As previously reported here, the Tobacco Control Act requires that, when you create a “new tobacco product,” you must submit a premarket tobacco product application (PMTA) and receive a marketing authorization order prior to marketing the product. A “new tobacco product” is defined as any tobacco product that was not commercially marketed in the United States as of February 15, 2007 or any modification of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007. The objective of the approval process is to determine whether the new tobacco product is “appropriate for the protection of the public health.”
In September, FDA issued lengthy guidance addressing the submission of PMTAs for “new tobacco products.” Some of the important takeaways from the guidance include:
- FDA intends to limit enforcement of the PMTA requirements to finished tobacco products and component parts of regulated tobacco products. At this time, FDA does not intend to enforce the requirements with respect to components of regulated tobacco products that are sold or distributed solely for further manufacturing into finished tobacco products.
- A PMTA should include:
o A cover letter;
o An executive summary of the application
o Reports of all investigations of health risks, including investigations that do not support, or are adverse to, the application and investigations conducted outside of the United States;
o List of all components, ingredients, and additives by quantity, including the applicable specifications and a description of the intended function of each;
o Narrative description of the properties of the tobacco product, including a description of the form of the product, product dimensions, design features, tobacco blending, shelf life, etc.;
o Statement of the principle or principles of operation of the tobacco product, meaning a description of the way in which a consumer will use the new product, how long it takes for a consumer to consume a single unit of the product, and a description of the heating source, if any;
o Description of methods of manufacturing and processing, accompanied by a list and summary of all standard operating procedures (SOPs) and examples of relevant forms and records for specified categories of information;
o Explanation of how the product complies with any applicable tobacco product standards;
o Samples in a quantity sufficient to permit testing by FDA;
o Specimens of proposed labeling;
o An environmental assessment; and
o A detailed explanation of how the data and information in the application support a finding that introducing the new product to the market is appropriate for the protection of public health.
- Applicants should note that, even if they submit a PMTA and FDA issues an order authorizing marketing of the new product, the applicant still cannot market the product until the conclusion of the 90-day period following submission of the listing of ingredients required by the Food, Drug, and Cosmetic Act (FDCA).
- FDA does not intend to enforce the PMTA requirements with respect to the use of tobacco products in investigational studies that follow certain specifications set forth in the guidance.
FDA must review PMTAs “promptly,” with 180 days being the maximum review time. During its review, FDA may request additional information from the applicant. For example, applicants should be prepared to submit copies of selected SOPs if requested. FDA must deny a PMTA if the applicant has not shown the product is appropriate for the protection of the public health; the manufacturing methods, facilities, or controls do not comply with section 906(e) of the FDCA; the proposed labeling is false or misleading; or the applicant has not shown that the product complies with applicable tobacco product standards. With respect to the first basis for denial, FDA is requesting comment on how it can best evaluate whether an applicant has demonstrated that the new tobacco product is appropriate for the protection of the public health.
Click here to read the guidance in its entirety.
If you have any questions or would like assistance with preparing a PMTA, contact the Troutman Sanders Tobacco Team.
Contributor: Brenna Newman
For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.