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Godshall/Smokefree Pennsylvania urge FDA to rescind ANPRM to ban cigarette sales

Discussion in 'FDA Regulations' started by Bill Godshall, Jul 13, 2018.

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  1. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    If you wish to comment on the ANPRM, you can do so here (deadline 11.59pm ET 16 July):
    Regulations.gov

    - - -

    Smokefree Pennsylvania
    1926 Monongahela Avenue
    Pittsburgh, PA 15218
    412-351-5880
    billgodshall@verizon.net

    July 13, 2018

    Food and Drug Administration
    21 CFR Part 1130
    Docket No. FDA–2017–N–6189
    Advance notice of proposed rulemaking
    Tobacco Product Standard for Nicotine Level of Combusted Cigarettes

    To further reduce cigarette smoking and to encourage addicted smokers to switch to far less harmful noncombustible vapor and smokeless tobacco products, FDA should
    - Rescind its 2018 ANRPRM for a Tobacco Product Standard for Nicotine Level of Combusted Cigarettes,
    - Rescind its 2016 Deeming Rule,
    - Rescind its 2017 proposed Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products, and
    - Support Representative Duncan Hunter’s bill (HR 2194) that would establish reasonable and responsible product standards for vapor products.

    FDA’s ANPRM for a Tobacco Product Standard for Nicotine Level of Combusted Cigarettes at
    Federal Register :: Tobacco Product Standard for Nicotine Level of Combusted Cigarettes
    FDA Seeks Public Comment on a Potential Product Standard to Lower Nicotine in Cigarettes to a Minimally or Non-Addictive Level
    would ban the sale of all cigarettes in the US, but FDA and many FDA funding recipients have deceptively promoted the ANPRM as a product standard to make cigarettes nonaddictive (because they know public support would plummet if it was truthfully called a cigarette ban).

    Just as the Volstead Act banned the sale of virtually alcohol beverages in the US during the 1920s (by establishing a standard limiting alcohol to no more than 0.5% in beverages), FDA’s ANPRM would ban the sale of all cigarettes in the US.

    And just as the 18th Amendment to the US Constitution and the subsequent Volstead Act created huge and profitable black markets for banned liquor, wine and beer during the 1920s, banning the sale of cigarettes would create black markets for untaxed and unregulated cigarettes, while depriving federal, state and local governments $30+ Billion in tobacco tax revenue and MSA payments each year (much of which is spent on smoking prevention and cessation programs, and other public health programs). FDA’s ANPRM and another document delineating the agency’s plans to enforce its proposed cigarette sales ban at
    https://www.fda.gov/downloads/TobaccoProducts/NewsEvents/UCM601047.pdf
    failed to acknowledge these potentially disastrous ramifications of its ANPRM to ban cigarettes.

    FDA’s contracted modeling study in the NEJM (promoting FDA’s ANPRM to ban cigarettes) at NEJM - Error
    NEJM - Error
    How Could Lowering Nicotine Levels in Cigarettes Change the Future of Public Health?
    estimated FDA's proposed cigarette sales ban would increase the rate and number of smokeless tobacco and vapor product users in the US from 6% (15M) to 10% (25M) within two years of its implementation (in 2020) and was touted by Scott Gottlieb in his press statement at
    Statement from FDA Commissioner Scott Gottlieb, M.D., on pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels

    But the FDA failed to acknowledge that FDA’s 2016 Deeming Rule banned the sale of all new vapor products since 8/8/2016, banned all vapor manufacturers from making truthful health claims about their products, and will ban ALL other vapor product sales on 8/8/2022 (unless/until FDA approves a PMTA for the product).

    The FDA’s study authors (and Scott Gottlieb) also failed to acknowledge that the TCA banned sales of new smokeless tobacco products on 2/15/2007 and banned truthful health claims by smokeless tobacco manufacturers, and failed to acknowledge that FDA’s proposed nitrosamine standard of 1.0ug/g for smokeless tobacco products at
    Federal Register :: Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products
    would ban >90% of smokeless tobacco products on the US market.

