FDA Solicits Feedback on Tobacco Firms' User Fee Reporting
Published Date: 5/1/2025
Notice
Summary
The FDA wants feedback on how tobacco makers and importers report info to calculate their user fees. This affects companies that make or bring in tobacco products and could change how they submit data, possibly impacting fees and deadlines. You’ve got 60 days to share your thoughts and help shape the process!
Analyzed Economic Effects
1 provisions identified: 0 benefits, 0 costs, 1 mixed.
Tobacco makers must submit fee data
If you are a domestic manufacturer or importer of tobacco products, the FDA is proposing requirements about what data you must submit so the Agency can calculate user fees for those manufacturers and importers. The notice is a Paperwork Reduction Act request for comment and allows 60 days for public comment.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-16939, GNT USA, LLC.; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by GNT USA, LLC., c/o Exponent, Inc., proposing that we amend our color additive regulations to provide for the safe use of safflower (Carthamus tinctorius L.) extract as a color additive in various foods at levels consistent with good manufacturing practices.
2026-16942, Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium DL- methionine chelate as a nutritional source of chromium in cattle feed. This action is in response to a food additive petition filed by Zinpro Corp.
2026-16944, Gardenia Blue Interest Group; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Gardenia Blue Interest Group (GBIG or petitioner), c/o Exponent, Inc., proposing that we amend our color additive regulations to expand the safe use of gardenia (genipin) blue in various foods at levels consistent with good manufacturing practice. The petition also proposes to lower the specification for arsenic in gardenia (genipin) blue.
Previous / Next Documents
Previous: 2025-07584, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License Application
The FDA is asking the government to approve a new form for companies that make medicated animal feed. This affects feed mill owners who need a license to keep things safe and legal. The goal is to keep paperwork clear and easy, with no extra costs or delays expected.
Next: 2025-07586, Notice of Determinations; Culturally Significant Objects Being Imported for Exhibition-Determinations: “Queer Lens: A History of Photography” Exhibition
The government has approved special photos and objects from other countries to be shown temporarily in the “Queer Lens: A History of Photography” exhibit at the Getty Museum in Los Angeles. These items are important to culture and sharing them in the U.S. is a big deal. This means the exhibit can go ahead, possibly traveling to other places, with no extra costs or delays for the public.