Source: FDA, 9/9/16

Today, FDA has revised Health Document Submission Requirements for Tobacco Products, a guidance for industry, to update its current thinking on this topic following the recent publication of the FDA’s final deeming rule.

When the Tobacco Control Act (TCA) was enacted in 2009, manufacturers of cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco were required to submit all documents to FDA that relate to any “health, toxicological, behavioral or physiological effects of their current or future tobacco products,” but FDA used its enforcement discretion to only require documents that were developed between June 23, 2009 and December 31, 2009. Following the publication of the deeming final rule, manufacturers of newly-regulated products must now also comply with these requirements by February 8, 2017 (small-scale manufacturers have until August 8, 2017) – and are afforded the same enforcement discretion – as they relate to current or future finished tobacco products.  

In addition to further explaining these documents and FDA’s enforcement of these requirements, the revised guidance explains, among other things:
• Statutory requirement to submit health documents
• Definitions
• Who should submit health documents
• FDA’s compliance policies
• What information to include
• How and when to make submissions

Failure or refusal to comply with these requirements could result in a tobacco product becoming misbranded and subject to regulatory and enforcement action, including seizure and injunction. For more information, and to read all of FDA’s current thinking on this topic, read the full revised guidance on FDA’s website: http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm208913.htm