The head of the U.S. Food and Drug Administration Tuesday said he has commissioned an independent review of the agency’s food and tobacco programs following months of criticism over its handling of the baby formula shortage and e-cigarette reviews, according to AP.
The announcement comes as FDA Commissioner Robert Califf attempts to push past several controversies that have dominated his second stint running the agency, including his issuing of a marketing denial order (MDO) to e-cigarette maker Juul Labs and later having to rescind that order and placing Juul’s premarket tobacco product application (PMTA) back under review.
“Fundamental questions about the structure, function, funding and leadership need to be addressed” in the agency’s programs, Califf said in a statement. The agency’s Center for Tobacco Products (CTP) is facing challenges navigating policy and enforcement issues from “an increasing number of novel products that could potentially have significant consequences for public health … CTP will continue its important work during the evaluation, including review pending applications and take enforcement actions as needed.”
Califf said the non-profit Reagan-Udall Foundation — a non-governmental research group created by Congress to support FDA’s work — would convene experts to deliver evaluations within 60 business days of both the food and tobacco operations.
“It may take some time to implement any recommended changes, but I am committed to addressing them and communicating them to the public in a timely manner,” Califf stated. “It is my belief that this effort will continue strengthening the FDA and better position the agency to deal with the many immediate public health issues we are facing, while preparing for the many scientific challenges and fascinating opportunities of the future.”
Two makers of flavored e-liquids lost their bid to force the U.S. Food and Drug Administration to allow them to market their vaping products, after the U.S. Court of Appeals for the Fifth Circuit denied their requests Monday for review of the agency’s orders.
Wages and White Lion Investments LLC, doing business as Triton Distribution, and Vapetasia LLC didn’t show that the FDA acted arbitrarily or capriciously when it rejected their premarket tobacco product applications (PMTAs), the Fifth Circuit said.
If the ruling holds, Triton and Vapetasia will not be able to sell their reduced-risk nicotine products.
Dozens of other smaller vape companies have accused the agency of operating unfairly, and will likely be disheartened by this ruling, reports Alex Norcia for Filter.
“Among the three judges who heard the Triton case, Catharina Haynes and Gregg Costa sided with the FDA. Edith Jones, the former chief judge of the Fifth Circuit who has served since the Reagan administration, dissented from her colleagues,” Norcia writes.
Todd Wages, a partner at Triton Distribution, told Filter he was “very disappointed” in the court. “We’re exploring our next steps. I will not stop fighting until I can’t any longer, until every door is closed,” he said.
The FDA rejected applications to market 55,000 flavored e-cigarettes in August, 2021, including Triton’s, and said applicants would likely need to conduct long-term studies establishing their products’ benefits to win approval.
A Fifth Circuit panel then in October agreed with Triton’s claim that the new requirement for long-term studies differed from earlier FDA guidance and was a “surprise switcheroo” and the panel allowed Triton to keep selling its e-cigarettes until another panel could hear its appeal.
Eric Heyer, the lawyer representing Triton Distribution, told Filter that the company “intends to file a petition for rehearing en banc by the entirety of the Fifth Circuit.”
Juul Labs on Friday said it is in the early stages of exploring several options including financing alternatives, as the company deals with lawsuits and a potential ban on sales of its e-cigarettes by U.S. health regulators.
Bloomberg News earlier reported, citing sources, that Juul’s bankers at Centerview Partners are sounding out investors for a possible $400 million first-lien term loan due August 2023.
The proceeds would help refinance an existing term loan, which has around $394 million outstanding and matures on the same date, the report added.
A spokesperson for Juul told Reuters that the company is looking at options to protect its business and to address the “impact of the FDA’s now stayed order so we can continue offering our products to adult consumers who have or are looking to transition away from traditional cigarettes.”
Bloomberg News in its report said Juul was also considering a new $150 million second-lien term loan, which may have an August 2024 maturity, to help pay down some of the first-lien term loan and to increase liquidity, the report said.
Financing proposals for either loan are due July 21, according to the report.
Last month, the Food and Drug Administration (FDA) blocked sales of Juul e-cigarettes and said the applications “lacked sufficient evidence” to show that sale of the products would be appropriate for public health.
