Revisions to Industry Guidance Regarding FDA Health Document Submission Requirements for Tobacco Products
On September 9, 2016, the Food and Drug Administration (FDA) issued revisions to its guidance regarding the Health Document Submission Requirements for Tobacco Products, as required by section 904(a)(4) of the Food, Drug, and Cosmetic Act (21 U.S.C. 387d(a)(4)), for comment purposes. The revised guidance provides further information to manufacturers and importers of tobacco products including those products newly regulated following the August 8, 2016 effective date of FDA's "Deeming Regulation," including cigars, pipe tobacco, shisha and e-vapor products that contain tobacco-derived nicotine. (See also: E-Vapor Industry Challenges Deeming Regulation.)
Notably, FDA now only intends to enforce the health document submission requirements with respect to "finished tobacco products," which are defined as a "tobacco product, including all components and parts, sealed in final packaging intended for consumer use" (and do not include "products that are sold or distributed solely for further manufacturing"). FDA reserves the right to change its compliance policy in the future and, as such, health documents related to components and parts must be preserved for potential future submission.
Manufacturers and importers of newly deemed tobacco products (such as e-vapor products) that were on the market on the August 8, 2016 effective date of the Deeming Regulation are required to submit health documents developed between June 23, 2009 and December 31, 2009 to FDA by February 8, 2017. Small-scale manufacturers ("meaning a manufacturer of any regulated tobacco product that employs 150 or fewer full-time equivalent employees and has annual total revenues of $5 million or less") have until August 8, 2017 to comply. Newly deemed products intended to be introduced to the U.S. market after August 8, 2016, in addition to obtaining FDA premarket authorization, must submit the relevant health documents to FDA at least 90 days prior to the delivery for introduction into interstate commerce of the tobacco product.
Although the guidance document states that FDA intends to enforce these submission requirements with respect to health documents developed between June 23, 2009 and December 31, 2009, manufacturers and importers should preserve health documents developed after December 31, 2009 for potential future submission to FDA.
The guidance explains that documents that fall within the health document submission requirements broadly include those documents "related to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives." For newly regulated tobacco products such as e-vapor products, "current or future tobacco products" refers to "products commercially distributed on or after August 8, 2016, or products in any state of research or development at any time after" that date.
FDA intends to enforce the health document submission requirement only with respect to documents in the "possession, custody, and control" of the manufacturer or importer. Manufacturers or importers who do not have any health documents to report must still let FDA know this by the aforementioned submission deadlines. Moreover, FDA will not enforce this requirement with respect to certain duplicative documents, substantively identical documents, or publically available information.
The guidance also outlines manufacturer/importer information that should be included in the health document submission, as well as the preferred organization, labeling, and formatting of the submitted documents. Electronic submission of documents via FDA's electronic submission tool (eSubmitter) is highly encouraged.