FDA Rule Describes Acceptance Threshold for Tobacco Product Applications

FDA Rule Describes Acceptance Threshold for Tobacco Product Applications

Today, FDA issued a direct final rule describing when the agency would refuse to accept a tobacco product application. Types of tobacco product applications include: requests for exemption from demonstrating substantial equivalence (SE), SE reports, premarket tobacco applications (PMTAs), and modified risk tobacco product (MRTP) applications.

For example, under this rule, FDA would not accept submissions that:

• Federal Food, Drug, and Cosmetic Act
• Do not include contact information, including the

• Are not in English or do not provide a complete and accurate translation
• Do not pertain to a tobacco product, as defined by the applicant’s name and address.

Refusing to accept such submissions will enable FDA to focus its resources on submissions that are more complete. The agency also expects that this rule will encourage quality submissions.

The final rule includes a comprehensive list of reasons for which FDA will refuse to accept a tobacco product application. To read the rule, please see the Federal Register notice.

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