Aug. 8 2014
WASHINGTON, DC – In public comments jointly filed today, 24 leading public health and medical organizations called on the Food and Drug Administration to issue a final rule to regulate all tobacco products by April 25, 2015 – one year after the FDA issued a proposed rule – and to reject a proposal to exempt so-called “premium cigars.”
The health groups also called on FDA to close gaps in its proposed rule by extending current restrictions on cigarette marketing to newly-regulated products, including cigars and electronic cigarettes, and prohibiting the use of flavorings that appeal to kids.
Today is the close of the period for public comments to the FDA on its proposed rule to assert authority over all tobacco products, including cigars and e-cigarettes. The FDA issued the proposed rule in April, three years after first announcing plans to do so. The agency currently regulates cigarettes, smokeless tobacco and roll-your-own tobacco under a landmark 2009 law, the Family Smoking Prevention and Tobacco Control Act.
“The deeming of all tobacco products as subject to FDA’s regulatory authority is critical to protecting the public health against the risks posed by an increasingly dynamic and diverse marketplace in tobacco products and ensuring continued, and accelerated, progress toward eliminating tobacco-related disease and death,” the health groups wrote.
“However, the proposed rule must be strengthened, and made comprehensive in scope, to prevent the manufacturers of tobacco products from designing and marketing their products in ways that undercut the full potential of the Tobacco Control Act to achieve its lifesaving objectives.”
The health groups specifically called for the following actions:
The FDA should issue a final rule asserting jurisdiction over all tobacco products by April 25, 2015. The FDA should also immediately begin to close regulatory gaps in its proposal and finalize any additional rules needed to close those gaps by that same date.
The FDA should not exempt so-called “premium cigars” from regulation. The FDA’s proposed rule includes an option for such an exemption. “There is no justification for exempting any cigars from FDA regulation,” the health groups wrote. “All cigars are harmful and potentially addictive to users… Moreover, all cigars threaten the health of non-users by giving off significant amounts of harmful secondhand smoke.” The health groups also point out that kids, and not just adults, smoke cigars, with a recent CDC survey showing that high school boys now smoke cigars at the same rate as cigarettes (16.5 percent for cigars and 16.4 percent for cigarettes).
The FDA should apply the same sales and marketing restrictions that currently apply to cigarettes to the newly-regulated products. The FDA’s proposed rule would prohibit sales to children under 18, require retailers to verify age for all over-the-counter sales and restrict vending machines to adult-only facilities. The health groups urged the FDA to go further by extending other regulations that apply to cigarettes, including prohibiting self-service displays that make tobacco products more accessible to kids and restricting marketing such as brand name sponsorship of events. They also called on the FDA to prohibit online sales of the newly-regulated products, or at the very least to impose tougher age verification requirements on internet sellers.
The FDA should prohibit the use of “characterizing flavors” in cigars, e-cigarettes and other tobacco products. The 2009 law prohibited the use of candy and fruit flavorings in cigarettes. An extension of this prohibition “is justified in light of the commonplace use of candy and fruit flavors in cigars and e-cigarette products, the appeal of such flavored products to young people and the marketing of those products in ways that enhance their appeal to young people.”
The FDA should require child-resistant packing of nicotine liquid products by April 25, 2015. Such a rule is needed to address a dramatic increase in calls to poison control centers involving nicotine poisoning of children exposed to the liquid nicotine used in e-cigarettes.
The FDA should revise its flawed cost-benefit analysis of the proposed rule that led the agency to vastly underestimate the likely benefits. Among other flaws, the FDA slashed its estimated benefits of the rule by 70 percent to account for the “pleasure” smokers lose if they quit smoking as a result of the regulations. Earlier this week, nine leading economists submitted a paper to the FDA that faulted the agency for inappropriately applying this concept to tobacco regulations.
The 24 groups joining the comments represent more than 560,000 healthcare and public health professionals, as well as millions of volunteers. The groups are:
American Academy of Family Physicians
American Academy of Pediatrics
American Association for Respiratory Care
American Cancer Society Cancer Action Network
American College of Cardiology
American Congress of Obstetricians and Gynecologists
American Heart Association
American Lung Association
American Psychological Association
American Public Health Association
American Thoracic Society
Association of Maternal & Child Health Programs
Campaign for Tobacco-Free Kids
Cancer Prevention and Treatment Fund
Lung Cancer Alliance
National African American Tobacco Prevention Network
National Association of City and County Health Officials
National Latino Alliance for Health Equity
Oncology Nursing Society
Partnership for Prevention
Society for Public Health Education
Trust for America’s Health
The comments can be read at http://tfk.org/2014_08_deeming_rule_document.