FDA Extends Comment Period for Proposed Tobacco Products Law

The U.S. Food and Drug Administration (FDA) has allotted a 30-day extension to the comment period for the “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports” rule that was proposed on April 2, 2019.

The proposed rule would regulate Substantial Equivalence (SE) Reports by establishing requirements regarding both the content and format of said reports, as well as for the procedure the FDA will use to determine a product’s status.

An SE Report is used to determine if a new tobacco product is “substantially equivalent” to an existing tobacco product on the market. The manufacturer of a new tobacco product needs to submit an SE report that includes data on the materials, heating apparatus, nicotine content, environmental impacts, etc. to the FDA in order for the agency to determine whether the new product poses a new public health risk.

There is currently uncertainty regarding new tobacco product applications as much of the required elements have yet to be clearly explained by the FDA. This comment period allows businesses the chance to have their voices heard.

The extension will allow for public comment until July 17, 2019.

For more information on the proposed rule, go to: https://www.federalregister.gov/documents/2019/04/02/2019-05787/content-and-format-of-substantial-equivalence-reports-food-and-drug-administration-actions-on

If you have any questions about FDA compliance, feel free to send us a message through the Contact form on the Home Page.