Report
fda-v-wages-white-lion-us-pet
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Cornell LII, CourtListener, Web search republishers, govinfo
65 matched in source text
Verification runs deterministically against authoritative public databases. Your brief is not sent to OpenAI, Anthropic, Google, or any other third-party model.
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§Authorities
1 Cases: American Manufacturers Mutual Ins. Co. v. Sullivan, 526 U.S. 40 (1999) clean
2 Avail Vapor, LLC v. FDA, 55 F.4th 409 (4th Cir. 2022) clean
3 Bidi Vapor LLC v. FDA, 47 F.4th 1191 (11th Cir. 2022) clean
4 Bowles v. Seminole Rock & Sand Co., 325 U.S. 410 (1945) clean
5 Burlington Truck Lines, Inc. v. United States, 371 U.S. 156 (1962) flagged
- At least one attributed quote wasn't located in the retrieved text.
6 Calcutt v. FDIC, 598 U.S. 623 (2023) clean
7 Cheek v. United States, 498 U.S. 192 (1991) clean
8 Christopher v. SmithKline Beecham Corp., 567 U.S. 142 (2012) clean
9 Chrysler Corp. v. Brown, 441 U.S. 281 (1979) clean
10 Cutter v. Wilkinson, 544 U.S. 709 (2005) clean
11 DHS v. MacLean, 574 U.S. 383 (2015) brief quality retrieval gap
- A case named 'Department of Homeland Security v. Robert J. MacLean' exists in CourtListener at [{'volume': '135', 'reporter': 'S. Ct.', 'page': '913'}, {'volume': '190', 'reporter': 'L. Ed. 2d', 'page': '771'}, {'volume': '2015', 'reporter': 'U.S. LEXIS', 'page': '755'}, {'volume': '25', 'reporter': 'Fla. L. Weekly Fed. S', 'page': '58'}, {'volume': '39', 'reporter': 'I.E.R. Cas. (BNA)', 'page': '945'}, {'volume': '83', 'reporter': 'U.S.L.W.', 'page': '4075'}] (scotus, 2015), but the brief's citation does not match.
We couldn't retrieve any opinion text for this citation from our public sources. The case may only be available on a paid service like Westlaw or Lexis. Without the text, we can't check whether the brief's quotes appear in the opinion.
These quotes have not been verified because the opinion text wasn't available.
12 Cases-Continued: Page Department of Commerce v. New York, 588 U.S. 752 (2019) clean
13 Electric Clouds, Inc. v. FDA, 94 F.4th 950 (10th Cir. 2024) flagged
- At least one attributed quote wasn't located in the retrieved text.
14 FCC v. Fox Television Stations, Inc., 556 U.S. 502 (2009) clean
15 FCC v. Prometheus Radio Project, 592 U.S. 414 (2021) clean
16 General Electric Co. v. EPA, 53 F.3d 1324 (D.C. Cir. 1995) clean
17 Grayned v. City of Rockford, 408 U.S. 104 (1972) clean
18 Gripum LLC v. FDA, 47 F.4th 553 (7th Cir. 2022) clean
19 Johnson v. United States, 576 U.S. 591 (2015) clean
20 Kisor v. Wilkie, 588 U.S. 558 (2019) clean
21 Liquid Labs LLC v. FDA, 52 F.4th 533 (3rd Cir. 2022) clean
22 Little Sisters of the Poor Saints Peter & Paul Home v. Pennsylvania, 591 U.S. 657 (2020) brief quality flagged
- A case named 'Little Sisters of the Poor Saints Peter and Paul Home v. Pennsylvania' exists in CourtListener at 140 S. Ct. 2367, 207 L. Ed. 2d 819 (scotus, 2020). The brief cites it as 591 U.S. 657 — the brief's citation does not match the real instrument.
23 Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024) brief quality flagged
- A case named 'Loper Bright Enterprises, et al., Petitioners v. Gina Raimondo, Secretary of Commerce, et al.' exists in CourtListener at [{'volume': '603', 'reporter': 'U.S.', 'page': '369'}] (scotus, 2024), but the brief's citation does not match.
- At least one attributed quote wasn't located in the retrieved text.
