FDA Now Collects Data for Tobacco User Fee Calculations

By: Bryan Walsh

The Family Smoking Prevention and Tobacco Control Act (FSPTCA) granted FDA the authority to regulate tobacco products and to collect user fees from tobacco manufacturers and importers to support FDA tobacco regulation activities. These fees provide the FDA with resources for building a regulation framework to reduce the impact of tobacco use on the nation’s health.

Bryan WalshOn July 10, 2014, FDA issued a final rule that changed some administrative aspects of the tobacco product user fee process. In the past, U.S. Department of Agriculture (USDA), under a separate tobacco assessment program, collected information from tobacco product manufacturers and importers and shared that information with FDA. FDA then used that information to calculate tobacco product user fees. However, the USDA program ended in September 2014, and FDA’s authority to collect the information directly from tobacco product manufacturers and importers began on October 1, 2014.

This change does not have a large impact on tobacco manufacturers and importers. The July rule applies only to domestic manufacturers and importers of four classes of tobacco products – cigarettes, snuff, chewing tobacco, and roll-your-own tobacco. They will submit essentially the same information to FDA as they did to USDA. The new Form FDA 3852 is very similar to the form manufacturers and importers have been sending to USDA. Thus, the new rule does not add additional administrative burdens to required data submissions.

The rule also addresses other issues related to tobacco product user fees. For example, it advises how manufacturers and importers might submit a dispute, explains FDA notification procedures and how to pay user fee assessments, and describes penalties for failure to report information or pay user fees.

The final rule will help ensure that FDA continues to have the information needed to assess and collect tobacco product user fees. You can find more information on our User Fees page, including the form FDA 3852 (which includes submission information).

If you are interested in learning more about user fees, please join us for a webinar on Nov. 5, 2014 at 2 p.m. EST.

Bryan Walsh is a Program Analyst, Office of Management, at FDA’s Center for Tobacco Products

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