Tag: U.S. Food and Drug Administration

  • Unauthorized Vapes Flood U.S. Market

    Unauthorized Vapes Flood U.S. Market

    Image: Tobacco Reporter archive

    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.

  • FDA Urged to Wrap Up E-Cigarette Reviews

    FDA Urged to Wrap Up E-Cigarette Reviews

    Photo: BillionPhotos.com

    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.

  • CTP to Host Regulatory Science Forum

    CTP to Host Regulatory Science Forum

    Photo: Lek

    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.  

  • Innokin and Breeze Warned

    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.

  • FDA Denies Marketing of 250+ E-liquids

    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. 

  • TPSAC to Discuss Proposed Manufacturing Rule

    TPSAC to Discuss Proposed Manufacturing Rule

    Photo: FEELM

    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.

  • FDA Rejects 6,500 Flavored Vape Products

    FDA Rejects 6,500 Flavored Vape Products

    Photo: Surendra

    On May 12, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to 10 companies, which collectively manufacture and market approximately 6,500 flavored e-liquid and e-cigarette products. The companies may not market or distribute these products in the U.S., and retailers who sell these illegal products risk FDA enforcement action.

    According to the FDA, the premarket tobacco product applications (PMTAs) provided insufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health. The flavor names of some of the products denied include Citrus, Strawberry Cheesecake, Cool Mint, and Menthol. 

    Since the spring of 2020, the FDA has received applications for over 26 million new tobacco products, the majority of which were for e-cigarette products. To date, FDA has completed review and taken action on over 99 percent of these applications, according to the agency.

    “Science is a cornerstone of FDA’s tobacco product review process,” said Matthew Farrelly, director of the Office of Science within FDA’s Center for Tobacco Products in a statement. “Today’s decision to deny approximately 6,500 products was based on the lack of scientific evidence provided in the applications. We will continue to ensure all new tobacco products undergo robust, scientific premarket evaluation to determine whether they meet the appropriate public health standard to be legally marketed.”  

    The companies that received MDOs include Imperial Vapors, Savage Enterprises, Big Time Vapes, SWT Global Supply, Great Lakes Vapor, DNA Enterprise (“Mech Sauce”), Absolute Vapor and ECBlend.

    FDA is withholding the names of the other two companies that received MDOs to protect potential confidential commercial information.

  • Modified-Risk Orders for Copenhagen Snuff

    Modified-Risk Orders for Copenhagen Snuff

    Photo: Altria Group

    The U.S. Food and Drug Administration has authorized U.S. Smokeless Tobacco Co.’s (UST) Copenhagen Classic Snuff, a loose moist snuff smokeless tobacco product, to be marketed as a modified-risk tobacco product (MRTP). Copenhagen’s moist snuff smokeless tobacco product has been marketed in the U.S. for years without modified-risk information.

    The FDA’s action now allows UST to market the product as a modified-risk product with the claim: “If you smoke, consider this: Switching completely to this product from cigarettes reduces risk of lung cancer.”

    After a rigorous review of the available evidence, including recommendations from the Tobacco Products Scientific Advisory Committee, public comments and other available scientific information, the FDA says it concluded that the specific claim related to lung cancer risk is scientifically accurate with respect to Copenhagen Classic Snuff. The review also found the public health gains are unlikely to be offset by nonusers starting to use the product.

    UST will be required to conduct post-market surveillance and studies that include an assessment of product users’ behavior, understanding and any previous use of cigarettes as well as a scientific model to assess continued impact on population health.

    This modified-risk granted order will expire in five years.

  • Hearing on FDA Manufacturing Rules

    Hearing on FDA Manufacturing Rules

    Photo: BAT

    Registration is open for U.S. Food and Drug Administration’s upcoming public oral hearing on April 12, 2023, from 9:30 a.m. to 5 p.m.

    The hearing is an opportunity for the public to verbally comment on the agency’s proposed rule Requirements for Tobacco Product Manufacturing Practice. The FDA is proposing new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products. Registration also includes a “listen-only” option for those who want to attend the session but do not want to request to speak.

    Speaking spots are limited, and the FDA says it cannot guarantee that it will be able to accommodate all requests. Groups and organizations should select a single spokesperson to help the agency hear as many different perspectives as possible. While speaking spots are limited, listening spots are unlimited. Registration to provide oral comments will close on March 31, 2023.

    The oral session will be recorded, and a transcript will be added to the docket of the proposed rule.

  • Webinar on FDA Warning Letters

    Webinar on FDA Warning Letters

    Photo: Song_about_summer

    The U.S. Food and Drug Administration has posted a new webinar to help manufacturers and vape shop owners respond to warning letters from the agency’s Center for Tobacco Products (CTP).

    The webinar outlines the appropriate items for a response to a warning letter, which should be received by FDA within 15 business days. The webinar also includes an explanation of proper documentation concerning corrective actions that entities have taken.

    In the webinar, participants will learn about:

    • Preparation for a response to CTP
    • Important items to include in a response
    • Additional compliance resources