FDA Issues Final Rule Regarding its Refuse to Accept Procedures for Premarket Tobacco Product Submissions

August 10, 2016

FDA Releases Refuse to Accept Policy for Tobacco Product Submissions

On Monday, August 8th, the FDA issued a final rule outlining its refuse to accept policy for tobacco product submissions that do not meet the minimum threshold for acceptability for FDA review.  According to the FDA, a ‘tobacco product’ is “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.”  Among other products, this includes cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, e-cigarettes (also called electronic cigarettes or electronic nicotine delivery systems (ENDS)), cigars, hookah, pipe tobacco, nicotine gels, and dissolvables.

“Under the rule, FDA will refuse to accept a premarket submission that:

  1. Does not pertain to 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; or
  10. Does not include an environmental assessment or claim of a categorical exclusion, if applicable.”

If a submission is not accepted by the FDA, the Agency will notify the contact person (if available); if FDA does accept the submission for further review, an acknowledgement letter will be sent.

In its Federal Register notice, FDA notes that “by refusing to accept submissions that have the deficiencies identified in the rule, FDA will be able to focus our review resources on submissions that meet a threshold of acceptability and encourage quality submissions.”

FDA is asking interested parties to submit either electronic or written comments by October 24, 2016.  Given the specific deficiencies that will result in FDA refusing to accept a submission, the Agency does not believe that there will be any significant oppositions to the rule.  As such, FDA states that “is issuing this action directly as a final rule,” which will take effect on December 21, 2016.

If any significant adverse comments are received, FDA states that it will publish a document withdrawing the direct final rule before its effective date.

Are you in the process of developing a tobacco product or do you already manufacture a tobacco product that is subject to this rule? We are leaders in the developing category of tobacco related submissions.  To learn more about our services and how we can help your product successfully move through FDA, contact us.


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