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    FDA Unveils New Roadmap for Tackling Tobacco

    Agency pushes back applications for newly deemed products.

    SILVER SPRING, Md. — Eight years after gaining the regulatory authority over tobacco products, the Food and Drug Administration (FDA) unveiled a new comprehensive plan for tobacco and nicotine regulation.

    The plan "will serve as a multi-year road map to better protect kids and significantly reduce tobacco-related disease and death," the agency said.

    The new approach places nicotine — and the issue of addiction — at the center of the FDA's efforts. The goal, according to the agency, "is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act."

    In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act giving the agency the authority to regulate tobacco products. President Obama signed into law in June of that year.

    The new plan comes as tobacco companies move into areas of harm reduction through innovative products like electronic cigarettes, vapor, snus, and heat-not-burn products.

    With the shifting of efforts, the FDA agency is also providing targeted relief on some timelines described in the May 2016 final deeming rule that extended the FDA's authority to additional tobacco products. The relief is "to make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes," it explained. 

    The agency will also seek input on critical public health issues such as the role of flavors in tobacco products.

    A key piece of the FDA's approach is demonstrating a greater awareness that nicotine — while highly addictive — is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes, it added.

    "The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes — the only legal consumer product that, when used as intended, will kill half of all long-term users," said FDA Commissioner Scott Gottlieb.

    "Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts — and we believe it's vital that we pursue this common ground," he added.

    As part of the new plan, the FDA will issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes.

    According to Bonnie Herzog, managing director of tobacco, beverage and convenience store research at Wells Fargo Securities LLC, the new approach can be viewed as a "negative" for cigarette manufacturers, this could prove to be an opportunity over the long term for reduced-risk products.

    "Although the announcement's timing was unexpected this morning, we've longed believed the FDA taking a more comprehensive approach toward nicotine was a natural next step," she added.

    However, the FDA's announcement is not without concerns — notably the increased risk of a federally mandated ban or restriction on menthol cigarettes.

    NEW TIMELINES

    The agency intends to extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016. 

    This action, the FDA explained, will afford the agency time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive. 

    For example, the agency intends to:

    • Develop product standards to protect against known public health risks such as electronic nicotine delivery systems (ENDS) battery issues and concerns about children's exposure to liquid nicotine; and
    • Provide manufacturers additional time to develop higher quality, more complete applications informed by additional guidance from the agency.

    The FDA will issue this guidance describing a new enforcement policy shortly. 

    Under expected revised timelines, applications for newly regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022. 

    Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.

    The anticipated new enforcement policy will not affect any current requirements for cigarettes and smokeless tobacco, only the newly regulated tobacco products such as cigars and e-cigarettes, the agency pointed out.

    It will also not apply to deadlines for provisions of the final rule that already passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors. 

    It also will not affect future deadlines for other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims, i.e., "light," "low," or "mild," or similar descriptors.

    SEEKING INPUT

    The FDA will move forward with ANPRMs to:

    • Seek public comment on the role that flavors (including menthol) in tobacco products play in attracting youth and may play in helping some smokers switch to potentially less harmful forms of nicotine delivery; and
    • Solicit additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars, which were included in the FDA's 2016 deeming rule. 

    In addition, the agency plans to examine actions to increase access and use of FDA-approved medicinal nicotine products, and work with sponsors to consider what steps can be taken under the safety and efficacy standard for products intended to help smokers quit.

    "This comprehensive plan and sweeping approach to tobacco and nicotine allows the FDA to apply the powerful tools given by Congress to achieve the most significant public health impact," said Mitch Zeller, director of the FDA's Center for Tobacco Products. 

    "Public input on these complex issues will help ensure the agency has the proper science-based policies in place to meaningfully reduce the harms caused by tobacco use," he added.

    To complement these larger policy considerations, the FDA will issue "foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers, while upholding the agency's public health mission," according to the agency.

    Among other things, the FDA intends to issue regulations outlining what information the agency expects to be included in Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product applications and reports to demonstrate Substantial Equivalence.

     The FDA also plans to finalize guidance on how it intends to review PMTAs for ENDS. The agency also will continue efforts to assist industry in complying with federal tobacco regulations through online information, meetings, webinars and guidance documents, it added.

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