in the case are expected to file a status report requesting their preferred argument date for a further extension.
“We know beyond reasonable doubt that vaping and other smoke-free nicotine products are very much less risky than smoking and that those who switch completely see rapid improvements in their health. Yet the WHO continues to promote the outright prohibition or extreme regulation of these products. How can it make sense to ban the much safer product when cigarettes are available everywhere?”
“[The] WHO is treating vaping products as though they are part of a ploy by Big Tobacco. But they have this 100 percent wrong. In fact, the new products are disrupting the profitable cigarette trade of the tobacco industry and driving down cigarette sales. It is exactly what we need from innovation, but [the] WHO and its private funders have lined up to oppose it with calls for prohibition. Though they don’t seem to realize it, they are siding with the cigarette interests of Big Tobacco, erecting barriers to entry to new technology and protecting the incumbent cigarette oligopoly.”
“When smoking is by far the dominant cause of disease caused by tobacco, why would the WHO use World No Tobacco Day to target one of the most effective and popular alternatives to smoking? We rarely see the vaping industry advertise to adolescents and we never see kids used in commercial vaping ads—but on World No Tobacco Day we have the absurd spectacle of [the] WHO promoting adverts with children vaping. What on Earth do they think they are doing?” – Clive Bates
“Unless it does something different and embraces innovation in tobacco policy, [the] WHO will miss the targets for reducing cancer [and] heart and lung disease by some distance. Encouraging people to switch to low-risk alternatives to smoking could make a large difference to the burden of disease by 2030 if [the] WHO got behind the idea instead of blocking it.”
“On World No Tobacco Day, the WHO should be driven by one overriding question: How do we get smoking down for the greatest number at the greatest rate? We know [the] WHO embraces harm reduction in other areas of public health, including for illicit drugs and sexual health. If [the] WHO wants to even come close to meeting its targets to reduce disease, it needs a strategy for smokers who can’t or won’t quit nicotine, and the rise of smoke-free products since 2010 makes that a practical option. [The] WHO’s ‘quit or die’ approach to smokers and opposition to harm reduction makes no sense.”
“When [the] WHO set out to build an international treaty for tobacco control from 2000, the goal was clear—it was trying to tackle the worldwide epidemic of smoking-related disease. Somewhere along the way, [the] WHO seems to have lost its sense of purpose and developed a closed mentality that is leading it to take unworkable, nonnegotiable or counterproductive positions that are not backed by sound science. It seems to have neglected its core mission, ‘the highest possible level of health for all people,’ including the 1 billion smokers globally, most of whom want to avoid disease and premature death.”
Experts say the spread of misinformation about vapor has a negative effect on public health.
By Timothy S. Donahue
It can be confusing for even the experts. During the pandemic, the vapor industry has struggled under conflicting reports about whether vaping makes you more susceptible to catching Covid-19. Several media stories have speculated that vaping could make having the illness even more severe (see “Up in the Air,” page 16). Anti-tobacco groups quickly began to claim smoking and vaping could even help spread the disease although no studies have found this to be true.
In the U.S., these news stories have prompted politicians to demand that the U.S. Food and Drug Administration (FDA) temporarily ban e-cigarettes. Several states are either considering or have passed vaping regulation as part of their coronavirus response. Globally, the World Health Organization (WHO) has accused the tobacco (and vapor) industry of creating doubt about the risks of nicotine and tobacco product and Covid-19. One country, South Africa, went as far as to ban tobacco products altogether as part of its coronavirus lockdown.
The controversy grew in April and May as researchers noted a remarkable underrepresentation of smokers among Covid-19 patients who had been admitted to the hospital. “This has led some scientists to hypothesize that there may be some protective effect from nicotine specifically to do with coronavirus,” said Guy Bentley, director of Consumer Freedom Research at the Reason Foundation, a libertarian think tank. Currently, clinical trials are underway investigating the effects of nicotine patches in France and now in Wales.
During a webinar held by the Reason Foundation in mid-May, a panel of harm reduction experts weighed in on the supportive new research as well as the misinformation being disseminated and the impact these factors have on both the vapor industry and overall public health.
Sally Satel, resident scholar at the American Enterprise Institute, an influential right-wing think tank, noted that every observational study concerning Covid-19 has seen that smokers are underrepresented in patients who are admitted to the hospital. These included thousands of patients in more than two dozen studies from several countries, including Italy, France, China and the United States. She also said that many of these studies have not been peer-reviewed, and concerns about data collection exist. “Nevertheless, they’re exciting, and they are especially exciting … because they are so counterintuitive,” said Satel.
