Tag: FDA

  • No Decision Timeline for Gripum Lawsuit Against FDA

    No Decision Timeline for Gripum Lawsuit Against FDA

    Seventh Circuit Court of Appeals

    Chicago-based e-liquid manufacturer Gripum had its lawsuit come before the Seventh Circuit on Wednesday morning, arguing it is the victim of regulatory malfeasance. The panel did not say when a decision would be reached.

    Gripum markets vaping products under a number of different brand names. In September 2021, the U.S. Food and Drug Administration denied Gripum’s applications to enter its products into interstate commerce on the grounds that the products would induce more youth to start vaping than they would help adult combustible users to drop traditional cigarettes.

    “All of [Gripum’s applications] lack sufficient evidence demonstrating that [their] flavored [vapes] will provide a benefit to adult users that would be adequate to outweigh the risks to youth,” the FDA’s rejection order stated.

    Gripum argues the rejection was improper because the FDA had used unclear standards to evaluate the company’s products and its conclusion was based on a selective reading of the available research into e-cigarette use, according to Courthouse News. The company specifically claims it should not have been penalized for not including long-term longitudinal studies of vape use in its applications, as the FDA did not state Gripum had to include such studies when it first submitted its applications in September 2020.

    “FDA repeatedly assured manufacturers that their [applications] would not need to include long-term studies (random controlled trials or longitudinal cohort studies). Gripum took FDA at its word,” the company’s brief to the Seventh Circuit states. “FDA, however, employed a secret ‘fatal flaw’ inquiry: it did not conduct an individualized review of the substance of Gripum’s [applications] once it observed the absence of long-term studies.” (Parentheses in original).

    The company also says the FDA ignored studies showing that youth smokers typically preferred “closed-system” flavored tobacco products, a separate technology from the “open-system” vapes Gripum sold. Closed-system vapes such as Juul pods mimic traditional cigarettes in form and contain tobacco liquids with a high nicotine concentration to compensate for their small size and short battery life. Open-system vapes, by contrast, are larger devices using refillable tobacco liquid cartridges with a lower nicotine concentration. According to Gripum’s brief, these open-system vapes are generally preferred by adult smokers in their 40s, regardless of flavor.

    Following this reasoning, Gripum’s attorney J. Gregory Troutman argued Wednesday that the company’s products, if allowed into interstate commerce, would help adult smokers quit traditional cigarettes more than they would attract young people in their teens or 20s. Getting people off traditional smokes is one element of the FDA’s evaluation criteria, given that the agency considers vaping relatively less harmful than traditional tobacco products for adult users.

    “We take the agency and its representatives at the public statements they’ve made, where they’ve talked about these products as less harmful,” Troutman said. “That’s the real rub here.”

    The three-judge panel was skeptical of this line of argumentation, however, given that the FDA’s statements referred to e-cigarettes in general and not Gripum’s products particularly.

    “You don’t have any evidence that your products are going to induce adults to stop using [cigarettes] that I saw,” said U.S. Circuit Judge Diane Wood. “That’s half the equation.”

    Troutman conceded that Gripum, in its applications, had not presented any evidence to the FDA that its specific products would help stop traditional tobacco use among adults. But he argued this is irrelevant given the studies it did provide the FDA, which showed e-cigarettes in general do lower the rate of traditional tobacco product use among adults.

    U.S. Circuit Judge David Hamilton remained unmoved by this argument. He questioned Troutman as to why Gripum had not distinguished between its flavored and non-flavored vapes when filing its applications, given youths’ potential preference for flavored products. Troutman again laid blame for the oversight at the FDA’s feet.

    “That was not something that we were told we had to do prior to the application deadline,” Troutman said.

    The response did not impress Hamilton, who rebutted that the FDA was authorized to use its own discretion in approving products for market. After Troutman conceded that the FDA has not yet cleared any flavored vape product in the U.S. for interstate commerce, Hamilton said the FDA rejecting Gripum’s application “sounds pretty consistent.”

    The judges were more sympathetic to the arguments put forward by the FDA. In both in its brief and via its attorney Kate Talmor, the agency said flavored vapes required further study before they could be approved for the market.

    “FDA has granted applications to market certain tobacco-flavored e-cigarettes based on evidence that youth use of tobacco-flavored products is limited and that such products may help adults switch from combustible cigarettes,” the FDA’s brief states. “But for e-cigarettes with flavors other than tobacco, ‘the risk of youth initiation and use is substantial’ and well documented.”

    Talmor added that the rejection of Gripum’s applications was “not a de facto ban” of all flavored vape products. Gripum, she said, simply failed to show that its products were more beneficial to adults than they were seductive to young people.

    “Gripum failed to submit any evidence in its application demonstrating benefits from its products to adults,” Talmor told the panel.

    She pointed out that there are many flavored vape products currently in markets across the U.S. with legally murky status, subject to FDA enforcement discretion. There are also several applications for flavored vape products from other manufacturers that are currently in consideration. In time and with further study, Talmor said, these applications may be approved.

