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?
While the FDA already regulates cigarettes, roll-your-own cigarette tobacco, and smokeless tobacco products, the tobacco deeming regulations propose to extend the FDA’s regulatory authority to cigars, pipe tobacco, electronic cigarettes, hookah tobacco, nicotine gels and dissolvables. However, even though the public comment period has expired, the proposed deeming regulations will not go into effect immediately.
Federal government agencies use a nine-step process in developing new regulations. The FDA’s public comment period was Step 6. Now, in Step 7, the FDA will review all of the comments and decide whether to draft additional regulations or change any of the proposed regulations. The law requires the FDA to review each of the submitted comments and it may take up to a year. However, as a result of the comment review process, if the FDA wants to add new regulations that were not included in the original deeming regulations issued this past April, then the FDA needs to begin a rulemaking process for any new regulations in order to allow the public time to submit comments on the additional regulations.
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.
In other words, the proposed tobacco deeming regulations are not in effect and will not become effective for an estimated 12 to 18 months because of these steps the FDA must follow in finalizing the deeming regulations. For retailers, this means that there will be no new federal tobacco regulations on cigars, pipe tobacco, e-cigarettes, hookah tobacco, nicotine gels, and dissolvables for the foreseeable future.