U.S. Food and Drug Administration - Tobacco Reporter

Menthol Rule Advances to U.S. Budget Office

The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) sent its rules to prohibit the sale of menthol cigarettes and flavored cigars to the White House Office of Management and Budget (OMB) for final review, reports CNN.

The final rules will be issued following this last regulatory step.

The American Lung Association (ALA) said this regulation may be the most significant action the FDA has taken in the 14 years since it was given the authority to regulate tobacco.

“It’s a big, vital and critical step on the way to banning these products,” said ALA Assistant Vice President of National Advocacy Erika Sward. “ Truly, it’s momentous.”

According to a 2022 study published in Tobacco Control, prohibiting menthol cigarettes would save up to 654,000 lives in the U.S. within 40 years, including the lives of 255,000 members of the Black community.

The Campaign for Tobacco-Free Kids called for the White House and the OMB to expedite their review and issue the final rule by the end of 2023.

October 17, 2023

Marketing Denials for Flavored Vuse Alto

The U.S. Food and Drug Administration on Oct. 12 issued marketing denial orders (MDOs) to R.J. Reynolds Vapor Co. for six flavored e-cigarette products under its Vuse Alto brand. This includes three menthol-flavored and three mixed berry-flavored products, with each flavor being offered in three nicotine strengths.

After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

Specifically, evidence submitted by the applicant did not demonstrate that the menthol- and mixed berry-flavored products provided an added benefit for adults who smoke cigarettes—in terms of complete switching or significant smoking reduction—relative to that of tobacco-flavored products that is sufficient to outweigh the known risks to youth, according to the agency.

“We review each application on its own merits, and it’s the responsibility of the applicant to provide sufficient science to support the product they’re seeking to market,” said Matthew Farrelly, director of the FDA’s Center for Tobacco Product’s Office of Science. “If an application contained sufficient scientific evidence to meet the necessary public health standard, including a non-tobacco-flavored product, we’d authorize the product. But such evidence was lacking in this case.”

Vuse is the most commonly sold e-cigarette brand in the U.S., with Vuse Alto being its most popular sub-brand. Further, findings from the National Youth Tobacco Survey (NYTS) show that Vuse e-cigarettes, which are cartridge-based products, have been the second most commonly reported e-cigarette brand used by youth in the U.S. since 2021.

These actions are among many the FDA has taken to ensure any tobacco products that are marketed in the U.S. undergo science-based review and receive marketing authorizations by the agency. The FDA has received applications for more than 26 million deemed products and has made determinations on 99 percent of these applications.

To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the U.S. These authorizations include other products under the Vuse brand, including tobacco-flavored Vuse Vibe and Vuse Ciro devices and accompanying cartridges. Applications for six tobacco-flavored Vuse Alto products remain under FDA review.

October 12, 2023

Retailers Chided for Youth-Appealing Products

On August 23, 2023, the U.S. Food and Drug Administration issued warning letters to 15 online retailers for selling and/or distributing unauthorized e-cigarette products packaged to look like youth-appealing characters, school supplies, toys and drinks.

“The design of these products is a shamelessly egregious attempt to target kids,” said Brian King, director of FDA’s Center for Tobacco Products, in a statement. “It’s a tough sell that adults using e-cigarettes to transition away from cigarettes need them to look like SpongeBob in order to do so successfully.”

The unauthorized products described in the warning letters include e-cigarettes that feature youth-appealing characters from TV shows, movies and video games; products that are designed to look like school supplies and toys; and vapes that imitate youth-appealing drinks such as Starbucks and Dunkin Donuts coffee cups.

The recipients of the letters have 15 working days to respond with the steps they’ll take to correct the violation and to prevent future violations.

leo.

August 23, 2023

Distributors Warned Over Unauthorized Products

The U.S. Food and Drug Administration has put ABS Distribution, EC Supply and Easy Wholesale on notice for selling and/or distributing multiple unauthorized e-cigarette products. The illegal products listed in the warning letters include the popular and youth-appealing e-cigarette products Elf Bar/EB Design, Esco Bars and Puff Max.

