22nd Century Group Inc (XXII)

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FDA Issues Proposed Rule to Require New Cigarette Health Warnings
https://www.fda.gov/news-events/press-announcements/fda-proposes-new-required-health-warnings-color-images-cigarette-packages-and-advertisements-promote?utm_source=Eloqua&utm_medium=email&utm_term=stratcomms&utm_content=pressrelease&utm_campaign=CTP%20News%26Connect%26SOS%3A%20CHW%20-%2081419

The warnings would be required to appear on packages and in advertisements 15 months after a final rule is issued.

The proposed rule will be open for public comments for 60 days through Oct. 15. Among other things, the FDA is seeking comments on the proposed cigarette health warnings and how many warnings should be selected for the final rule. Given the degree of public and stakeholder interest in this area, the FDA is also seeking proposals for alternative text and images, as well as scientific information to support a finding that the alternative text and images would advance the government interest in promoting greater public understanding of the negative health consequences of smoking.

In addition to the newly proposed cigarette health warnings, the FDA also continues to move forward on a number of separate measures to protect kids and significantly reduce tobacco-related disease and death as part of the agency’s comprehensive plan for tobacco and nicotine regulation.

If this will take ~15 months... we might be looking at 2 years for the change to VLN... FDA appears to hint at NPRM for nicotine coming in October...