Tag: FDA

  • U.S. FDA Cracking Down on Kid Friendly Products

    U.S. FDA Cracking Down on Kid Friendly Products

    Credit: FDA

    Regulators in the United States are cracking down on online retailers selling vaping products that are attractive to youth. The Food and Drug Administration today issued warning letters to 16 (the agency reported 15, but lists 16) online retailers for selling and/or distributing unauthorized e-cigarette products packaged to look like cartoon 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 (CTP). “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, including “SpongeBob,” “Lots-o’-Huggin’ Bear,” and “Mario.” The also imitate drinks from companies such as Starbucks and Dunkin coffee cups, soda and water bottles, according to press release.

    “The retailers receiving these warning letters sell and/or distribute e-cigarettes in the United States that lack authorization from FDA, which is a requirement under the Federal Food, Drug, and Cosmetic (FD&C) Act to legally market a new tobacco product,” the FDA states. “In addition to the specified products mentioned in the warning letters, the retailers were warned to address any violations that are the same as or similar to those stated in the warning letter, and promptly take any necessary actions to bring the tobacco products that they offer for sale in the United States into compliance with the FD&C Act.”

    The retailers were given 15 working days to respond with the steps they’ll take to correct the violation and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.

    “CTP will continue to closely monitor all those in the supply chain, including retailers, for compliance with federal law,” said attorney Ann Simoneau, director of the Office of Compliance and Enforcement within the CTP. “As always, we will hold anyone accountable that sells unauthorized tobacco products labeled, advertised, and/or designed to encourage use by our nation’s youth.”

    The companies receiving warning letters include:

    • VR Products I LLC d/b/a eJuiceDB
    • Titan Star Resources d/b/a Vape Vandal Ltd
    • Vapesstores.com
    • Disposable Vapes Wholesale
    • Vapestore.to
    • Venture Concept Groups d/b/a High Light Vape Co.
    • Best Vapes Store
    • Apex Vape
    • The Juice Machine
    • StrikesUSA
    • Finest Ounce Vape Stor d/b/a Finest Ounce Vape Malaysia
    • Spongbob Vape
    • Mini Cup Vape
    • Vape123
    • Viper Vapor d/b/a Viper Vapor Kelso
    • Mochivap

    These new warning letters mark another step in the FDA’s continued efforts to remove illegal e-cigarettes from the market, particularly those that appeal to youth, the agency states. As of August 2023, the FDA has issued approximately 600 warning letters to firms for manufacturing and/or distributing illegal tobacco products, including e-cigarettes, filed civil money penalty complaints against 26 e-cigarette manufacturers, and worked with the Department of Justice to seek injunctions against 6 e-cigarette manufacturers.

  • Tomorrow: FDA Tobacco Center Strategic Plan Event

    Tomorrow: FDA Tobacco Center Strategic Plan Event

    Vapor Voice Archive

    Tomorrow, Aug. 22, 2023 is the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) online forum centered on developing a 5-year strategic plan to advance its mission.

    As part of an iterative, center-wide process, CTP has developed five proposed goal areas. These goal areas are intended to be interconnected with four proposed cross-cutting themes: health equity, science, transparency, and stakeholder engagement.

    The center intends to publish the strategic plan by the end of 2023, following receipt and consideration of public input.

    Beginning at 10 a.m. EDT, the CTP virtual listening session will give the public an opportunity to verbally provide open public comment on the development of the 5-year strategic plan, including proposed strategic goals.

    CTP will begin with an overview of the process used to develop the center’s strategic plan, including proposed goal areas. Registered speakers will then have approximately 4 minutes each to verbally share their comments on any topics related to the strategic plan.

    Live closed captioning and ASL interpreters will be provided during the listening session. If you have issues registering or have any questions, please email malini.runnells@fda.hhs.gov or call 1-877-CTP-1373 between 9 a.m. and 4 p.m. EDT.

    A transcript and recording will be made available after the listening session.

    Use this link to view the session.

