The FDA is expected to have a new leader today. Robert Califf will likely be confirmed as the next commissioner of the U.S. Food & Drug Administration (FDA) by midday Tuesday.
On Monday night, the Senate voted 49-45 to advance his nomination as part of a cloture vote, a key procedural hurdle that can also show whether or not Senate leadership has enough votes to succeed. Technically, cloture simply streamlines the vote by limiting down the time a matter can be discussed and also restricting Senators from certain actions such as amendments that are unrelated to the vote.
Robert Califf / Credit: Modern Healthcare
While this vote was close—five Republicans and one Democrat did not vote—Senate leadership typically does not call for cloture unless it believes it has the votes to pass a measure, writes Charlie Minato, an editor with Halfwheel.
He garnered the support of five Republicans, while simultaneously having five members of the Democratic caucus vote against his nomination.
The 11th Circuit Court of Appeals granted the stays to Diamond Vapor, Johnny Copper and Vapor Unlimited. The ruling was in conjunction with Bidi Vapor’s stay. The 11th Circuit handles petitions for review from vaping businesses based in Florida, Georgia and Alabama. All four companies are based in Florida.
The decision allows the companies to continue selling their tobacco harm reduction products while the lawsuits remain active. A three-judge panel heard motions from the businesses and granted the stays by a 2-1 vote. The stays don’t guarantee that the companies will succeed in their challenges to the FDA denials, but they are an encouraging sign, according to Azim Chowdhury, a partner with Keller & Heckman law firm. He said courts usually grant stays only if the plaintiff’s case has a good chance of “succeeding on its merits.”
More than 30 companies have now sued the FDA and many of those appeals will be heard in federal courts over the next few weeks. No decisions have yet to be handed down, and early decisions could affect later ones, according to several attorneys. If there are conflicting decisions in multiple courts, the FDA’s PMTA process could eventually wind up being sorted out by the Supreme Court, according to Chowdhury.
In a highly anticipated case for the vapor industry, Triton Distribution made its opening arguments Monday in its battle with the U.S. Food and Drug Administration over how the regulatory agency conducted it premarket tobacco product application (PMTA) reviews. Triton’s lawyer urged a three-judge panel of the 5th U.S. Circuit Court of Appeals in Houston to conclude the FDA could not force manufacturers to provide studies that the agency had previously stated would not be required.
“The question before the court concerns how exactly the FDA ended up denying Triton’s PMTA—with potential implications for comparable applications by many other denied companies,” said Triton’s attorney Eric Heyer, a partner at Thompson Hine.
Credit: Sergign
In August, the FDA rejected applications to market 55,000 flavored e-cigarettes, including Triton’s, and said applicants would likely need to conduct long-term studies establishing their products’ benefits to win approval, according to Reuters. The new requirement for long-term studies differed from earlier FDA guidance and was a “surprise switcheroo,” a 5th Circuit panel concluded in October when it allowed Triton to keep selling e-cigarettes until another panel could hear its appeal.
In recently released internal FDA correspondence, the agency’s scientific staff conducted “fatal flaw” reviews that only looked for the presence of the newly required long-term studies, and if those studies were not present the agency issued a marketing denial order (MDO). During oral arguments, Heyer said the FDA’s new requirement was “arbitrary and capricious, a position conservative U.S. Circuit Judge Edith Jones appeared to agree with.
“It seems to me that’s the height of arbitrariness and capriciousness, to say we are the FDA, trust us, which I might say some of us are becoming skeptical about in light of recent vaccine experiences,” she said, alluding to COVID-19 vaccines.
Heyer argued that the process the FDA established set Triton up for failure because the new requirements were only conveyed after the deadline for when PMTAs needed to be submitted (Sept.9, 2020) had passed. It was only then that the FDA indicated that applicants would likely need randomized controlled trials (RCTs) and longitudinal cohort studies to demonstrate “comparative efficacy.”
The other two judges questioned Triton’s case. U.S. Circuit Judge Gregg Costa asked whether Triton’s products, such as one called Jimmy the Juiceman Strawberry Astronaut, were really targeted to adults. “That’s supposed to be appealing to a 40-year-old?” he asked.
