Guidance for Industry and FDA Staff

Guidance for Industry and FDA Staff1 General Questions and Answers on the Ban of Cigarettes that Contain Certain Characterizing Flavors (Edition 2) This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance document. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance. Introduction The Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), establishes a tobacco standard special rule for cigarettes that is effective on September 22, 2009. This special rule for cigarettes prohibits a cigarette or any of its component parts (including the tobacco, filter, or paper) from containing, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. The issues identified in this guidance document represent those that we believe are frequently asked regarding the ban of cigarettes that contain certain characterizing flavors. In developing the guidance document, we carefully considered the relevant statutory criteria regarding the ban. General Questions and Answers: 1. What is the significance of today’s announcement on flavored cigarettes? 1 This guidance has been prepared by the Center for Tobacco Products at the U.S. Food and Drug Administration. 1 Contains Nonbinding Recommendations Smoking is the leading cause of preventable death in the United States, claiming over 400,000 lives each year. An important way to reduce the death and disease caused by smoking is to prevent children and adolescents from starting to smoke. Studies have shown that 17 year old smokers are three times as likely to use flavored cigarettes as are smokers over the age of 25. In addition to being more attractive to young people, flavored products make it easier for new smokers to start smoking by masking the unpleasant flavor of tobacco. Studies have also demonstrated that young people believe that flavored tobacco products are safer than unflavored tobacco products. Flavored cigarettes are just as addictive and have the same types of harmful effects as regular cigarettes. Removing these flavored products from the market is important because it removes an avenue that young people can use to begin regular tobacco use. Congress specifically enacted the ban on sale of cigarettes and their component parts, such as filters and papers, which contain certain characterizing flavors. The removal from the market of cigarettes that contain certain characterizing flavors is an important step in the Nation’s efforts to reduce the burden of illness and death caused by tobacco products as authorized by the FSPTCA, signed by President Obama on June 22, 2009. 2. What products are covered? Several key definitions in the law define which products are covered. The ban applies to all tobacco products that meet the definition of a cigarette in section 900(3) of the FDCA even if they are not labeled as cigarettes or are labeled as cigars or as some other product. Specifically, section 900(3) defines cigarettes as: ‘‘(3) CIGARETTE.—The term ‘cigarette’— ‘‘(A) means a product that— ‘‘(i) is a tobacco product; and ‘‘(ii) meets the definition of the term ‘cigarette’ in section 3(1) of the Federal Cigarette Labeling and Advertising Act; and ‘‘(B) includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco. ‘‘(4) CIGARETTE TOBACCO.—The term ‘cigarette tobacco’ means any product that consists of loose tobacco that is intended for use by consumers in a cigarette. Unless otherwise stated, the requirements applicable to cigarettes under this chapter shall also apply to cigarette tobacco.” This definition refers to a provision of the Federal Cigarette Labeling and Advertising Act which defines the term ‘cigarette’ as: “(1) The term “cigarette” means— (A) any roll of tobacco wrapped in paper or in any substance not containing tobacco, and