On September 25, 2015, FDA published a notice of proposed rulemaking (NPRM) regarding the regulation of products made or derived from tobacco. In the Federal Register announcement, "FDA requested comments on the proposed regulation that describes the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)." Initially, the comment period was to be open until November 24, providing industry professionals with 60 days to review the regulation and submit comments.
For details on the proposed rule, view our FDA News article here.
On Monday, November 30, 2015, FDA reopened the comment period, extending the closing date from November 24, to December 30, 2015. This action was taken by the Agency "in response to a request for an extension to allow interested persons additional time to submit comments."
For additional details, view the proposed rule here; or view the Federal Register announcement here.
The Agency is accepting all electronic and written (paper) comments that are submitted on or before the closing date. Are you interested in providing feedback? Submit your comments here.
Are you in the process of developing a tobacco product? Do you already have a product that is made or derived from tobacco? Assuring you are compliant with FDA’s regulations for these products can be tricky, but that is why we are here to help. We have a history of working with various tobacco and e-cigarette products; and, using our unique approach that combines scientific knowledge with regulatory expertise, we have been able to help numerous clients get through FDA successfully. To learn more about our tobacco and e-cigarette services, or for more information on how we can help you obtain FDA compliance and/or approval, please contact us.