Latest FDA Filing Highlights NTU's Commitment to Free Market Principles

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December 21, 2018
Commissioner Scott Gottlieb, M.D.
Food and Drug Administration
Dockets Management Staff
5630 Fishers Lane Room 1061
Rockville, Maryland 20852
RE: Docket No. FDA-2018-N-3261 for “Application for Copenhagen® Snuff Fine Cut, a Loose Moist Snuff Tobacco Product Submitted by U.S. Smokeless Tobacco Company LLC."
Commissioner Gottlieb,
On behalf of National Taxpayers Union (NTU), we welcome this opportunity to comment on the U.S. Smokeless Tobacco Company’s pending modified risk tobacco product (MRTP) application under Section 911 of the Federal Food, Drug, and Cosmetic Act.
NTU is the nation’s oldest taxpayer advocacy organization. We are a nonpartisan, nonprofit citizen group that actively works to promote lower taxes, limited government, and free market principles. To that end, NTU regularly participates in Food and Drug Administration (FDA) comment proceedings to encourage this agency to avoid imposing unnecessary burdens on businesses, consumers, and taxpayers. For example, we have previously commented regarding the approval of the MRTP IQOS product (FDA Docket No. FDA-2017-D-3001, filed September 12, 2017), and on nicotine levels in combustible cigarettes (FDA Docket No. FDA-2017-N-6189, filed July 16, 2018).
With the enactment of the Tobacco Control Act of 2009, the FDA was granted the authority to regulate cigarettes and other tobacco products, including products derived from tobacco. Among the Tobacco Act’s long list of goals is to provide FDA with “new and flexible enforcement authority to ensure that there is effective oversight of the tobacco industry’s efforts to develop, introduce, and promote less harmful tobacco products.” While the Tobacco Act allocates a great degree of authority to the FDA, the agency should adhere to a pragmatic, market-based approach when promulgating rules and reviewing applications.
Consistent with our free-market goal of reining in excessive government regulation, NTU believes the most effective way to limit the harmful health impacts of traditional smoking is to provide consumers with a combination of less-harmful alternatives. Accordingly, NTU strongly believes that the FDA should approve the application for Copenhagen Snuff Fine Cut, a moist smokeless tobacco (MST) product that is not smoked or burned. It may be used to satisfy tobacco users seeking an alternative to cigarettes.
According to research, the lit end of a cigarette can reach a temperature upwards of 1600 degrees fahrenheit. High temperatures cause the tobacco to release harmful, and potentially deadly chemicals, which can lead to a higher risk of cancer and other health problems associated with smoking. The FDA has stated on many occasions that there are more than 70 chemicals in cigarettes that can lead to cancer and other perverse health outcomes.
Despite declining smoking rates in the United States, it is estimated that nearly a half-million people will die as a result of harmful effects caused by cigarettes. Since cigarette consumption is the most common method of consuming nicotine, the drug that makes smoking addictive, users should have safer alternatives readily available to wean themselves off traditional cigarettes. While the best policy to avoid addiction to cigarettes is to never take up smoking, the next-best alternative would be for tobacco harm reduction products to either be allowed to remain in or enter into the marketplace. That way consumers can have the freedom to choose between which product best fits their lifestyle.
While smokeless tobacco products may not be considered “safe” by FDA standards, it is a scientific fact that they are far less hazardous than traditional cigarettes. Since there is no combustion, many of the chemical reactions that occur with burning do not take place. According to a scientific study, “the consumption of non-combustible tobacco is of the order of 10-1,000 times less hazardous than smoking.”
The absence​ ​of​ ​less​ ​harmful​ ​alternatives​ ​will​ ​also​ ​negatively impact​ ​the​ ​health​ ​of​ ​the​ ​U.S.​ ​economy​ ​and​ ​strain taxpayer​ ​funds.​ ​According to the Center for Disease Control, cigarette​ ​use​ ​leads​ ​to​ ​more​ ​than​ ​$156​ ​​billion​​ ​in​ ​lost​ ​annual​ ​productivity, including​ ​$5.6​ ​billion​ ​in​ ​lost​ ​productivity​ ​due​ ​to​ ​secondhand​ ​smoke​ ​exposure.​ ​Further,​ ​smokers report​​ ​about​ ​2.5​ ​fewer​ ​work days​ ​each​ ​year​ ​compared​ ​to​ ​their​ ​counterparts​ ​who​ ​do​ ​not​ ​smoke.

U.S.​ ​adults​ who are ​enrolled​ ​in​ ​Medicaid​ ​or​ ​uninsured​ ​smoke​ ​at​ ​​rates​​ ​more​ ​than​ ​double​ ​than​ ​that​ ​of people​ ​who​ ​have​ ​private​ ​insurance.​ ​Diseases​ ​and​ ​health​ ​implications​ ​from​ ​smoking​ ​increase Medicare​ ​​outlays​​ ​by​ ​$45​ ​billion;​ ​Medicaid​ ​by​ ​$40​ ​billion;​ ​and​ ​government-sponsored​ ​insurance programs​ ​by​ ​$24​ ​billion​ ​annually.​ ​In​ ​essence,​ ​taxpayers​ ​are​ ​paying a heavier price due to the ​use​ ​of​ ​cigarettes​.​ ​Combined,​ ​private​ ​insurance​ ​and​ ​government programs​ ​​pay​ ​out​​ ​nearly​ ​$170​ ​billion​ ​per​ ​year,​ ​or​ ​8.7​ ​percent​ ​of​ ​all​ ​health​ ​care​ ​costs,​ ​on tobacco-related​ ​illnesses​ ​and​ ​diseases.
In general, consumers should have the ability to decide which type of product they want to use -- especially when opening up the marketplace offers an opportunity to improve public health and reduce excessive costs. We once again appreciate the opportunity to offer our views on this proposed application. We are eager to work with you to represent the nation’s taxpayers as the FDA evaluates its path forward. Thank you for your consideration of these views.
Brandon Arnold, Executive Vice President
National Taxpayers Union