Timeframe on FDA Proposed Tobacco Product Regulations

Published in Tobacco E-News

By  Thomas A. Briant, Executive Director

In the Jan. 8, 2013, Tobacco E-News bulletin, NATO reported that the Food and Drug Administration had released its annual Regulatory Agenda, which states that the agency intends to issue a proposed rule to regulate other tobacco products sometime by April of 2013. While the FDA stated its intention to release proposed regulations on other tobacco products by April of this year, there are various steps that a federal agency needs to follow in drafting, proposing, obtaining public feedback and finalizing a new regulation.

Accompanying this article is a chart that shows the various steps that a federal agency needs to follow when considering, drafting, publishing, allowing public input, and adopting a new rule involving government regulations. Once a notice of proposed rulemaking is published by a federal agency under Step 5 on the chart, then under Step 6 the public has 60 days to file comments about the proposed regulations. In Step 7, the federal agency reviews comments and may make changes to the proposed rule based on the comments. When Step 9 is reached, a federal agency will publish the final rule in the Federal Register to finalize the rulemaking process.

This means that when the FDA releases its proposed regulations on other tobacco products, the public will have 60 days to submit comments and make recommendations on the proposed rules. Then, the FDA will review all public comments and determine whether any changes should be made to the proposed regulations prior to issuing the regulations in a final form.