FDA Comments Supporting Tobacco Harm Reduction Products

August 10, 2017

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD  20852

Re: Docket No. FDA-2017-D-3001
Modified Risk Tobacco Product Applications for the Philip Morris International Tobacco Heating System, or IQOS, and Three Heatsticks Products

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, mismanagement, and inefficiency in government.  Founded in 1984 by the late industrialist J. Peter Grace and syndicated columnist Jack Anderson, CAGW was created to follow up on the report of the President's Private Sector Survey on Cost Control, also known as the Grace Commission.  CAGW appreciates the opportunity to provide comments on Docket No.  FDA-2017-D-3001, the Philip Morris Modified Risk Tobacco Product Application (MRTPA) for its heat-not-burn and harm reduction Tobacco Heating System (THS).

Background

Passage of the Family Smoking Prevention and Tobacco Control Act (TCA) in June 2009 gave the Food and Drug Administration (FDA) regulatory control over tobacco products.  The purpose of the TCA, as stated in the bill’s report language, was to permit the FDA “to restrict the sale and distribution of tobacco products, including advertising and promotion” and to “take specified actions, including public notification and recall, against unreasonably harmful products.”  The law also required the FDA “to establish tobacco product standards to protect the public health” but prohibited the agency from “banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products” and barred “requiring reducing nicotine yields of a tobacco product to zero.”  The law set forth standards for the sale of modified-risk tobacco products and these products are defined as “any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.”

The best way to reduce harm is for people to not begin smoking.  According to the Center for Disease Control and Prevention, in 1965, 42.5 percent of adults smoked; in 2014, 16.8 percent of adults smoked.  FDA Commissioner Scott Gottlieb, M.D., pointed out in his agency’s July 28, 2017 release of its comprehensive plan to shift downward the trajectory of tobacco-related disease and death, that even at these lower rates of smoking, 480,000 people will die every year if nothing is done to encourage smokers to move away from cigarettes.  This means 17,280,000 Americans will die a premature death by the mid-21st century.  Direct healthcare and lost productivity costs will be nearly $300 billion a year.

The next best alternative to not smoking at all would be for tobacco harm reduction products to either be allowed to remain, or enter, the marketplace.  The FDA plays a pivotal role in allowing these types of products to be researched, developed, and sold in the U.S., and any action the agency takes will greatly influence whether people will continue to smoke cigarettes or utilize tobacco products that are less harmful.  The FDA’s March 2012 draft guidance for companies that wish to submit a MRTPA stated:  “The modified risk tobacco product provisions of the FD&C [Food, Drug, and Cosmetic] Act may be valuable tools in the effort to promote public health by reducing the morbidity and mortality associated with tobacco use, particularly if companies take advantage of these provisions by making bold, innovative product changes that substantially reduce, or even eliminate altogether, either the toxicity or addictiveness of tobacco products, or both.”

Along with the FDA’s plans to shift downward the trajectory of tobacco-related disease and death through its comprehensive regulatory plan, the agency must also carry through on its commitment to strike “an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes.”  The FDA promised to advance foundational rules to make the tobacco product review process more efficient and predictable for manufacturers.  Promulgating such regulations and specifying how to demonstrate Substantial Equivalence (SE), as well as the information the FDA expects sponsors to include in their Premarket Tobacco Applications (PMTAs) and MRTPAs, have been too long in coming.

On July 28, 2017, the FDA extended the timeline for submission of PMTAs for non-combustible tobacco products, such as electronic nicotine delivery systems (ENDS), to August 8, 2022.  CAGW believes this will go a long way in providing safer alternatives to cigarette smoking.  During this extended timeline, Congress should pass legislation that would change the TCA’s predicate date of February 2007 to August 2016.  This would permit ENDS manufacturers to avoid submitting onerous and costly PMTAs that would likely force them out of business.

Other countries are beginning to recognize the benefits of ENDS and similar non-combustible products.  On July 18, 2017, England’s Department of Health (DoH) announced its long-awaited tobacco control plan to cut smoking rates, which will include an emphasis on the important role e-cigarettes and similar devices can play in smoking cessation and reducing harm.  The DoH recognizes that ceasing smoking is difficult and that many smokers are turning to e-cigarettes to assist them in their efforts. 

