Category: Regulation

  • Warnings for Unauthorized Smokeless Products

    Warnings for Unauthorized Smokeless Products

    Image: calypso77

    The U.S. Food and Drug Administration sent a warning letter to Amarillo Snuff Co. on Aug. 11, 2023, for manufacturing, selling and/or distributing unauthorized smokeless nicotine products, including products that are made with corn husks instead of tobacco leaves, according to an FDA release.

    The unauthorized products contain nontobacco nicotine, which falls under the FDA’s regulation authority. 

    “Last year, Congress clarified FDA’s authority to regulate tobacco products containing nicotine from any source, which closed a loophole that several companies were using to try to evade regulation,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “Our authority over these products is clear, and FDA is committed to holding those responsible for illegal products accountable for their actions.” 

    The cited products lack FDA marketing authorization. To date, the FDA has not authorized any nontobacco nicotine products.

    After receiving a warning letter, recipients have 15 working days to respond with steps they will take to correct and prevent future violations; failure to promptly correct violations can result in additional FDA actions such as injunction, seizure and/or civil money penalties.

    “A majority of firms that receive warning letters correct their violations, but if they fail to do so, the products are subject to enforcement,” said Ann Simoneau, director of the CTP’s Office of Compliance and Enforcement. “FDA continues to bring enforcement actions, including injunctions and civil money penalties, as appropriate.”

    As of July 28, 2023, the FDA has issued about 600 warning letters to manufacturers of unauthorized tobacco products, with 100 of the letters being for unauthorized nontobacco nicotine products. As of June 30, 2023, the FDA has issued more than 2,800 warning letters and 825 civil money penalties for sales of e-cigarettes to underage purchasers, with over 1,000 warning letters and more than 140 civil money penalties relating to sales violations of nontobacco nicotine products to underage consumers.

  • Registration Open for CTP Listening Session

    Registration Open for CTP Listening Session

    Credit: Postmodern Studio

    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.

  • Kazakhstan to Ban Vapes

    Kazakhstan to Ban Vapes

    Photo: natatravel

    Lawmakers in Kazakhstan voted on July 29 to ban the sale, import, export and production of e-cigarettes and liquids, reports Atlas News.

    “The harm of vapes is undeniable,” said Deputy Nurgul Tau. “That is why the Ministry of Health has been sharply raising the issue of introducing a ban on the circulation of vapes since 2021. In my request, I proposed a complete ban on the sale of vapes.”

    The legislation has been in the works since May 10 following a ban of the use of e-cigarettes in public spaces. The ban was triggered by concern about increased vaping among minors.

  • TPSAC Meeting Materials Available

    TPSAC Meeting Materials Available

    Credit: Postmodern Studio

    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.

  • CTP Invites Input on Strategic Plan

    CTP Invites Input on Strategic Plan

    Credit: Monticello

    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.

  • FDA Grant to Study Effects of Flavors

    FDA Grant to Study Effects of Flavors

    Image: Tobacco Reporter archive

    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.

  • FDA Denies Marketing of Myblu Menthol

    FDA Denies Marketing of Myblu Menthol

    Image: Tobacco Reporter archive

    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.

  • Ghana Outlaws Vape Sales and Promotion

    Ghana Outlaws Vape Sales and Promotion

    Ghana has banned all recreational use of vaping and e-cigarette products.

    In a press release, the country’s Food and Drugs Authority (FDA) states that the “sale, advertisement and recreational use of electronic nicotine delivery systems (ENDS) such as vapes and other non-nicotine tobacco products by the public” is illegal.

    However, ENDS can be registered as a prescription-only medicine for the purposes of cessation therapy.

    The FDA claims it has sent notice to manufacturers, importers, wholesalers, and retailers to remove all advertisements on social media, billboards and neon signs immediately and refrain from the importation of the products.

    The FDA states that there “will be repercussions including sanctions” for failure to adhere to the rules.

  • Ninth Circuit Denies Lotus MDO Review

    Ninth Circuit Denies Lotus MDO Review

    Entrance to United States Court of Appeals for the Ninth Circuit . Headquartered in San Francisco, California, the Ninth Circuit is by far the largest of the 13 courts of appeals. (Credit: Eric BVD)

    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.

  • Best Practices

    Best Practices

    Photo: doidam10

    How to approach environmental assessments for the best chance of success

    By Adam Bonin and Antony Jones

    An Environmental Assessment (EA) is an analysis prepared in accordance with the U.S. National Environmental Policy Act (NEPA) to determine if a product’s approval would significantly affect the environment. It applies to all federal actions in the U.S., including regulations, policies, projects, licensing and permission granting. The assessments give insights into potential risks associated with a product’s manufacture, use and disposal and help manufacturers develop effective mitigation strategies to reduce or avoid possible environmental consequences.

    EAs therefore help regulatory agencies identify potential adverse environmental impacts from the manufacture, use and disposal of electronic nicotine-delivery systems and oral nicotine products. They are a small yet important part of premarket tobacco product applications (PMTAs) and modified-risk tobacco product submissions. The U.S. Food and Drug Administration requires manufacturers to submit EAs for each individual tobacco product, or stock-keeping unit, within a PMTA.