    When pressed by Wood regarding Gripum’s complaint that it was penalized for not including longitudinal studies that it was never advised it had to include, Talmor dismissed this as the company being obtuse. She argued the agency gave the whole e-tobacco industry a heads up in 2019 that it would be looking for “robust” evidence of flavored products’ public health benefits in any market application.

    “Looking at the [2019] guidance as a whole, it plainly advised industry that they were going to need robust evidence to demonstrate the benefits of their products outweigh any harms,” Talmor said.

    Talmor concluded her arguments by saying that the FDA had to be granular – Gripum, she argued, cannot use generalized research into e-tobacco products as the sole basis for asking that its own specific products be approved. If it could, she said, the FDA would have to allow far more potentially unsafe vape products onto the market than it currently does.

    “Gripum… did not attempt to submit evidence that was specific to its products and made the required showing,” Talmor said. “And I just don’t think there’s any way to look at the 2019 guidance and conclude that could possibly meet [the guidance’s] standard.”

    The panel – rounded out by the mostly silent U.S. Circuit Judge Thomas Kirsch – took the arguments under advisement but did not say when they would issue a ruling.

  • U.S. Senators Pen Letter Urging FDA to Combat Youth Use

    U.S. Senators Pen Letter Urging FDA to Combat Youth Use

    Credit: Ekim

    U.S. senators Jeanne Shaheen and Maggie Hassan joined a bipartisan group of their Senate colleagues in calling on the Food and Drug Administration to take long-overdue action to combat the youth vaping crisis, which includes steps that could remove kid-friendly, addictive e-cigarettes from the market.

    The letter, which was signed by 13 additional legislators, including senators Mitt Romney and Elizabeth Warren, claims the FDA has not prioritized its review of e-cigarettes with the largest market share and “therefore greatest public health implication.” Instead, the agency has deferred its decisions on the most critical applications—including for those products that are most popular with youth—to the end, the Senators wrote to FDA Commissioner Robert Califf.

    “Now that FDA is six months past the court deadline, these unreviewed products are only being permitted to stay on the market due to the agency exercising enforcement discretion. It makes no sense, and runs contrary to the Tobacco Control Act’s statutory framework, that products that have not been granted authorization are being allowed to stay on the market and attract new, young users,” the letter states.

    “FDA has the authority and responsibility to halt this grace period today and restore the statutory burden of proof on manufacturers to demonstrate their product is ‘appropriate for the protection of public health’ prior to market entrance,” the Senators continued. “It is our hope and expectation that you can bring a new approach and commitment to using all of FDA’s tools and prioritizing public health to protect youth from the harms of tobacco and nicotine.”

  • Biden Expected to Sign De Facto Synthetic Ban Tuesday

    Biden Expected to Sign De Facto Synthetic Ban Tuesday

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

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

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

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

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

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

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

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

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

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

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

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

  • Synthetic Nicotine Rule Clears Senate, Goes to Biden’s Desk

    Synthetic Nicotine Rule Clears Senate, Goes to Biden’s Desk

    Synthetic nicotine will now require U.S. Food and Drug Administration marketing approval. The U.S. Senate approved a $1.5 trillion legislation by a 68-31 bipartisan margin that includes language that changes the definition of a tobacco product to include synthetic nicotine. The Senate sent Biden the omnibus appropriations bill, and a separate bill financing agencies through Tuesday in case it takes time to complete the required reprinting and proofreading of the lengthy omnibus measure. Biden has said he will sign the bill into law.

    Credit: f11photo

     

    “We thank leaders in the House and Senate for their partnership in getting this bill done, and the President looks forward to signing it into law,” wrote White House spokesperson Jen Psaki in an email. “The bipartisan funding bill proves once more that members of both parties can come together to deliver results for the American people.”

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

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

    Synthetic nicotine—nicotine that is made in a lab rather than derived from tobacco—has long existed in a legal grey area, and many companies started using it after their natural nicotine products were denied market access by the FDA. Public health groups have been warning that synthetic nicotine e-cigarettes, such as Puff Bar, have grown in popularity among teens while skirting FDA oversight.

    The House passed the bill late last night. Leaders in both parties have declared the legislation a win. Democrats boast of the almost 7 percent increase they secured for non-defense agencies, increasing that funding to $730 billion. Top Republicans tout the $782 billion they locked in for national defense, a 6 percent hike from current spending, according to Politico.

    Proponents of the policy change refer to it as closing a loophole. Meanwhile critics of the rider contend that, given the well documented flaws and deficiencies in the FDA approval process, the budget rider will likely result in the prohibition of products that former smokers have used to quit smoking and stay off cigarettes. Vaping advocates have been working on overdrive the last three days trying to get the nicotine rule removed form the bill.

    Amanda Wheeler, president of American Vapor Manufacturers association, said the of banning synthetic products is going to drive millions back to combustible cigarettes.

