The U.S. Food & Drug Administration (FDA) has announced that it has withdrawn restrictions regarding the minimum amount of information needed for the agency to consider a tobacco product application.

While the rule will, likely positively, impact cigar companies as they begin to comply with FDA’s deeming regulations; it has very little effect on the regulation of cigars or the timeline to do so. This change simply means the agency will have to evaluate more fully a larger number of applications.

“FDA is withdrawing the direct final rule because the Agency received significant adverse comment,” said the agency in a to-be-published memo. “FDA will consider the comments we received on the direct final rule to be comments on the companion proposed rule published at 81 FR 52371 (August 8, 2016).”

The directive, formally known as Refuse to Accept Procedures for Premarket Tobacco Product Submissionsoutlined a variety of requirements needed for FDA to even consider a tobacco product application.

Previously, FDA stated for efficiency reasons, it would not evaluate applications under the following circumstances:

  1. Does not pertain a tobacco product;
  2. Is not in English (or does not include a complete translation);
  3. Is submitted in an electronic format that FDA cannot process, read, review, or archive;
  4. Does not include the applicant’s contact information;
  5. Is from a foreign applicant and does not include the name and contact information of an authorized U.S. agent (authorized to act on behalf of the applicant for the submission);
  6. Does not include a required form(s);
  7. Does not identify the tobacco product;
  8. Does not identify the type of submission;
  9. Does not include the signature of a responsible official authorized to represent the applicant;
  10. Does not include an environmental assessment or claim of a categorical exclusion, if applicable.

If an application met any of those circumstances, FDA would contact the applicant informing them that the application would not be considered because it did not meet the minimum threshold.

It’s unclear what negative feedback FDA received regarding the rule. The rule was set to go into effect on Dec. 21, 2016.

Now FDA will evaluate submissions that previously wouldn’t have qualified for the above reasons, though it seems likely the agency would require an applicate to provide additional details.

For more information on FDA’s regulation of cigars, please visit halfwheel.com/fda.

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Charlie Minato

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I have written about the cigar industry for more than a decade, covering everything from product launches to regulation to M&A. In addition, I handle a lot of the behind-the-scenes stuff here at halfwheel. I enjoy playing tennis, watching boxing, falling asleep to the Le Mans 24, wearing sweatshirts year-round and eating gyros. echte liebe.