Comment on FDA's Proposed Rule Regarding Tobacco Product Flavors | Citizens Against Government Waste

Comment on FDA's Proposed Rule Regarding Tobacco Product Flavors

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 Regulations of Flavors in Tobacco Products

Docket ID No – FDA-2017-N-6565


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 urge the FDA to move cautiously in its regulation of flavors for tobacco products, particularly those found in electronic nicotine delivery systems (ENDS). While CAGW appreciates the concern that some flavors may be attractive to youth, adult smokers rely on the flavors to help them switch from combustible cigarettes to less harmful ENDS.


CAGW appreciates the opportunity to comment on how the FDA should regulate flavors for tobacco products, including ENDS. As a taxpayer advocacy organization, our main concern regarding regulating flavors in tobacco products revolves around how the federal government could make it more difficult for adult smokers to switch from harmful combustible cigarettes to less harmful ENDS, such as e-cigarettes, vape pens, e-cigars, e-hookahs, personal vaporizers, or any other type of vaporizing device.

On April 13, 2018, the California Department of Public Health called on the FDA to abolish the sale of flavored tobacco products.[1] On June 5, 2017, San Franciscans voted to uphold a ban on the sale of flavored tobacco products, including menthol. Other cities, like Chicago, New York, and Providence are looking at or have established restrictions on flavors. As these bans and restrictions continue to grow, smokers will find it increasingly difficult to move away from dangerous combustion cigarettes and utilize less harmful ENDS.

Ironically, as politicians and state governments stumble all over themselves to legalize recreational marijuana, they are at the same time passing laws and implementing taxes to make it more difficult for smokers to access ENDS products, which have been found to be very effective in weaning smokers off of combustible cigarettes.

ENDS work by using a battery to heat and vaporize a liquid, often called “juice,” which is mostly composed of propylene glycol and vegetable glycerin, like the products used in FDA-approved inhalers or in food. The liquid usually contains a certain percentage of nicotine, or none, and is flavored.

According to the American Vaping Association, ENDS were developed as a replacement to combustible cigarettes. ENDS come in a variety of shapes and sizes, including a cigarette, a pen, a flash drive, or a pipe.[2]

Nicotine, while addictive, is not the biggest health risk to smokers. It is the tar and carbon monoxide that is created from burning tobacco that causes harm. Tar, a brown residue particulate matter produced by combustion, contains thousands of harmful and potentially harmful constituents (HPHCs), such as ammonia, benzene, lead, and acetaldehyde that causes cancer, heart, and lung diseases.

CAGW believes it is time for the United States to adopt the smoking cessation policies that have been developed in England. Health officials have recognized the benefits of having smokers move away from combustible cigarettes to non-combustion tobacco products. In April 2016, the Royal College of Physicians released a report that concluded e-cigarettes are proving to be a much more popular substitute and competitor for smoking than nicotine replacement therapy (NRT); that any health hazard arising from vapor inhalation is unlikely to exceed 5 percent of the harm from smoking tobacco; that evidence available today indicates that e-cigarettes are being used almost exclusively as a safer alternative to smoking; and that in the interest of public health, it is important to promote the use of e-cigarettes, along with NRT, and other non-tobacco nicotine products.[3]

In July 2017, England’s Department of Health (DOH) announced its tobacco-control plan, “Towards a Smokefree Generation,” to cut smoking rates. England recognizes that while the nation has made great strides in reducing smoking rates, much more can be done. The report noted smoking continues to remain higher in England among those who already suffer from poor health, are the lowest wage earners, and have a mental illness.[4] Similar smoking patterns exist in the United States.[5] Part of the DOH’s strategy to achieve a smoke free generation is to assist people in quitting smoking by allowing innovative technologies that reduce the risk of harm and to increase the availability of safer alternatives to smoking.

The DOH recognized that, “the 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. Going even further, Public Health England [PHE] has produced guidance for employers and organisations looking to introduce policies around e-cigarettes and vaping in public and recommend such policies to be evidence-based.” Notably, the PHE recommends that e-cigarettes should not be included in smoke free legislation and should not be part of an organization’s smoke free policy.[6]

Actions the FDA Should Take

All indications are that flavors play a major role in encouraging adult smokers to switch from combustible cigarettes to ENDS, such as e-cigarettes, or other vaping products. CAGW urges caution in restricting flavors that are to be made available to consumers.

A study by Konstantinos E. Farsalinos, M.D., a research fellow at the Onassis Cardiac Surgery Center in Athens, Greece, published in the December 17, 2013 International Journal of Environmental Research and Public Health, found that flavors are marketed to satisfy demand and appear to contribute both to a perceived pleasure and the effort to reduce combustible cigarette consumption. His internet survey of 4,618 persons found that the 91.1 percent of those surveyed were former smokers, while current smokers had reduced their cigarette consumption from 20 per day to 4 per day. On average, the vapers used three different types of flavors per day. Fruit flavors were the most popular at the time the survey was being conducted, but tobacco flavors were more popular when a person began to use an e-cigarette. According to the survey, a variety of flavors were very important in the user’s effort to reduce or quit smoking.[7]

A review of testimonials posted on the American Vaping Association website and the Consumer Advocates for Smoke Free Alternatives Association clearly shows that flavors are integral to quitting smoking and moving to harm-reducing ENDS products.[8]

The FDA will review many studies that will assist the agency in making decisions about flavored tobacco products. It is important that all scientific studies that are provided to the agency concerning flavor toxicity or positive and adverse health effects, particularly if they will be used to promulgate regulations, must be evidence-based, transparent, and reproducible. There must be appropriate notice and comment periods for the public to weigh in throughout the process prior to finalizing any regulations.

