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 U.S. Food and Drug Administration 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]

As of August 2018, the FDA has accepted no applications for MRTP status and denied 18 applications. All applications for MRTP status to date have been for snus products, except for a single application for a heat-not-burn tobacco product (Philip Morris' iQOS).[3]

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 FDA.[4] On June 11, the 135,000-page MRTP application was submitted electronically to the FDA in compliance with formatting and data requirements.[5]

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 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 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.[4] In December 2016, the FDA rejected Swedish Match's application on the grounds that its snus were not actually safer than other smokeless tobacco products or cigarettes.[6]

The 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.[3]

Public FDA scientific advisory committee meetings

At the conclusion of public meetings hosted by the 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.[7] 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.[8]

See also

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 & Drug Administration. Retrieved 19 May 2015.
  3. 1 2 "Modified Risk Tobacco Products". U.S. Food and Drug Administration. January 22, 2018. Retrieved 27 April 2018.
  4. 1 2 Tavernise, Sabrina. "Swedish Company Asks F.D.A. to Remove Warnings From Smokeless Tobacco Product". The New York Times. Retrieved 19 May 2015.
  5. ↑ "US FDA Tobacco Submissions". GlobalSubmit. Retrieved 27 August 2015.
  6. ↑ 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.
  7. ↑ Tavernise, Sabrina. "Milder Warning Opposed for Swedish Tobacco Item". The New York Times. Retrieved 19 May 2015.
  8. ↑ Page, Barnaby (January 25, 2018). "FDA committee rejects two IQOS MRTP claims, approves one". ECig Intelligence. Retrieved 27 April 2018.
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