The Harm Reduction Opportunity
New and Modified Risk Tobacco Products
Sections 910 and 911 of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), which was enacted with overwhelming bipartisan support in 2009, gives the U.S. Food and Drug Administration (FDA) a powerful tool to improve public health. The statute ensures that new tobacco products are reviewed and issued a marketing order by FDA prior to being marketed to consumers (Section 910). Further, the statute also ensures that tobacco products intended to be marketed with claims of reduced exposure to the harmful substances in tobacco smoke or claims of reduced risk of causing tobacco-related disease (Section 911) will actually reduce exposure or risk of disease. Such new or modified risk tobacco products (MRTPs) must benefit not only individual smokers, but the health of the population as a whole.
What is a New Tobacco Product?
A New Tobacco Product is any product that was not commercially marketed in the United States as of February 15, 2007, a date established by the statute. With limited exceptions, New Tobacco Products may not be legally marketed in the United States unless FDA has issued an order permitting their marketing. To issue an order, FDA must evaluate the product based on a public health standard that considers the risks and benefits of the product on the population as a whole, including tobacco product users as well as non-users. When seeking authorization of any new tobacco product, manufacturers must submit a premarket tobacco application (PMTA). FDA will evaluate the application to determine whether the product is appropriate for the protection of public health. FDA will consider the risks and benefits, including the relative health risks of the product and the likelihood of changes in tobacco initiation and cessation rates. These considerations will allow for an evaluation of the impact of the new tobacco product on morbidity and mortality for the population as a whole. Section 910(c)(1) of the Tobacco Control Act requires that FDA issue an order stating whether the product may be introduced into interstate commerce “[a]s promptly as possible, but in no event later than 180 days after the receipt of an application.”
What is a Modified Risk Tobacco Product?
A Modified Risk Tobacco product (MRTP) is a tobacco product that may be sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. Aspects of MRTP marketing may communicate to consumers, among other things, that the product:
- is less harmful or presents a lower risk of tobacco-related disease than other commercially marketed tobacco products, or
- reduces exposure to a harmful substance, or does not contain or is free of a harmful substance.
Tobacco products cannot be marketed with modified risk claims without a written order from FDA. FDA’s review of MRTP applications aims to ensure that marketing and claims about the risks of tobacco products are substantiated and supported by scientific evidence, and that advertising and labeling help the public understand these claims in relation to overall health. FDA must also consider the potential impacts, such as the likelihood that users who would have otherwise quit tobacco use will instead switch to the MRTPs or use MRTPs along with other tobacco products, or the likelihood that non-users of tobacco products will start using an MRTP.
In addition to rigorous scientific review, MRTP applications have other, unique requirements. For example, FDA is required to make MRTP applications available for public comment before an FDA action. FDA must also refer MRTP applications to the Tobacco Products Scientific Advisory Committee (TPSAC), which provides advice to FDA. While advice from TPSAC is not binding, FDA considers it along with other relevant information (including public comments) when making a final decision. The TPSAC consists of representatives from public health and non-voting members of the industry.
FDA can issue an order authorizing the marketing of a product only if the evidence submitted in the application meets the requirements of Section 911. FDA said that it intends to issue a decision on an MRTP application within 360 days of its receipt of a complete application.
An FDA order permitting marketing of an MRTP is not permanent; it is for a fixed period of time that will be specified in the order. To continue to market a modified risk tobacco product after the set term, a company would need to seek renewal of the order and FDA would need to determine that the findings continue to be satisfied. In addition, companies will be required to conduct postmarket surveillance and studies and submit the results to FDA annually. FDA will review these results and collect further information about the product’s use and health risks. If, at any time, FDA determines based on new information that the applicant can no longer demonstrate that the requirements for an order are satisfied or FDA can no longer make the determinations required for an MRTP order, FDA is required to withdraw the order.
PMI submitted modified risk tobacco product applications (MRTPA) to FDA in December 2016 and premarket tobacco product applications (PMTA) in 2017 to obtain an order permitting marketing of its heat-not-burn tobacco product, IQOS tobacco heating system, as a Modified Risk Tobacco Product as well as a New Tobacco Product. FDA has not, however, granted a marketing order to PMI for an MRTP or determined the data to be sufficient to prove the product reduces the risk.
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