Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061 (HFA-305)
Rockville, Maryland 20852
August 8, 2014
Comments of members of the Patient, Consumer, and Public Health Coalition
On proposed Deeming Rule
Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products; Extension of Comment Period
Docket No. FDA-2014-N-0189
As members of the Patient, Consumer, and Public Health Coalition we are writing to comment on various aspects of the proposed rule to extend FDA’s jurisdiction to tobacco (including made or derived from tobacco) products other than cigarettes, including e-cigarettes. It is essential that the proposed rule be strengthened, since nicotine is highly addictive.
1. We strongly oppose exempting any cigars from the rule, including those designated as “premium.” According to the FDA’s deeming rule, “a large cigar may contain as much tobacco as a whole pack of cigarettes” and “nicotine levels in cigar smoke can be up to 8 times higher than levels in cigarette smoke.” We concur with the FDA that “all cigars are harmful and potentially addictive,” and this is true regardless of their price, the size of the manufacturer, and whether or not they are handmade. In addition, providing cigars special treatment encourages cigarette and other tobacco-related product manufacturers to continue to misclassify products that are actually cigarettes as cigars, in order to take advantage of this regulatory loophole.
2. We also strongly oppose exempting or weakening the rules for smaller manufacturers or manufacturer of “premium” tobacco products, regardless of their so-called “unique challenges.” As noted above, cigars can be more dangerous than cigarettes. Regardless of the cost or whether they are manufactured on a small scale, cigars have large-scale, long-term health consequences.
3. The FDA’s proposed rule does not go far enough to safeguard the health of young people. It proposes a national minimum age of 18 for the purchase of the newly deemed products, which we wholeheartedly endorse, but it permits sale through the internet where age verification is difficult if not impossible to enforce. For this reason, we urge the FDA to prohibit internet sales of the deemed products (and eventually all tobacco products), or require sellers to adopt the same age verification procedures established under the 2009 Prevent All Cigarette Trafficking Act for internet sales of cigarettes and smokeless tobacco.
4. The proposed rule does not go far enough to restrict the marketing and advertising of e-cigarettes and cigars to minors. The number of middle and high school students who reported ever using e-cigarettes doubled between 2011 and 2012; and high school boys are just as likely to smoke cigars as they are cigarettes (16.4% vs. 16.5%). E-cigarettes, cigars and other newly deemed tobacco products should be kept behind store counters just like cigarettes. They should not be displayed in the open, like the candy that many of these newer tobacco products try to emulate, with flavors like “Cinnamon Apple Crunch,” “Tahitian Punch,” and “Iced Berry.
The proposed rule permits self-service displays, does not prohibit low-cost, mini packs of cigars (that are obviously more affordable to children) and also allows brand sponsorship of concerts or sporting events popular with teenagers. These should all be strictly prohibited. Moreover, the FDA has not proposed limiting the advertising of the deemed products the way cigarettes and smokeless tobacco advertising has been limited. By allowing unfettered advertisement of e-cigarettes and cigars, the FDA is ensuring that youth will continue to be exposed to ad campaigns as effective as the ones in years past, which equated cigarette use with glamour, sex appeal, and cartoon characters like Joe Camel.
5. We strongly support the FDA’s proposal to include health warnings about nicotine addiction on all nicotine-containing tobacco products, including e-cigarettes and cigars. We also support the FDA proposal to require that all cigars, including premium cigars, carry additional rotating health warnings on the risk of mouth and throat cancer; the risk of lung cancer and heart disease; the risk of lung cancer and heart disease from secondhand smoke; and stating that cigars are not a safe alternative to cigarettes. However, we strongly urge the FDA to include a fifth warning on the increased risk of infertility, stillbirth and low birth weight. This is particularly important, given the growing popularity of cigars among teenagers and the fact that teenage girls and young women have the highest rates of smoking during pregnancy (16.6% for girls 15-19 and 18.6% for women 20-24 in 2005). We also urge the FDA to revert to the 12-month compliance period (from the date of the final rule) which was changed after OMB review to an unacceptably long 24 months.
According to the CDC’s June 2014 report, nearly one-quarter of all male high school seniors smoke cigars (23%). To save lives, the FDA should mandate its proposed warning about nicotine addiction for all tobacco products; require all cigar manufacturers to rotate all five of the warnings that the FTC imposed on seven cigar manufacturers in 2000; and stipulate that all warnings must be in effect no later than 12 months from the final rule.
6. We also urge the FDA to strengthen the proposed rule regarding characterizing flavors in cigars or e-cigarettes. Cigarettes, for instance, can only be sold with tobacco-flavor or menthol flavor; the newly deemed products should be held to the same standard as they are similarly addictive, nicotine-containing products. More than 80% of adult cigarette smokers began smoking before the age of 18; flavors like “bubble gum” and “banana split” are specifically designed to appeal to children and teens and attract people who otherwise would not use a tobacco product.
The bottom line regarding flavored nicotine products: any flavor that makes the use of tobacco products more palatable should be banned. If a major benefit of e-cigarettes is to cut back on regular cigarette use, then those buying e-cigarettes will not be seeking candy or fruit flavors. These flavored options clearly promote the use of tobacco products by new customers.
7. The proposed rule does not mention requiring child-resistant packaging of liquid nicotine for use in e-cigarettes. Given the alarming rise in nicotine poisonings resulting from children coming into contact with “e-juice,” FDA should issue a proposed rule to prevent this public health problem.
8. The FDA is proposing a premarket review requirement for all newly deemed products, while recommending that manufacturers have 24 months from the final rule to file substantial equivalence and new product applications. This would allow manufacturers to keep existing products on the market and introduce new deemed products for two full years following the promulgation of the final rule. It would also allow products for which an application has been submitted to stay on the market unless or until FDA denies it. These loopholes are unacceptable, given that there has already been a 3-year delay in issuing the deeming rule, giving companies more than enough time to prepare for regulatory requirements. To reduce any further delay, the FDA should: a) issue a final rule within a year of the proposed rule’s issuance, and no later than April 25, 2015, and b) shorten the period for submitting new application or proving substantial equivalence to one year from the final rule.
The Tobacco Control Act (TCA) was enacted in 2009 to give FDA the authority to prevent and control tobacco use. The deeming rule is meant to extend that authority so as to protect children and adults from the harms of cigars and e-cigarettes. We recommend further strengthening the deeming rule in the ways described above and/or concurrently issuing additional proposed rules. The FDA’s mission is to protect and advance public health, and unfortunately the proposed rule falls short.
American Medical Women’s Association
Annie Appleseed Project
Breast Cancer Action
Cancer Prevention and Treatment Fund
Connecticut Center for Patient Safety
National Alliance for Hispanic Health
National Consumers League
National Organization for Women
Our Bodies Ourselves
Women Advocating Reproductive Safety
The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or at firstname.lastname@example.org