Hearing on FDA Manufacturing Rules

Registration is open for U.S. Food and Drug Administration’s upcoming public oral hearing on April 12, 2023, from 9:30 a.m. to 5 p.m.

The hearing is an opportunity for the public to verbally comment on the agency’s proposed rule Requirements for Tobacco Product Manufacturing Practice. The FDA is proposing new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products. Registration also includes a “listen-only” option for those who want to attend the session but do not want to request to speak.

Speaking spots are limited, and the FDA says it cannot guarantee that it will be able to accommodate all requests. Groups and organizations should select a single spokesperson to help the agency hear as many different perspectives as possible. While speaking spots are limited, listening spots are unlimited. Registration to provide oral comments will close on March 31, 2023.

The oral session will be recorded, and a transcript will be added to the docket of the proposed rule.