Under the new law governing synthetic nicotine products signed on March 15, 2022, Congress imposed a short 60-day deadline for companies to file premarket tobacco product applications (PMTAs) and declared that if such applications were not approved within 120 days (the Act) they would be “in violation of” the Federal Food Drug & Cosmetic Act’s (FDCA) PMTA requirement.
Since no authorizations have been granted as of today, the question is will FDA use its enforcement discretion to continue reviewing PMTAs, or will it precipitously declare that all synthetic nicotine products must be removed from the market after July 13, 2022?
There is no question that the FDA should use its enforcement discretion. In a series of direct engagements with FDA since the Act’s passage, the Vapor Technology Association (VTA) has provided a complete set of scientific and policy justifications for synthetic nicotine products, and specific recommendations on how FDA should use its enforcement discretion – just as it has in the past – to allow synthetic nicotine products to remain on the market during the PMTA review process.
However, some have suggested that Congress mandated all products be removed from the market this week if they are not approved by FDA. But a close review of the Act reveals that the opposite is true: Congress did not require synthetic nicotine products with pending PMTAs to be removed from the market after July 13.
In interpreting laws, a court will first look to the plain language of the Act and, only if there is an ambiguity, will it look to Congressional intent to resolve such a question. Here, both support the FDA’s continued use of enforcement discretion for pending PMTAs.
The Plain Language Supports Enforcement Discretion
There are four relevant sections of the Act. First, under Section (d)(2)(A), Congress expressly stated that “as a condition to market” all manufacturers wishing to continue selling their products must file a PMTA no later than May 14, 2022.
Tony Abboud
Second, under Section (d)(2)(B), Congress expressly stated that companies which filed PMTAs “may continue to market” their products during what the Act calls a “transition period.”
Third, under Section (d)(2)(C), Congress expressly required that if a company did not file a PMTA for its synthetic products by May 14, 2022, that company is “not eligible for continued marketing.” In each of these sections, Congress expressly uses some variation of the term “market” to articulate its direction on what may (not) be marketed and when.
However, in the operative Section (d)(3), which addresses what happens after July 13, 2022, Congress makes no statement regarding marketing at all. Instead, it states that products with pending PMTAs not yet approved would be “in violation of…section 910” of the FDCA (21 USC 387g).
When presented with this question, a court likely would rule that because Congress did not expressly state that pending applicants are “not eligible for continued marketing” or that they “may not market” after July 13, as it clearly said in the immediately preceding sections, Congress did not require the removal of products with pending PMTAs.
This places synthetic nicotine products with pending PMTAs in precisely the same position as all other products with pending PMTAs which, for years, FDA has made clear are “illegal” (i.e., in violation of section 910) but are allowed to remain on the market at FDA’s enforcement discretion.
Even if a court finds that Section (d)(3) is ambiguous, there is nothing in Congressional intent that would lead to the conclusion that Congress intended for products with pending PMTAs to be removed from the market.
First, Congress could have banned synthetic nicotine products, if that is what it intended, but it did not do so. To the contrary, Congress expressly authorized manufacturers to bring new products to market after the Act’s passage. Thus, it would be folly to suggest that Congress intended all synthetic nicotine products be removed from the market without PMTA review.
Second, Congressional intent is generally divined by on the record statements made in committee hearings and in floor debate (not from press releases or media statements). But there is little to nothing which a court could rely on [with] this question because the provision was quietly slipped into the Ukraine-omnibus spending bill with no relevant hearing or floor debate.
Third, Congress was fully aware that FDA could not review PMTAs within 180 days (as required under the FDCA). In fact, the FDA told a court it will not be finished reviewing tobacco derived PMTAs until June of 2023. Thus, no one could suggest that there ever was any reasonable expectation or intent that the FDA would rule on synthetic nicotine PMTAs in 60 days.
Hence, the only reasonable conclusion that can be drawn from the plain language and Congressional intent is that Congress did not require removal of products with pending PMTAs but, rather, expected the FDA to continue to use its discretion in enforcing its PMTA regulation after July 13.
Congress did, however, expressly state that products for which no PMTA was timely filed have no continuing ability to market, authorizing the FDA to take immediate action. VTA has repeatedly communicated to the FDA the need for it to aggressively remove all tobacco products from the market for which no PMTA has been filed and to publish a list of all products covered by a synthetic nicotine PMTA so that retailers know which products can be sold.