Satel pointed to one study conducted by Konstantinos Farsalinos, a cardiologist and research fellow at the Onassis Cardiac Surgery Center in Athens, Greece. Farsalinos found that across 13 studies from China, only 6.5 percent of all hospitalized patients with Covid-19 were smokers whereas 26 percent of the population smokes cigarettes. If smoking made no difference, you would expect a 26 percent representation, according to Satel. “If smoking was harmful [relating to Covid-19] you certainly wouldn’t expect lesser representation,” she said. “So that was very eye-catching. This pattern has since been found in many of the studies. They’re all in the same ballpark … a U.S. study found [the same] … A French study also found similar results.”
Satel explains that the research has shown two ways nicotine could have an impact on Covid-19 with one being more plausible. The first theory is, very basically, that nicotine blocks the entry of the virus into receptor cells. The more plausible theory, however, is that nicotine has a suppressing effect on the cytokine pathway, says Satel. The immune system depends on cytokine signaling to keep the human body healthy.
“Now, cytokines are chemicals produced by white cells in the body or the infection-fighting cells. And specifically, in this case, a macrophage is one of those cells, and macrophages literally eat viruses,” explains Satel. “Anyway, briefly, there is a receptor on the macrophage called the citicoline receptor or a neuronal type, and nicotine also can attach to that receptor and influence the release of those cytokines, and the mechanism of that is called a cytokine storm.”
WHO is to blame?
Tobacco may also be potentially part of a Covid-19 cure. British American Tobacco (BAT) researchers announced in May that BAT’s potential Covid-19 vaccine was moving to human trials after it generated a positive immune response in preclinical trials. The vaccine candidate uses proteins from tobacco leaves. Yet rather than welcoming BAT’s effort to help tackle the pandemic, the WHO cautioned health authorities against engaging with the tobacco industry.
Many experts believe that even if BAT is successful in creating a vaccine, organizations such as the WHO would ignore the science and possibly put lives at risk. It would not be the first time, explains Tim Andrews, executive director for the Taxpayers Protection Alliance, a group that monitors federal spending. He says the WHO has a long history of hostility to alternative nicotine products.
Andrews says that the WHO’s failures “have cost millions of lives,” not just because of the Covid-19 issues but because its track record of trying to prevent the acceptance of reduced-risk tobacco health alternatives has led to more people smoking and more people dying from combustible cigarettes. “The more I looked over the last few years, the more horrified I was by how [the WHO’s] actions are actively harming and not helping public health,” said Andrews.
Since the electronic nicotine-delivery system (ENDS) came to market, the WHO has attempted to block its advance at every turn. As early as 2008, the WHO has stated that it “does not consider [ENDS] to be a legitimate therapy for smokers trying to quit.” Andrews said that as studies started to show that vapor products were “95 percent safer than combustible cigarettes” and ENDS products became accepted by Public Health England (PHE), the WHO had to make a choice: admit failure and accept ENDS as part of tobacco harm reduction plans or ignore science.
“Unfortunately, they have doubled down on their position contrary to all available evidence. And in fact, not only are they now … working towards further restrictions on e-cigarettes, they’re actually going out spreading deliberate misinformation,” says Andrews. “And it seems the more evidence [that] is coming out on the fact that they’re an effective harm reduction tool, the more the WHO is going to try … to call on countries to do large-scale campaigns against them.”
As an example of WHO dishonesty, Andrews pointed to a large-scale social media campaign started by the health body in January suggesting that ENDS can cause lung injuries and increase the risk of heart disease. According to Andrews, there is not a shred of evidence for either claim.
The WHO campaign included statements such as, “The liquid in e-cigarettes can burn skin and rapidly cause nicotine poisoning if absorbed through the skin,” and “The liquid is also highly flammable.” Not a single thing in those sentences is true, according to Andrews. “It is completely 100 percent made up. These aren’t stupid people. They aren’t writing this out of ignorance. This is a deliberate lie. And then you can see all of these people on Twitter responding by taking vape liquid and lighting [it on] fire. It does not light on fire. It does not burn your skin if you get it on your skin. This is blatant misinformation to scare people. And what is the result of this? If people are scared of something that is 95 percent safer than smoking, they will end up sticking to combustible cigarettes, which are much more deadly for them.”
