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FINDING CURES TOGETHER<sup>SM</sup>

Leading Cancer Organizations Urge FDA to Regulate All Tobacco Products

AACR, ASCO Issue Joint Response to Proposed Rule
8/11/2014

PHILADELPHIA — The American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO), in a joint letter responding to a proposal by the U.S. Food and Drug Administration (FDA) to extend its regulatory authority over tobacco products, today urged the agency to regulate electronic cigarettes (e-cigarettes), cigars, and all other tobacco products and to strengthen the proposed regulations for newly deemed products.

“There is no safe form of tobacco use,” said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR. “Tobacco is the leading cause of preventable deaths in the United States, and among its dire health consequences are 18 different types of cancer. It is imperative that the FDA takes action to regulate all tobacco products. The future health of the American people, in particular our nation’s children, depends on it.”

The AACR and ASCO applauded the FDA’s proposal to regulate e-cigarettes. “We believe it is vitally important for the FDA to begin regulating these products, especially because we don’t know much about the health effects of e-cigarette use. We are also quite concerned that e-cigarettes may increase the likelihood that nonsmokers or former smokers will use combustible tobacco products or that they will discourage smokers from quitting,” said Peter P. Yu, MD, FASCO, president of ASCO.

“There are insufficient data on the long-term health consequences of e-cigarettes, their value as tobacco cessation aids, or their effects on the use of conventional cigarettes. Any benefits of e-cigarettes are most likely to be realized in a regulated environment in which appropriate safeguards can be implemented,” said Roy S. Herbst, MD, PhD, chair of the AACR Tobacco and Cancer Subcommittee and chief of medical oncology at Yale Comprehensive Cancer Center.

The AACR and ASCO support many of the FDA’s proposals for regulating e-cigarettes and other products, but urge the agency to do more. Specifically, preventing children from using tobacco products is crucial and can be achieved by efforts such as banning youth-oriented advertising and marketing, self-service product displays, and tobacco company sponsorship of youth-oriented events, in addition to restricting sales to minors and implementing age-verification procedures for internet sales.

Expressing grave concern about the proliferation of flavored e-cigarettes, the AACR and ASCO encouraged the agency to ban e-cigarette flavors or flavor names that are brand names of candy, cookies, soda, and other such products, and to prohibit e-cigarettes containing candy and other youth-friendly flavors, unless there is evidence demonstrating that they do not encourage young people to use these products.

The AACR and ASCO strongly discouraged the FDA from exempting “premium” cigars from regulation, an option the agency is considering. “All cigars pose serious health risks,” said Graham Warren, MD, PhD, chair of ASCO’s Tobacco Cessation and Control Subcommittee. “As the FDA itself noted in the proposed rule, even cigar smokers who do not inhale have a seven to 10 times higher overall risk of mouth and throat cancer compared with individuals who have never smoked. Exempting these dangerous products from FDA regulation is clearly not in the best interest of public health.”

Noting that both large and small cigars are of increasing interest to youth and adult users, the AACR and ASCO underscored that the continued availability of premium cigars in an unregulated market, compounded with the ability of the tobacco industry to strategically market its products to youths and young adults, could reverse the progress made in reducing youth tobacco use.

Finally, the AACR and ASCO urged the FDA to drop the “consumer surplus” discount used to assess the net impact of the proposed deeming rule. This discount allows the FDA to only consider 30 percent of the benefits achieved via tobacco cessation due to the costs associated with this proposed regulation, including the “lost pleasure” of smoking. The AACR and ASCO stressed that addiction is an unwelcome burden for many tobacco users and that many consumers are not making rational and fully informed choices when initiating and continuing their use of tobacco products.

Read the joint AACR and ASCO letter to the FDA ​(Adobe Reader required).