24 Lotus Vaping Technologies, LLC v. FDA, 73 F.4th 657 (9th Cir. 2023) clean
25 Magellan Technology, Inc. v. FDA, 70 F.4th 622 (2d Cir. 2023) clean
26 Page Morgan Stanley Capital Group Inc. v. Public Utility Dist. No. 1, 554 U.S. 527 (2008) clean
27 NLRB v. Bell Aerospace Co., 416 U.S. 267 (1974) clean
28 Neder v. United States, 527 U.S. 1 (1999) clean
29 Ohio v. EPA, 144 S. Ct. 2040 (2024) brief quality flagged
- A case named 'Ohio, et al., Applicants v. Environmental Protection Agency, et al.' exists in CourtListener at [{'volume': '603', 'reporter': 'U.S.', 'page': '279'}] (scotus, 2024), but the brief's citation does not match.
30 Perez v. Mortgage Bankers Ass'n, 575 U.S. 92 (2015) clean
31 Prohibition Juice Co. v. FDA, 45 F.4th 8 (D.C. Cir. 2022) clean
32 SEC v. Chenery Corp., 318 U.S. 80 (1943) clean
33 SEC v. Chenery Corp., 332 U.S. 194 (1947) clean
34 Shinseki v. Sanders, 556 U.S. 396 (2009) clean
35 United States v. L. Cohen Grocery Co., 255 U.S. 81 (1921) clean
36 Vermont Yankee Nuclear Power Corp. v. NRDC, Inc., 435 U.S. 519 (1978) clean
37 Waters-Pierce Oil Co. v. Texas, 212 U.S. 86 (1909) clean
38 90 F.4th 357 flagged
- We couldn't independently verify this citation against our public sources.
39 41 F.4th 427 brief quality flagged
- Case name in the brief differs materially from the official record.
40 16 F.4th 1130 brief quality flagged
- Case name in the brief differs materially from the official record.
41 81 Fed. Reg. at 29,004-29,008 flagged
- No matching case-law record found via CourtListener (citation lookup, docket lookup, name search), court-specific adapters, govinfo, or web search. The citation triple did not appear in any of our case-law databases.
42 556 U.S. at 515 flagged
- No matching case-law record found via CourtListener (citation lookup, docket lookup, name search), court-specific adapters, govinfo, or web search. The citation triple did not appear in any of our case-law databases.
- We couldn't retrieve the source text from any of our public sources.
We couldn't retrieve any opinion text for this citation from our public sources. The case may only be available on a paid service like Westlaw or Lexis. Without the text, we can't check whether the brief's quotes appear in the opinion.
These quotes have not been verified because the opinion text wasn't available.
43 Pub. L. No. 111-31 clean
44 123 Stat. 1776 manual verify
This citation falls outside our automated coverage. Law reviews, treatises, restatements, and legislative packages predating govinfo's collection window don't have a free full-text source we can reliably retrieve. The citation itself looks well-formed; a reviewer with access to HeinOnline, Westlaw, Lexis, or a law library can confirm. This isn't a defect in the citation; it's a coverage gap in our automated sources.
45 123 Stat. 1777 manual verify
This citation falls outside our automated coverage. Law reviews, treatises, restatements, and legislative packages predating govinfo's collection window don't have a free full-text source we can reliably retrieve. The citation itself looks well-formed; a reviewer with access to HeinOnline, Westlaw, Lexis, or a law library can confirm. This isn't a defect in the citation; it's a coverage gap in our automated sources.
These quotes have not been verified because the source text wasn't retrieved.
46 123 Stat. 1778 manual verify
This citation falls outside our automated coverage. Law reviews, treatises, restatements, and legislative packages predating govinfo's collection window don't have a free full-text source we can reliably retrieve. The citation itself looks well-formed; a reviewer with access to HeinOnline, Westlaw, Lexis, or a law library can confirm. This isn't a defect in the citation; it's a coverage gap in our automated sources.
These quotes have not been verified because the source text wasn't retrieved.
47 123 Stat. 1779 manual verify
This citation falls outside our automated coverage. Law reviews, treatises, restatements, and legislative packages predating govinfo's collection window don't have a free full-text source we can reliably retrieve. The citation itself looks well-formed; a reviewer with access to HeinOnline, Westlaw, Lexis, or a law library can confirm. This isn't a defect in the citation; it's a coverage gap in our automated sources.
48 123 Stat. 1781 manual verify
This citation falls outside our automated coverage. Law reviews, treatises, restatements, and legislative packages predating govinfo's collection window don't have a free full-text source we can reliably retrieve. The citation itself looks well-formed; a reviewer with access to HeinOnline, Westlaw, Lexis, or a law library can confirm. This isn't a defect in the citation; it's a coverage gap in our automated sources.