    “At a time when FDA is under scrutiny from multiple federal courts for unlawful regulatory overreach on nicotine, handing the agency even more powers to prevent Americans from switching to vaping is like handing car keys and a bottle opener to your drunk uncle,” she said. “It’s already lunatic that FDA is prohibiting adult American smokers from switching to vaping but this legislation is so absurd that it will extend FDA’s reach to products that have no actual, physical connection to tobacco whatsoever.

    “This bill ought to be called the Cigarette Protection Act, because the indisputable outcome will be countless more Americans pushed away from nicotine vaping and back into combustible smoking.”

  • House to Vote on Budget Bill, Synthetic Nicotine Today

    House to Vote on Budget Bill, Synthetic Nicotine Today

    Update: At 2:56 pm the House went into recess, to presumably make amendments to the bill. Media outlets have reported it is to remove some Covid-19 related measures (30 states at risk of losing Covid relief funding previously promised). Currently, the vote on the omnibus appropriations bill is expected to occur this evening or late tonight.

    It is possible that the omnibus appropriations bill vote is delayed. In case Congress does not complete work on the omnibus by the end of the week, the House is also expected to vote on a CR through March 15 today to allow time for Senate passage and signing by the President.

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

    The U.S. House of Representatives is expected today to vote on an omnibus appropriations bill (page 1,870) that includes language that would give the U.S. Food and Drug Administration the power to regulate synthetic nicotine . Lawmakers have said some add-ons have already been agreed to, such as a package of health care provisions including Medicare program extensions and eliminating the synthetic nicotine loophole.

    The House is planning to vote sometime today before going to Philadelphia for its annual issues conference. The bill must clear the Senate before stopgap funding expires at midnight Friday. GOP objections to a unanimous consent agreement to speed consideration in the Senate could delay final passage into the weekend, lawmakers warned, but both sides expect the process to be complete in time to avoid a partial government shutdown when federal agencies open Monday.

    House Appropriations Chair Rosa DeLauro was adamant after a private House Democratic Caucus meeting Tuesday morning the omnibus would be ready for the House to pass on Wednesday, according to RollCall

    “It’s not going to get delayed. We’re going to vote tomorrow,” she said.

    If the spending bill currently under consideration passes, the language of the Tobacco Control Act would change to define a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.”

    Amanda Wheeler, president of American Vapor Manufacturers association, said the of banning synthetic products is going to drive millions back to combustible cigarettes.

    “At a time when FDA is under scrutiny from multiple federal courts for unlawful regulatory overreach on nicotine, handing the agency even more powers to prevent Americans from switching to vaping is like handing car keys and a bottle opener to your drunk uncle,” she said. “It’s already lunatic that FDA is prohibiting adult American smokers from switching to vaping but this legislation is so absurd that it will extend FDA’s reach to products that have no actual, physical connection to tobacco whatsoever. This bill ought to be called the Cigarette Protection Act, because the indisputable outcome will be countless more Americans pushed away from nicotine vaping and back into combustible smoking.”

    Amanda Wheeler

    Yaël Ossowski, deputy director of the Consumer Choice Center, said the legislation will actively harm adults who want to quit smoking. He says that the method of “fattening up continuing resolution bills with laws that benefit special interests, without broader democratic debate or analysis of the costs and benefits,” is shameful in a modern American Republic.

    “The byzantine process of asking permission to sell harm reducing vaping products in the 21st century is asinine in itself. But using sleight of hand during an emergency government funding bill to castigate millions of vapers and the entrepreneurs who make and sell the products they rely on is the definition of active harm,” said Ossowski. “Only the largest and most powerful vaping and tobacco companies can afford the lawyers and the time necessary to complete the paperwork necessary to pass the FDA’s process, meaning thousands of hard-working American business owners will now be forced to close, depriving millions of adult consumers of harm reducing options. Many will be forced back to cigarettes.

    “Synthetic nicotine is an innovative method of providing nicotine independent of tobacco, and millions of American adults now use these products as a less harmful method of consuming nicotine. A back door bureaucratic power move like this represents a sledgehammer to the men and women of our country who have sought out vaping devices to kick their cigarette habit.”

    Yaël Ossowski

    Ossowski said he hopes elected representatives reject the synthetic nicotine inclusion and “go back to the drawing board” to offer a more permanent policy.

    Congress has tried numerous times over the past year to give the FDA authority over synthetic products. The FDA said last year that synthetic nicotine could be considered a component of e-cigarettes, which would allow for the product to be regulated by the agency. Many states have already begun banning synthetic products.

    Sens. Richard Burr, Dick Durbin and Patty Murray, along with Rep. Frank Pallone led the effort to get the language into the omnibus, according to two Senate sources familiar with the discussions. “This is an enormous win for public health and American consumers,” Pallone said in a statement. “I’m grateful to members on both sides of the aisle for working with me to close this loophole in the omnibus.”

