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Tobacco Product Importers Would Submit User Fee Information to FDA Under Proposal

Friday, May 31, 2013
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is proposing to require domestic tobacco product manufacturers and importers to submit to the FDA information needed to calculate the amount of user fees assessed under the Federal Food, Drug and Cosmetic Act. The Department of Agriculture has been collecting this information and providing it to the FDA, but USDA intends to cease collecting this information starting in fiscal year 2015 (October 2014). Under this proposal, domestic manufacturers and importers would be required to submit essentially the same information to the FDA that they are currently submitting to the USDA. Comments on this proposed rule are due no later than Aug. 14.

The FDA notes that under this rule failure to pay a user fee or submit the information needed to calculate a user fee would result in the tobacco product being deemed adulterated. Adulterated tobacco products are subject to enforcement action, which may include injunction, seizure and civil money penalties. In addition, any person who knowingly fails to provide required information or provides false information may be subject to criminal penalties.

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