Modified risk tobacco product

A Modified Risk Tobacco Product (MRTP) poses lower health risks to individual users and the population as a whole when compared to existing products on the market such as cigarettes.[1] The Family Smoking Prevention and Tobacco Control Act, signed into law in 2009, gave the U.S. Food & Drug Administration broad authority to regulate tobacco products, including approval or rejection of MRTP applications.

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

First application 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.[3] On June 11, the 135,000-page MRTP application was submitted electronically to the FDA in compliance with formatting and data requirements.[4]

The application cites historical data and various studies to support the modified risk claim.[5]

Swedish Match is seeking approval to remove warnings about mouth cancer, gum disease, and tooth loss from its product packaging. 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 is asking 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.[3]

Public FDA scientific advisory committee meeting

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.[6] The panel's recommendations are not legally binding.

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 Tavernise, Sabrina. "Swedish Company Asks F.D.A. to Remove Warnings From Smokeless Tobacco Product". The New York Times. Retrieved 19 May 2015.
  4. ↑ "US FDA Tobacco Submissions". GlobalSubmit. Retrieved 27 August 2015.
  5. ↑ Clarke, Toni. "Swedish Match gears up for closely watched FDA panel meeting". Reuters. Retrieved 19 May 2015.
  6. ↑ Tavernise, Sabrina. "Milder Warning Opposed for Swedish Tobacco Item". The New York Times. Retrieved 19 May 2015.
This article is issued from Wikipedia - version of the Friday, February 19, 2016. The text is available under the Creative Commons Attribution/Share Alike but additional terms may apply for the media files.