October Term 2024 · Docket 23-1038
Does the FDA require new tobacco products to prove they help smokers quit?
The FDA demands new tobacco products prove they help smokers quit. Manufacturers argue this rule contradicts prior agency guidance.
Verified source milestones
- — An official oral-argument transcript was verified.
- — An official oral-argument transcript was verified.
- — An official Court opinion was verified.
The arguments, in order
This case may have been argued more than once. Each entry below uses that session's official transcript. Later arguments do not erase earlier ones.
Argument 1 ·
What happened at the argument
Mr. Gannon argued the law requires FDA authorization for new products.
Mr. Heyer argued the agency contradicted its own prior guidance.
Mr. Heyer noted most adult users prefer flavored products.
Justice Alito questioned the adequacy of the agency's position summary.
Read the official transcript for this argument · Official argument details
Sources used for this argument breakdown
- Official Supreme Court Transcript — file page 10, lines 21-47 — Transcript, file page 10, lines 21-47
- Official Supreme Court Transcript — file page 11, lines 45-45 — Transcript, file page 11, lines 45-45
- Official Supreme Court Transcript — file page 11, lines 53-9 — Transcript, file page 11, lines 53-9
- Official Supreme Court Transcript — file page 12, lines 53-19 — Transcript, file page 12, lines 53-19
- Official Supreme Court Transcript — file page 13, lines 23-27 — Transcript, file page 13, lines 23-27
- Official Supreme Court Transcript — file page 13, lines 31-33 — Transcript, file page 13, lines 31-33
- Official Supreme Court Transcript — file page 14, lines 25-25 — Transcript, file page 14, lines 25-25
- Official Supreme Court Transcript — file page 14, lines 31-33 — Transcript, file page 14, lines 31-33
- Official Supreme Court Transcript — file page 14, lines 37-49 — Transcript, file page 14, lines 37-49
- Official Supreme Court Transcript — file page 4, lines 11-23 — Transcript, file page 4, lines 11-23
- Official Supreme Court Transcript — file page 4, lines 25-23 — Transcript, file page 4, lines 25-23
- Official Supreme Court Transcript — file page 58, lines 37-39 — Transcript, file page 58, lines 37-39
- Official Supreme Court Transcript — file page 6, lines 25-33 — Transcript, file page 6, lines 25-33
- Official Supreme Court Transcript — file page 67, lines 51-9 — Transcript, file page 67, lines 51-9
- Official Supreme Court Transcript — file page 68, lines 11-37 — Transcript, file page 68, lines 11-37
- Official Supreme Court Transcript — file page 68, lines 41-51 — Transcript, file page 68, lines 41-51
- Official Supreme Court Transcript — file page 69, lines 49-25 — Transcript, file page 69, lines 49-25
- Official Supreme Court Transcript — file page 71, lines 11-21 — Transcript, file page 71, lines 11-21
- Official Supreme Court Transcript — file page 71, lines 35-13 — Transcript, file page 71, lines 35-13
- Official Supreme Court Transcript — file page 72, lines 35-1 — Transcript, file page 72, lines 35-1
- Official Supreme Court Transcript — file page 73, lines 13-49 — Transcript, file page 73, lines 13-49
- Official Supreme Court Transcript — file page 74, lines 11-21 — Transcript, file page 74, lines 11-21
- Official Supreme Court Transcript — file page 74, lines 37-39 — Transcript, file page 74, lines 37-39
- Official Supreme Court Transcript — file page 74, lines 45-1 — Transcript, file page 74, lines 45-1
- Official Supreme Court Transcript — file page 75, lines 35-45 — Transcript, file page 75, lines 35-45
- Official Supreme Court Transcript — file page 75, lines 49-11 — Transcript, file page 75, lines 49-11
- Official Supreme Court Transcript — file page 77, lines 13-21 — Transcript, file page 77, lines 13-21
- Official Supreme Court Transcript — file page 8, lines 45-47 — Transcript, file page 8, lines 45-47
- Official Supreme Court Transcript — file page 8, lines 7-15 — Transcript, file page 8, lines 7-15
- Official Supreme Court Transcript — file page 95, lines 21-43 — Transcript, file page 95, lines 21-43
A citizen's guide to the whole case
What this case is about
The FDA requires new tobacco products to prove they help smokers quit. Manufacturers argue this rule contradicts prior agency guidance.
Official sources for this section
- Official Supreme Court Transcript — file page 4, lines 25-23 — Transcript, file page 4, lines 25-23
- Official Supreme Court Transcript — file page 58, lines 37-39 — Transcript, file page 58, lines 37-39
- Official Supreme Court Transcript — file page 67, lines 51-9 — Transcript, file page 67, lines 51-9
- Official Supreme Court Transcript — file page 95, lines 21-43 — Transcript, file page 95, lines 21-43
How the case got here
The Supreme Court heard oral argument in this case on December 2, 2024.