These quotes have not been verified because the source text wasn't retrieved.
49 81 Fed. Reg. 28,974 manual verify
This citation falls outside our automated coverage. Law reviews, treatises, restatements, and legislative packages predating govinfo's collection window don't have a free full-text source we can reliably retrieve. The citation itself looks well-formed; a reviewer with access to HeinOnline, Westlaw, Lexis, or a law library can confirm. This isn't a defect in the citation; it's a coverage gap in our automated sources.
50 84 Fed. Reg. 50,566 manual verify
This citation falls outside our automated coverage. Law reviews, treatises, restatements, and legislative packages predating govinfo's collection window don't have a free full-text source we can reliably retrieve. The citation itself looks well-formed; a reviewer with access to HeinOnline, Westlaw, Lexis, or a law library can confirm. This isn't a defect in the citation; it's a coverage gap in our automated sources.
51 1969 Duke L.J. 199 manual verify
This citation falls outside our automated coverage. Law reviews, treatises, restatements, and legislative packages predating govinfo's collection window don't have a free full-text source we can reliably retrieve. The citation itself looks well-formed; a reviewer with access to HeinOnline, Westlaw, Lexis, or a law library can confirm. This isn't a defect in the citation; it's a coverage gap in our automated sources.
These quotes have not been verified because the source text wasn't retrieved.
91 U.S. Const. Amend. V clean
§Record & filing references (116)
Citations to filings in this case or its record — appendices, docket entries, pleadings. These aren't published authority, so we don't retrieve or verify them. They're listed here so every citation in the brief is accounted for.
- interest in tobacco flavor is low among youth.
- complete switching
- established cigarette smokers,
- as a way to reduce or stop smoking
- flavor of interest.
- known and substantial risk to youth,
- sufficiently reliable and robust evidence
- turned around and denied [respondents'] applications
- categorical ban
- surprise switcheroo.
- over one million
- appeal to adults as well.
- growing body of scientific evidence
- flavors are crucial to getting adult smokers to make the switch and stay away from combustible cigarettes.
- a number of surveys
- minors are increasingly using flavored [e-cigarettes].
- flavors are crucial to getting adult smokers to make the switch and stay away from combustible cigarettes.
- observational cohort studies had mixed results
- cross-sectional studies that addressed flavor did not do so in a manner t[hat] directly answer[ed] this secondary research question.
- can aid in smoking cessation,
- State of the Science
- there is not enough evidence from well-designed studies to determine whether e-cigarette flavors aid in smoking cessation.
- the most widely used tobacco product among youth by far.
- because they come in flavors I like.
- more palatable for novice youth and young adults, which can lead to initiation, more frequent and repeated use, and eventually established regular use.
- known and substantial risk to youth.
- the removal of one flavored product option prompted youth to migrate to another [product] type that offered the desired flavor options,
- the fundamental role of flavor in driving appeal.
- variability in the popularity of [e-cigarette] device types among youth,
- consisten[cy]
- the role of flavor.
- did not find such evidence
- the same degree of risk of youth uptake.
- the literature does not establish that flavors differentially promote switching amongst [e-cigarette] users in general.
- [F]or the sake of efficiency,
- known risks to youth,
- robust and reliable evidence
- not aware of access restrictions that, to date, have been successful in sufficiently decreasing the ability of youth to obtain and use
- theoretically possible that significant mitigation efforts could adequately reduce youth access and appeal such that the risk for youth initiation would be reduced.
- FDA did in fact look at 'summaries' of [respondent's] marketing plans.
- harmless-error rule simply does not apply
- discretionary administrative decisions
- categorical ban
- de facto ban
- material distinction
- material distinction
- changed its position
- This evidence could have been provided using a randomized controlled trial and/or longitudinal cohort study[.] * * * Alternatively, FDA would consider other evidence[.] * * * We did not find such evidence in your [application].
- randomized controlled trials and longitudinal cohort studies.
- in some cases, it may be possible to support a marketing order
- without conducting new * * * studies.
- if there is an established body of evidence regarding the health impact
- published literature,
- may be sufficient to support
- literature reviews
- are considered a less robust form of support,
- studies may be necessary.