  • Congress May Give FDA Power Over Synthetic Nicotine Soon

    Congress May Give FDA Power Over Synthetic Nicotine Soon

    The regulation of synthetic nicotine has been a recent focus for many U.S. states. If a yet-to-be unveiled budget bill is passed, it is expected to include giving the U.S. Food and Drug Administration new powers to regulate synthetic nicotine, a lawmaker confirmed on Tuesday. The omnibus appropriation bill is slated to be passed in the next few days.

    Language included in the omnibus spending package bill to fund the government through September would give the FDA the authority to regulate products that contain nicotine but aren’t derived from tobacco, such as synthetic nicotine, according to a document obtained by Bloomberg.

    Congress has tried numerous times over the past year to give the FDA authority over synthetic products. The FDA said last year that synthetic nicotine could be considered a component of e-cigarettes, which would allow for the product to be regulated by the agency. Many states have already begun banning synthetic products.

    Sens. Richard Burr, Dick Durbin and Patty Murray, along with Rep. Frank Pallone led the effort to get the language into the omnibus, according to two Senate sources familiar with the discussions. “This is an enormous win for public health and American consumers,” Pallone said in a statement. “I’m grateful to members on both sides of the aisle for working with me to close this loophole in the omnibus.”

    The change will stop “bad actors attempting to evade FDA regulation and hook a new generation of young people into a lifetime of nicotine addiction,” Pallone said.

    Public health groups have been warning that synthetic nicotine e-cigarettes such as Puff Bar have grown in popularity among teens while skirting FDA oversight. The FDA has authority to regulate natural tobacco products, but it’s unclear if that extends to lab-made nicotine.

    More than a quarter of middle and high school e-cigarette users reported using Puff Bar as their usual brand, according to a survey from the Centers for Disease Control and Prevention. Puff Bar didn’t immediately respond to a request for comment.

    The same survey found brands that use traditionally derived nicotine, such as those sold by Vuse, SMOK, and JUUL Labs Inc., are also popular among teens, even though people under age 21 can’t purchase them legally.

  • Look Back: Vapor in 2021

    Look Back: Vapor in 2021

    Last year was a difficult one for vapor companies as regulation, taxation and flavor bans made their impact on the industry.

    By VV staff

    On Sept. 9, 2020, e-cigarette manufacturers needed to have submitted premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration to keep their electronic nicotine-delivery system (ENDS) products on the market. Going into 2021, many applicants hoped to receive marketing approval orders. That didn’t work out. Instead, the FDA rejected the vast majority of applications—many of them for excluding studies that the agency didn’t appear to require at the start of the process.

    By Dec. 31, 2021, the FDA had issued marketing denial orders (MDOs) for most of the more than 6.5 million PMTAs submitted by 500 companies. Only an estimated 80,000 products remain under review and, as of press time, only the Vuse Solo and two tobacco-flavored Solo pods have received a marketing approval order. Many of the applications still under review are “ones submitted by the companies with the largest market shares because they tend to be the largest and most complex applications,” according to Mitch Zeller, head of the FDA’s Center for Tobacco Products (CTP).

    The U.S. Postal Service (USPS) banned the mailing of vapor products in 2021, and Congress started debating a federal nicotine tax, which at press time had been removed from the legislation. Last year, many MDO recipients had those orders stayed by a court or rescinded by the FDA. Withdrawn products returned to market, leaving retailers confused. Misinformation about vaping was widespread throughout the year. Synthetic nicotine and disposable vape pens began to dominate sales and several new cannabinoids came to market. Let’s look back at the top stories of 2021.

    January

    Beverly Hills and Manhattan Beach, both in the Los Angeles area, began to enforce a ban on vapor products, the strictest vaping rules in the U.S.

    Shares in Chinese e-cigarette maker RLX Technology, parent to the RELX brand, jumped 146 percent in their trading debut after raising $1.4 billion in its U.S. initial public offering.

    Following the enactment of smoke-free laws in Paraguay, every South American country banned vaping and smoking in most public places.

    The FDA sent its first warning letters to manufacturers of ENDS products that did not submit PMTAs by the Sept. 9, 2020, deadline.

    Credit: TPB

    February

    Turning Point Brands announced a proposed private offering of $250 million aggregate principal amount of its senior secured notes due 2026.

    The public comment period began for the U.S. Postal Service’s ENDS mailing rules. R.J. Reynolds Vapor Co.’s (RJRV) Vuse Alto began selling nationally in the U.S.

    Utah Senator Mitt Romney pushed for flavored vaping products to be pulled from shelves across the United States.

    March

    The World Health Organization study group on Tobacco Product Regulations recommended prohibiting open systems.

    The litigants in two lawsuits challenging the constitutionality of the FDA’s Deeming Rule for vapor products, Big Time Vapes and Moose Jooce, asked the Supreme Court of the United States (SCOTUS) to take up their cases.

    The Preventing Online Sales of E-Cigarettes to Children (PACT) Act forced many companies to end online sales to U.S. customers. Many went out of business altogether because of the new rules.

