October 20, 2017
Authored and Edited by Jeffrey D. Smyth; Thomas L. Irving
On October 18, 2017, FDA released revised Guidance for Industry on Listing Ingredients in Tobacco Products. The Guidance is directed to manufacturers and importers of tobacco products and provides information on submitting tobacco product ingredient information to FDA. The Guidance outlines statutory requirements, and explains who must submit information, and what, how and when to submit it.
The Tobacco Control Act establishes requirements for tobacco product ingredient submissions. Certain products, including cigarettes and smokeless tobacco, have been covered by FDA’s regulations since 2009. On August 8, 2016, FDA’s “Deeming Rule” became effective and expanded FDA’s tobacco product authority to include all products meeting the statutory definition of a tobacco product (except for certain accessories). Manufacturers and importers of newly covered products (under the Deeming Rule) are now required to comply with the ingredient submission regulations. Failure to comply can trigger an FDA enforcement action, including seizure of and/or injunction on noncompliant products.
Who Must Comply: For domestic tobacco products, the domestic manufacturer is responsible for ensuring compliance with the ingredient listing regulations. For imported products, either the foreign manufacturer or the product importer can submit the information and they should coordinate to ensure that at least one of them does so.
What Information to Submit: The name and address of each tobacco manufacturer/importer is required. The Guidance describes the specific types of ingredient information required for different categories of ingredients. Ingredient lists must be submitted for each product that differs in any way from other products (other than packaging differences that do not affect the product). Additional identifiers (e.g., SKU, UPC) should be included as needed to uniquely identify the product.
How to Submit: FDA strongly encourages electronic submission of ingredient information. Although not preferred, FDA also provides a mechanism for paper submissions.
When to Submit: For cigarettes first marketed after June 22, 2009, ingredient lists are due at least 90 days before product introduction into interstate commerce. For newly deemed tobacco products, FDA does not intend to enforce the requirement until November 8, 2017 (and May 8, 2018 for small-scale manufacturers). FDA also extended compliance deadlines for manufacturers located in areas recently impacted by natural disasters. Updated ingredient information must be provided whenever an additive or the quantity of an additive changes.
Confidentiality: FDA recognizes that ingredient information may include a company’s nonpublic trade secret information. The guidance mentions several statutory provisions that restrict FDA’s ability to disclose such information.
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