FDA - Tobacco Reporter

Registration Open for CTP Listening Session

Registration is open for the virtual listening session on the development of the Center for Tobacco Products’ (CTP) five-year strategic plan, which will take place on Aug. 22 beginning at 10 a.m. EDT.

The virtual listening session is an opportunity to verbally provide open public comment on the development of the new strategic plan, including proposed strategic goals. After introductions, the center will begin the listening session with an overview of the process used to develop the CTP’s strategic plan, including proposed goal areas. Registered speakers will then have approximately four minutes each to verbally share their comments on any topics related to the strategic plan. Submit a request to verbally provide open public comment by Aug. 14 at 11:59 p.m. EDT.

Registration also includes a “listen-only” option for those who want to attend the session but do not request to speak. Listen-only registration slots are unlimited, but registration is required. There is no deadline to register for listen-only slots.

In addition to this listening session, the public can submit electronic or written comments to the Federal Register notice. Electronic comments must be submitted, and written comments must be postmarked, by Aug. 29.

August 8, 2023

TPSAC Meeting Materials Available

The U.S. Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) met on May 18 to discuss the “Requirements for Tobacco Product Manufacturing Practice” proposed rule. All the meeting materials, including the recording, transcript and summary minutes, are now available online.

The proposed rule, if finalized, lays out the FDA’s requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of tobacco products.

Comments on the proposed rule must be submitted by 11:59 p.m. Eastern Time on Sept. 6, 2023.

July 25, 2023

CTP Invites Input on Strategic Plan

The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) will hold a virtual listening session on Aug. 22 to give the public an opportunity to comment on its five-year plan it developed to advance its mission.

Part of its response to the Reagan-Udall Foundation evaluation, the CTP plan includes five proposed goal areas that are interconnected with the themes of health equity, science, transparency and stakeholder engagement.

The proposed goals and the questions that the CTP would like commenters to address are on the agency’s virtual listening session event page.

Following receipt and consideration of public input, the CTP intends to publish its strategic plan by the end of 2023.

After introductions, the center will begin the listening session with an overview of the process used to develop the CTP’s strategic plan. Registered speakers will then have approximately four minutes each to verbally share their comments on any topics related to the strategic plan.

Request to verbally provide open public comment must be submitted by Aug. 14 at 11:59 p.m. Eastern Time.

In addition to this listening session, the public can submit electronic or written comments to the Federal Register notice. Electronic comments must be submitted and written comments must be postmarked by Aug. 29.

July 21, 2023

FDA Grant to Study Effects of Flavors

The U.S. Food and Drug Administration has given the Center for Tobacco Research at The Ohio State University Comprehensive Cancer Center a $3.9 million grant to evaluate the effects of e-cigarette flavors on smoking behaviors of current adult smokers, according to News Medical Lifesciences.

The study will be co-led by Theodore Wagener, director of Ohio State’s Center for Tobacco Research, and Tracy Smith from the Medical University of South Carolina Hollings Cancer Center.

Wagener says, “the FDA must decide how to balance its goals of protecting young people and offering harm-reduction options to adults. This new trial will generate critical data to help make more informed public health decisions that have a lasting impact.”

“The FDA is currently making regulatory decisions about e-cigarette flavors with incomplete scientific data,” Wagener said. “Existing data show that smokers also prefer flavored e-cigarettes, and while there are a few survey studies suggesting that flavored e-cigarettes may be more helpful for switching to vaping, these studies are not rigorous enough for the FDA to base its regulatory decisions on. Our study will be the first to provide the FDA with definitive information as to the benefit, if any, of e-cigarette flavors to adult smokers.”

The national, randomized, controlled trial will recruit up to 1,500 cigarette users from across the country, and researchers will measure e-cigarette flavor impact on product uptake and appeal, cigarette craving, symptoms, dependence and smoking behavior. Combination nicotine-replacement therapy will be used as a comparator to determine potential increased benefit of e-cigarettes versus nicotine-replacement therapy.

“If our study demonstrates no significant improvements in switching with flavored e-cigarette use, then the continued sale of these products is likely indefensible; however, if improvements are significant, these findings will provide a critical counterweight to the current FDA regulations and will aid future decision-making,” Wagener said.