A Careful and Complete Evaluation of Synthetic Nicotine PMTAs is Required
We live in a world that remains captive to [combustible] cigarettes. Congress won’t ban them and Congress has prevented the FDA from doing so. While electronic nicotine-delivery system (ENDS) products offer a technological solution to delivering nicotine in a substantially less harmful way, synthetic nicotine now represents the first technological innovation in nicotine itself.
Synthetic nicotine uniquely offers consumers the cleanest and purest form of nicotine with numerous benefits, i.e., the absence of heavy metals, nitrosamines, and pesticides. Synthetic nicotine uniquely offers consumers the opportunity to break free from the last remaining vestige of the tobacco plant.
Synthetic nicotine uniquely offers the FDA unprecedented product constituent clarity, replicability, and traceability down to the batch level. Not only does synthetic nicotine offer companies the opportunity to change the dynamics regarding total reliance on tobacco-derived nicotine for all tobacco and pharmaceutical nicotine products, but it also provides companies the ability to address their ESG [sustainability] goals and take a significant step to ameliorate the adverse environmental impacts of tobacco.
Our message to the FDA has been constructive and clear: it is critical to the adult smoker that FDA takes aggressive steps to create an orderly and regulated marketplace with a diversity of desirable nicotine alternatives.
Given recent history with tobacco derived PMTAs, the best way for FDA to realize that objective now is to avoid the blanket denial mistakes of the past which have mired the agency in protracted litigation. Such litigation will only delay the time until we achieve an orderly and regulated marketplace.
Instead, we have asked the FDA to work companies which timely filed synthetic nicotine PMTAs – the good actors – through the PMTA scientific process and provide them the requisite time and guidance to fulfill FDA’s requirements.
At the same time, we have asked the FDA to aggressively enforce against the non-compliant companies that have refused participate in the PMTA process – the bad actors – by interdicting such products at the border and removing such products from the market Congress has clearly required.
In the end, it is incumbent on the new FDA leadership to use its power to create an orderly marketplace by embracing scientific innovations, stimulating additional financial investment, accelerating authorizations of pending tobacco-derived PMTAs, and ensuring that synthetic nicotine products which now contain the cleanest and purest form of nicotine that science has created are available to adult smokers.
Tony Abboud serves as president for Strategic Government Solutions, and executive director of the Vapor Technology Association.
RELX International and SABA IP recently trained officials from the Abu Dhabi Customs Authority and Department of Economic Development to help them combat the illegal trade in vapor products.
The session covered topics such as distinguishing legal products from illegal ones, raising awareness about the consequences of the illegal e-cigarette trade and sharing research and intelligence. The program also discussed product authentication, tracking and tracing technologies.
According to RELX, contraband and counterfeit e-cigarettes are produced in unregulated facilities and pose a serious health risk to legal age consumers and minors. Counterfeit e-cigarettes often use inferior e-liquid formulas; capsules frequently leak and provide misleading information about the nicotine dosage in the capsules.
“The training sessions for the Abu Dhabi Customs Authority, Department of Economic Development and Ras Al Khaimah Customs Authority showcase RELX International’s commitment, as a responsible company, to working with local authorities, investigation firms and e-commerce platforms to identify and remove contraband and counterfeit e-cigarette products from the market, as part of the RELX Pledge,” said Robert Naouss, external affairs director, MENA and Europe at RELX International, in a statement.
In 2019, RELX International established the Golden Shield Program to prevent the production and sale of illicit goods. Since its inauguration, the program has helped remove more than 550,000 fake products from the market, plus over 77,000 websites.
Additional training sessions are planned in countries across the Middle East, including in Egypt and Jordan. Earlier this year, RELX concluded a training session with customs officials in Saudi Arabia.
During a recent product launch broadcast live worldwide on June 29, ZoVoo released four new products, its Gene Tree special edition ceramic core technology, and ZoVoo shared information on its peak performance in the electronic atomization field.
The first disposable product in the DRAG family, the new DRAGBAR R6000 is ZoVoo’s pod-style disposable. It has a classic leather texture design and its new airflow adjustment function, according to a press release.
ZoVoo also launched its lightest and thinnest ceramic core disposable product, the DRAGBAR Z700 GT, which “adopts the latest upgraded ceramic core technology, and reconstructs a new thin and light experience,” according to a release.
The new core is the latest nano-microcrystalline ceramic core independently developed by ZoVoo, GENE TREE Special Edition is the first “powder free” ceramic core with proprietary patented technology in the industry, according to the release.
