The Family Smoking Prevention and Tobacco Control Act of 2009 (FSPTCA)1 grants the Food and Drug Administration (FDA) broad authority to regulate the manufacturing, distribution, and marketing of tobacco products, including “modified risk tobacco products” (MRTPs). Generally, an MRTP is defined by the law as any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease.

Under the FSPTCA, no MRTP may be marketed without an order for sale from the U.S. Department of Health and Human Services (HHS). To be marketed, the product must meet one of two public health standards: either (1) an empirically demonstrated Modified Risk claim or (2) a Special Rule for Certain Products claim, specifying a reduced-exposure product.

To meet the Modified Risk standard, the applicant must prove with scientific evidence that the product, as actually used by consumers, will (1) significantly reduce harm and the risk of tobacco-related disease to individual users and (2) benefit the health of the population as a whole, taking into account both users and nonusers of the product.

Under the Special Rule for Certain Products, the Secretary of HHS may issue an order for the sale of a reduced-exposure product for which there is inadequate long-term epidemiologic data to support a finding under the Modified Risk standard but where the available evidence demonstrates that a substantial reduction in morbidity and mortality is “reasonably likely.”

In regard to both standards, the law further specifies that the Secretary should also take into account how the marketing of the MRTP affects the likelihood of current users continuing tobacco product use with an MRTP who otherwise would have quit, nonusers initiating tobacco use with an MRTP, and the risks and benefits compared to other smoking-cessation products.

The concept of harm reduction informs the public health rationale for permitting the development and potential marketing of modified risk tobacco products. The basic premise of harm reduction is the continuation of a potentially hazardous or dangerous behavior, with the aim of decreasing the potentially adverse consequences of these behaviors (Marlatt, 2002). In the context of tobacco harm reduction, “a product is harm reducing if it lowers total tobacco-related morbidity and mortality, even though use of that product may involve continued exposure to tobacco-related toxicants” (IOM, 2001).


1 Family Smoking Prevention and Tobacco Control Act of 2009, Public Law 111-31, 123 Stat. 1776 (June 22, 2009).

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