Modified Risk Granted Orders
*The product categories listed in this chart only reflect FDA’s categorization for the purposes of premarket review. Some products may fit in one category for the purposes of premarket review but may come under different product category definitions by statute and regulation, and thus may be subject to different or additional requirements than the category indicated in the chart.
Note: To prioritize resources and provide the public with the most helpful information in a timely manner, starting FY 2021 FDA will be posting only order letters and decision summaries related to marketing orders on the FDA website. Additionally, due to requirements to redact confidential commercial information (CCI) and ensure documents posted to the FDA website are accessible to everyone, the full decision summary and order letter for marketing authorizations may not be posted to the website until after the order issuance date. In the interim, to provide as much information as possible at this time, we are making redacted versions of the decision summaries’ “Executive Summary” section are being made available to broadly explain the public health rationale for any authorized products. However, other documents, such as the environmental assessment (EA) and finding of no significant impact (FONSI), will remain available to the public upon request. To request records related to a recently issued marketing order please submit a FOIA request. For general tobacco-related questions and information please contact CTP.