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.
Several tobacco companies have reached an agreement in long-running litigation brought by the U.S. Department of Justice (DOJ) and certain public health organizations regarding the communication of tobacco-related messaging at retail locations.
The agreement will require Altria, Philip Morris USA, R.J. Reynolds Tobacco and ITG Brands to supply their contracted stores with court-ordered signs that must be posted for 21 months.
The agreement covers the last remaining dispute from the lawsuit DOJ filed against Altria, Philip Morris USA and R..J Reynolds in the 1990s, according to the National Association of Convenience Stores (NACS).
“This litigation has always put the retailers in a uniquely bad position,” said Doug Kantor, NACS general counsel. “Retailers were not parties to the lawsuit and should not be burdened with a court-ordered remedy, but this negotiated outcome avoids even worse results that DOJ and public health groups were advocating.”
The agreement provides that each store under contract with one of the manufacturers will have to post at least one sign carrying one of 17 different, pre-approved health messages that will be distributed at random to retailers around the country.
Each store will be required to rotate to a new message halfway through the time period required in the agreement. The manufacturers will be required to hire auditors to check whether the signs are properly posted. A summary of the agreement explaining the requirements on retailers as well as answers to frequently asked questions about it can be found here.
A hearing on the proposed agreement will be held in the U.S. District Court for the District of Columbia on July 28 and 29. The court will then decide whether to accept the agreement and enter an order to implement it.
The timing of the requirements for signs to be posted will depend on when the court decides whether to accept the agreement.
The U.S. Senate on Tuesday voted to confirm Steve Dettelbach to serve as director of the Bureau of Alcohol, Tobacco, Firearms and Explosives.
Dettelbach, 56, was confirmed by a 48-46 vote that went largely along party lines.
“Following the passage of the Bipartisan Safer Communities Act, today’s vote is another important sign that both parties can come together to support law enforcement and stand up against the horrific scourge of gun violence,” President Joe Biden said in a statement following the vote.
Prior to landing the job as the head of the ATF, Dettelbach worked as a federal prosecutor for the Justice Department – the ATF’s parent agency.
“Steve understands the importance and urgency of ATF’s mission and I am confident he will lead ATF with integrity, dedication and skill,” U.S. Attorney General Merrick Garland said in a statement.
Tuesday’s vote marked the first time the Senate has confirmed an ATF director since 2013.
According to a new study, individuals who viewed tobacco content on social media were more than two times as likely to use the substance compared with those who were not exposed. Both organic content, such as friends’ post, and curated content, or advertisements, were included in the study.
Findings of the meta-analysis were published in JAMA Pediatrics and also showed that even among never-users, those who viewed tobacco-related content on social media were more than twice as likely to use it in the future than non-viewers.
Because results are based largely on surveys conducted at one point in time, a direct cause cannot be confirmed, according to The Hill.
The review included 24 datasets, complete with information from 139,624 individuals, the majority of whom were adolescents. The studies also took place in a range of countries that included the United States, Indonesia and Australia.
“The proliferation of social media has offered tobacco companies new ways to promote their products, especially to teens and young adults,” said study co-author Jon-Patrick Allem of the Keck School of Medicine in a statement.
Those exposed to tobacco on social media were also more likely to have had past 30-day tobacco use, while similar associations of past, current and future use were seen for exposure to tobacco promotions, active engagement with content, passive engagement and exposure among youths and adolescents.
Individuals who consumed content on more than one platform were more likely to report current use or future susceptibility compared with single platform viewers.
Facebook, Twitter, YouTube, Pinterest, Tumblr, Instagram and Snapchat were among the platforms hosting tobacco-related content. Notably, relative social media newcomer TikTok was not included in the analysis, but researchers have plans to conduct further studies on new platforms including TikTok and refine associations by different tobacco form, such as e-cigarettes and smokeless tobacco.
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.
The U.S. Supreme Court’s recent decision to block the Environmental Protection Agency from curbing power-plant emissions also threatens the Food and Drug Administration’s attempts to limit nicotine and ban menthol in cigarettes, according to an article published by Bloomberg Law.
In their ruling, the Supreme Court judges endorsed a legal approach that requires agencies to obtain Congressional approval to address issues of major financial or political importance in novel ways. The court’s conservative members have lamented the power agencies have to create and enforce their own rules.
According to Lindsay Wiley, a professor at UCLA School of Law, the decision will be considered in any situation where an administrative agency is trying to solve a problem using authority given to it by Congress in more general terms.
In the case of tobacco, the FDA will face greater pressure to prove it is authorized by Congress to propose its draft ban on menthol in cigarettes and cigars and other major rule changes, according to Marc Scheineson, a former FDA commissioner.
While the Tobacco Control Act gives the FDA the authority to adopt product standards—including on the content of cigarettes—through notice and comment rulemaking, legal experts believe the June 30 court ruling will embolden tobacco manufacturers to challenge the menthol ban and other policies once they are finalized.
“It definitely provides a roadmap that the industry will follow trying to attack the menthol regulation with everything they can come up with,” said Joelle Lester, director of commercial tobacco control programs at the Mitchell Hamline School of Law’s Public Health Law Center.
Smoore has been recognized by the Shenzhen Municipality Industrial Design Development Support Program for its innovation and design capabilities.
The municipality singled out the vaping technology’s specialist for its “innovative design and achievement transformation of closed-pod electronic atomizer based on leadless ceramic heating technology.”
The industrial design team of Feelm, Smoore’s flagship atomization brand, has designed a number of solutions that combine consumer experience with advanced smart manufacturing.
Between 2020 and 2022, Feelm’s industrial design team won eight prestige International design awards, including the Red Dot Award, the iF Design Award, the German National Design Award and the MUSE Design Award.
In 2022, won a Red Dot Product Design Awards for four products, including a lipstick-inspired vaporizer with a twistable nozzle that prevents dust from collecting on the mouthpiece, and an eco-friendly disposable e-cigarette composed of recyclable and reusable aluminum foil.
“Feelm design is devoted to helping clients in improving the user experience from the perspective of a vaping tech brand,” said Totom Lu, head of Feelm Industrial design team, in a statement. “I think the future direction of design of closed-pod vaping solution should lean on three dimensions: product experience, emotional experience—to identify problems before users notice them—and sustainable experience, to focus on product sustainability.”
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.