- [T]he evidence regarding the role of flavors in promoting switching among adult smokers is far from conclusive. In fact, the findings are quite mixed and as a result the literature does not establish that flavors differentially promote switching amongst [e-cigarette] users in general.
- randomized controlled trial
- longitudinal cohort study
- known risks
- robust and reliable evidence [wa]s needed regarding the magnitude of the potential benefit to adult smokers.
- This evidence could have been provided using a randomized controlled trial and/or longitudinal cohort study[.]
- would consider other evidence
- reliably and robustly evaluated the impact
- did not find such evidence
- even a cursory read
- over time.
- flavored product[s]
- unflavored products
- bridging
- other flavors * * * in the same flavor category (e.g., 'fruit').
- draw inferences about flavored products
- scientific studies involving unflavored products.
- the impact of the new flavored [products].
- bridg[e]from studies based on comparable products.
- one of [its] flavors
- specify the * * * scientific goal line
- literature reviews involving non-flavored products
- the public health benefits of flavored e-cigarettes,
- fair notice
- fair notice
- not only must its understanding of the [guidance] be reasonable, but the manufacturers' understanding of those rules also must be unreasonable.
- could be reasonably read
- certainly could be read in good faith the way
- decide all relevant questions of law
- [F]or FDA to prevail,
- marketing plans were 'critical' to the success of e-cigarette applications.
- [r]estrictions on advertising and promotion,
- not advertising on billboards located within 500 feet of any elementary or secondary schools.
- [b]ecause these restrictions are intended to curb youth appeal but do not directly prevent youth use, they do not in themselves provide enough assurance of a sufficient reduction in youth use to mitigate the substantial risk that flavored [e-cigarette products] pose to youth.
- these restrictions do not by themselves mitigate the high risk to youth posed by flavored [e-cigarettes] to a degree material enough to establish that a product is [appropriate for the protection of public health] in the absence of robust and reliable evidence of benefit to adults.
- This is because youth have been able to obtain products, including flavored [products], despite sales restrictions.
- [r]estrictions on sales access,
- requiring ageand identity-verification prior to selling products
- called for their products to be sold only in age-gated vape and specialty tobacco shops and through age-gated online sales.
- But FDA has already explained that such attempts do not work.
- [N]othing in [respondents'] briefing to [the Fifth Circuit] indicate[d]that their marketing plan was in fact unique.
- APA errors are only harmless where the agency would be required to take the same action no matter what. In all other cases, an agency cannot avoid remand.
- [i]n administrative law, the harmless error rule is quite narrow.
- narrow
- [i]n administrative law,
- did not matter
- would not affect the agency's decisionmaking.
- cannot forgive procedural violations simply because the court thinks they did not matter
- look past the error on the supposition that the error would not affect the agency's decisionmaking.
- the preference for device types and popularity of certain styles is likely fluid,
- shift[ed]
- a ten-fold increase
- disposable flavored [e-cigarettes].
- the removal of one flavored product option prompted youth to migrate to another [device] type that offered the desired flavor options, underscoring the fundamental role of flavor in driving appeal.
- the removal of one flavored product option prompted youth to migrate to another [product] type that offered the desired flavor options,
- the fundamental role of flavor in driving appeal.
- which were most appealing to youth at the time.
- categorical ban
- de facto ban on flavored e-cigarettes
- across-the-board ban on all flavored products.
- pretended otherwise,
- de facto ban on flavored e-cigarettes.
- de facto ban.
- across-the-board ban on all flavored products.
- as the known risks increase, so too does the burden of demonstrating a substantial enough benefit.
- In order for marketing of a new flavored [e-cigarette] product to be found [appropriate for the protection of the public health], an applicant would have to show that the significant risk to youth could be overcome by likely benefits substantial enough such that the net impact to public health would be positive[.]
- insufficient to demonstrate that these products would provide an added benefit that is adequate to outweigh the risks to youth.
- across-the-board ban.
- to explain why * * * it approved menthol products
- how [FDA] could rationally approve menthol products while denying [respondents'] flavored products.
- FDA ha[d] approved menthol-flavored e-cigarette products notwithstanding its ban on 'flavored' products.
- FDA ha[d]not approved any [applications] for menthol-flavored [e-cigarette] products
- [a]vailable data
- few non-tobacco users,
- including youth,
- would be likely to choose to start using
- approach to the [appropriate for the protection of the public health] analysis for mentholflavored
- [y]outh use of menthol [products] is greater than tobacco flavor, but lower than other flavors such as candy, desserts, and sweets.