Official sources for this section
- Official Supreme Court Transcript — file page 4, lines 11-23 — Transcript, file page 4, lines 11-23
- Official Supreme Court Transcript — file page 77, lines 13-21 — Transcript, file page 77, lines 13-21
What each side wants
The FDA wants to enforce the new study requirement.
The manufacturers want the agency to accept their prior applications.
Official sources for this section
- Official Supreme Court Transcript — file page 4, lines 25-23 — Transcript, file page 4, lines 25-23
- Official Supreme Court Transcript — file page 58, lines 37-39 — Transcript, file page 58, lines 37-39
- Official Supreme Court Transcript — file page 67, lines 51-9 — Transcript, file page 67, lines 51-9
- Official Supreme Court Transcript — file page 95, lines 21-43 — Transcript, file page 95, lines 21-43
What each side says
The FDA argues new products must prove they help smokers quit.
The manufacturers argue the agency changed the rules after the deadline.
Official sources for this section
- Official Supreme Court Transcript — file page 4, lines 25-23 — Transcript, file page 4, lines 25-23
- Official Supreme Court Transcript — file page 58, lines 37-39 — Transcript, file page 58, lines 37-39
- Official Supreme Court Transcript — file page 67, lines 51-9 — Transcript, file page 67, lines 51-9
- Official Supreme Court Transcript — file page 95, lines 21-43 — Transcript, file page 95, lines 21-43
What the justices asked
Justice Alito asked what evidence substitutes for randomized trials.
Justice Barrett asked about fair notice for the new requirement.
Official sources for this section
- Official Supreme Court Transcript — file page 10, lines 21-47 — Transcript, file page 10, lines 21-47
- Official Supreme Court Transcript — file page 11, lines 45-45 — Transcript, file page 11, lines 45-45
- Official Supreme Court Transcript — file page 11, lines 53-9 — Transcript, file page 11, lines 53-9
- Official Supreme Court Transcript — file page 12, lines 53-19 — Transcript, file page 12, lines 53-19
- Official Supreme Court Transcript — file page 13, lines 23-27 — Transcript, file page 13, lines 23-27
- Official Supreme Court Transcript — file page 13, lines 31-33 — Transcript, file page 13, lines 31-33
- Official Supreme Court Transcript — file page 14, lines 25-25 — Transcript, file page 14, lines 25-25
- Official Supreme Court Transcript — file page 14, lines 31-33 — Transcript, file page 14, lines 31-33
- Official Supreme Court Transcript — file page 14, lines 37-49 — Transcript, file page 14, lines 37-49
- Official Supreme Court Transcript — file page 6, lines 25-33 — Transcript, file page 6, lines 25-33
- Official Supreme Court Transcript — file page 68, lines 11-37 — Transcript, file page 68, lines 11-37
- Official Supreme Court Transcript — file page 68, lines 41-51 — Transcript, file page 68, lines 41-51
- Official Supreme Court Transcript — file page 69, lines 49-25 — Transcript, file page 69, lines 49-25
- Official Supreme Court Transcript — file page 71, lines 11-21 — Transcript, file page 71, lines 11-21
- Official Supreme Court Transcript — file page 71, lines 35-13 — Transcript, file page 71, lines 35-13
- Official Supreme Court Transcript — file page 72, lines 35-1 — Transcript, file page 72, lines 35-1
- Official Supreme Court Transcript — file page 73, lines 13-49 — Transcript, file page 73, lines 13-49
- Official Supreme Court Transcript — file page 74, lines 11-21 — Transcript, file page 74, lines 11-21
- Official Supreme Court Transcript — file page 74, lines 37-39 — Transcript, file page 74, lines 37-39
- Official Supreme Court Transcript — file page 74, lines 45-1 — Transcript, file page 74, lines 45-1
- Official Supreme Court Transcript — file page 75, lines 35-45 — Transcript, file page 75, lines 35-45
- Official Supreme Court Transcript — file page 75, lines 49-11 — Transcript, file page 75, lines 49-11
- Official Supreme Court Transcript — file page 8, lines 45-47 — Transcript, file page 8, lines 45-47
- Official Supreme Court Transcript — file page 8, lines 7-15 — Transcript, file page 8, lines 7-15
Why it matters
This case determines if the FDA can impose new scientific standards on existing applications. It affects how manufacturers prove their products help smokers quit. It shapes the scope of federal tobacco regulation.
