August 21, 2014

Next Steps in the Tobacco Deeming Regulation Process


Proposed regulations won’t go into effect for at least a year

By  Thomas A. Briant, Executive Director

MINNEAPOLIS — The U.S. Food and Drug Administration allowed the public to submit comments in response to the agency’s proposed tobacco deeming regulations until August 8th. The FDA issued the deeming regulations on April 24, 2014.  When the comment period closed earlier this month, almost 82,000 individual comments had been submitted on-line in response to the deeming regulations.  So, what happens next?


Then, in Step 8, the FDA submits the revised regulations to the White House Office of Management and Budget (OMB), which will conduct a final review of the regulations from an economic impact perspective. There is no set timetable or deadline that the OMB must abide by in conducting a final review of the tobacco deeming regulations. If the OMB approves the final deeming regulations, then in Step 9 the FDA issues the final regulations and sets a date that the regulations will actually take effect.  

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