- the effectiveness of a product in promoting switching among smokers arises from a combination of its product features,
- [i]n April 2019, FDA authorized the marketing of a menthol-flavored IQOS heat-not-burn cigarette product.
- used the term 'e-cigarette products' as a catch-all term to refer to a wide array of products,
- Pink Lemonade,
- Rainbow Road,
- Chewy Clouds Sour Grape,
- Jimmy The Juice Man Peachy Strawberry.
- Cloud Science Alpha,
- [s]imilar to cotton candy,
- Cloud Science Epsilon,
- delivers the memorable taste of your favorite little rainbow fruit candies.
- Crème Brulee,
- Killer Kustard,
- Strawberry Parfait,
- Suicide Bunny Mother's Milk and Cookies.
- in a Coalition with other, similarly situated e-liquid companies
- important insight into the impact of [flavored e-liquids] on public health.
- no conclusions can be made about the association of e-cigarettes flavors and smoking cessation as there have not been enough studies investigating this research question.
- no conclusions can be made about the association of e-cigarettes flavors and smoking cessation.
- would not be sufficient to address youth use of these products.
- how the product was sold
- enforcement priorities for flavored [e-cigarette] products.
- [F]ocusing on how the product was sold would not be sufficient.
- Suicide Bunny Mother's Milk and Cookies,
- Jimmy The Juice Man Peachy Strawberry,
- seem designed to have appeal for kids.
- the types of information an applicant should include
- Ideally,
- will include studies conducted using the new tobacco product.
- [i]deally
- studies conducted using the new tobacco product,
- bridging of data from one product to another may be feasible
- additional information
- to strengthen the likelihood
- adult smokers to make the switch and stay away from [conventional] cigarettes.
- comprehensive review of the scientific literature,
- considered a less robust form of support,
- in general, FDA does not expect that applicants will need to conduct long-term studies to support an application.
- studies that are conducted over six months or longer.
- long-term health impacts.
- [I]nstead of conducting [new] clinical studies that span months or years,
- applicants could demonstrate possible long-term health impact
- extrapolating from short-term studies
- existing longer duration studies in the public literature
- robust and reliable evidence
- the trends by which users consume the product over time,
- surveys.
- why the data used are applicable to [the] new tobacco product.
- unique studies for each nicotine concentration
- may be bridged to other concentrations,
- justification
- the attractiveness of flavors to youth and young adults,
- impact of the flavoring
- adult appeal of such flavors.
- This is not a formal dissemination of information by FDA and does not represent Agency position or policy.
- d[id] not represent Agency position or policy,
- change in [FDA's] position,
- [n]o specific studies are required.
- scientific goal line
- literature reviews involving non-flavored products
- the public health benefits of flavored e-cigarettes
- does not establish any rights for any person and is not binding on FDA or the public.
- Contains Nonbinding Recommendations.
- recommend[ed] sharing your marketing plan.
- vigorously enforc[ing]
- age verification alone is not sufficient to address this issue.
- mystery shopper programs
- contractual penalties
- age-verification technology
- the quantity of [e-cigarette] products that a customer may purchase within a given period of time.
- surge in youth use of [e-cigarette] products.
- alarming data
- youth use of [e-cigarette] products,
- show[ed] that the FDA's enforcement efforts to date did not adequately address this problem.
- The reality [wa]s that youth
- continued access to [e-cigarette] products in the face of legal prohibitions and even after voluntary actions by some manufacturers.
- [F]ocusing on how the product was sold would not appropriately address youth use.
- [A]ge verification alone is not sufficient to address this issue, given the most recent data that youth use of [e-cigarette] products continues to increase.
- required to take the same action no matter what.
- [f ]lavored, cartridge-based [e-cigarettes].
- small, enclosed unit,
- pod.
- youth overwhelmingly prefer[red] cartridge-based [e-cigarette] products.
- relatively small size
- easy to conceal
- used discreetly.
- intuitive and convenient features
- there are no settings to change and very little assembly is required.
- variability in the popularity of device types among youth,
- applications for about 55,000 flavored [ecigarette] products
- three applicants.
- sensory and subjective experience (taste, throat hit, nicotine delivery),
- how the device itself looks and feels.
- flavored product