Numerous public health professionals have joined Andrews in criticizing the WHO’s approach to harm reduction. In June, an international group of independent experts with no conflicting links to the tobacco or vapor industry criticized the WHO for its “backward-looking” approach to innovation and new technology, such as vapor products. The experts say they are exasperated by the WHO’s “dogmatic hostility” toward new technology and fear the U.N. health agency will squander the opportunity to avoid millions of premature deaths that will be caused by smoking.
Iowa state Attorney General Tom Miller, who was the first to publicly release the collaborative letter, said the WHO has lost its sense of mission and purpose. “It’s as if the WHO has forgotten what it is there to do—to save lives and reduce disease,” Miller said. “We can do that by helping and encouraging consumers to switch from cigarettes to lower risk products. This means being honest about the much lower risks and by using smarter regulation to make switching more attractive.”
The group criticizing the WHO includes David Abrams of the School of Global Public Health at New York University; Tikki Pangestu, visiting professor of Lee Kuan Yew School of Public Policy at the National University of Singapore; John Britton, professor of epidemiology at the University of Nottingham; Rajesh Sharan of North-Eastern Hill University in Shillong, India; David Sweanor of the Centre for Health Law, Policy and Ethics at the University of Ottawa; and Clive Bates, director of Counterfactual Consulting.
While making no mention of tobacco control policies, U.S. President Donald Trump in late may announced the U.S. would terminate its relationship with the WHO. He said that the U.N. agency failed to adequately respond to the coronavirus because China has “total control” over the global organization. He also said Chinese officials “ignored” their reporting obligations to the WHO and pressured the WHO to mislead the world when the virus was first discovered, according to a story by The Associated Press.
United against vapor
While the WHO does carry a portion of the blame for the misinformation about vapor products, Michelle Minton, senior fellow at the Competitive Enterprise Institute, another libertarian think tank, says the problem isn’t limited to one or more organizations. She believes that public health across the board has been suppressing evidence.
“This is something I’ve been writing about for many years, and I think really what we are seeing is the worst of it expressed at the time when we need our public health institutions to be at their most effective,” said Minton.
A lot of the evidence has been coming out showing that e-cigarettes are far less harmful and extremely effective as a smoking cessation tool, according to Minton. Studies are showing that ENDS are more efficient than other available nicotine-replacement therapies. However, this is not the message disseminated by the FDA.
“In April 2019, the FDA put out a warning … that they had noticed that in 10 years, from 2009 till 2019, there were 35 seizures reported while somebody was using an e-cigarette,” explains Minton. “And given the fact that there are 70,000 people in this country or more, I believe, that have seizure disorders, and a lot of [people] also vape, it would make sense that at one point or another someone [who also vaped] might actually have a seizure. Thirty-five in 10 years is really a minuscule figure. And as far as I can tell, nothing really came of that.”
In August of 2019, a mysterious lung disease began to appear in the U.S. Then, on Sept. 29, 2019, the first case of e-cigarette or vaping-associated lung injury (EVALI) was announced. “These lung injuries, which at first were described by news reporters—who were getting their information from [the] CDC [Centers for Disease Control and Prevention] and [the] FDA—as vaping,” says Minton. “So vaping-associated pulmonary injury, which suddenly by September changed to EVALI. I even asked [the] CDC about what was the choice of the change putting e-cigarettes up front even at that time as the information [was widely known at the time] that it was linked to illicit THC vaporized products on the black market. So vaping was already too broad of a term, and then when New York started reporting that every single one of their patients admitted or tested positive for THC, and then when they went to test the THC products they were using, they all contained vitamin E acetate. That’s when [the] CDC suddenly decided to use the term ‘EVALI,’ emphasizing e-cigarettes.”
The data now shows that many of the lung injuries occurred in people who are too young to legally purchase marijuana products, according to Minton. EVALI also occurred frequently in states that didn’t have legal marijuana. The CDC waited until late-October 2020 to give that information to the public. As late as Nov. 1, the CDC still advised: “Because the specific compound or ingredient causing lung injury is not yet known, and while the investigation continues, persons should consider refraining from the use of all e-cigarette or vaping products.”
The CDC narrative is still that e-cigarettes had something to do with the EVALI outbreak. However, there continues to be zero evidence that nicotine vapor products were ever found culpable in the lung injuries, says Minton, adding that “the messaging is perfect for [the] CDC who wants to continue this [image] of vaping as an epidemic.”