    FDA still hasn't approved Swedish Match's MRTP application to make truthful claims for General Snus (which contains very low levels of NNN), that was submitted more than 3 years ago.

    Therefore, it is disingenuous for FDA to estimate (and to claim) the number of vapor and smokeless tobacco product users in America will increase from 15M to 25M (in response to FDA's proposed cigarette ban) in or around 2022 since FDA imposed its cigarette protecting Deeming Rule in 2016 (that bans all vapor product sales in 2022), and after FDA proposed (but hasn’t rescinded) its nitrosamine standard for smokeless tobacco products (that will ban >90% of smokeless tobacco products).

    In sharp contrast to assertions by FDA, if FDA implements and aggressively enforces the Deeming Rule’s 8/8/2022 vapor sales ban, the number of vapers in the US is likely to decrease (even if/as black markets for vapor products sharply increase). And if FDA issues a Final Rule for its proposed NNN standard for smokeless tobacco, the number of smokeless tobacco users is likely to decrease (even if/as black markets for smokeless tobacco products sharply increase).

    The FDA’s ANPRM to ban cigarette sales failed to acknowledge that several different tobacco companies already spent lots of money trying to market very low nicotine cigarettes (including Vector’s Quest a decade ago), but all of those products were removed from the market shortly afterwards because no smokers bought them.

    FDA’s ANPRM to ban cigarette sales touted totally unrealistic clinical studies that paid smokers money to smoke free VLN cigarettes, and failed to acknowledge that the only company that makes VLN cigarettes remains in business only due to funding by the US Government.

    FDA’s ANPRM to ban cigarette sales also stated (on page 61) the agency is considering banning the sales of e-liquid in order to purportedly prevent very low nicotine cigarettes from being nicotinized, which also would reduce the number of vapers in the US, while creating a huge black market for e-liquid.

    If FDA truly desires addicted smokers to lawfully switch to lower risk vapor products, the agency has no alternative but to rescind its 2016 Deeming Rule, which protects Big Tobacco’s cigarette cartel by banning the sale of all far lower risk vapor products. Although the Deeming Rule allows FDA to approve the sale of vapor products and to allow vapor manufacturers to make truthful health claims about their products, no more than six companies in the world have the $100 million and human resources to successfully submit PMTA and MRTP applications to FDA for their cigalike e-cigs (Altria, BAT/Reynolds, PMI and perhaps Imperial, JTI and/or JUUL), which would create a monopoly or cartel for e-cigarettes (that Big Tobacco will likely control).

    Congressman Duncan Hunter introduced HR 2194 at H.R.2194 - 115th Congress (2017-2018): Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017 that would establish reasonable, responsible and affordable vapor product standards and would allow thousands of different vapor products to remain on, and to be introduced to, the US market. This legislation can sharply reduce cigarette smoking in future years and decades (without creating black markets), and should be supported by FDA.

    In sum, to further reduce cigarette smoking and to encourage addicted smokers to switch to far less harmful noncombustible vapor and smokeless tobacco products, FDA should
    - Rescind its 2018 ANRPRM for a Tobacco Product Standard for Nicotine Level of Combusted Cigarettes,
    - Rescind its 2016 Deeming Rule,
    - Rescind its 2017 proposed Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products, and
    - Support Representative Duncan Hunter’s bill (HR 2194) that would establish reasonable and responsible product standards for vapor products.

    Since 1990, Smokefree Pennsylvania has advocated policies to ban smoking in workplaces, reduce tobacco marketing to youth, hold cigarette companies accountable, increase cigarette tax rates, inform smokers that smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes, and ensure that smokefree alternatives remain legal and affordable to smokers.

    For disclosure, neither I nor Smokefree Pennsylvania have ever received funding from any drug, tobacco or vapor company or trade association.

    Bill Godshall
    Executive Director
     
    • Informative Informative x 6
    • Like Like x 1
  2. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    • Informative Informative x 3
    • Like Like x 2
  3. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    • Like Like x 3
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