  • U.S. FDA to Hold Public Meeting on PMTA Process

    U.S. FDA to Hold Public Meeting on PMTA Process

    The U.S. Food and Drug Administration will hold a two-day public meeting on the agency’s premarket tobacco product application (PMTA) process on Oct. 23–24, 2023.

    The meeting will be held on the FDA’s White Oak Campus in Silver Spring, Maryland, and will be in a hybrid format with the option to attend virtually.

    Staff from the Center for Tobacco Products’ Office of Science will present on topics related to the PMTA process and be available to respond to questions received from stakeholders on the topic, according to a press note.

    Additional information, including registration and question submission processes, will be available soon.

  • FDA Tobacco Chief Discusses Relative Risk of Vapes

    FDA Tobacco Chief Discusses Relative Risk of Vapes

    CTP Director Brian King

    In an article published in Addiction magazine, Brian King, director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), explores the chances and considerations for informing adults who smoke cigarettes about the relative dangers of tobacco products, including e-cigarettes. He collaborated with Benjamin Toll, director of the Medical University of South Carolina Tobacco Treatment Program and co-director of the Lung Cancer Screening Program.

    The commentary highlights the findings of a recent survey about misperceptions of tobacco product harms, including cigarettes and e-cigarettes. The survey found that only about 20 percent of adults who smoke cigarettes believed e-cigarettes contain fewer harmful chemicals than cigarettes. While there are no safe tobacco products, the available scientific evidence indicates that tobacco products exist on a continuum of risk, with cigarettes being the most harmful. 

    The commentary notes that opportunities exist to educate adults who smoke about the relative risks of tobacco products, including e-cigarettes. However, these efforts should be accompanied by efforts to prevent youth tobacco product use; encourage first-line use of FDA-approved cessation therapies; and for adults who both smoke and use e-cigarettes, reinforce the importance of completely transitioning to e-cigarettes.

    The commentary further emphasizes that any education efforts on the relative risks of tobacco products must be evidence-based. In particular, it is important to assess the benefits among the intended population (i.e., adults who smoke) and risks among unintended populations (e.g., youth). Currently, FDA is in the early stages of a research effort to assess messaging about the continuum of risk of tobacco products among adults who smoke.

    Last week, the FDA announced a virtual listening session 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.

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

  • Registration Open for US FDA Tobacco Strategic Plan

    Registration Open for US FDA Tobacco Strategic Plan

    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.

  • Biden Opposed to Limiting FDA Power to Regulate Flavors

    Biden Opposed to Limiting FDA Power to Regulate Flavors

    Credit: Lux Blue

    The Biden administration has published a Statement of Administration Policy outlining its opposition to parts of a proposed funding bill that would limit the U.S. Food and Drug Administration’s ability to ban flavored cigars and menthol cigarettes, reports Halfwheel.

    The proposed bill would prevent the FDA from receiving funding if it introduced bans on flavored cigars and menthol cigarettes or introduced rules limiting the amount of nicotine a product can have.

    The policy statement does not mention nicotine limits, although the FDA has proposed limiting nicotine.

    The Statement of Administration Policy is not binding.

    A new study has found that smokers who get help picking flavored e-cigarettes and receive supportive text messages are more likely to quit smoking.

    Last month, the FDA gave 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.

  • FDA Warns 3 Major Flavored Disposable Distributors

    FDA Warns 3 Major Flavored Disposable Distributors

    The U.S. Food and Drug Administration today issued warning letters to three distributors for selling and/or distributing multiple brands of unauthorized e-cigarette products.

    The illegal products listed in the warning letters sent to ABS Distribution Inc., EC Supply, Inc. and Easy Wholesale, LLC include the popular and youth-appealing e-cigarette products Elf Bar/EB Design, Esco Bars, and Puff Max (Puff Bars).

    “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 Brian King, director of FDA’s Center for Tobacco Products (CTP). “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.”

    The distributors receiving warning letters sell and/or distribute e-cigarettes in the United States that lack authorization from FDA, which is a prohibited act under the Federal Food, Drug, and Cosmetic Act, according to an FDA release.

    All of the brands cited in these warning letters have been identified as being among the most popular e-cigarettes among U.S. youth.

