The Food and Drug Administration (FDA) issued a final rule outlining criteria for rejecting applications to market, alter or request exemptions for tobacco products.

The tobacco regulator in November withdrew its first final rule after receiving criticism, and asked for comment on the current version. Only editorial changes were made to the latest version, FDA said. The rule establishes grounds for automatic refusal that include using an electronic format the agency cannot process, incomplete applications, submissions in a language other than English and, in the case of a foreign company, failure to list an authorised US agent.
The final rule and FDA’s response to comments are available at: https://goo.gl/QTUI8a
FDA also made available its revised guidance on listing ingredients in tobacco products, which is intended to assist in making submissions to the agency. That document is available at: https://goo.gl/1rJpJj
Cigar manufacturers will find FDA guidance on submitting plans to place warning labels on cigar packaging and advertising from 10 May 2018 at: https://goo.gl/7TJ2QH