What Are Modified Risk Tobacco Products?
The term modified risk tobacco products came onto the scene after regulators became concerned that tobacco products marketed using words like light or mild might give consumers the impression that the products posed less of a health risk than other tobacco products. Consequently, the Family Smoking Prevention and Tobacco Control Act, enacted into law in 2009, made it illegal for tobacco products to be marketed as lower risk products unless the Food and Drug Administration (FDA) authorized such a designation. Based on the Family Smoking Prevention and Tobacco Control Act, the FDA created an application process for manufacturers to seek authorization to market their product as lower-risk alternatives as prescribed by the FDA. Seeking MRTP Status  Manufacturers must apply for each product they wish to have designated as a MRTP; that is, they cannot submit one application for an entire class of products. After it is filed with the agency, the application is made available for public comment and referred to the FDAs Tobacco Product Scientific Advisory Committee, which undertakes a rigorous scientific analysis of the manufacturers claims and the scientific data provided to support that claim. When filing a MRTP application, manufacturers are required to provide the FDA with a great deal of detailed information regarding each product, including:  The relative health risks to individuals who would use the product. The likelihood that existing users of tobacco products will switch to the product rather than quit altogether or that persons who do not use tobacco products will use the product. The risks and benefits to persons from the use of the product compared to approved smoking cessation products. The FDA will only authorize a product as a modified risk tobacco product if, at the end of the agencys detailed review of this information, a determination is made that the product will or is expected to benefit the health of the entire population. If the application is authorized, the manufacturer is directed to conduct certain studies to determine how the modified risk authorization order impacts consumer perception, behavior and health, giving the FDA the ability to review whether the basis for its grant of the MRTP application was correct. MRTP designations are only granted for fixed time periods. To continue marketing the product as a MRTP beyond that time, the manufacturer must submit a new application to the FDA that shows it still satisfies the requirements of MRTP authorization. Thus far, the FDA has authorized 12 products to be marketed as MRTPs. The first products to be authorized to use the MRTP designation were eight General Snus products manufactured by Swedish Match Inc. (Loose; Dry Mint Portion Original Mini, Portion Original Large, Classic Blend Portion White Large-12 ct, Mint Portion White Large, Portion White Large and Wintergreen Portion White Large). These authorizations were issued on Oct. 22, 2019, and are in effect for five years, and Swedish Match may make the following statement about these products: Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.  On July 7, 2020, the FDA authorized four products manufactured by Philip Morris Products S.A., namely the IQOS system holder and charger and three heatsticks for use with that system: Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks. Although the FDA found the products to be modified risk tobacco products, it denied the marketing of the products with reduced risk claims at that time, but authorized their marketing for four years with this reduced exposure claim:  Available Evidence to Date:  The IQOS system heats tobacco but does not burn it. This significantly reduces the production of harmful and potentially harmful chemicals. Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your bodys exposure to harmful or potentially harmful chemicals. Currently, FDA is reviewing three MRTP applications: On March 31, 2017, R. J. Reynolds Tobacco Co. applied for Camel Snus Frost; on March 20, 2018, U.S. Smokeless Tobacco Company applied for Copenhagen Snuff Fine Cut; and on July 19, 2019, 22nd Century Group Inc. applied for two cigarette products, VLN King and VLN Menthol King. The public comment period on each of these products expired in 2020, demonstrating how long the MRTP application process can be. Thomas Briant is the executive director for the National Association of Tobacco Outlets (NATO). NATOs mission is to enhance the business interests of retailers that sell tobacco products, support the legislative and regulatory interests of members and encourage the expansion of the retail tobacco segment in a responsible manner. He can be reached at [email protected].