    China announced its intent to overhaul rules governing the ENDS market. The news caused a steep drop in the value of RLX Technology shares, from which the company has yet to recover.

    Kate Wang / Credit: RELX

    April

    Virginia became the 16th state and first southern U.S. state to legalize the possession of small amounts of marijuana.

    Charlie’s Holdings, parent to the Charlie’s Chalk Dust and Pacha Mama brands, raised $3 million in a private stock sale.

    American TV personality Phillip Calvin McGraw, also known as Dr. Phil, wrongly blamed the e-cigarette or vaping use-associated lung injury (EVALI) lung illness outbreak on vaping nicotine products. The USPS published its guidance for mailing vaping products in the Federal Register.

    The FDA stated its intent to ban menthol as a characterizing flavor in cigarettes, saying it would exclude e-liquids.

    May

    An estimated 3,000 people visited the Tobacco Plus Expo (TPE) on the opening day of the three-day event, the first vapor trade show since the pandemic began.

    The WHO reasserted its abstinence-only approach to nicotine. The U.S. International Trade Commission (ITC) ruled that Philip Morris International’s IQOS device infringes on two patents owned by BAT subsidiary Reynolds American Inc.

    Meanwhile, a judge ruled that RJRV’s Vuse Solo and Ciro e-cigarettes infringe patents owned by Fuma International. Joining a growing number of U.S. states, New York expressly prohibited Delta-8 THC and other THC isomers derived from hemp.

    The FDA published a list of ENDS products that could be legally marketed in the U.S.

    June

    Poda Holdings launched its “zero cleaning” heat-not-burn (HnB) product after six years of development. SCOTUS denied Big Time Vapes and Moose Joose a request for a writ of certiorari. The German Bundestag signed off on a bill to raise taxes on combustible cigarettes, e-cigarettes and HnB tobacco products.

    An investor filed a class action suit against RLX Technology, claiming the manufacturer overstated its financials and misrepresented potential regulatory risks when it filed its IPO. San Francisco, Connecticut, Washington, D.C., Los Angeles and Canada proposed or enacted flavor bans.

    A study in the U.K. gave homeless people free e-cigarette starter packs. North Carolina settled its lawsuit with Juul Labs for $40 million.

    July

    Vaporesso and FEELM parent, Smoore International Holdings, was the only vaping technology company to make the Forbes 2021 Global 2000 list.

    Australia set maximum fines of up to aus11 million ($8.2 million) for businesses caught selling illegal nicotine vaping products.

    The FDA was accused of issuing unwarranted warning letters and leaving companies off of its list of accepted PMTAs. The agency was also criticized for using poorly functioning PMTA filing software.

    Juul Labs paid $51,000 to buy an entire issue of the American Journal of Health Behavior to publish its own vapor studies and make it publicly available. The town of Brookline, Massachusetts, prohibited the sale of all tobacco-related products to anybody born after Jan. 1, 2000. The Chinese vaping company Aspire Global announced terms for its U.S. IPO—which didn’t happen.

    The Federal Bureau of Investigation and the Drug Enforcement Administration raided the cannabis culture and accessories trade show, CHAMPS, because vendors were giving unauthorized Delta-8 THC product samples. Bidi Vapor parent, Kaival Brands, began trading on the NASDAQ.

    August

    The FDA issued a Refuse to File letter to the JD Nova Group for its estimated 4.5 million PMTAs, which accounted for approximately two-thirds of the total number of PMTA submissions.

    Smok Parent, IVP Technology, considered a Hong Kong IPO—which didn’t happen. The FDA issued the first MDOs covering more than 55,000 products.

    A study found that, contrary to what earlier studies suggested, vaping products are not associated with increased heart attack incidence among people without a history of smoking combustible cigarettes.

    September

    As the PMTA deadline approached, the FDA asked for more time before deciding whether some “e-cigarettes from market leader Juul Labs” and others are appropriate for the protection of public health. Numerous companies received MDOs from the FDA the night before the deadline.

    Vuse became the No. 1 global vaping brand by value share. No product got marketing orders on the court-imposed Sept. 9 deadline; instead, the FDA issued MDOs to more than 130 small companies, including Turning Point Brands, requiring companies to pull an estimated 946,000 products from the market.

    Congress proposed the U.S. Tobacco Tax Equity (TTE) Act, which would tax vaping products the same as combustible cigarettes. The legislation later gets attached to the Build Back Better (BBB) Act. The FDA released its annual National Youth Tobacco Survey (NYTS) showing that youth use of e-cigarettes fell sharply in 2021, the second consecutive year of major declines.

    The FDA said the 2021 NYTS can’t be compared to previous years because Covid-19 caused schools to close and altered testing procedures.  

    October

    Zanoprima Lifesciences announced the commercial production of its SyNic brand of synthetic (S)-nicotine. Turning Point Brands had its MDO rescinded by the FDA because the company did in fact submit newly required studies.

    The FDA’s Fatal Flaw review process was revealed after court documents were released. After more than six months, the USPS finally posted for public inspection its rules for mailing e-cigarettes in the Federal Register.

