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FDA Finalizes Refuse to Accept Rule for Tobacco Submissions

On December 29, 2016, the U.S. Food and Drug Administration (FDA) published a final rule (81 FR 95863) describing the circumstances under which the agency will refuse to accept a tobacco product submission.  Covered submissions include:

  • Premarket tobacco product applications (PMTAs)
  • Modified risk tobacco product applications (MRTPAs)
  • Substantial equivalence (SE) applications
  • Exemption requests

According to the rule, FDA will refuse to accept submissions that:

  • Are not in English
  • Do not pertain to a tobacco product
  • Do not identify the tobacco product or the type of submission
  • Are submitted in an electronic format that cannot be processed, read, reviewed, or archived
  • Do not include the applicant’s contact information (or for foreign applicants, the U.S. Agent’s contact information)
  • Do not include the required forms
  • Do not include the signature of a responsible official authorized to represent the applicant
  • Do not include an environmental assessment or claim of a categorical exclusion, if applicable

Submissions that meet these circumstances will be refused before they enter FDA’s review queue.  FDA will inform the listed contact as to whether or not the submission was accepted.  FDA expects this rule to accelerate the review process for submissions that meet all requirements by freeing the agency’s review resources.

This rule applies to covered submissions for all tobacco products.  Until last year, FDA’s authority over tobacco products was limited to cigarettes and cigarette, roll-your-own, and smokeless tobacco.  In May 2016, FDA finalized a rule that extended the agency’s authority to all tobacco products, including (but not limited to) e-cigarettes, cigars, hookah tobacco, and pipe tobacco (81 FR 28973).  The rule became effective in August 2016 and requires tobacco manufacturers to submit new products to FDA for premarket review.

Registrar Corp assists tobacco manufacturers with FDA compliance, including registration, listing, and labeling requirements.  For more information on FDA regulations for tobacco manufacturers, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.