“FDA is committed to keeping a finger on the pulse of the rapidly evolving e-cigarette landscape, including through a variety of scientific assets equipped to quickly identify products with high youth appeal,” said FDA Center for Tobacco Products Director (CTP) Brian King in a statement. “We will continue to use this data-driven approach to inform actions across the entire supply chain, including against those who distribute illegal products between manufacturers and the point of sale.”

Warning letters are generally the first step once an inspection reveals a violation of the law. “We will monitor to ensure these violations are corrected, and if they are not, the recipient is at risk of further actions such as civil money penalties, seizures, and injunctions,” said Ann Simoneau, director of the CTP Office of Compliance and Enforcement.

July 28, 2023

Unauthorized Vapes Flood U.S. Market

The number of vapor devices on the U.S. market has nearly tripled since 2020, with a majority being unauthorized disposables from China, according to IRI sales data reported by the AP.

The influx comes more than three years after the U.S. Food and Drug Administration declared a crackdown on kid-friendly flavors; many of the unauthorized products come in sweet and fruity flavors that are technically illegal. This means the FDA must focus on removing unauthorized products from the market rather than carefully reviewing individual products that could help adult smokers.

Last year, cheaper disposables made up 40 percent of the $7 billion retail market for e-cigarettes, according to IRI data. IRI collects barcode scanner sales from convenience stores, gas stations and other retailers. The data shows that more than 5,800 unique disposable products are being sold in numerous flavors and formulations, up 1,500 percent from 365 in 2020, when the FDA banned all flavors except menthol and tobacco from cartridge-based e-cigarettes. The ban excluded disposables, though.

“The FDA moves at a ponderous pace, and the industry knows that and exploits it,” said Robert Jackler of Stanford University, who has studied the rise of disposables. “Time and again, the vaping industry has innovated around efforts to remove its youth-appealing products from the market.”

“I don’t think there’s any panacea here,” said Brian King, director of the FDA’s Center for Tobacco Products. “We follow a comprehensive approach and that involves addressing all entities across the supply chain, from manufacturers to importers to distributors to retailers.”

The surge of disposables was preventable, according to Mitch Zeller, former FDA head. “I told them: ‘It doesn’t take a crystal ball to predict that kids will migrate to the disposable products that are unaffected by this [ban], and you ultimately won’t solve the problem,’” Zeller said.

IRI restricts access to its data, selling it to companies, investment firms and researchers. The data was shared with the AP by an anonymous person not authorized to share the information. IRI declined to comment or confirm the data, stating the company doesn’t offer that information to news organizations.

June 28, 2023

FDA Urged to Wrap Up E-Cigarette Reviews

U.S. lawmakers are urging the Food and Drug Administration to wrap up its review of pending e-cigarette premarket tobacco product applications, reports Law360.

In a letter to FDA Commissioner Robert Califf, 50 members of Congress requested the agency finalize its review of pending applications for e-cigarette products; deny applications for all nontobacco-flavored e-cigarette products, including menthol; and utilize the enforcement tools that have been given to the agency to remove all synthetic nicotine products from the market, including those with pending applications.

The lawmakers’ call comes after the FDA failed to meet a court-ordered deadline of Sept. 9, 2021, to complete its review of all pending e-cigarette applications submitted to the agency. In its most recent filings with the court, the FDA has indicated that it will not be able to finalize its review of products with the largest market share until December 2023.

“FDA’s repeated delays in removing flavored e-cigarettes from the market is putting children’s health at risk,” said Colorado Representative Diana DeGette in a statement. “FDA needs to step up its enforcement of these harmful products and get them off our store shelves now. Every day that these products remain on the market, the more harm they cause to young people’s health.”