Also launched, DRAGBAR F8000, with max 8000 puffs, adopts the infinite airflow adjustment system, and matches with high-performance of a mesh coil. Also, the new VINCIBAR F2500 adopts Kevlar texture, integrates light and shadow aesthetics, elegant and comfortable. With max 2500 puffs, 15 flavors and mesh coil design.
The U.S. Food and Drug Administration overlooked a key part of Juul’s premarket tobacco product application (PMTA) when the agency ordered Juul Labs’ products off the U.S. market, according to court documents.
In court filings Tuesday, Juul said the agency overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale, according to the Wall Street Journal.
Juul also said the agency failed to consider the totality of Juul’s evidence, which the company said established that the public-health benefits of Juul products significantly outweighed the potential risks.
“FDA’s order acknowledged that ‘exposure to carcinogens and other toxicants present in cigarette smoke were greatly reduced with exclusive use’ of Juul products compared with combustible cigarettes,” Juul Labs stated in court documents.
A federal appeals court last week granted Juul Labs a temporary stay of the FDA’s marketing denial order that requires the vaping company to pull its e-cigarettes off the U.S. market.
“The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion,” the court wrote.
The FDA has until July 7 to respond to Juul’s motion and Juul Labs has until July 12 to reply to the FDA response if submitted.
The U.S. Food and Drug Administration has approved the premarket tobacco product applications (PMTA) for NJOY’s Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%.
“It should be noted that our determination that the marketing of these products is APPH [appropriate for the protection of public health] is based in part on the submitted microbial stability data,” the agency wrote in its marketing granted order (MGO).
The designation does not mean the products are safe and they are not “FDA approved,” the agency said, but the MGOs allows the NJOY to legally market the authorized products in the United States.
While approving NJOY’s Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%, the FDA denied authorization for multiple other Daily e-cigarette products. These are presumed for products with nontobacco flavors. Any of those products that remain on the market must be removed or risk FDA enforcement, the agency said. Applications for two menthol-flavored Daily products remain under FDA review.
Additionally, the authorization imposes marketing restrictions on the company to greatly reduce the potential for youth exposure to advertising for these products. The FDA said it will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products.
The U.S. Food and Drug Administration on May 12 gave R.J. Reynolds Vapor Co. (RJRVC) permission to continue marketing the original-flavor varieties of its Vuse Vibe and Vuse Ciro products. In October 2021, the FDA authorized the marketing of Vuse Solo original flavor.
“These authorizations represent the broadest portfolio of market authorizations provided to any company in the U.S for premarket tobacco product applications (PMTA),” said David O’Reilly, director of scientific research at RJRVC’s parent company, BAT, in a statement. “Continued focus on science and innovation has supported the robust submissions, which have enabled FDA to evaluate and authorize the marketing of these products.
“We are proud of the work undertaken by the team to achieve this significant regulatory milestone and are confident in the quality of our applications.”
While approving the original-flavor varieties, the FDA denied RJRVC’s applications for the marketing of Vuse-branded products with other flavors. Those flavored vapor products are not currently marketed or sold in the U.S., according to BAT. The company says it is reviewing the FDA’s decision on those applications to determine next steps.
RJRVC’s application to market menthol-flavored Vuse products remains under FDA review and those products can remain on market pending a decision from the agency.
The ban on menthol cigarettes is closer to becoming a reality. After years of discussion, the U.S. Food and Drug Administration has instituted a proposed rule to place a ban on menthol combustible cigarettes and flavored cigars. Whether the menthol ban will also cover next-generation tobacco products, such as e-cigarettes, has not yet been clarified.
“The authority to adopt tobacco product standards is one of the most powerful tools Congress gave the FDA and the actions we are proposing can help significantly reduce youth initiation and increase the chances that current smokers quit. It is clear that these efforts will help save lives,” said FDA Commissioner Robert M. Califf. “Through the rulemaking process, there’s an important opportunity for the public to make their voices heard and help shape the FDA’s ongoing efforts to improve public health.”
When finalized, the FDA states that the proposed menthol product standard will:
reduce the appeal of cigarettes, particularly to youth and young adults, decreasing the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular smoking; and
improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation.