    The FDA gave the first ENDS marketing approval to RJRV’s Vuse Solo device and two tobacco-flavored pods, which are widely regarded as antique products compared to current vaping offerings.

    The FDA authorized the marketing of four oral tobacco products that are no longer on the market. Ten MDOs were rescinded or stayed by the FDA or in court.

    November

    More details surfaced surrounding the Fatal Flaw review, a simple review in which the reviewer examines the submission to identify whether it contains the necessary types of studies. “The Fatal Flaw review will be limited to determining presence or absence of such studies; it will not evaluate the merits of the studies,” an FDA memorandum states.

    Previously proposed nicotine/vapor tax increases were removed from the BBB Act.

    The Conference of the Parties to the WHO Framework Convention for Tobacco Control held its ninth session, this time virtually.

    The nicotine tax resurfaced in the BBB Act. RJRV settled its Fuma lawsuit two days before the trial was set to start.

    Biden nominated former FDA chief Robert Califf to again lead agency.

    December

    Draft rules governing e-cigarettes and vapor products were issued by China’s tobacco regulator.

    The nicotine tax was again removed from the BBB Act.

    The U.S. Trade Representative upheld the ITC’s finding that Philip Morris International’s IQOS infringes on BAT patents and Altria ended all U.S. sales.

    The Spanish government took control the country’s sales and distribution of vaping products.

    CTP Director Mitch Zeller announced plans to retire from the CTP in April.

    Once the largest chain of vape shops, Avail Vapor sold the majority of its retail locations and closed its remaining stores.

    Turning Point Brands received a USPS exemption for its VaporBeast subsidiary’s vape mail.

    The FDA authorized the marketing of 22nd Century Group’s low-nicotine, combustible filtered cigarettes as modified-risk tobacco products.

    Looking ahead

    The outlook for 2022 is vague at best for vapor. The FDA has a new director, and Zeller is retiring from the CTP, and things can change quickly under new leadership. It’s expected that the FDA will make decisions on the major ENDS brands at some point in the year, and there are still an estimated 44 lawsuits pending over the issuing of MDOs. The industry has already seen numerous vapor-related businesses close, consolidate or be bought out by larger competitors. Experts say that much of the same can be expected in 2022.

    “With the announcement of Zeller stepping down, I think we will continue to see vastly extended approval times for the majority of vapor products still being evaluated by the FDA, especially with open litigation covering many of these products,” said Josh Church, managing director of Roots Holding. “The products that do make it through the approval process will be high-value SKUs to large tobacco product manufacturers and will likely either be bought outright or there will be some agreement in equity share to utilize tobacco’s historic distribution network.”

    Last year left a lot of questions that the industry still needs answers to in 2022. There also probably won’t be many major changes in the vapor market other than continued sales growth in 2022, according to Church. “I think we can all agree that 2021 was a rough year. I believe that this year, we will observe the run out of the mail ban—effects of the PACT Act—on ecommerce,” he said. “That will come alongside continued brick-and-mortar business closures for those who don’t diversify their product offerings. I wouldn’t say 2022 is going to be worse than 2021, but I don’t expect it to change very much either.”

  • What’s Next for Vapor?

    What’s Next for Vapor?

    The long roller coaster ride for the vapor industry will likely continue for the foreseeable future.

    By Chris Howard and Rich Hill

    It’s been a long and arduous journey since the finalization of the Deeming Rule in 2016. As most of you will recall, this was the moment when we transitioned from operating in an unregulated market to plowing forward under a complicated and onerous regulatory scheme in the blink of an eye. Shortly thereafter, the U.S. Food and Drug Administration announced a renewed prioritization of harm reduction and proclaimed that vapor could play a leading role in that effort.

    Chris Howard
    Chris Howard
    Rich Hill

    Then, as quickly as a bright future for harm reduction blossomed, the lights dimmed, and vapor became the villain in the harm reduction story overnight. In addition to paralyzing propaganda and misplaced demonization by activist groups throughout the U.S., the industry also faced an onslaught of crippling requirements associated with a 10-month window to submit premarket tobacco product applications (PMTAs). Costing millions of dollars, 99 percent of the PMTAs ultimately submitted to the FDA’s Center for Tobacco Products (CTP) were summarily rejected based upon a standard, akin to a clinical cessation trial, that none in the industry expected.

    As of the date of this writing, some of the largest players in the e-liquid space have closed their doors or have moved into yet another risky proposition—synthetic nicotine. Despite the setbacks over the past several years, many still believe reports of vapor’s death as a harm reduction tool are greatly exaggerated. Notwithstanding this cautious optimism, it is clear that 2022 is going to be yet another difficult year for the vapor category.

