The directive known as Refuse to Accept Procedures for Premarket Tobacco Product Submissions, was released last August, and listed the following requirements as prerequisites in order for a PMTA to be even considered in the first place.

  • Does not pertain a tobacco product;
  • Is not in English (or does not include a complete translation);
  • Is submitted in an electronic format that FDA cannot process, read, review, or archive;
  • Does not include the applicant’s contact information;
  • 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);
  • Does not include a required form(s);
  • Does not identify the tobacco product;
  • Does not identify the type of submission;
  • Does not include the signature of a responsible official authorized to represent the applicant;
  • 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.

Why was it set in place?

On releasing the above directive, the FDA had said that these specifications are being put in place for efficiency reasons, and it’s withdrawal will now mean that the agency will have a larger number of applications to sift through.

FDA is withdrawing the direct final rule because the Agency received significant adverse comment.US Food and Drug Administration

When announcing the directive’s retraction the following statement was released, “FDA is withdrawing the direct final rule because the Agency received significant adverse comment,” adding, “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).”

Now, all are eligible to apply

This regulation was set to be implemented as of next December. While nothing is known about the negative feedback that the FDA is said to have received with regards to the Refuse to Accept Procedures for Premarket Tobacco Product Submissions directive, its removal means that the FDA will now have to accept and evaluate applications that would not have previously qualified.

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Mitch Clarke
Mitch Clarke
7 years ago

Is there any difference between the proposed and retracted final directives? It seems like the two are completely identical?