    An inadequate or absent EA will result in either a “refuse-to-accept” or a “refuse-to-file” order from the FDA. In 2021, the FDA rejected 4.5 million vaping applications on the grounds that they “lacked an adequate environmental assessment.” With companies spending millions on PMTA submissions, they cannot afford to miss out on approval due to such a small part of the process. So, what does a good EA look like?

    What to Include in an Environmental Assessment

    In general, an EA includes an executive summary, applicant details, description of the proposed action and purpose and need of the proposed action. Further EA sections include the identification of alternatives, including the proposed action and no action alternative, potential environmental impacts of the alternatives (affected environment [or existing conditions] and environmental impacts), cumulative impacts and mitigation measures. An EA is appropriate for submission if it is determined that the impacts of the proposal will not be significant or the FDA concludes a finding of no significant impact. Mitigation measures may be recommended if impacts are anticipated, to reduce them below the significance threshold.

    The initial stage of the EA process is building a well-defined project description, covering the purpose and need for the regulatory decision (marketing granted order) that triggers the requirement for an EA under the NEPA. The applicant will also need to include details of product components, product formulation (where applicable) and predicted sales projections for the first and fifth years. It is particularly important to include the mass of individual metals in product hardware components (e.g., devices, pods) to assess potential impacts at the end of life.

    A good EA includes a thorough screening and comprehensive modeling of product components (e.g., e-liquid ingredients), with all conclusions and results backed up with hard data. The evaluation of the potential release of materials to the environment should be quantitively assessed, with the resulting potential concentrations in the environment explicitly stated and compared with relevant ecotoxicity standards to determine the possible impact.

    Throughout, it is important to appropriately manage confidential information. EAs include both confidential and nonconfidential appendices, and it is important that these are prepared correctly. For example, if there is proprietary information in the e-liquid formulation, this would be best listed in the confidential appendices, as would sales and marketing projections. It can be difficult to know which information is appropriate for inclusion in the confidential apprentices, and working with an experienced team offers the best chance of success.

    Determining the Possible Impacts

    E-liquids typically consist of a mixture of ingredients, including propylene glycol, vegetable glycerin and nicotine. The formulation can be screened using a predictive tool to determine which ingredients are of most ecotoxicological concern and should be carried forward into the analysis. The selected ingredients can be assessed for estimated acute and chronic aquatic toxicity for aquatic organisms, including plants, fish and invertebrates, and then be assessed in subsequent fate and transport modeling.

    The EA should analyze the plausible scenarios for the impact of the identified substances being released into the environment, including quantitative release modeling. For example, this could include the possible impact of the material being released into surface water or soils at quantities considered reasonable based on predicted sales data.

    The project supply chain should also be documented, including details of manufacturing and shipping to retail entities. The environmental and social resources around U.S. manufacturing facilities require characterization to provide an understanding of the affected environment (existing or baseline conditions). The potential impacts of projects can then be evaluated based on changes to the baseline conditions—for example, if chemical mixtures or raw ingredients are accidentally released into surface water or chemicals are released down the drain during manufacturing.

    It is important that the EA is realistic. In our experience, the inclusion of conservative analyses appears to be the soundest approach. It may be tempting to conduct modeling for a wide variety of release scenarios, but if they are deemed unlikely by the FDA, you may receive a deficiency for evaluating unreasonable scenarios.

    Tips and Tricks

    • Start early. Considering the EA process early in the application can improve efficiencies, particularly for characterizing natural resources around U.S.-based facilities and engaging with manufacturers and other vendors to understand product supply chains.
    • Use a robust standard operating procedure. In an EA, it is vital that every section includes explicit information that satisfactorily evaluates the product against FDA requirements.
    • Choose an experienced team. Many businesses do not have employees with sufficient NEPA experience; in this case, we recommend working with a consultancy. NEPA-specific jargon and other regulatory nuances can be challenging for new practitioners.
    • Stay up to date. Attending FDA and NEPA meetings can be a great way to stay up to date with any changes in the guidance. In addition, manufacturers can engage directly with an FDA project manager if they receive deficiency comments.
    Adam Bonin is a senior consultant at Broughton with over 22 years of scientific consulting experience. He earned a Bachelor of Science degree in environmental management from the University of Rhode Island and a doctorate in environmental microbiology from Portland State University. Bonin also completed a postdoctoral appointment in microbial ecology at Oregon Health and Science University.
    Antony Jones is a managing consultant at Broughton with more than 22 years of experience in risk assessment with a focus on characterizing and reducing risks across the pharmaceutical, biotechnology, food, nicotine and environmental industries. He earned a Bachelor of Science degree in biology from the University of York and a doctorate in molecular biology and microbiology from Newcastle University. Jones also completed a postdoctoral appointment at King’s College London.

    Broughton is a global scientific consultancy-based Contract Research Organization serving industries in pharmaceuticals, next-generation nicotine-delivery products and cannabinoids. Its team has developed a robust and proven approach for preparing defensible NEPA-compliant EAs for the FDA PMTA. For more information, visit www.broughton-group.com/us-pmta-and-mrtp-nepa-environmental-assessments-ea.