CAGW’s concern about transparency and reproducibility arises out of a February 22, 2017 BBC News report, “Most scientists can’t replicate studies by their peers.” The report disturbingly recounted that, “more than two-thirds of researchers have tried and failed to reproduce another scientist’s experiments.” According to the article, Dr. Tim Errington, who runs the Reproducibility Project at the University of Virginia, attempted to repeat the findings in five landmark cancer studies. His team was only able to confirm two of the original studies’ findings. Dr. Errington said, “it’s worrying because replication is supposed to be a hallmark of scientific integrity.”[9]

On April 30, 2018, the Environmental Protection Agency issued a proposed rule to strengthen transparency in regulatory science.[10] CAGW believes this protocol should be used across all agencies. Taxpayers should not be forced to shoulder the cost and burdens of regulations for which the data used to promote a policy decision is not publicly available. If there is any proprietary and sensitive information with respect to analyzing tobacco flavors, the FDA has demonstrated it is able to protect personal or sensitive data while still allowing other researchers to duplicate scientific findings.

While there has been a lot of focus on youth utilizing vaping products and criticism directed toward manufacturers, these products cannot be bought legally unless a person is 18 years of age or older. For example, e-cigarette manufacturer Juul has been facing a barrage of criticism for producing flavors such as Crème Brûlée and Mango that supposedly attract youth. However, these flavors could just as easily be appealing to adult vapers. A May 29, 2018 survey by the Truth Initiative found that 74 percent of youth that had used a Juul product within 30 days obtained the product from a physical retail location. This is a retail issue, not a flavor issue.[11]

While there is reason to be concerned when any young person uses a tobacco product, the good news is the Centers for Disease Control and Prevention reported on June 8, 2018, that the use of any tobacco product is down among all youth. Among high school students, use of any tobacco product went from 24.2 percent in 2011 to 19.6 percent in 2017. Among middle school students, use of any tobacco product went from 7.5 percent in 2011 to 5.6 percent in 2017. While e-cigarettes remain the most commonly used tobacco product for high schoolers, the rate was 11.7 percent in 2017, below the 2015 high of 16 percent. For middle school students, it was 3.3 percent in 2017, down from the high of 5.3 percent in 2015.[12]

Meanwhile, from 2011 to 2017, cigarette smoking declined by almost 50 percent among middle and high school students. For middle school students it was 2.1 percent in 2017, down from 4.3 percent in 2011. For high school students, it was 7.6 percent in 2017, down from 15.8 percent in 2011.[13] It appears some students that used to engage in the risky behavior of smoking cigarettes are moving to using less risky ENDS products.

These figures contradict the narrative there is a youth vaping epidemic and helps to emphasize the need for balanced FDA regulation and congressional action to help smokers move to less risky tobacco products. Ultimately, the best education and oversight of youth and tobacco use of any kind are parents.

While Congress struggles to pass a law that would create a new predicate date for ENDS products, CAGW asks that the FDA change the grandfather date for ENDS products to the day the deeming rule went into effect on August 8, 2016.[14] Although CAGW appreciates the FDA extending the compliance dates for substantial equivalence exemptions requests (SE EX) and substantial equivalence reports (SE) until August 8, 2022 for newly regulated noncombustible tobacco products, such as most ENDS, the delay will not help the majority of manufacturers.

Since there were no vaping products on the market, at least within the United States, prior to the current predicate date of February 15, 2007, manufacturers will not be able to use the SE EX or SE process to comply with current FDA regulations and therefore will be forced to submit a PreMarket Tobacco Application (PMTA) to remain on the market. For most manufacturers of ENDS, or any vaping product, it will be too complex and expensive to comply with the regulatory application requirements, ranging anywhere from $117,000 to $10,000,000 per vaping product for a PMTA.[15]

The American Vaping Association stated that failing to change the arbitrary predicate date of February 2007 will “shrink the vapor industry to almost nothing.” Economics 21, the economic portal for the Manhattan Institute for Policy Research, stated the e-cigarette “regulations will destroy the burgeoning [vaping] industry, leading to increased mortality and higher healthcare costs. Consumer Advocates for Smoke Free Alternatives Association declared that FDA’s tobacco deeming regulations “will effectively ban 99.9% of the vapor products currently on the market” and the agency’s actions “demonstrate a clear preference for the status-quo which keeps dangerous products in place while stifling their low-risk competitors. In no uncertain terms, the FDA regulations are an unmitigated disaster which will only increase suffering by prolonging the war on smoking.”[16]