Ultimately, says Minton, organizations like the WHO, FDA and CDC are losing their credibility because of the way the agencies are handling vaping and ignoring the science. “It really damaged their credibility. On the eve of a crisis, a real crisis, where we would have had or we should have been able to rely on the CDC, their credibility took a major hit,” says Minton. “So that’s what we have going on here. It’s bad all around. But, I’m an optimist, so I think that one of the best things that might be able to come out of this is that Congress and other entities take a look at our public health system and try and narrow the focus of some of these agencies, maybe reign them in a little bit, maybe bring them back to talking about actual science.”
Lawmakers in the U.S. House asked the U.S. Food and Drug Administration (FDA) to ban Puff Bar. The disposable device is the fastest-growing vapor product on the market and has quickly replaced Juul as the vape of choice among young people, according to a story in The New York Times.
The disposable devices come in more than 20 flavors, among them piña colada, pink lemonade, watermelon and O.M.G. Puff Bar, which launched last year, has been the key beneficiary of an FDA loophole allowing flavors in disposable devices. Based on data used only for tracked channels, which include convenience stores and some other retailers but not online sales or vape shops, Puff Bar sales have consistently been over $3 million a week since April, with volumes now over 300,000 sticks per week.
“Puff Bar is quickly becoming the new Juul,” Rep. Raja Krishnamoorthi, Democrat of Illinois, wrote in a letter to the F.D.A. on Monday. Mr. Krishnamoorthi, the chairman of the House Subcommittee on Economic and Consumer Policy, accused the e-cigarette company of exploiting the coronavirus to sell its products to schoolchildren.
To make his case, the lawmaker included a copy of a Puff Bar advertisement featuring a photograph of a bedroom, with the words: “We know that the inside-vibes have been … quite a challenge. Stay sane with Puff Bar this solo-break. We know you’ll love it. It’s the perfect escape from the back-to-back zoom calls, parental texts and WFH stress.”
Mr. Krishnamoorthi said that “this advertisement is designed to convince children home from school to vape in their rooms without their parents noticing.”
A second advertisement included in the complaint features an attractive young woman wearing a tight T-shirt and spewing big clouds of vapor. The same picture was used in a separate advertisement that suggested vaping a Puff Bar as a way to relax over spring break.
Todd Eric Gallinger, a lawyer who represented a company called Cool Clouds Distribution in a trademark application for the Puff logo, did not return a call seeking comment. The Puff Bar website does not list the names of any of the company’s executives. Indeed, since it began, the provenance of the Los Angeles-based business has been a secret. Its website states: “Who makes Puff Bar? Everyone wants to know the mastermind team behind the latest craze in the world of electronic cigarettes. Where did the Puff Bar team come from and where do they plan to go from here?”
Wherever it is, the company isn’t telling. The only details revealed indicate that the product is made in China and the flavors are developed in Malaysia.
The F.D.A. declined to discuss Puff Bar. Still, in an email, Mitchell Zeller, the director of the agency’s Center for Tobacco Products, wrote that the agency intended to take action against any electronic nicotine product “if it is targeted to youths, if its marketing is likely to promote use by minors, or if the manufacturer fails to take adequate measures to prevent minors’ access, according to the story.
In recent weeks, the agency has blocked the importing of two e-cigarette products from China: EonSmoke, which sold disposable e-cigarettes in a number of flavors before shutting down, and RELX, available in flavors including Drunk in Mexico, Naked in Iceland and Mango
Recent warning letters demonstrate that the FDA is looking beyond devices when enforcing its rules against youth appeal.
By Bryan Haynes, Agustin E. Rodriguez and Dascher Pasco
On April 27, 2020, the U.S. Food and Drug Administration (FDA) sent warning letters to 10 retailers and manufacturers who “sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth.”1 Nine of these warning letters targeted ENDS products such as flavored e-liquids and ENDS designed to look like handheld gaming systems, watches and fidget spinners.
However, one warning letter targeted products “such as a backpack and sweatshirt designed with stealth pockets to hold and conceal an e-cigarette.” In its warning letter to Vaprwear Gear, the FDA asserted authority over Vaprwear’s sweatshirts and backpacks because they were components and parts of tobacco products.
Pursuant to the “Deeming Rule,” published in May of 2016, the FDA has asserted authority over all tobacco products, including ENDS products and their “components and parts.” However, the FDA does not have authority over tobacco products’ “accessories.”2 The practical consequence of the Deeming Rule is that ENDS, and their components and parts, are subject to the tobacco control authorities set forth in the Tobacco Control Act (TCA). This includes premarket authorization requirements, which, when not met, result in deemed new tobacco products being considered adulterated.