The DoH noted that in 2016, an estimated 2 million consumers in England had used e-cigarettes to completely stop smoking and 470,000 were using them as a tool to help them stop smoking.  Furthermore, while the DoH stated that the “best thing a smoker can do for their health is to quit smoking,” it added that “evidence is increasingly clear that e-cigarettes are significantly less harmful to health than smoking tobacco.  The government will seek to support consumers in stopping smoking and adopting the use of less harmful nicotine products.”

Public Health England, an executive agency within DoH, produced guidance for employers and other organizations regarding e-cigarette policies.  To encourage use of e-cigarettes and similar novel technology, the agency recommended that use of these products should not be covered by smoke-free legislation and should not be routinely included in the requirements of an organization’s smoke-free policy.

Comment

Philip Morris International’s (PMI) innovative product, the Tobacco Heating System (THS), which heats tobacco but does not burn it, had its MRTPA accepted for review by the FDA in order to market its tobacco product as one that will substantially reduce toxicity and exposure to harmful or potentially harmful constituents (HPHCs).  The product is called IQOS and is currently available for sale in Japan, as well as in cities in 26 other countries, including Italy, Germany, Romania, Russia, Switzerland, and the United Kingdom.  According to PMI, more than 2.9 million adults have switched from cigarettes to IQOS.

The heat-not-burn product consists of a tobacco stick or plug made from tobacco powder, a holder that heats the stick, and a charger.  According to PMI, the lit end of a cigarette can reach 1600°F.  High temperatures cause the tobacco to release chemicals, including HPHCs, which lead to cancer and other health problems associated with smoking.  But PMI’s product heats tobacco to a temperature of less than 600°F.  Instead of smoke, an aerosol is created composed mainly of water and glycerol.  Since there is no combustion, many of the chemical reactions that occur with burning do not take place.  Thus, the THS aerosol contains significantly lower levels of HPHCs than cigarette smoke.  Because the THS replicates the taste of tobacco and nicotine delivery, the ritual characteristics of cigarettes are maintained, which are important for appealing to and acceptance by an adult smoker.  As a result, users will be more likely to move away from smoking cigarettes.

PMI’s MRPTA data provided on the website PMIScienceUSA.com provides information that shows the THS reduces toxicity.  For example, “the levels of [HPHCs] required to be reported to FDA were measured in the aerosol generated by THS and are over 90% lower, on average, than those in cigarette smoke from a 3R4F reference cigarette.  Similarly, the levels of chemicals classified by the International Agency for Research on Cancer (IARC) as Group 1 carcinogens are reduced on average by more than 95% compared to a reference cigarette.”

Clinical trials carried out in Japan and the United States showed similar results.  Smokers who switched from smoking to the THS were exposed to reduced levels of 15 HPHCs, including carbon monoxide, acrolein, benzene, and butadiene, compared to smokers who continued to smoke.  The reductions in levels of the HPHCs for the THS users were similar to levels seen in smokers that quit smoking for the duration of the study.

In regard to perception and behavior assessments, PMI found that “premarket assessments show negligible interest in THS among adult never-smokers and former smokers.  The assessments also showed substantial potential for full switching among adult smokers.”  This indicates PMI’s product provides an experience close to smoking as possible but, without the exposure to harmful chemicals.  As a result, many adult smokers will likely abandon cigarettes and move to PMI’s harm reduction heat-not-burn technology.

PMI also submitted a PMTA to the FDA to market the THS in the U.S.  If the FDA issues an authorization marketing order, Altria Group Inc. would be responsible for commercializing and marketing the product in the United States under the terms of a licensing agreement with PMI.  But, only a Modified Risk Order will allow Altria (and PMI) to communicate to adult smokers that using the THS, or the IQOS, will reduce their exposure to harmful chemicals and corresponding risk to smoking diseases.

The THS and other tobacco harm reduction products such as heat-not-burn technology should be allowed into the marketplace.  Not only will lives be saved, money currently being spent on preventable smoking diseases in private healthcare and taxpayer-funded programs, such as Medicare and Medicaid, could be redirected to other important healthcare needs or returned to taxpayers.

CAGW urges the FDA to grant PMI a modified risk marketing order for the company’s Tobacco Heating System, also known as the IQOS.

Sincerely,

Tom Schatz

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