    “Warning letters are generally the first step once an inspection reveals a violation of the law,” said Ann Simoneau, director of the Office of Compliance and Enforcement within CTP. “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.”

    The FDA has stepped up enforcement of flavored disposable products after several lawmakers complained the agency wasn’t fulfilling its duties.

    Credit: Pastel Cartel
  • Amicus Brief Supports Limiting ‘Chevron Deference’

    Amicus Brief Supports Limiting ‘Chevron Deference’

    Image: Tobacco Reporter archive

    Keller and Heckman has filed an amicus brief with the U.S. Supreme Court on behalf of members of the electronic nicotine-delivery system (ENDS) industry in support of petitioners in a case to overturn or limit the so-called Chevron deference.

    Named after a landmark Supreme Court decision dating from 1984, the Chevron deference is a legal doctrine that generally requires courts to defer to an administrative agency’s interpretation of ambiguous statute so long as that interpretation is reasonable. 

    In practice, Chevron deference often gives agencies broad leeway to reach beyond the limits of a statute’s plain language, often bypassing the rulemaking process otherwise required under the Administrative Procedure Act and making it more difficult to challenge an agency action in court.

    In the years since ENDS became subject to Food and Drug Administration regulation, the vast majority of courts reviewing ENDS industry challenges to premarket application denials, as well as FDA rulemakings and guidance documents, have rubber-stamped the agency’s interpretation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the “appropriate for the protection of the public health” standard, Keller and Heckman wrote on its blog.

    Critics contend that the Chevron deference has enabled the FDA to impermissibly interpret the TCA to implement a de facto ban on all nontobacco-flavored ENDS products without any requisite notice and comment rulemaking or congressional amendments to the TCA.

    The filers on the amicus brief urge the Supreme Court to at least restrict the application of Chevron deference so that it is the exception, not the rule. The Supreme Court will hear oral arguments in the case in its fall 2023 term.

    The petition to overturn or limit the Chevron deference was brought by a group of fishing companies challenging the National Marine Fisheries Service’s construction of the Magnuson-Stevens Act to require the industry to pay the salaries of federal monitors.

    The ENDS industry amici include the American Vaping Manufacturers Association, the American Vapor Group and Bidi Vapor.

  • FDA Seeks Input on 5-Year Tobacco Center Strategic Plan

    FDA Seeks Input on 5-Year Tobacco Center Strategic Plan

    Credit: FDA

    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 the five-year plan it developed to advance its mission.

    As 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.

  • Lawmakers File Bills To Address FDA CBD Regulation

    Lawmakers File Bills To Address FDA CBD Regulation

    Courtesy: US FDA

    Four U.S. senators separately filed legislation on Thursday that would remove regulatory barriers that the U.S. Food and Drug Administration claims prevent it from allowing CBD sales in the food supply or as dietary supplements.

    The Hemp Access and Consumer Safety Act, which was also introduced last Congress but did not advance, would exempt “hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp” from certain federal restrictions while permitting officials to enact labeling and packaging rules, according to media reports.

    Now lawmakers are gearing up to address FDA’s inaction at the subcommittee hearing formally.

    A congressional committee has scheduled a hearing for next week focused on the FDA’s refusal to enact regulations to allow for the marketing of hemp-derived CBD products. And bipartisan and bicameral lawmakers have separately reintroduced a bill to fill the regulatory gap.

    The House Oversight and Accountability Subcommittee on Health Care and Financial Services scheduled the hearing—titled “Hemp in the Modern World: The Years long Wait for FDA Action”—for July 27.

    Rep. James Comer, who chairs the full committee, has sharply criticized FDA after the agency announced in January that it would not be developing CBD regulations, stating that there is not an available pathway to create such rules and it would require congressional action.

    Meanwhile, Comer said in April that his panel would be launching an investigation into the matter, and he requested that the FDA turn over documents related to its decision not to regulate the cannabinoid. Even before the agency made that decision, the congressman expressed his intent to address the lack of rules.

    Jonathan Miller, general counsel to the U.S. Hemp Roundtable, will be among those testifying at the meeting, the organization announced in a press release on Thursday.