July 13, 2023

FDA Denies Marketing of Myblu Menthol

The U.S. Food and Drug Administration on July 10 issued a marketing denial order (MDO) for Myblu Menthol 2.4 percent, an e-cigarette product made by Fontem US. The order prohibits the company from marketing or distributing this product in the United States.

“Thorough scientific review of tobacco applications is a key pillar under FDA’s role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products. “This application lacked the scientific evidence needed to demonstrate that the product provided a net benefit to the public health that outweighs the known risks.”

Among other shortcomings, the application presented insufficient scientific evidence to show that the menthol-flavored e-cigarette products provided an added benefit for adults who smoke relative to tobacco-flavored e-cigarettes, according to the FDA.

Fontem US may resubmit a new application to address the deficiencies for the product subject to this MDO.

To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. Last year, the FDA issued MDOs to Fontem US for several other Myblu products, which are the subject of ongoing litigation.

July 10, 2023

Ninth Circuit Denies Lotus MDO Review

The U.S. Court of Appeals for the 9th Circuit on June 30 declined to review a Food and Drug Administration marketing denial order for Lotus Vaping Technologies’ flavored e-liquid products.

The FDA issued marketing denial orders for Lotus’ flavored products, finding that the petitioners’ applications lacked sufficient evidence showing that the flavored products would provide a benefit to adult users that outweighs the risks such products pose to youth.

Lotus challenged the ruling in court, but the judges held that the text of the Family Smoking Prevention and Tobacco Control Act authorizes the FDA to require that manufacturers submit comparative health risk data, which necessarily includes comparisons of flavored e-liquids to tobacco-flavored e-liquids.

The judges also held that the FDA did not arbitrarily or capriciously deny Lotus’ applications and that any error the agency committed by failing to consider Lotus’ marketing plans was harmless.

July 8, 2023

CTP Reports Progress on Reagan-Udall Review

Brian King, director of U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), published a statement summarizing the CTP’s progress in addressing the recommendations from the Reagan-Udall evaluation.

At the request of FDA Commissioner Robert Califf, the Reagan-Udall Foundation evaluated the CTP’s operations. In December, the foundation submitted its report, which identified several problems hindering the agency’s ability to regulate the industry and reduce tobacco-related disease. Among other recommendations, the foundation urged the CTP to make process improvements and increase transparency.

According to King, the CTP has made significant strides in putting its plans for improvement into action. The agency, he said, is on track to issue proposed goals this summer, and to release the final plan by December 2023. The CTP intends to hold a public meeting in summer 2023 to seek stakeholder feedback about the strategic plan.

Meanwhile, said King, the CTP Ombuds Office is leading the creation of an operational strategy to improve transparency and information sharing across all programmatic areas, including through the establishment of transparency liaisons. Externally, the center is planning for upcoming public meetings to gather stakeholder input. CTP also published a webpage of all the tobacco products-related citizen petitions received by the center to provide the public with information about such citizen petitions that is easy to access and user-friendly.

According to King, the center has reviewed 99 percent of tobacco product applications submitted over the past three years, authorizing 23 tobacco-flavored e-cigarette products and devices. The CTP is currently planning a public meeting to take place in fall 2023 regarding the application review process.

Meanwhile, the center is in the process of finalizing rules related to menthol cigarettes and flavored cigars and continues to work toward publishing a proposed rule that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products.

CTP also recently proposed new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products.

King also highlighted the CTP Office of Science leadership’s participation in conferences and external meetings. For example, representatives from the Office of Science recently presented at the Food and Drug Law Institute’s Nicotine Product Regulatory Science Symposium, the E-Cigarette Summit and the TMA annual meeting (see Todd Cecil’s TMA presentation here).

“I am proud of the significant progress the center has made to date in addressing the external evaluation recommendations, and I am confident that we’ll continue to make important strides in continuing to build and strengthen FDA’s tobacco program in the future,” said King.

A comprehensive list of CTP status updates for each Reagan-Udall Foundation recommendation is available here.

June 29, 2023

FDA Issues Warning Letters to 189 Retailers

The U.S. Food and Drug Administration issued warning letters to 189 retailers for selling unauthorized products, specifically Elf Bar and Esco Bars, according to a press release.