U.S. Circuit Judge Catharina Haynes questioned why companies like Triton did not have enough time to develop such support for their products’ health benefits for adults given the years they have had to prepare for FDA regulation. The FDA in 2016 deemed e-cigarettes to be tobacco products like traditional cigarettes subject to agency review under the Tobacco Control Act. Manufacturers were ultimately given until 2020 to seek approval to market them.
If the court disagrees with Triton’s argument, Heyer has requested that the judges “enjoin FDA from taking further adverse action on the Petitioners’ PMTAs for 18 months to allow Petitioners to conduct the necessary studies to prove comparative efficacy,” according to legal documents.
There is no timeline for a decision in the Triton lawsuit. Judges are expected to take at a minimum weeks, if not months, to make a decision.
Several anti-tobacco groups have sent a letter to the U.S. Food and Drug Administration urging the agency to act on the outstanding premarket tobacco product applications (PMTAs) and pushing for the denial of all flavored e-cigarette products.
It’s been more than four months since the FDA was supposed to decide which e-cigarette products can remain on the market, but the agency still hasn’t completed some of the reviews, including some of the bestselling e-cigarettes.
“We write to urge the U.S. Food and Drug Administration (FDA) to expedite decisions on the premarket tobacco product applications (PMTAs) still pending before the agency involving the flavored e-cigarette products, including those with menthol flavoring and, based on the best available scientific evidence, deny the pending applications for all non-tobacco flavored e-cigarettes in order to protect the nation’s young people from the health harms of these products,” the letter said.
The letter was signed by the American Academy of Pediatrics, the American Heart Association and the Campaign for Tobacco-Free Kids, among others.
“Every day that FDA delays action, more of our kids remain at risk,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids. “While the FDA has ruled on applications from a lot of small companies, it hasn’t ruled on the applications from the large companies whose products are being used by a majority of kids.”
American Vaping Association President Gregory Conley pointed to data showing that youth vaping has been declining. According to the Centers for Disease Control and Prevention (CDC), use of e-cigarettes went down among middle and high school students from 2019 to 2020.
But even with the drop, the CDC said it “estimated that more than 2 million U.S. middle and high school students reported currently using e-cigarettes in 2021.”
Several court cases challenging the U.S. Food and Drug Administration’s issuing of marketing denial orders (MDOs) in response to its review of premarket tobacco product applications are still pending. Last week, three high profile tobacco harm reduction advocates filed their fourth amicus brief in support of companies that are challenging the FDA.
Credit: Sang Hyun Cho
Clive Bates, director of Counterfactual Consulting, David Abrams, a professor of social and behavioral sciences at the NYU College of Global Public Health, and David Sweanor, adjunct professor of law at the University of Ottawa, filed the latest brief in support of Chicago-based Gripum LLC, which has had its MDO temporarily stayed by the court while the FDA’s actions are reviewed.
“The PMTA process and [appropriate for the protection of public health] APPH test do not apply to combustible cigarettes, which have a much less onerous path to market; accordingly, the most dangerous products are easily accessible throughout the United States, and their manufacturers do not face the threat of financial ruin from FDA’s regulatory burdens and determinations,” the brief states. “FDA’s regime for evaluating ENDS amounts to a major barrier to entry for less harmful products than cigarettes and unjustified regulatory protection of the incumbent combustible cigarette trade. The harms arising from adult and adolescent cigarette smoking far outweigh the harms arising from youth use of ENDS.”
The group also addressed the FDA’s having established an onerous new standard of evidence in PMTAs. The FDA has admitted to using a “fatal flaw” checklist to deny over one million PMTAs without further consideration because they do not provide randomized controlled trials, cohort studies, or other types of (unspecified) evidence that FDA had retrospectively deemed necessary. They also state that the APPH test doesn’t differentiate between adults and youth.
“The APPH test applies to the ‘population as a whole.’ There is no distinction drawn between adolescents and adults in the Act. In some circumstances, ENDS use can be beneficial to adolescents who would otherwise smoke,” the brief states. “As a matter of policy, FDA chooses to take no account of such benefits to youth, but that approach is incompatible with the APPH test in either the PMTA pre-market review process TCA §910(c)(4) or in rulemaking for setting product standards §907(a)(3).”