    Current state as we enter 2022

    As we enter 2022, much of the flavored e-liquid market is gone and may never return. While we have seen marketing orders for first-generation e-cigarettes and tobacco disks that are no longer marketed, we have not seen marketing orders for any modern electronic nicotine-delivery system (ENDS) or oral nicotine products. We have seen a marketing order for a combustible low-nicotine cigarette, along with a reduced exposure order for the same. While litigation continues around the rejected PMTAs, the FDA still lacks a commissioner, and we have no knowledge of who will replace retiring CTP Director Mitch Zeller. Most importantly, other than removing flavors from the market, we have no clear understanding of the FDA’s harm reduction strategy.

    Predicting the future in 2022

    PMTAs. Few question the fact that the CTP was given a Herculean task by the Maryland federal court. Processing, let alone reviewing, 6.5 million PMTAs in a year was unquestionably an impossible requirement. Candidly, the fact that the CTP was able to get the majority through acceptance and filing was a significant achievement. Of course, for most reading this, the outcome was obviously disappointing as nearly all requests for marketing orders for flavored ENDS products were rejected in late 2021. As the various challenges to the marketing denial orders play out over the next year, many hold out hope that the CTP will be found to have violated the Administrative Procedures Act and/or acted arbitrarily or capriciously in its decision-making process.

    Credit: JHVEPhoto

    With respect to those applications that remain pending with the CTP (primarily tobacco and menthol flavors, pod systems and disposable devices), we believe the FDA will issue marketing orders for several tobacco-flavored pods and disposable e-cigarettes in 2022. Assuming the remaining applications otherwise meet the statutory standards, there is little reason for the CTP to deny applications for tobacco-flavored pods, e-liquids and disposables given the evidence that such products are not particularly attractive to youth. That said, we question whether any action will occur before the new FDA commissioner and CTP director are in place and have an opportunity to address policy concerns.

    As for menthol offerings, we anticipate that the FDA will not act until the proposed product standard banning menthol is released. It was interesting to note that a menthol-flavored combustible cigarette with lower nicotine levels was granted an exposure modification order. The CTP’s action may indicate a desire to provide “off-ramps” for combustible menthol cigarette smokers in a world where menthol cigarettes are potentially banned. Ideally, the CTP will grant marketing orders for menthol-flavored ENDS to provide an alternative product for current menthol cigarette smokers. This would provide a potential cessation or maintenance product to the millions of menthol smokers in the U.S.—thus reducing the risk of the formation of black and gray market activities.

    Credit: SYCprod

    Finally, marketing orders for flavored ENDS products seem unlikely in 2022. If the clinical cessation trial/longitudinal cohort study requirement proves to be administratively appropriate, it would seem difficult, if not impossible, that any flavored product will even make it to the review phase with such data for six months to 12 months at a minimum. Even then, it is an open question as to how much and what kind of data will be deemed to be sufficient by the CTP. We see a world where flavored ENDS are once again marketed, but it seems unlikely to occur in the near future.

    Product standards. We have all heard that the CTP intends to issue draft product standards banning both menthol in cigarettes and flavored cigars by April of this year. These purported product standards, along with the recent marketing orders granted for lower nicotine combustible cigarettes, are telling with where the focus of the FDA’s policy stands. The standards appear to demonstrate an agency bent on removing any flavors from combustible tobacco products unless those products cannot create or sustain addiction. We can be assured that the product standards will face a blizzard of regulatory and legal challenges and will likely take many years to implement.

    Synthetic nicotine. A few months ago, synthetic nicotine seemed like the last bastion of flavored ENDS products in the marketplace. While these products currently do not have a regulatory home, we fully expect that the existing legislative efforts will ultimately provide the CTP the authority to regulate synthetic nicotine. Once granted, all regulatory requirements for deemed tobacco products will apply, such as PMTAs. In the unlikely event Congress does not successfully provide such authority, we expect state legislatures to address the issue with prohibitive laws banning synthetic nicotine.

    FDA administration. One wildcard in the mix is the turnover in key personnel at the FDA. In his largely collegial confirmation hearing, the commissioner nominee, Robert Califf, stated that his top two priorities upon confirmation were not tobacco related. Rather, he intends to focus on (a) emergency preparedness and response and (b) patient and consumer protection through “systematic evidence generation” related to medical and food products. While he faced few questions on tobacco-related issues, many skeptics believe his views toward tobacco products are similar to the current administration. Whether he will take a proactive stance toward prioritizing harm reduction is unknown.

    Credit: Neil Lockhart

    Unfortunately, Zeller’s retirement removes a harm reduction proponent. What can we expect in a replacement? In short, the most likely replacement will be a candidate who has solid tobacco control chops and is aligned with the current policy flow against flavored products. We don’t expect to see any novel tobacco control or harm reduction policies (akin to former FDA commissioner Scott Gottlieb’s approach in 2018).

    The roller coaster ride continues

    Unfortunately, it appears that the long roller coaster ride for the vapor industry will continue for the foreseeable future. The good news, if you can call it that, is that the Biden administration has a variety of nontobacco-related issues to address—particularly up to the mid-term elections—which could lessen the likelihood of additional draconian polices imposed on the industry. At this point, it appears that 2022 will be about waiting—waiting for court decisions, waiting for policymakers and waiting for policy decisions.

