View source for Modified risk tobacco product

{{Short description|United States legal designation}}
{{Use mdy dates|date=December 2021}}
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 [[Public health|population as a whole]] when compared to existing products on the market such as [[cigarettes]] (see [[health effects of tobacco]]).<ref>{{cite web|title=Modified Risk Tobacco Products - U.S. Food and Drug Administration|url=https://www.fda.gov/TobaccoProducts/Labeling/TobaccoProductReviewEvaluation/ucm304465.htm|website=Tobacco Products}}</ref> 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.<ref>{{cite web|title=Family Smoking Prevention and Tobacco Control Act|url=https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm237092.htm|publisher=U.S. [[Food and Drug Administration]] (FDA)|accessdate=May 19, 2015}}</ref>

General [[Snus]] from [[Swedish Match]] became the first FDA-approved MRTP in October 2019; the designation is valid for five years.<ref name=generalsnus>{{Cite web|title=FDA grants first-ever modified risk orders to eight smokeless tobacco products|url=https://www.fda.gov/news-events/press-announcements/fda-grants-first-ever-modified-risk-orders-eight-smokeless-tobacco-products|date=October 22, 2019|website=U.S. [[Food and Drug Administration]] (FDA)|access-date=May 6, 2020}}</ref> 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.<ref name="FDA PR 20211223" /> 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.<ref name="FDA PR 20211223">{{cite press release | title=FDA Authorizes Marketing of Tobacco Products that Help Reduce Exposure to and Consumption of Nicotine for Smokers Who Use Them | website=U.S. [[Food and Drug Administration]] (FDA) | date=December 23, 2021 | url=https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-tobacco-products-help-reduce-exposure-and-consumption-nicotine-smokers-who | access-date=December 26, 2021}} {{PD-notice}}</ref>

== 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.<ref name="Tavernise 2015">{{cite news|last1=Tavernise|first1=Sabrina|title=Swedish Company Asks F.D.A. to Remove Warnings From Smokeless Tobacco Product|url=https://www.nytimes.com/2015/04/09/health/swedish-company-asks-fda-to-remove-warnings-from-smokeless-tobacco-product.html|website=The New York Times|date=April 8, 2015|accessdate=May 19, 2015}}</ref> On June 11, the 135,000-page MRTP application was submitted electronically to the FDA in compliance with formatting and data requirements.<ref>{{cite web|title=US FDA Tobacco Submissions|url=http://www.globalsubmit.com/Services/Tobacco-Submissions|website=GlobalSubmit|accessdate=August 27, 2015}}</ref>

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.<ref name ="Tavernise 2015"/> 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.<ref>{{cite techreport |first=Conrad |last=Choiniere |title=Modified Risk Tobacco Product (MRTP) Application Technical Project Lead (TPL) Review |number=MR0000020 -MR0000022, MR0000024-MR0000025, MR0000027-MR0000029 |institution=FDA Center for Tobacco Products |url=https://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM533233.pdf |date=December 14, 2016 }}</ref> In October 2019, FDA finally approved the MRTP request for the product.<ref name=generalsnus />

The US FDA has also accepted applications from the [[R. J. Reynolds Tobacco Company]] for removing warnings from its [[Camel (cigarette)|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.<ref name="table2">{{cite web|title=Modified Risk Tobacco Products|url=https://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm304465.htm#2|date=January 22, 2018|publisher=U.S. Food and Drug Administration|accessdate=April 27, 2018}}</ref> 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.<ref name=FDAIQOS>{{cite news|url=https://www.fda.gov/news-events/press-announcements/fda-permits-sale-iqos-tobacco-heating-system-through-premarket-tobacco-product-application-pathway|title=FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway|publisher=Food and Drug Administration|date=April 30, 2019}}</ref>

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.<ref>{{Cite web|last=Commissioner|first=Office of the|date=December 23, 2021|title=FDA Authorizes Marketing of Tobacco Products that Help Reduce Exposure to and Consumption of Nicotine for Smokers Who Use Them|url=https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-tobacco-products-help-reduce-exposure-and-consumption-nicotine-smokers-who|access-date=December 25, 2021|website=FDA|language=en}}</ref>

== 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.<ref name=NYT>{{cite news|last1=Tavernise|first1=Sabrina|title=Milder Warning Opposed for Swedish Tobacco Item|url=https://www.nytimes.com/2015/04/11/science/milder-warning-opposed-for-swedish-tobacco-item.html|website=The New York Times|date=April 11, 2015|accessdate=May 19, 2015}}</ref> The panel's recommendations are not legally binding.

On January 25, 2018, the TPSAC rejected Philip Morris' claims that its iQOS [[Heat-not-burn product|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.<ref>{{cite news|last1=Page|first1=Barnaby|title=FDA committee rejects two IQOS MRTP claims, approves one|url=https://ecigintelligence.com/fda-committee-rejects-two-iqos-mrtp-claims-approves-one/|accessdate=April 27, 2018|work=ECig Intelligence|date=January 25, 2018}}</ref>

== References ==
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{{DEFAULTSORT:Modified Risk Tobacco Product}}
[[Category:Food and Drug Administration]]
[[Category:Tobacco control]]
[[Category:Tobacco in the United States]]