It has been argued that the FDA has considerable discretion in establishing the predicate date. An October 2015 Vape Magazine article, “The Grandfather Date – What are the FDA’s Alternatives,” Adam Chowdhury of Keller and Heckman, LLP wrote that the Food, Drug, and Cosmetic Act (FDCA) “has always been interpreted as providing FDA with much rulemaking and enforcement flexibility. For example, Section 701(a) of the FDCA gives the Agency the authority to promulgate substantive rules that will provide for the ‘efficient enforcement’ of the Act.”  He noted the Tobacco Control Act “states in Section 3 that the purpose of the law is to ‘provide 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.’”[17]

Chowdhury argued that the February 2007 date is arbitrary because it simply represents the date the House and Senate reintroduced tobacco control bills in Congress after previous versions had failed. On March 3, 2009, the bill, which was ultimately signed into law, was introduced again, but it still contained the February 2007 date. Chowdhury theorizes the reason is because it put the tobacco industry on notice it was subject to FDA authority and how it would be regulated.

Another plausible date, according to Chowdhury, includes April 25, 2011. This is the day the FDA published a letter to e-cigarette stakeholders that it would not appeal the Sottera Inc. v. FDA decision, which held that e-cigarettes that contain tobacco-derived nicotine and are sold as recreational tobacco product, are not drug delivery devices.

Or perhaps April 25, 2014 would work as it is the date the Notice of Proposed Rule Making for the deeming regulation was published in the Federal Register, putting the e-vapor industry on notice that the agency intended to regulate e-vapor products as tobacco products.

By changing the deeming rule for ENDS to August 8, 2016, and implementing regulations that would allow most of the vaping industry to remain in business, but under FDA control, smokers will have a broader selection of less harmful choices to utilize, enabling them to move away from smoking cigarettes.


Smoking causes 480,000 deaths per year in the United States. In 2016, nearly $170 billion was spent on direct medical care for smokers. These figures could be reduced because nearly 7 in 10 adult smokers wanted to quit smoking, according to 2015 statistics, and 5 in 10 smokers tried to quit in the past year.[18]

With numbers like these, surely a better approach for U.S. health officials, like their British counterparts, would be to encourage smokers to move to less harmful ENDS, where a wide variety of flavors exist that motivate and enable smokers to move away from combustible cigarettes. CAGW urges the FDA not to over-regulate flavors for tobacco products, particularly for ENDS. The FDA should make it easier, not more difficult, for smokers to quit cigarettes.


Tom Schatz
President, CCAGW

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[1] California Department of Public Health, Comment to FDA Docket FDA-2017-N-6525, April 13, 2018.
[2] American Vaping Association, “What is Vaping?”
[3] Royal College of Physicians, “Nicotine Without Smoke: Tobacco Harm Reduction.”
[4] Department of Health (DOH), England; Towards a Smokefree Generation: A Tobacco Plan for England,” July 2017, p. 4.
[5] Centers for Disease Control and Prevention, “Current Cigarette Smoking Among Adults in the United States (2016).”
[6] DOH, p. 15.
[7] Konstantinos E. Farsalinos, Impact of Flavour Variability on Electronic Cigarette Use Experience: An Internet Survey, International Journal of Environmental Research and Public Health, December 17, 2013, Volume 10, Issue 12, pp. 7272-7282.
[8] Testimonials, American Vaping Association; Testimonials, Consumer Advocates for Smoke Free Alternatives Association.
[9] BBC News, “Most Scientists ‘Can’t’ Replicate Studies by Their Peers,” February 22, 2017.
[10] EPA, Strengthening Transparency in Regulatory Science, Federal Register, April 30, 2018.
[11] Truth Initiative, “Where are Kids Getting Juul?,” May 29, 2018.
[12] Center for Disease Control and Prevention, “Tobacco Product Use Among Middle and High School Students-United States 2011-2017,” June 8, 2018; U.S. Department of Health and Human Services, “E-Cigarette Use Among Youth and Young Adults – A Report by the Surgeon General,” 2016, p. 6.
[13] Center for Disease Control and Prevention, “Youth and Tobacco Use.”
[14] Food and Drug Administration (FDA), Center for Tobacco Products, “Extension of Certain Tobacco Compliance Deadlines Related to the Deeming Rule – Guidance for Industry,” November 2017.
[15] FDA, “Commonly Asked Questions: About the Center for Tobacco Products”; “FDA to Regulate E-Cigarettes, Ban Sales to Minors,” Wall Street Journal, May 5, 2016.
[16] American Vaping Association, “August 8, 2016 – What Does it Mean for Vaping?;” E21, “FDA’s New E-Cig Regs Will Kill,” May 5, 2016; CASAA, “New FDA E-Cigarette Regulations Condemned by CASAA,” May 6, 2016.
[17] Azim Chowdhury, Vape Magazine, October 2015, pp. 70-71.
[18] Centers for Disease Control and Prevention, “Smoking and Tobacco Use – Fast Facts,” 2018.

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