    We won’t be so naive as to say that things can’t get worse in 2022. That said, if you have made it this far, now certainly doesn’t seem like the time to give up.

    Chris Howard is vice president, general counsel and chief compliance officer, and Rich Hill is compliance director and associate general counsel of E-Alternative Solutions, an independent, family-owned innovator of consumer-centric brands.

  • Robert Califf Confirmed, Returns as FDA Commissioner

    Robert Califf Confirmed, Returns as FDA Commissioner

    He’s back. The U.S. Senate on Feb. 15 narrowly confirmed Robert Califf as commissioner of the U.S. Food and Drug Administration, reports The New York Times.

    The vote was 50-to-46, with six Republicans crossing the aisle to support him while five senators who caucus with Democrats opposed him. One senator voted present.

    Credit: Bill Clark/CQ Roll Call

    A cardiologist who has served as the deputy commissioner of the FDA’s Office of Medical Products and Tobacco, as President Barack Obama’s FDA commissioner and as the head of medical strategy at Alphabet, Google’s parent company, Califf takes over the position from Janet Woodcock, the acting commissioner since President Joe Biden assumed office more than a year ago.

    According to Vaping360, Califf has been generally antagonistic toward vaping as a consumer product. He was at the FDA helm in 2016 when the agency rolled out the Deeming Rule, which gave the FDA authority over e-cigarettes and other tobacco-free nicotine products.

    Tellingly, the Campaign for Tobacco-Free Kids (CTFK) enthusiastically welcomed Califf’s appointment. “Dr. Califf is highly qualified and prepared on day one to address the enormous challenges facing the FDA, including the most significant decisions on tobacco in the agency’s history,” wrote CTFK President Matthew L. Myers in a statement.

    Califf is expected to be sworn in this week. He faces a looming flurry of decisions, including reviews of premarket tobacco applications from leading e-cigarette companies, such as Juul Labs. He will also have to contend with litigation from vapor companies over marketing denial orders (MDOs).

    After issuing MDOs to hundreds of manufacturers for hundreds of thousands flavored product, the agency has been challenged in court by more than 30 companies that claim their PMTAs were denied based on a standard that was not in place when the applications were submitted.

    One of the new commissioner’s first tasks will be working with Health and Human Services Secretary Xavier Becerra to find a replacement for Center for Tobacco Products Director Mitch Zeller, who plans to retire in April.

  • U.S. Army Article Wrongly Places EVALI Cause on E-Cigs

    U.S. Army Article Wrongly Places EVALI Cause on E-Cigs

    Credit: Media VN

    It doesn’t stop. Since the U.S. Centers for Disease Control and Prevention and U.S. Food and Drug Administration wrongly blamed nicotine vaping products as the cause of e-cigarette or vaping use-associated lung injury (EVALI) numerous news outlets continue to spread the misinformation.

    The official website for the U.S. Army yesterday published an article wrongly blaming EVALI on nicotine vaping products. The article states that “vaping has been commercially available since the early 2000s, and there have been hundreds of reports” of EVALI since then. “Public Health officials advise against the use of e-cigarettes, but highly recommend purchase from known vendors, if consuming … Washington says an estimated 200,000–300,000 active duty service members are diagnosed with acute respiratory issues annually.”

    After the CDC announced that vitamin E acetate in black market marijuana vaping products was the cause EVALI more than two years ago, many media outlets continue to falsely blame nicotine vaping products for the lung illness that was first identified in 2019.

    Credit: Master1305

    A study published in January 2020 in the journal Toxics provided important insight into the lung intoxication epidemic. The study presented, for the first time, a comprehensive analysis of products used by EVALI patients. Vitamin E acetate was the main finding in cannabinoid liquids. No compound that could be linked to EVALI was found in the two nicotine products tested.

    Some tobacco control experts said the CDC created panic with its refusal to directly blame the actual causes of EVALI, vitamin E acetate in illegal THC vapes. Following CDC’s lead, state health departments spread the word that using an e-cigarette to quit smoking could be life-threatening — so much so that seven states issued emergency bans on the sale of most or all electronic cigarettes.

    “Throughout its investigation of the first outbreak, CDC created public hysteria over the dangers of electronic cigarettes by attributing the outbreak to all vaping products, whether they contained nicotine or THC and whether they were purchased at a highly regulated vape shop or from a drug dealer on the street,” wrote Michael Siegel, a professor in the Department of Community Health Sciences, Boston University School of Public Health, where he has conducted research on tobacco for 25 years, at the time. “The very name that CDC attached to the outbreak directly implicated electronic cigarettes, which are nicotine-delivery devices that are effective in helping adult smokers to quit smoking. Following CDC’s lead, state health departments spread the word that using an e-cigarette to quit smoking could be life-threatening — so much so that seven states issued emergency bans on the sale of most or all electronic cigarettes.”