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  • ACOEM Comments to FDA on Electronic Cigarettes


    August 6, 2014

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

    Re: Docket No. FDA-2014-N-0189

    To Whom It May Concern:

    The American College of Occupational and Environmental Medicine (ACOEM) welcomes the opportunity to comment on the U.S. Food and Drug Administration’s (FDA’s) proposed “deeming” rule to extend its authority to regulate products that meet the definition of “tobacco product” under federal law. These comments were prepared by an ACOEM Presidential Task Force on the proposed rule and include input from ACOEM’s Board of Directors and other members.

    ACOEM represents more than 4,500 physicians specializing in occupational and environmental medicine (OEM). Founded in 1916, ACOEM is the nation’s largest medical society dedicated to promoting the health and safety of workers, workplaces, and environments.

    ACOEM supports FDA’s proposed rule extending its jurisdiction to various “deemed” tobacco products, including electronic cigarettes (e-cigarettes). FDA’s efforts are a notable and important step to improve public health. As preventive medicine specialists, OEM physicians have proudly supported anti-tobacco efforts to improve public health and have long advocated for the FDA to extend its tobacco regulations to include deemed products to deter the sale of tobacco to minors. In the workplace, from the plant floor to the restaurant, ACOEM has advocated for both smoke-free environments and inclusion of validated smoking cessation programs in workplace wellness initiatives.

    Employers have adopted bans on the use of tobacco products in the workplace out of concern for the health of their employees, both the smoker and the worker who is exposed to environmental tobacco smoke. Most employer programs have deemed electronic cigarettes as a tobacco product and prohibit their use in all areas where other tobacco products are banned. ACOEM urges FDA to deem electronic cigarettes to be a “tobacco product” meeting the statutory definition of “tobacco product” and subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

    Tobacco-free workplaces protect workers and visitors from the adverse effects of exposure to smoking. They also establish a social norm with the clear message that tobacco products are harmful and encourage smokers to consider quitting. We urge that FDA rule not permit electronic cigarettes to circumvent workplace prohibitions on tobacco use.

    Workplace smoking cessation programs are a very effective way to help employees improve their lives and reduce health care costs and absenteeism. Comprehensive worksite wellness initiatives with a robust smoking cessation program can help prevent or manage the risk of a variety of cancers, heart disease, COPD, and other serious medical conditions. ACOEM encourages the use of proven methods of tobacco cessation and will not recommend electronic cigarettes as a cessation aid unless and until the medical evidence conclusively demonstrates their effectiveness and benefit as a cessation device.

    We believe that the proposed rule does not go far enough in several closely related areas. Despite the FDA’s expression of concern about the rapidly increasing reports of nicotine poisoning of children, the proposed rule would do nothing to address the widespread availability of the candy-flavored, nicotine-laced liquid used in e-cigarettes and related products in containers with no child-resistant features. In the final rule, FDA should require child-resistant packaging of e-liquids and related products.

    Similarly, in September 2013, the U.S. Centers for Disease Control and Prevention (CDC) released new data showing an alarming increase in e-cigarette use among middle school and high school students in the U.S. From 2011 to 2012, the number of students in grades 6-12 who reported having ever used an e-cigarette doubled from 3.3 percent to 6.8 percent. Recent use of e-cigarettes among 6-12th graders also essentially doubled from 1.1 percent to 2.1 percent. To address this growing problem, FDA should restrict both marketing to children and the flavors that appeal to them. In addition, restrictions that apply to cigarettes and smokeless tobacco should be extended to newly covered tobacco products. This should include requirements for minimum package sizes, prohibition on breaking packages by retailers, prohibition on tobacco brand names on non-tobacco products, and prohibition on brand name sponsorship of sporting and cultural events. These are measures that are likely to help reduce access to these products, and therefore help prevent youths from starting to use these addictive products.

    The Tobacco Control Act prohibits a manufacturer from making claims that its product presents a lower risk of tobacco-related disease unless the basis for such a claim is thoroughly substantiated by FDA and the agency grants an application permitting the claim to be made. FDA’s proposed deeming rule would apply the modified risk provisions to the deemed products. ACOEM believes that it is important for FDA to apply the modified risk provisions with rigor, particularly in light of the health claims often made for electronic cigarettes. The modified risk provisions of the Tobacco Control Act both protect against the adverse public health consequences of misleading risk claims and provide a pathway to market for evidence-based modified risk claims.

    There is no health related justification for a “premium cigar” regulatory exemption. The exemption of any category of tobacco products, including premium cigars, creates a dangerous precedent that could lead to other products being exempted. The proposed exemption from regulation would not be in the interest of public health.

    The cigar industry has taken advantage of the lag in FDA oversight of these products. In August 2012, CDC released a series of studies showing a rapid increase in use of cigars, including large cigars. CDC found that while cigarette use declined 33 percent from 2000 to 2011, the use of large cigars increased 233 percent. Additional CDC studies have found that current rates of cigar and smokeless tobacco use — particularly among high school boys — nearly match the rates of cigarette smoking, and that cigar use among African-American high school students increased from 7.1 percent in 2009 to 16.7 percent in 2012.

    We are also concerned that e-cigarette types of devices can also be used to vape or administer illicit substances, which can be readily obtained in special preparations for this purpose. Clandestine use is thereby facilitated by such devices (sometimes with minor modifications).

    For these reasons, ACOEM recommends that FDA move quickly to implement the above recommendations to strengthen the proposed rule in order to protect the public from the dangers of e-cigarettes and other tobacco products.

    Sincerely,

    Kathryn Mueller, MD, MPH, FACOEM
    President