Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Revised)
Find answers to FAQs about demonstrating the substantial equivalence (SE) of a new tobacco product.
Stay updated with breaking news from Docket Number. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.
Find answers to FAQs about demonstrating the substantial equivalence (SE) of a new tobacco product.
Guidance on how manufacturers may establish that a tobacco product is grandfathered, or was commercially marketed in the U.S. as of February 15, 2007.
FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
This guidance document provides a list of questions that frequently have been asked about the requirements of the prior notice regulation, and the answers to those questions. It is being issued to help the food industry and others comply with the legal requirements.