In April, FDA issued two proposed rules: Tobacco Product Standard for Menthol in Cigarettes and Tobacco Product Standard for Characterizing Flavors in Cigars. FDA is extending the comment period for these two proposed rules from 60 days to 90 days. The public may now submit comments on these proposed rules through August 2, 2022. FDA is extending the comment period to a total of 90 days following...

On April 28, FDA announced proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and to prohibit all characterizing flavors (other than tobacco) in cigars. The public may provide comments on these proposed rules through July 5.  Menthol Product Standard Menthol is a flavor additive with a minty taste and aroma that is widely used in consumer and medicinal...

On March 14, FDA posted three amendments to the U.S. Smokeless Tobacco Company (USSTC) modified risk tobacco product (MRTP) application for Copenhagen Snuff Fine Cut. The amendments were submitted in response to a deficiency letter from FDA. You may submit a public comment about the amendments to Docket FDA-2018-N-3261 on regulations.gov. There may be conflicting deadlines posted on regulations.gov...

NOT-CA-22-053: Request for Information (RFI): Priorities for Cancer Control and Population Sciences at NCI (nih.gov) 

Draft Guidance Open for Comment, “Validation and Verification of Analytical Testing Methods Used for Tobacco Products” (Docket Number: FDA-2021-D-0756) The FDA is announcing the availability of a draft guidance for industry entitled "Validation and Verification of Analytical Testing Methods Used for Tobacco Products" and requesting comments, including scientific and other information...

FDA has posted an amendment from the modified risk tobacco product (MRTP) application submitted by Philip Morris Products S.A. (PMPSA) for the IQOS 3 System Holder & Charger. Public comments on these materials should be submitted to FDA-2021-N-0408-0001 by Dec. 10, 2021. The application materials, redacted in accordance with applicable laws, can be read on the FDA website. FDA takes into...

Docket No: FDA-2021-D-0373  Summary: The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled “Tobacco Product User Fees:  Responses to Frequently Asked Questions.”  This draft guidance provides information in response to frequently asked questions related to tobacco product user fees assessed and collected under the Federal Food, Drug...

FDA has posted final materials from the modified risk tobacco product (MRTP) application submitted by Philip Morris Products S.A. (PMPSA) for the IQOS 3 System Holder & Charger. Public comments on these materials should be submitted to FDA-2021-N-0408-0001 by Aug. 2, 2021. The application materials, redacted in accordance with applicable laws, can be read on the FDA website. FDA takes into...

Recently, NIH launched an effort to end structural racism in biomedical research through a new initiative called UNITE. NIH Director Francis Collins issued a statement committing NIH to instituting new ways to support diversity, equity, and inclusion, and identifying and dismantling any policies and practices that may harm our workforce and our science. As a key stakeholder invested in biomedical...

The FDA is opening a docket to obtain data and information related to the use of vaping products that are associated with recent lung injuries. This request for information (RFI) responds to direction from Congress to gather information from the public that could help identify and evaluate additional steps the Agency could take to “address the recent pulmonary illnesses reported to be associated...

The FDA is announcing the availability for public comment of a modified risk tobacco product (MRTP) application for Copenhagen Snuff Fine Cut, a loose moist snuff tobacco product submitted by U.S. Smokeless Tobacco Co. LLC. FDA will post the application materials on a rolling basis as they are redacted in accordance with applicable laws. More information.

The FDA is announcing the availability for public comment of modified risk tobacco product applications for VLNTM King and VLNTM Menthol King, combusted, filtered cigarettes, submitted by 22nd Century Group Inc. FDA will post the application materials on a rolling basis as they are redacted in accordance with applicable laws.  More information.

FDA is reopening the comment period for the “Premarket Tobacco Product Applications (PMTA) and Recordkeeping Requirements” proposed rule published on Sept. 25, 2019. The agency is reopening the comment period for the proposed rule in response to a request for an extension to the comment period to give people additional time to submit comments. The reopened comment period will be open through...

FDA has reopened the comment period for the “Required Warnings for Cigarette Packages and Advertisements” proposed rule published on Aug. 16, 2019, which when finalized, would require new cigarette health warnings on cigarette packages and in advertisements to promote greater public understanding of the negative health consequences of smoking...

The Food and Drug Administration (FDA, the Agency, or we) is issuing a proposed rule to establish new required cigarette health warnings for cigarette packages and advertisements. The proposed rule would implement a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the negative health...

URL: https://www.federalregister.gov/documents/2019/09/25/2019-20315/premarket-tobacco-product-applications-and-recordkeeping-requirementsThe Food and Drug Administration (FDA) is issuing a proposed rule that would set forth requirements for premarket tobacco product applications (PMTAs) and would require manufacturers to maintain records establishing that their tobacco products are legally...