FDA issues revised guidance

| September 12, 2016

The US Food and Drug Administration has revised its guidance, Health Document Submission Requirements for Tobacco Products, to update current thinking on this topic following the recent publication of its 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,’ the FDA said.

‘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.’

The full revised guidance is at: http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm208913.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Category: Breaking News

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