Comment on FDA's Proposed Rule Regarding Nicotine Levels
Agency Comments
July 11, 2018
Food and Drug Administration (FDA) 5630 Fishers Lane Room 1061 Rockville, MD 20852
Comment on FDA’s Advanced Notice of Proposed Rule Making regarding Tobacco Product Standard for Nicotine Level of Combusted Cigarettes
Docket ID No – FDA-2017-N-6189
Background
Citizens Against Government Waste (CAGW) is a private, nonpartisan, nonprofit, organization representing more than one million members and supporters nationwide. CAGW’s mission is to eliminate waste, fraud, abuse, mismanagement, and inefficiency in government. Founded in 1984 by the late industrialist J. Peter Grace and syndicated columnist Jack Anderson, CAGW was established to follow up on the work of the President’s Private Sector Survey on Cost Control, also known as the Grace Commission.
On behalf of CAGW’s members and supporters, I ask that the Food and Drug Administration (FDA) move swiftly to protect current and allow new tobacco harm reduction products onto the marketplace before regulating the amount of nicotine present in combustible cigarettes. CAGW believes it is vitally important that smokers have many options for moving away from combustible cigarettes, which are well-known and demonstrated to be harmful, to less harmful products such as electronic nicotine delivery systems (ENDS), which include e-cigarettes, personal vaporizers, and heat-not-burn technology such as Phillip Morris’s IQOS. CAGW also urges caution in over-regulating the nicotine quantity in combustible cigarettes, as doing so could lead to an unregulated and potentially dangerous black market.
Comment
On July 28, 2017, the FDA announced a new policy “for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death,” which will strike, “an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes … ”[i] However, the public has seen more attacks against ENDS products than any strong movement to encourage smokers to switch to these less harmful alternatives, such as the acceptance of ENDS products by health officials in England as a legitimate way to stop smoking.[ii]
CAGW remains concerned that many ENDS products could be removed from the marketplace if Congress does not act and change the predicate date by law, or if the FDA does not change the predicate date from February 15, 2007 to August 8, 2016, the date the deeming rule took effect. It has been argued that the FDA has the authority to change the predicate date under the Food, Drug, and Cosmetic Act.[iii]
CAGW believes that a robust, tobacco harm-reduction market must be securely in place before the FDA devotes its resources to reducing nicotine levels in combustible cigarettes. CAGW has made its feelings known on the importance of tobacco harm-reduction products in a comment submitted to the FDA on July 11, 2018 for the ANPRM regarding Regulations of Flavors in Tobacco Products, Docket ID No. FDA-2017-N-6565.
The July 2017 notice included the FDA beginning “a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards.” CAGW encourages the FDA not to overstep its mandate. The agency’s actions on regulating nicotine levels must be taken with the best available science to determine whether non-addictive levels are achievable. Any studies used to promulgate nicotine regulations must be evidence-based, transparent, and reproducible.
CAGW appreciates why the FDA would like to lower nicotine levels to non-addictive levels for products marketed in the United States but, we urge caution in achieving this goal. The U.S. is not alone in growing tobacco. According to Statista, mainland China produced 2,806 metric tons of tobacco in 2016. India followed with 761 metric tons, Brazil with 676 metric tons, then the United States with 285 metric tons.[iv] It is conceivable that bad actors in any of the three leading tobacco-growing countries, or the six other countries like Indonesia, which produced 196 metric tons in 2016, or Pakistan, which produced 116 metric tons in 2016, would be willing to engage in a black market to provide American smokers with cigarettes that have a higher nicotine level than could be purchased legally in the United States.
Again, CAGW urges the FDA to move forward on making sure that a strong harm-reduction market that includes ENDS, or similar non-combustible products, is in place before vital resources are used to regulate and reduce nicotine levels in combustible cigarettes.
