Scientific Standards for Studies on Modified Risk Tobacco Products (2012) / Chapter Skim
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1 Introduction
1 Introduction
Pages 21-44
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. Cigarette smoking is the most common form of tobacco use; there are an estimated 46.6 million current adult smokers, and initial use of tobacco typically occurs in youth (CDC, 2010; HHS, 1994)
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B Tumor site for which there is limited evidence: • emale breast F Cardiovascular • oronary heart disease C diseases • erebrovascular disease C • therosclerosis A • ortic aneurysm A Respiratory • Chronic obstructive pulmonary disease (bronchitis, emphysema, diseases in chronic airway obstruction) adults • neumonia P • Premature onset of and an accelerated age-related decline in lung function • All major respiratory symptoms (e.g., coughing, phlegm, wheezing, dyspnea)
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Secondhand smoke (also called environmental tobacco smoke, involuntary smoke, or passive smoke) is responsible for approximately 50,000 annual deaths, largely due to lung cancer, coronary heart disease, and sudden infant death syndrome (HHS, 2006)
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HARM REDUCTION The concept of harm reduction informs the public health rationale for permitting the development and potential marketing of modified risk tobacco products (MRTPs)
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In 2001 the Institute of Medicine (IOM) specifically addressed the potential of tobacco harm reduction in Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction.
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Several products remain on the market; however, no products have been proven to reduce harm or risk. HISTORY OF TOBACCO REGULATION IN THE UNITED STATES The Family Smoking Prevention and Tobacco Control Act of 2009 (FSPTCA)
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In 1970, Congress strengthened the regulation through the Public Health Cigarette Smoking Act, which banned cigarette advertisements on any medium of electronic communication subject to the jurisdiction of the Federal Trade Commission. In total between 1965 and 2000, Congress passed six pieces of legislation to address the harm of tobacco use, including • the Federal Cigarette Labeling and Advertising Act of 1965;3 • the Public Health Cigarette Smoking Act of 1970;4 • the Alcohol and Drug Abuse Amendments of 1983;5 • the Comprehensive Smoking Education Act of 1984;6 • the Comprehensive Smokeless Tobacco Health Education Act of 1986;7 and • the Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act of 1992.8 Additional smoking-related regulations and interventions have followed, with the recognition of secondhand smoke as a serious public health hazard (IOM, 2010)
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1988 A congressionally mandated smoking ban takes effect on all domestic airline flights of 2 hours or less. New York City's ordinance for clean indoor air takes effect; the ordinance bans or severely limits smoking in various public places and affects 7 million people.
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Utah enacts a law restricting smoking in most workplaces. 1995 New York City passes a comprehensive ordinance effectively banning smoking in most workplaces.
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2000 The New Jersey Supreme Court strikes down a local clean-indoor-air ordinance adopted by the city of Princeton on the grounds that state law preempts local smoking restrictions. A congressionally mandated smoking ban takes effect on all international flights departing from or arriving in the United States.
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In 1996, 13 years before the passage of the FSPTCA, the FDA unsuccessfully attempted to assert regulatory authority over tobacco. The FDA argued that tobacco products fell within its purview, claiming that nicotine is a drug, and that cigarettes and smokeless tobacco are combination products that consist of the drug (nicotine)
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Table 1-2 displays significant scientific reports and clean-air policies enacted in the United States since 1971, when the Surgeon General first proposed a federal smoking ban for public spaces (IOM, 2010)
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The IOM recommended that "Congress should enact legislation that delegates to an appropriate agency authority to regulate tobacco products for the dual purposes of discouraging consumption and reducing the morbidity and mortality associated with use of tobacco" (IOM, 1994)
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Among other things, Chapter IX gives the FDA authority to regulate the sale, distribution, labeling, and advertising of tobacco products, to set product standards, and to require reporting and disclosure of tobacco product ingredients and components. SECTION 911 This report provides advice to the FDA on the minimum scientific standards for studies on MRTPs.
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Smokeless tobacco products are not considered an MRTP solely because they use the word smokeless or other similar descriptors; if the smokeless tobacco product sponsor wishes to make additional modified risk claims, then the product must first apply for this claim. A product that is intended for tobacco cessation that is regulated by Chapter V of the FD&C Act cannot be considered an MRTP (for further detail, see Box 1-2)
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MODIFIED RISK TOBACCO PRODUCT- The term "modified risk tobacco product" means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commer cially arketed tobacco products.
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, "Tobacco Dependence Products": A product that is intended to be used for the treatment of tobacco dependence, including smoking cessation, is not a modified risk tobacco product under this section if it has been approved as a drug or device by the Food and Drug A dministration and is subject to the requirements of Chapter V From Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction: The etymology of the term "Potential reduced-exposure products" or "PREP": Many tobacco and cigarette-like products have been introduced in the distant and recent past that do, under measurement systems such as the smoking machine, result in decreased emission of some toxicants compared to conventional prod ucts.
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According to the FSPTCA, the Secretary's actions regarding tobacco products, such as setting product standards or restricting sales of certain products and advertising, must be based on a finding that the action is "appropriate for the protection of public health." In Section 911 the law specifies that the Secretary must take into account the effect of the product on nonusers when evaluating whether to issue an order for the sale of an MRTP.12 The law also requires the Secretary take into account the increased or decreased likelihood of tobacco users quitting and nonusers initiating, and the risks and benefits compared to other smoking cessation products. This public health standard is a significant departure from the standards for drugs and devices.
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Third, orders for the marketing of an MRTP must expire, and manufacturers must reapply for additional orders to allow for the ongoing sale of a product. MRTPs granted orders to market under the Special Rule for Certain Products are given a maximum of 5 years, while the terms of the orders granted under the Modified Risk standard are unspecified by the law.
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The CTP also provided direction about the task to the committee during an open session of the first committee meeting. In a presentation BOX 1-3 Statement of Task The Institute of Medicine will establish a committee of 15 public health and medical experts to advise the Food and Drug Administration on the minimum standards for scientific studies to support the marketing of modified risk tobacco products and for post market studies of approved products.
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Deyton described tasks that he regarded as out side the committee's charge. Specifically, he indicated that he did not expect the committee to • assess the evidence for any particular product; • opine on whether any tobacco product or class of products is a potential candidate for modified risk determination; • offer regulatory principles; • define or recommend a conceptual or regulatory framework for modified risk assessment; and • define terms from the act, such as "reasonably likely" or "measurable and substantial reduction." The statutory mandate and the limits articulated by the sponsor pre sented a challenge to the committee.
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2009. Abuse liability assessment of tobacco products including potential reduced exposure products.
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2006. Biomarkers to assess the utility of potential reduced exposure tobacco products.
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2009. Surveillance methods for iden tifying, characterizing, and monitoring tobacco products: Potential reduced exposure products as an example.
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