After regulators worry that tobacco products sold using words such as "light" or "mild" may leave consumers with the impression that the product poses a lower health risk than other tobacco products, "improved risk tobacco products "The word appeared.

Therefore, the Family Smoking Prevention and Tobacco Control Act, which was enacted into law in 2009, makes it illegal to sell tobacco products as low-risk products unless the Food and Drug Administration (FDA) authorizes such a designation.

Under the Family Smoking Prevention and Tobacco Control Act, the FDA has created an application procedure for manufacturers to seek authorization to sell their products as low-risk alternatives as specified by the FDA. To obtain the designation of a modified risk tobacco product (MRTP), the manufacturer must certify to the FDA that the product "will or is expected to benefit the health of the entire U.S. population."

In other words, after considering the entire user and non-user population of the product, is the product beneficial to public health?

Manufacturers must apply for each product they wish to designate as MRTP; that is, they cannot submit one application for a whole class of products. After submitting an application to the FDA, the application will be publicly solicited for comments and submitted to the FDA's Tobacco Products Scientific Advisory Committee, which conducts rigorous scientific analysis of the manufacturer's statement and the scientific data supporting the statement.

When submitting an MRTP application, the manufacturer needs to provide the FDA with a large amount of detailed information about each product, including:

The FDA will authorize the product as an "modified risk tobacco product" only when it is determined that the product will or is expected to benefit the health of the entire population at the end of the FDA's detailed review of the information. If the application is authorized, the manufacturer will be instructed to conduct certain studies to determine how the revised risk authorization order affects consumer perception, behavior, and health, so that the FDA can review whether the basis for approving the MRTP application is correct.

MRTP specifies that it will only be granted within a fixed period of time. In order to continue to market the product as an MRTP after this time, the manufacturer must submit a new application to the FDA to prove that it still meets the requirements for MRTP authorization.

So far, the FDA has authorized 12 products to be sold as MRTP. The first batch of products authorized to use the MRTP name are eight general snuff products produced by Sweden Match Inc. (in bulk; dried mint part original mini, part original large, classic mixed part white large -12 ct, mint part white large, part white Tuba and holly part (white Tuba). These authorizations were issued on October 22, 2019 and are valid for five years. Swedish Match may issue the following statement on these products: "Using normal snuff instead of cigarettes can reduce the risk of oral cancer, heart disease, lung cancer, stroke, lung gas Swelling and chronic bronchitis."

On July 7, 2020, the FDA approved four products produced by Philip Morris Products SA, namely the IQOS system stand and charger, and three heating rods for the system: Marlboro heating rods, Marlboro smooth mint heating rods and Marlboro Fresh Peppermint heating rod. Although the FDA found that these products were modified risk tobacco products, at the time it denied the marketing of products with reduced risk statements, but authorized them to market for four years with this reduced exposure statement:

Currently, the FDA is reviewing three MRTP applications: March 31, 2017, RJ Reynolds Tobacco Co. applied for Camel Snus Frost; March 20, 2018, US Smokeless Tobacco Company applied for Copenhagen Snuff Fine Cut; July 19, 2019 On Japan, 22nd Century Group Corporation applied for two cigarette products, VLN King and VLN Menthol King. The public comment period for these products will expire in 2020, which shows how long the MRTP application process can last.

Thomas Briant is the executive director of the National Association of Tobacco Specialty Stores (NATO). NATO’s mission is to increase the commercial interests of retailers selling tobacco products, support the legislative and regulatory interests of members, and encourage the expansion of the retail tobacco sector in a responsible manner. You can reach him at [email protected].

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