The group filed similar briefs in three other cases: Triton v FDA – Fifth Circuit (17 Nov 2021), My Vape Order v FDA – Ninth Circuit (24 Nov) and Bidi Vapor v FDA – Eleventh Circuit (24 Nov).
Today, the U.S. Food and Drug Administration authorized the marketing of 22nd Century Group Inc.’s “VLN King” and “VLN Menthol King” combusted, filtered cigarettes as modified risk tobacco products (MRTPs). The FDA has not yet granted a MRTP to a vaping product, even though the agency has said e-cigarettes are less harmful than combustible cigarettes. Many experts have said the low-nicotine cigarettes from 22nd Century will actually cause people to smoke more cigarettes.
These are the first combusted cigarettes to be authorized as MRTPs by the agency and the second tobacco products overall to receive “exposure modification” orders, which allows them to be marketed as having a “reduced level of, or presenting a reduced exposure to,” a substance, according to a press release.
“Our mission is to find ways to stop tobacco-related disease and death. We know that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers. If adult smokers were less addicted to combusted cigarettes, they would likely smoke less and may be exposed to fewer harmful chemicals that cause tobacco-related disease and death.”
The exposure modification orders specifically authorize the manufacturer to market “VLN King” and “VLN Menthol King” with certain reduced exposure claims regarding nicotine, including:
“95% less nicotine.” “Helps reduce your nicotine consumption.” “…Greatly reduces your nicotine consumption.”
When using any of the reduced exposure claims in the product label, labeling or advertising, the company must include, “Helps you smoke less.” The FDA also recommends that the labeling and advertising include the statement, “Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death.”
Despite today’s action, these products are not considered safe or “FDA approved.” There are no safe tobacco products, so people, especially young people, who do not currently use tobacco products should not start using them or any other tobacco product, according to a press release. The exposure modification orders do not permit the company to make any other modified risk claims or any express or implied statements that convey or could mislead consumers into believing that the products are endorsed or approved by the FDA, or that the FDA deems the products to be safe for use by consumers. These orders do not allow the company to market these products with therapeutic or cessation claims.
Robert Califf vowed to close the synthetic nicotine loophole if appointed commissioner of the U.S. Food and Drug Administration, according to a report by Vaping360.
During Califf’s nomination hearing on Dec. 14, Wisconsin Senator Tammy Baldwin expressed concern over reports that companies are switching to making flavored synthetic nicotine products in the wake of FDA marketing denial orders.
“As FDA commissioner, how would you work to address the rise in youth use of synthetic nicotine, and will you commit to working with Congress to ensure that the FDA has the authorities and resources it needs to crack down on these products?” Baldwin asked.
In response, Califf first noted that is crucial to appoint the right person to succeed Center for Products Director Mitch Zeller, who plans to retire in April 2022.
“Secondly,” Califf continued, “this is not limited to children. I may have some family members using synthetic nicotine, I learned as I was going through the paces here. And what people don’t realize is that there are two enantiomers of nicotine—one of which is not occurring in nature—that are in this product, and its properties are not known.
“So we’ve got to close this loophole,” Califf added, “so that we make sure that we understand the risks and benefits, and particularly deal with the issues in children.”
The Senate Health, Education, Labor & Pensions Committee will vote soon on whether to recommend Califf’s nomination to the full Senate. If the committee approves him, the former commissioner can expect full Senate confirmation to be the new commissioner soon, probably in January.
Mitch Zeller, the director of the Food and Drug Administration’s Center for Tobacco Products, plans to retire in April 2022 after serving in the post since 2013, reports The Washington Post. In a letter to staff, acting FDA Commissioner Janet Woodcock praised his work as “invaluable and instrumental” to advancing “numerous historic public health milestones in tobacco regulation.”
A graduate of Dartmouth College and the American University Washington College of Law, Zeller has been working on FDA issues for more than 30 years. He began his career as a public interest attorney in 1982 at the Center for Science in the Public Interest (CSPI). In 1988, Zeller left CSPI to become counsel to the human resources and intergovernmental relations subcommittee of the House of Representatives’ government operations committee, where he conducted oversight of enforcement of federal health and safety laws.