While the FDA has completed its review of many e-cigarette products, it has not yet completed its review of thousands of pending applications—including those for popular products manufactured by Juul Labs, Reynolds Vapor Co. and Smok.

The lawmakers urged the agency to complete its review of all its pending applications no later than Dec. 31, 2023.

June 15, 2023

CTP to Host Regulatory Science Forum

The U.S Food and Drug Administration Center for Tobacco Products (CTP) will a hold a forum titled “Advancing Regulatory Science Through Innovation” on June 13-14.

This free, virtual forum is open to the public, industry, academia, patient advocates, sister agencies and current or potential FDA collaborators. Forum attendees will explore how FDA’s researchers use novel science and technologies to inform regulatory decisionmaking.

This year’s keynote address will be given by Murray Lumpkin, deputy director of integrated development at the Bill & Melinda Gates Foundation.

FDA scientific experts and nationally renowned scientists will present and answer questions on improving clinical and post-market evaluation, empowering patients and consumers and advancing products based on novel technologies, among other topics.

To register, click here.

June 6, 2023

Innokin and Breeze Warned

The U.S. Food and Drug Administration has warned the manufacturers of two popular disposable e-cigarette brands that their products are unauthorized for sale in the United States.

The product involved are Esco Bars, which is manufactured by Shenzhen Innokin Technology Co., and Breeze, which is imported into the U.S. by Breeze Smoke. Esco Bars and Breeze are presently among the most commonly sold brands of disposable products in the country, according to the FDA.

“The science clearly shows that a majority of youth who use e-cigarettes report that the products they are using are disposable and flavored” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement. “Given their appeal to youth, these products are a priority for FDA compliance and enforcement action.”

The recent FDA actions could signal that the agency will no longer consider pending premarket tobacco product applications (PMTAs) when deciding which companies to enforce against. Esco Bar is believed to have a pending PMTA, according to Vaping360. Breeze Smoke reportedly received marketing denials orders for several products in 2021.

Thousands of other products remain on the market awaiting PMTAs without facing enforcement actions.

Innokin and Breeze Smoke have 15 days to dispute the allegations in the FDA’s warning letters.

May 26, 2023

FDA Denies Marketing of 250+ E-liquids

The U.S. Food and Drug Administration on May 18 issued marketing denial orders to Mothers Milk WTA for more than 250 flavored and tobacco-flavored e-liquids.

After completing initial acceptance review and subsequently proceeding to and completing a substantive scientific review of the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence to show the products are appropriate for the protection of public health.

For example, the applications did not provide sufficient evidence to show comparative health risk data relative to other tobacco products on the U.S. market, information assessing the abuse liability of the new products, or that the new products could be manufactured consistently.

“One of our most important responsibilities is to ensure new tobacco products undergo scientifically rigorous premarket review,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products, in a statement. “We remain committed to evaluating these applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole.”

To date, the agency has received premarket tobacco applications for more than 26 million deemed products, the majority of which are e-cigarettes. The agency says it has made determinations on 99 percent of these applications. This includes more than 1 million applications for non-tobacco nicotine products, including those containing synthetic nicotine, after Congress clarified FDA’s authority to regulate these products in April 2022.

Further, FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the U.S. FDA has also denied marketing applications for millions of products that did not meet the requirements in the law.

May 18, 2023

TPSAC to Discuss Proposed Manufacturing Rule

The Tobacco Products Scientific Advisory Committee (TPSAC) will hold a meeting to discuss the Requirements for Tobacco Product Manufacturing Practice (TPMPs) proposed rule on May 18, 2023, from 9 a.m. to 2 p.m.

The proposed rule is open for public comment until Sept. 6, 2023.

The TPSAC meeting will be available via a free webcast. Electronic or written comments on the meeting needed to be submitted by May 11 for consideration by the committee.

More information about the meeting is available at the FDA’s website.

May 17, 2023

Tag: U.S. Food and Drug Administration