Earlier this year, the FDA published guidance clarifying how it intended to prioritize enforcement resources regarding the marketing of certain deemed new tobacco products that do not have premarket authorization. Specifically, the FDA stated it would prioritize enforcement against flavored, cartridge-based ENDS products, as well as ENDS products that were targeted to minors or the marketing of which was likely to promote use of ENDS by minors. The guidance noted that the FDA is particularly concerned with ENDS products with flavors that youth find appealing as well as products with design features that make them more appealing to youth by allowing discreet use, or enabling youth to “use the product in circumstances where the use of tobacco products is prohibited.”3
Given the FDA’s stated priorities, much of what was seen in the April 27 warning letters did not come as a surprise. For example, some of the warning letters targeted e-liquids that the FDA claimed were labeled and/or advertised in a way that resulted in the product resembling “food products that are typically marketed toward and/or appealing to children.”4 Others targeted ENDS products that resembled smartwatches, identified by FDA as a product that is “commonly worn by children” allowing the ENDS product to “be carried and worn without revealing to parents, teachers, or other adults that the product is a tobacco product.”5 As e-liquids and ENDS products, the products targeted in those warning letters are well recognized as regulated products within the FDA’s authority as stated in the Deeming Rule.
Bryan Haynes (Credit: Troutman Sanders)
Less obvious is the basis of the FDA’s authority to regulate products such as sweatshirts and backpacks as “components and parts” of ENDS. For purposes of the Deeming Rule, components and parts are defined as “any software or assembly of materials intended or reasonably expected: (1) to alter or affect the tobacco product’s performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product.” In contrast, accessories do not contain tobacco, are not derived from tobacco and do not affect or alter the performance, composition, constituents, or characteristics of a tobacco product.6
The warning letter to Vaprwear states that the Vaprwear Weekend Pullover, Vape-Ready Hoodies and Vaprwear HydroVape, as well as the Vape-Ready Backpacks are all components or parts of tobacco products and, as such, are subject to FDA jurisdiction. While FDA’s regulation of these products initially seems like a startling overreach, upon closer inspection of the products and their marketing it becomes more apparent how FDA claims authority.
Each of these products contains a “hosing system” that can be connected to a pod system and used to deliver vapor to the wearer. For example, the Vape-Ready Hoodies contain a drawstring made from hosing and woven into the hood. One end of the drawstring connects to the device and the other end is used to inhale. The Vaprwear products are largely monochromatic with few or no graphics and contain pockets that allow for storage of the ENDS device while it is being used with the products’ vapor delivery system, allowing for discreet use of ENDS devices in a number of environments.
Agustin E. Rodriguez (Credit: Troutman Sanders)
The hosing system, which is an integral part of Vaprwear’s products, physically connects to the ENDS device and is used to deliver vapor directly to the consumer. This system is identified by Vaprwear as a “vapor delivery system” that “delivers compatibility with the hundreds of vape devices now on the market,”7 and allows the FDA to claim that the products are used for the consumption of a tobacco product and alter or affect the tobacco product’s performance, composition, constituents or characteristics.
There are a couple of takeaways from FDA’s warning letter to Vaprwear. First, the FDA’s decision to target Vaprwear’s sweatshirts and backpacks demonstrates FDA’s view that a product does not have to be a necessary element of an ENDS device, such as an e-liquid or an atomizer, to be considered a component or part within the FDA’s purview. Additionally, the FDA is not only focused on discreet ENDS devices, but on all products that may be appealing to youth because they facilitate discreet use.
Dascher Pasco (Credit: Troutman Sanders)
In conclusion, the April 27 warning letters highlight the FDA’s continued focus on ENDS marketing. The FDA appears to be keeping up with the ENDS market and its consumers, recognizing and regulating the new ways individuals can easily and discreetly vape. Much of this regulatory energy is focused on retailers.
For example, while some of the companies that received an April 27 warning letter were manufacturers, each of the 10 entities operates as a retailer. Further emphasizing this point, both Wizman Limited, a manufacturer and online retailer, and EighCIt, an online retailer, received warning letters regarding a product manufactured by Wizman Limited.
The bottom line is that the FDA expects retailers to undertake appropriate due diligence with regard to all marketed products. Retailers may ultimately be held responsible by the FDA, whether or not any action is taken against the manufacturer, as the agency continues to focus on the ENDS industry and the potential youth appeal of its products.
Bryan Haynes, a partner with Troutman Sanders, specializes in tobacco industry regulatory compliance and enforcement matters.
