Modified-risk requests made

| December 19, 2017

The US Food and Drug Administration on Monday filed for substantive scientific review six modified-risk-tobacco-product (MRTP) applications submitted by R.J. Reynolds Tobacco Company in respect of Camel Snus products.

Through its Center for Tobacco Products, the FDA said it was making these applications available for public comment in accordance with applicable laws. ‘Due to the large size of these applications, FDA will post application materials on the Center for Tobacco Products’ website on a rolling basis,’ it said.

‘There is currently a 180-day public comment period, which we plan to extend, if necessary, to provide additional time for comment as further materials are received and posted.

‘The public may comment on any part of the application, including amendments, until the docket is closed, which FDA will announce separately and will be no sooner than 30 days after the last application document is posted. FDA is committed to giving the public meaningful time and opportunity to comment on these applications and will provide more than 30 days for comment in the event the final documents posted are complex or extensive.

‘Currently, FDA has posted the applicant’s executive summary and the following seven application modules:

  • Module 1: Cover Letters
  • Module 2: Table of Contents, Glossary, Summary & References
  • Module 3: Descriptive Information for Camel Snus Smokeless Tobacco Products
  • Module 4: Labels, Labeling and Advertising
  • Module 5: Environmental Assessments
  • Module 8: Foreign Language Certification
  • Module 9: Proposed Post-market Surveillance Program for Camel Snus Products Under a Modified Risk Tobacco Product Order.

‘The agency will issue subsequent communications when additional application documents are made public.’

The MRPTs have been made in respect of Camel Snus Frost, Camel Snus Frost Large, Camel Snus Mellow, Camel Snus Mint, Camel Snus Robust, and Camel Snus Winterchill.

Starting today, public comments on these applications may be submitted to docket FDA-2017-N-4678 on regulations.gov.

The applications are at: https://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm564399.htm?utm_source=Eloqua&utm_medium=email&utm_term=stratcomms&utm_content=mrtp&utm_campaign=CTP%20News%3A%20RJR%20MRTP%20-%20121817.

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Category: Breaking News, Harm reduction, OTP

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