Modified risk tobacco product

A modified risk tobacco product (MRTP) is a legal designation in the United States for a tobacco product that poses lower health risks to individual users and the population as a whole when compared to existing products on the market such as cigarettes (see health effects of tobacco).[1] The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration (FDA) broad authority to regulate tobacco products; the FDA's power extends to approving or rejecting MRTP applications.

Without approval from the FDA's Center for Tobacco Products, a tobacco company may not legally make reduced risk claims or change warning label statements.[2]

General Snus from Swedish Match became the first FDA-approved MRTP in October 2019; the designation is valid for five years.[3] In December 2021, the U.S. Food and Drug Administration (FDA) authorized the marketing of 22nd Century Group Inc.'s "VLN King" and "VLN Menthol King" combusted, filtered cigarettes as modified risk tobacco products (MRTPs), which help reduce exposure to, and consumption of, nicotine for smokers who use them.[4] These are the first combusted cigarettes to be authorized as MRTPs and the second tobacco products overall to receive "exposure modification" orders, which allows them to be marketed as having a reduced level of, or presenting a reduced exposure to, a substance.[4]

Applications accepted for review

An MRTP application submitted by smokeless tobacco maker Swedish Match in 2014 was the first ever accepted for review by the US FDA.[5] On June 11, the 135,000-page MRTP application was submitted electronically to the FDA in compliance with formatting and data requirements.[6]

Swedish Match sought approval to remove warnings about mouth cancer, gum disease, and tooth loss from packaging of eight of its General Snus products. The company also asked the US FDA to strike a statement reading "this product is not a safe alternative to cigarettes" as required by the Family Smoking Prevention and Tobacco Control Act. The company asked the US FDA to replace the statement with language acknowledging the harmful nature of all tobacco products and the reduced risk profile of Swedish snus by comparison.[5] In December 2016, the FDA initially rejected Swedish Match's application on the grounds that its snus were not actually safer than other smokeless tobacco products or cigarettes.[7] In October 2019, FDA finally approved the MRTP request for the product.[3]

The US FDA has also accepted applications from the R. J. Reynolds Tobacco Company for removing warnings from its Camel Snus product and from Philip Morris International for permission to market its heat-not-burn tobacco product iQOS as safer than a traditional cigarette.[8] iQOS was ultimately approved for sale in the United States using pre-market tobacco application method on April 30, 2019, which subjected it to marketing restrictions.[9]

The FDA, on December 23, 2021, approved an MRTP application from 22nd Century Group for their VLN King and VLN Menthol King very low nicotine cigarettes (VLNC). These cigarettes have up to 96% less nicotine than conventional cigarettes and help reduce exposure to, and consumption of, nicotine for smokers who use them. These are the first combusted cigarettes to be authorized as MRTPs and the second tobacco products overall to receive "exposure modification" orders, which allows them to be marketed as having a reduced level of, or presenting a reduced exposure to, a substance.[10]

Public FDA scientific advisory committee meetings

At the conclusion of public meetings hosted by the US FDA on April 9–10, 2015, the Tobacco Products Scientific Advisory Committee (TPSAC) voted against recommending a labeling change that would give Swedish Match's snus product a modified risk designation. The committee tied 4–4 in a yes or no vote when asked whether the snus product demonstrated substantially lower risk compared to cigarettes.[11] The panel's recommendations are not legally binding.

On January 25, 2018, the TPSAC rejected Philip Morris' claims that its iQOS heat-not-burn tobacco product was safer than a traditional cigarette. The committee voted 8–0 with one abstention to reject Philip Morris' claim that switching from cigarettes to iQOS can reduce the risks of tobacco-related disease and 5–4 to reject its claim that iQOS is less harmful than a traditional cigarette. However, it voted 8–1 to approve Philip Morris' claim that iQOS contains fewer harmful chemicals than a traditional cigarette.[12]

References
  1. "Modified Risk Tobacco Products - U.S. Food and Drug Administration". Tobacco Products.
  2. "Family Smoking Prevention and Tobacco Control Act". U.S. Food and Drug Administration (FDA). Retrieved May 19, 2015.
  3. "FDA grants first-ever modified risk orders to eight smokeless tobacco products". U.S. Food and Drug Administration (FDA). October 22, 2019. Retrieved May 6, 2020.
  4. "FDA Authorizes Marketing of Tobacco Products that Help Reduce Exposure to and Consumption of Nicotine for Smokers Who Use Them". U.S. Food and Drug Administration (FDA) (Press release). December 23, 2021. Retrieved December 26, 2021. This article incorporates text from this source, which is in the public domain.
  5. Tavernise, Sabrina (April 8, 2015). "Swedish Company Asks F.D.A. to Remove Warnings From Smokeless Tobacco Product". The New York Times. Retrieved May 19, 2015.
  6. "US FDA Tobacco Submissions". GlobalSubmit. Retrieved August 27, 2015.
  7. Choiniere, Conrad (December 14, 2016). Modified Risk Tobacco Product (MRTP) Application Technical Project Lead (TPL) Review (PDF) (Technical report). FDA Center for Tobacco Products. MR0000020 -MR0000022, MR0000024-MR0000025, MR0000027-MR0000029.
  8. "Modified Risk Tobacco Products". U.S. Food and Drug Administration. January 22, 2018. Retrieved April 27, 2018.
  9. "FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway". Food and Drug Administration. April 30, 2019.
  10. Commissioner, Office of the (December 23, 2021). "FDA Authorizes Marketing of Tobacco Products that Help Reduce Exposure to and Consumption of Nicotine for Smokers Who Use Them". FDA. Retrieved December 25, 2021.
  11. Tavernise, Sabrina (April 11, 2015). "Milder Warning Opposed for Swedish Tobacco Item". The New York Times. Retrieved May 19, 2015.
  12. Page, Barnaby (January 25, 2018). "FDA committee rejects two IQOS MRTP claims, approves one". ECig Intelligence. Retrieved April 27, 2018.
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