Augustin Rodriguez, counsel for Troutman Sanders, provides cross-functional, multidisciplinary counsel to advertising, marketing and consumer goods and services companies.
Dascher Pasco, an associate with Troutman Sanders, specializes in government and regulatory white collar and government investigations and enforcement actions and investigations.
1 FDA, news release, “FDA Warns Manufacturers and Retailers to Remove Certain E-cigarette Products Targeted to Youth from the Market,” April 27, 2020, available at https://bit.ly/2LIenHu.
2 21 CFR § 1100.1.
3 FDA, “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization” (Revised), April 2020, available at https://bit.ly/3dYFkTu.
4 FDA, Warning Letter to VapeCentric, MARCS-CMS 607375, April 27, 2020, available at https://bit.ly/36dWGZO (finding the product appeared “very similar to Pocky Strawberry biscuit sticks”) and FDA, Warning Letter to Vape Royalty, MARCS-CMS 606271, April 27, 2020, available at https://bit.ly/3bHKDVX (finding the product appeared “very similar to Sour Patch Kids candy”).
5 FDA, Warning Letter to Vapewear, MARCS-CMS 605196, April 27, 2020, available at https://bit.ly/2XfBs9O and Warning Letter to Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc., April 27, 2020, available at https://bit.ly/2yf7uu8.
6 81 FR 28973 at 28975. The Deeming Rule defines an accessory as “any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following: (1) is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product or (2) is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but (i) solely controls moisture and/or temperature of a stored product or (ii) solely provides an external heat source to initiate but not maintain combustion of a tobacco product.”
The Fourth Circuit on Monday dismissed an appeal from various vaping groups challenging a compliance deadline for vapor products. The decision states that January directives from the U.S. Food and Drug Administration (FDA) have rendered the appeal moot.
In a per curiam opinion, the appellate judges held that guidance issued by the FDA in January moots the vape groups’ appeal because that guidance supersedes older directives from August 2017 at issue in the appeal and leaves “no possible meaningful relief” that the court could grant, according to law360.com.
“Any ruling by this court as to the procedural or substantive reasonableness of the August 2017 guidance would amount to nothing more than an advisory opinion,” the court said.
The appeal stems from a Maryland district court ruling that ordered the agency to set a May 2020 deadline for premarket tobacco product applications (PMTA) on smokeless tobacco products. The FDA, along with various health and anti-vaping groups, had argued that the January guidance restricting the sale of flavored, cartridge-based vapes rendered moot the vape groups’ appeal.
“Because the enforcement timetable for e-cigarettes set out in the January 2020 guidance is independent of the district court’s order, an order by this court reversing the district court would have no effect on FDA’s enforcement of the statute and regulations against e-cigarette manufacturers,” the agency had previously said.
But the vape groups disagreed, saying the January guidance was enacted without proper notice-and-comment procedures, according to the opinion.
While the court said it can’t offer the vape groups relief in this case, the panel added in a footnote that the groups can challenge the January guidance in a separate action in federal court. The panel also ruled that a Maryland district court did not abuse its discretion in denying cigar industry groups’ motion to intervene, saying those groups did not intervene in a timely manner.
Counsel for the cigar and vape groups and a representative of the FDA did not immediately respond to requests for comment Monday.
Last month, a Maryland federal judge said that in light of the coronavirus pandemic, he would grant a 120-day extension to the May 12 deadline for e-cigarette PMTAs, which have proceeded slowly since the FDA first determined vapes should be regulated like tobacco products. The new deadline is Sept. 9, 2020.
The FDA had previously asked the Fourth Circuit for approval for the lower court to extend the May deadline, saying it would not affect the merits of the appeal brought by the industry groups. The FDA said many of the laboratories and research organizations conducting the clinical trials for the regulatory applications have shut down or otherwise halted in-person testing in light of the COVID-19 pandemic.
Public health groups previously sought to accelerate the FDA’s regulation of vaping products under the Tobacco Control Act, citing vaping-related lung injuries that sickened thousands of people and left nearly 70 dead in 2019. In July 2019, a Maryland district judge effectively allowed the FDA to set the May 2020 deadline, prompting the vape groups to claim the decision was an arbitrary overextension of both the FDA and the court’s authority.
The vape groups had also argued that the May deadline left too little time for manufacturers to file complete applications. Cigar industry groups that filed joint briefs on appeal argued that the district court’s order on deadlines unfairly ensnared cigar and pipe tobacco manufacturers as well.
