

Comment Info: =================

General Comment:June 23, 2014

Mr. Mitch Zeller
Director, Center for Tobacco Products
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD  20850

Re:  FDA-2014-N-0189 Request for Extension of Comment Period

Dear Director Zeller:

The International Premium Cigar & Pipe Retailers Association (IPCPR) writes in response to the April 25, 2014, Notice of Proposed Rulemaking (NPRM) on the deeming of tobacco products under the Family Smoking Prevention and Tobacco Control Act.  The NPRM states that the Food and Drug Administration (FDA) will accept comments, data, research, and other information in response to the NPRM for a period of 75 days.  While we applaud FDA for recently extending the comment period an additional 30 days, we respectfully request that FDA extend this comment period again by an additional 45 days.  We base our request on the following considerations.

FDA is charged with addressing public health issues raised by tobacco products through a science-based approach.  The Agency has spent several years evaluating the regulation of tobacco products not included in the original Tobacco Control Act, illustrating the complexity of the questions on this topic.  FDA now proposes to permit the public, including the regulated industry, only 105 days to provide substantive comments on both the NPRM and the underlying FDA scientific evaluation.  Previous public comment periods for Agency rulemakings have lasted for as many as 180 days.

In addition to the scientific complexity of the issue, the NPRM proposes a regulatory structure that would have significant bearing on a wide range of affected parties.  As FDA has previously acknowledged, the NPRM would have an impact on international trade and investment and small businesses across America.  Furthermore, FDA has previously received communications from foreign governments and directives from the U.S. Congress on the issue.  Those entities, as well as ours, should be afforded a reasonable period of time to quantify the impacts of the NPRM and then communicate assessments to the Agency.

Accordingly, we ask the Agency to provide the public with additional time to provide scientific and evidence-based responses to inform FDA’s future decision making.  We appreciate your consideration of our request.

Sincerely,

 
Finnie P. Helmuth, President