According to the FDA, the proposed product standards are based on clear science and evidence establishing the addictiveness and harm of the products. Many organizations were quick to condemn the regulatory agency for proposing the rule that is opposed by all major law enforcement, civil rights and criminal justice reform organizations. Opponents of the menthol ban say that banning menthol products will do nothing to reduce combustible cigarette smoking rates but will lead to an increase in people purchasing products on the black market.
“This misguided proposal will have disastrous impacts on public health and public safety. It will do nothing to reduce smoking rates and instead make the United States less safe.” said Tim Andrews, director of Consumer Issues for Americans for Tax Reform (ATR). “It is unfortunate that as violent crime rates rise across the country, the FDA chooses to divert valuable police resources to pursue an unnecessary ban on menthol products.”
Andrews argues that a menthol ban exposes “vulnerable members of minority communities to conflict with law enforcement, and their purchases could also fund sophisticated international criminal syndicates.” According to the U.S. Department of State, illicit tobacco’s links to funding terrorist organizations already present a “serious threat” to national security. “This policy would worsen the problem while also depriving state governments of excise revenue, putting state government programs at risk,” says Andrews.
Richard Marianos, a senior law enforcement consultant who has served more than 27 years at the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and who is now a consultant and adjunct lecturer at Georgetown University, says that in many markets, such as Asia, companies are creating products to make mentholated cigarettes, because those types of products are not covered by the rule.
“They flavor packets you just slide into a pack of cigarettes. You buy your cigarettes, you put that in there and by the time you get home, the whole pack is mentholated. They also have these– it’s like a little Tic Tac box with a round, small, little mint … but what it does is you put it into the filter, shake, crush and now it’s a menthol cigarette,” said Marianos. “Are we eventually going to be asking border protection to now start looking for minty flavor packets or Tic Tac boxes when they have to concentrate on biological and nuclear threats? When you overlook public safety surrounding this matter, you’re creating an unhealthy situation, not just for smokers, but anybody who’s out there.”
Marianos says that a menthol ban will create a greater level of diversion and criminal activity with high-value targets overseas, it’ll bring more organized crime into the United States. It’ll also create a greater market for border countries to begin manufacturing menthol and bring it into the United States.
“There was one investigation in particular, I remember, where the individual said on a wire that once they banned menthol cigarettes in the United States, you can pave the roads in gold because of the boost in sales of black market and DIY menthol cigarettes,” he said. “Prohibition doesn’t work. Your quality of police work goes down; they can’t concentrate on violent crime as much and it creates a greater wedge between themselves and the community.”
Guy Bentley
Guy Bentley, director of Consumer Freedom Research for the Reason Foundation, said that similar bans have had minimal effects on tobacco consumption in other countries such as Canada and the U.K., adding that a menthol ban is likely to lead to more policing in minority communities, more incarceration, boost black market sales and undermine criminal justice reforms in the U.S.
Bentley explained that a recent study funded by the Norwegian Cancer Society in partnership with the Polish Health Ministry found that in Poland – the EU state with the largest pre-ban menthol share – found “mixed evidence” that the ban is working as intended.
Bentley argues the FDA and Biden administration should apply a harm reduction model, educating the public about safer alternatives to conventional cigarettes and the latest smoking cessation options. Andrews concurs with Bentley, adding that the proposed rulemaking will inevitably lead to further growth of illicit markets, put members of minority communities in danger and divert law enforcement resources away from real crime.
“It ignores best practice expert recommendations on how to reduce smoking rates through proven harm reduction technologies, is a disaster for public health, and will make all Americans less safe,” Andrews said. “If the Biden Administration truly cared about the American people, they would junk this anti-science and genuinely harmful proposal immediately.”
Beginning May 4, 2022, the public can provide comments on these proposed rules, which the FDA will review as it considers future action. The agency also will convene public listening sessions on June 13 and June 15 to expand direct engagement with the public, including affected communities.
The public will have the opportunity to submit either electronic or written comments directly to the dockets on the proposed rules through July 5, 2022. Once all the comments have been reviewed and considered, the FDA will decide whether to issue final product standards.
The FDA also states that it cannot and will not enforce against individual consumers for possession or use of menthol cigarettes or flavored cigars. If the proposed rules are finalized and implemented, FDA enforcement will only address manufacturers, distributors, wholesalers, importers and retailers who violate the rules.
The U.S. Food and Drug Administration on May 12 