“The FDA is prepared to use all of its authorities to ensure these and other illegal and youth-appealing products stay out of the hands of kids,” said FDA Commissioner Robert M. Califf. “We are committed to a multipronged approach using regulation, compliance and enforcement action and education to protect our nation’s youth.”

The warning letters were the result of a nationwide retailer inspection blitz over the past several weeks, according to the FDA.

“All players in the supply chain—including retailers—have a role in keeping illegal e-cigarettes off the shelves,” said Brian King, director of the FDA’s Center for Tobacco Products. “This latest blitz should be a wake-up call for retailers of Elf Bar and Esco Bars products nationwide. If they’re waiting for a personal invitation to comply with the law, they might just get it in the form of a warning letter or other action from the FDA.”

Elf Bar and Esco Bar products do not have the required marketing authorization from the FDA. The FDA has authorized 23 tobacco-flavored e-cigarette products and devices to date. The distribution and sale of unlawfully marketed products is subject to compliance and enforcement action.

As of June 16, the FDA has issued more than 570 warning letters to firms for manufacturing, selling and/or distributing illegal tobacco products, including e-cigarettes, and filed civil money penalty complaints against 12 e-cigarette manufacturers.

June 23, 2023

Second Circuit Appeals Court Rules for FDA

The U.S. Food and Drug Administration acted reasonably in denying vapor maker Magellan Technology’s request for a marketing order for its flavored vaping products, the U.S. Court of Appeals for the 2nd Circuit ruled May 16.

The court upheld the FDA’s finding that Magellan failed to show the product would provide a benefit to adult users that would outweigh the risks to youth.

The agency found Magellan’s evidence—four nonclinical studies—was insufficient to establish that the flavored pods would be more effective than tobacco-flavored electronic nicotine-delivery systems in helping smokers switch to e-cigarettes to stop smoking altogether, according to Bloomberg Law.

The manufacturer of Hyde and Juno brand e-cigarettes sued the FDA and the U.S. Department of Health and Human Services, claiming the agencies violated the Administrative Procedure Act.

New York-based Magellan Technology accused the agencies of refusing to review the company’s premarket tobacco product applications (PMTAs) for 12 products, a process that cost the company $1 million. Magellan claims the FDA “arbitrarily” and “capriciously” rejected the applications.

“Magellan had already spent over $1 million on the PMTAs at the time the RTA [refuse-to-accept] order [was] issued and plans to spend over $10 million on the PMTAs in total,” the suit states.

Texas-based retailer Vapor Train 2 is also a plaintiff in the suit. The companies asked a Texas federal court to temporarily stay the RTA order that the FDA issued to Magellan, according to the lawsuit filed Thursday.

The companies are expected to appeal the ruling. Magellan could now seek an en banc review of the case (a rehearing by the full 2nd Circuit) or could appeal to the Supreme Court of the United States.

June 19, 2023

Justice Groups Push Back Against Flavor Ban

A coalition of more than 50 criminal justice reform groups sent a letter to U.S. President Joe Biden warning that the U.S. Food and Drug Administration’s proposed ban on flavored tobacco products will lead to overpolicing in communities of color, according to The Hill.

Prohibition-style policies, like the one proposed, “have serious racial justice implications,” wrote the organizations, which include Blacks in Law Enforcement, the National Association of Criminal Defense Lawyers, the National Latino Officers Association and the Sentencing Project.

“Banning the legal sale of menthol cigarettes through licensed businesses will lead—and, in fact, has already led in some states—to illegal, unlicensed distribution in communities of color while triggering criminal laws in all 50 states, increasing the incidence of negative interactions with police and ultimately increasing incarceration rates,” the letter said. “There are far better solutions for reducing menthol cigarette use than criminalizing these products and turning this issue over to the police.”

The aim of the flavor ban is not only to make smoking less attractive but also to advance health equity, according to Health and Human Services Secretary Xavier Becerra

“FDA has the power to provide smokers with less harmful options and information to help accelerate reductions in smoking,” the coalition wrote in its letter. “Rushing forward with a total ban without these alternatives in place contradicts everything we know—and everything the administration has been saying in other spheres—about why harm reduction works and criminalization doesn’t.” The coalition urged the FDA to reconsider the ban and find solutions opposed to criminalization.

June 16, 2023

Category: FDA