Official sources for this section
- Official Supreme Court Transcript — file page 4, lines 25-23 — Transcript, file page 4, lines 25-23
- Official Supreme Court Transcript — file page 58, lines 37-39 — Transcript, file page 58, lines 37-39
- Official Supreme Court Transcript — file page 67, lines 51-9 — Transcript, file page 67, lines 51-9
- Official Supreme Court Transcript — file page 95, lines 21-43 — Transcript, file page 95, lines 21-43
What happens next
This article currently covers the argument record. Use the official docket link for later case activity.
Official sources for this section
- Official Supreme Court Transcript — file page 10, lines 21-47 — Transcript, file page 10, lines 21-47
- Official Supreme Court Transcript — file page 11, lines 45-45 — Transcript, file page 11, lines 45-45
- Official Supreme Court Transcript — file page 11, lines 53-9 — Transcript, file page 11, lines 53-9
- Official Supreme Court Transcript — file page 12, lines 53-19 — Transcript, file page 12, lines 53-19
- Official Supreme Court Transcript — file page 13, lines 23-27 — Transcript, file page 13, lines 23-27
- Official Supreme Court Transcript — file page 13, lines 31-33 — Transcript, file page 13, lines 31-33
- Official Supreme Court Transcript — file page 14, lines 25-25 — Transcript, file page 14, lines 25-25
- Official Supreme Court Transcript — file page 14, lines 31-33 — Transcript, file page 14, lines 31-33
- Official Supreme Court Transcript — file page 14, lines 37-49 — Transcript, file page 14, lines 37-49
- Official Supreme Court Transcript — file page 4, lines 11-23 — Transcript, file page 4, lines 11-23
- Official Supreme Court Transcript — file page 6, lines 25-33 — Transcript, file page 6, lines 25-33
- Official Supreme Court Transcript — file page 68, lines 11-37 — Transcript, file page 68, lines 11-37
- Official Supreme Court Transcript — file page 68, lines 41-51 — Transcript, file page 68, lines 41-51
- Official Supreme Court Transcript — file page 69, lines 49-25 — Transcript, file page 69, lines 49-25
- Official Supreme Court Transcript — file page 71, lines 11-21 — Transcript, file page 71, lines 11-21
- Official Supreme Court Transcript — file page 71, lines 35-13 — Transcript, file page 71, lines 35-13
- Official Supreme Court Transcript — file page 72, lines 35-1 — Transcript, file page 72, lines 35-1
- Official Supreme Court Transcript — file page 73, lines 13-49 — Transcript, file page 73, lines 13-49
- Official Supreme Court Transcript — file page 74, lines 11-21 — Transcript, file page 74, lines 11-21
- Official Supreme Court Transcript — file page 74, lines 37-39 — Transcript, file page 74, lines 37-39
- Official Supreme Court Transcript — file page 74, lines 45-1 — Transcript, file page 74, lines 45-1
- Official Supreme Court Transcript — file page 75, lines 35-45 — Transcript, file page 75, lines 35-45
- Official Supreme Court Transcript — file page 75, lines 49-11 — Transcript, file page 75, lines 49-11
- Official Supreme Court Transcript — file page 77, lines 13-21 — Transcript, file page 77, lines 13-21
- Official Supreme Court Transcript — file page 8, lines 45-47 — Transcript, file page 8, lines 45-47
- Official Supreme Court Transcript — file page 8, lines 7-15 — Transcript, file page 8, lines 7-15
Official Court provenance
Official docket and case history · Official Supreme Court oral-argument detail page
Verified official opinions and orders
Title and summary sources
- Official Supreme Court Transcript — file page 4, lines 25-23 — Transcript, file page 4, lines 25-23
- Official Supreme Court Transcript — file page 58, lines 37-39 — Transcript, file page 58, lines 37-39
- Official Supreme Court Transcript — file page 67, lines 51-9 — Transcript, file page 67, lines 51-9
- Official Supreme Court Transcript — file page 95, lines 21-43 — Transcript, file page 95, lines 21-43
- Official Supreme Court Transcript — file page 4, lines 25-23 — Transcript, file page 4, lines 25-23
- Official Supreme Court Transcript — file page 58, lines 37-39 — Transcript, file page 58, lines 37-39
- Official Supreme Court Transcript — file page 67, lines 51-9 — Transcript, file page 67, lines 51-9
- Official Supreme Court Transcript — file page 95, lines 21-43 — Transcript, file page 95, lines 21-43
Revision history
- Revision 1 · Post Opinion ·
Correction: Rewritten to the concise citizen-facing editorial standard.
- Revision 2 · Post Opinion ·
Correction: Migrated to the dated official Court activity contract without model use.