July 11, 2018
Food and Drug Administration (FDA)
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Comment on FDA’s Advanced Notice of Proposed Rule Making regarding Tobacco Product Standard for Nicotine Level of Combusted Cigarettes
Docket ID No – FDA-2017-N-6189
Background
Citizens Against Government Waste (CAGW) is a private, nonpartisan, nonprofit, organization representing more than one million members and supporters nationwide. CAGW’s mission is to eliminate waste, fraud, abuse, mismanagement, and inefficiency in government. Founded in 1984 by the late industrialist J. Peter Grace and syndicated columnist Jack Anderson, CAGW was established to follow up on the work of the President’s Private Sector Survey on Cost Control, also known as the Grace Commission.
On behalf of CAGW’s members and supporters, I ask that the Food and Drug Administration (FDA) move swiftly to protect current and allow new tobacco harm reduction products onto the marketplace before regulating the amount of nicotine present in combustible cigarettes. CAGW believes it is vitally important that smokers have many options for moving away from combustible cigarettes, which are well-known and demonstrated to be harmful, to less harmful products such as electronic nicotine delivery systems (ENDS), which include e-cigarettes, personal vaporizers, and heat-not-burn technology such as Phillip Morris’s IQOS. CAGW also urges caution in over-regulating the nicotine quantity in combustible cigarettes, as doing so could lead to an unregulated and potentially dangerous black market.
Comment
On July 28, 2017, the FDA announced a new policy “for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death,” which will strike, “an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes … ”[i] However, the public has seen more attacks against ENDS products than any strong movement to encourage smokers to switch to these less harmful alternatives, such as the acceptance of ENDS products by health officials in England as a legitimate way to stop smoking.[ii]
CAGW remains concerned that many ENDS products could be removed from the marketplace if Congress does not act and change the predicate date by law, or if the FDA does not change the predicate date from February 15, 2007 to August 8, 2016, the date the deeming rule took effect. It has been argued that the FDA has the authority to change the predicate date under the Food, Drug, and Cosmetic Act.[iii]
CAGW believes that a robust, tobacco harm-reduction market must be securely in place before the FDA devotes its resources to reducing nicotine levels in combustible cigarettes. CAGW has made its feelings known on the importance of tobacco harm-reduction products in a comment submitted to the FDA on July 11, 2018 for the ANPRM regarding Regulations of Flavors in Tobacco Products, Docket ID No. FDA-2017-N-6565.
The July 2017 notice included the FDA beginning “a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards.” CAGW encourages the FDA not to overstep its mandate. The agency’s actions on regulating nicotine levels must be taken with the best available science to determine whether non-addictive levels are achievable. Any studies used to promulgate nicotine regulations must be evidence-based, transparent, and reproducible.
CAGW appreciates why the FDA would like to lower nicotine levels to non-addictive levels for products marketed in the United States but, we urge caution in achieving this goal. The U.S. is not alone in growing tobacco. According to Statista, mainland China produced 2,806 metric tons of tobacco in 2016. India followed with 761 metric tons, Brazil with 676 metric tons, then the United States with 285 metric tons.[iv] It is conceivable that bad actors in any of the three leading tobacco-growing countries, or the six other countries like Indonesia, which produced 196 metric tons in 2016, or Pakistan, which produced 116 metric tons in 2016, would be willing to engage in a black market to provide American smokers with cigarettes that have a higher nicotine level than could be purchased legally in the United States.
Again, CAGW urges the FDA to move forward on making sure that a strong harm-reduction market that includes ENDS, or similar non-combustible products, is in place before vital resources are used to regulate and reduce nicotine levels in combustible cigarettes.
Sincerely,
Tom Schatz
President, CCAGW
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[i] FDA, “FDA Announces Comprehensive Regulatory Plan to Shift Trajectory of Tobacco-related Disease Death,” July 28, 2017.
[ii] Department of Health (DOH), England; “Towards a Smokefree Generation: A Tobacco Plan for England,” July 2017.
[iii] Azim Chowdhury, Vape Magazine, October 2015, pp. 70-71.
[iv] Statista – The Statistics Portal, Leading Tobacco Producing Countries Worldwide 2016.