FDA Updates Requirements Regarding Health Document Submissions for Tobacco Products

September 12, 2016

FDA Issues Revised Draft Guidance Regarding Health Document Submissions for Tobacco Prorudcts

On Friday, September 9th, FDA announced the availability of a revised draft guidance, entitled “Health Document Submission Requirements for Tobacco Products.”  The document was initially published in 2010 and, when finalized, “is intended to assist persons making certain document submissions to FDA as required by the Tobacco Control Act.”

Tobacco Control Act

On June 22, 2009, the Tobacco Control Act was enacted, granting FDA with the authority to regulate the manufacture, marketing, and distribution of tobacco products.  With this, section 904(a)(4) was added to the Federal Food, Drug, and Cosmetic (FD&C) Act (21 USC 387d(a)(4)).  This section requires “each tobacco product manufacturer or importer, or agents thereof to submit all documents developed after June 22, 2009, that relate to any ‘health, toxicological, behavioral, or physiological effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives.’”

Draft Guidance

Numerous tobacco products, including cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco have been subject to the Agency’s requirements under section 904(a)(4), as well as the rest of the FD&C Act since it was initially enacted.  However, on May 10, 2016, the FDA issued a final rule stating that all products meeting the statutory definition of “tobacco product” are deemed subject to the FD&C Act and are now required to comply with all FDA regulations.

According to the FDA, a ‘tobacco product’ is “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.”  This includes, but is not limited to:

  • Cigarettes
  • Cigarette tobacco
  • Roll-your-own tobacco
  • Smokeless tobacco
  • Electronic cigarettes (also called e-cigarettes or electronic nicotine delivery system (ENDS))
  • Cigars
  • Hookah
  • Pipe tobacco
  • Nicotine gels
  • Dissolvables

The FDA’s recently revised draft guidance updates the previous document to include all manufacturers and importers of tobacco products that are now subject to the Agency’s regulations.  As such, these parties must now abide by FDA’s requirements regarding health document submissions.

Are you in the process of developing a tobacco product or do you already manufacture a tobacco product that is subject to FDA’s regulations? We are leaders in the developing category of tobacco related submissions.  To learn more about our services and how we can help your product successfully move through FDA, contact us today.


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