In 1993, Zeller joined the staff of then FDA Commissioner David Kessler. What began as a two-week assignment by Kessler to examine the practices of the tobacco industry led to his serving as associate commissioner and director of the FDA’s first Office of Tobacco Programs. Instrumental in crafting the agency’s 1996 tobacco regulations, Zeller also represented the FDA before Congress, federal and state agencies. Zeller also served as an official U.S. delegate to the World Health Organization working group for the Framework Convention on Tobacco Control.
In 2000, Zeller became executive vice president of the American Legacy Foundation. His responsibilities there included marketing, communications, strategic partnerships and, in 2002, creating the foundation’s first Office of Policy and Government Relations. That year, Zeller joined PinneyAssociates, where, as senior vice president, he provided strategic planning and communications advice.
He left PinneyAssociates in 2013 to begin his second stint at the FDA.
The U.S. Food and Drug Administration has issued warning letters to four companies marketing “wellness” vaping products. The FDA says the vaping devices contain vitamins and/or essential oils and the companies are making unproven health claims about them. Currently, no vaping products are approved by the FDA to prevent or treat any health conditions or diseases. The devices in question do not contain nicotine. The FDA calls the products “unapproved new drugs” sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act.
Credit: FDA
“The FDA issued warning letters to companies for illegally selling these vaping products with unproven health claims. The letters provide the companies notice and request that they take prompt action to address any violations of the law,” according to an FDA press release. “If companies refuse to comply, the FDA may take enforcement actions to prevent the products from reaching consumers.”
The FDA stated that it had received complaints concerning several “wellness” products being advertised and sold to minors. “Online advertising, especially social media posts, often make false claims and cite the latest ‘scientific study,’ or do not include important details that may apply to you or allow you to make an informed decision,” the release states. “Other red flags include claims like “miracle cure” or “guaranteed results.” Remember, if a company really made a breakthrough, revolutionary health-related discovery, the news, researchers, and the government would discuss it in depth.” The letters were issued through the FDA’s Center for Drug Evaluation and Research (CDER).
The letters to Vitastick, Vitacig, NV Nutrition (NVN) and Vitamin Vape were issued on Dec. 1. Some of the unproven health or wellness claims include improving mental clarity or treating tumors or asthma. Some examples of the fraudulent product claims are:
“Fight off tumors and alleviate symptoms of chemotherapy!”
“It’s been used as a [sic] organic asthma remedy, ADHD remedy, and dementia treatment.”
“Helps prevent a type of anemia called megaloblastic anemia that makes people tired and weak.”
“Neroli oil… has long been used as a treatment against anxiety and depression, to calm the mind and soothe away tension.”
The FDA, Centers for Disease Control and Prevention, state and local health departments, and other clinical and public health partners are continuing to monitor and research vaping-associated lung injury. The FDA warns consumers to not be misled by vaping products claiming to contain “vitamins” and other “natural” ingredients or being advertised for “wellness” purposes.
The health groups that brought forward the submission deadline for U.S. premarket tobacco product applications (PMTAs) through litigation have asked the federal judge in that case to require the Food and Drug Administration to regularly report on its PMTA review process, reports Vaping360.
On Nov. 15, an attorney representing the plaintiffs sent a letter to U.S. District Court Judge Paul Grimm. The groups want Judge Grimm to force the FDA to explain its progress on PMTAs submitted by mass-market vaping brands.
“Plaintiffs will seek a modification that would require FDA to provide regular status reports to the Court giving FDA’s estimate of the date(s) by which it expects to complete its review of the Premarket Tobacco Product Applications (PMTAs) for all products for which PMTAs were filed by Juul, Vuse, NJOY, Blu, SMOK, Suorin, and any other brands that rank among the top 10 brands in market share, according to FDA,” wrote attorney Jeffrey Dubner on behalf of his clients.
Earlier in the review process, the FDA announced it would prioritize its resources to complete assessments of the most popular products first. But when the agency’s self-imposed one-year review deadline rolled around, the FDA had made no decisions on the products with the greatest market share.
To date, the FDA has ruled on only one mass-market vaping product—Vuse Solo, a dated product with limited market share.
In addition to asking Judge Grimm to monitor the FDA’s PMTA review progress on popular vape brands, the plaintiffs complain that the agency has not taken any enforcement actions against companies still waiting for a PMTA decision.
The plaintiffs in the lawsuit against the FDA are the American Academy of Pediatrics and its Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative.
