Articles by mjlst

Contracting Babies: The Dark Side of Surrogacy and the European Union’s Recent Condemnation of the Practice

February 23, 2026
EU Law, Health Law, Reproductive Health

Rachel King, MJLST Staffer

Introduction

In January 2026, Meghan Trainor (Trainor) took to Instagram to reveal the birth of her third child, Mikey Moon Trainor, a baby born via surrogate.[1] Surrogacy is the process in which someone (the “surrogate”) carries and delivers a child for a couple or an individual (the intended parent(s), or “IPs”).[2] This process occurs through in vitro fertilization (IVF), an assisted reproductive technology where doctors create and implant an embryo into a surrogate.[3]

Almost immediately, Trainor was met with intense criticism about the ethics of her choice, with some calling her baby “her most recent purchase,” and others commenting on Reddit: “surprise: meghan trainer [sic] is a piece of shit.”[4] Although surprising to some, this is only the most recent public uproar against the practice of surrogacy. Lily Collins, Anderson Cooper, and Kim Kardashian are other celebrities who have similarly sparked online debate about the ethics of surrogacy.[5]

History of Surrogacy

Since the practice of modern surrogacy began in the 1970s, there has been extensive debate about whether surrogacy is an ethical practice that should be condoned in any circumstance.[6] Many of these debates highlight the autonomy of the surrogates, the enforceability of surrogacy contracts, whether the benefits of surrogacy outweigh the inherent risks, and whether those risks are evenly distributed between the surrogate and the IPs.[7] These debates highlight that while surrogacy can be an incredibly positive thing for IPs, there is some discomfort in placing monetary value on the ability of a surrogate to have a healthy child. Given that the European Union (EU) recently passed a resolution condemning surrogacy, it is unlikely these debates will end any time soon.[8]

The EU Condemns Surrogacy

In November 2025, the European Parliament convened to discuss the moral and ethical implications of surrogacy following the EU’s complete condemnation of the practice earlier that month.[9] The EU’s condemnation of surrogacy was in response to a UN report which discussed the human rights violations happening as a result of the global surrogacy market. Specifically, the report highlights increased instances of human trafficking, as women across the world are lured into surrogacy agencies that keep them in confinement, confiscate passports, and force reproductive labor.[10] The report likens these practices to slavery, as these agencies exercise ownership over the surrogates’ bodies and severely limit their freedom of movement and autonomy.[11]

Surrogacy Contracts

The UN report further highlighted the issues with surrogacy contracts, which can require the surrogates to waive their right to make medical decisions about their own bodies, entitle IPs to constant surveillance over the surrogate’s life and movements, and often involve unequal bargaining power; even in the best situations.[12]

These issues are well exemplified in a story reported on by Wired about a surrogate contracted in the United States whose baby died in utero.[13] Believing the surrogate mother responsible for the baby’s passing, the IPs sued the surrogate, launched a public smear campaign against her, disclosed her private health information online, and are refusing to pay for the medical treatments she received while pregnant, causing the surrogate severe financial strain.[14] Additionally, the surrogate faces ongoing and intense trauma from her health complications and the passing of the child.

This story speaks to the fundamental imbalances in surrogacy contracts:

When a surrogate breaks contract, her IPs can stop paying her and stop paying the medical bills for her pregnancy. But if an IP breaks contract—say, by sharing their [surrogate’s] private information online or withholding compensation—a [surrogate] typically has to hire a lawyer. No matter what, IPs get the baby at the end.[15]

Although it could be debated whether these exploitative practices are present in all surrogacy arrangements, the UN report claims that no legislation nor international human rights treaties could effectively address the exploitation involved in surrogacy, arguing for a full eradication of the practice.[16]

Conclusion

It seems unlikely that the United States will follow suit in condemning the practice of surrogacy, especially since Michigan, Massachusetts, and New York have all legalized the practice within the past five years.[17] But it remains important to keep the dangers of surrogacy in mind when family planning. And although Meghan Trainor’s experience with surrogacy was clearly positive, there’s still a long way to go before it’s a safe practice for everyone.[18]

 

Notes

[1] Leyla Mohammed, After Her Third Child Announcement Sparked a Load of Discourse, Meghan Trainor has Explained Why She and Her Husband Opted for Surrogacy, BuzzFeed (Jan. 22, 2026), https://www.buzzfeed.com/leylamohammed/meghan-trainor-explains-why-she-chose-surrogacy.

[2] Surrogacy, Yale Med., https://www.yalemedicine.org/conditions/gestational-surrogacy.

z Id.; In Vitro Fertilization (IVF), Mayo Clinic, https://www.mayoclinic.org/tests-procedures/in-vitro-fertilization/about/pac-20384716 (last visited Feb. 20, 2026).

[4] (@Timely_Guitar_881), Reddit (Jan. 23, 2025), https://www.reddit.com/r/popculture/comments/1qkmb4i/meghan_trainors_picture_lays_bare_the_cruelty_of/; Victoria Smith, Meghan Trainor’s Picture Lays Bare the Cruelty of Surrogacy, Telegraph (Jan. 23, 2026, 7:00), https://www.telegraph.co.uk/news/2026/01/23/meghan-trainor-picture-lays-bare-the-cruelty-of-surrogacy/.

[5] Martha Gill, Sorry, Lily Collins, but When People Outsource Childbirth, Their Motives Really Count, Guardian (Feb. 8, 2025, 14:30), https://www.theguardian.com/commentisfree/2025/feb/08/sorry-lily-collins-but-when-people-outsource-childbirth-their-motives-really-count; Youha Kim, Consent, Commodification, and Anderson Cooper’s Surrogacy Case, Prindle Post (June 18, 2020), https://www.prindleinstitute.org/2020/06/consent-commodification-and-anderson-coopers-surrogacy-case/;

Ali Rosen, Surrogacy is Misunderstood and Unfairly Maligned. We Need to Change the Narrative, Washington Post (Jan. 24, 2020), https://www.washingtonpost.com/lifestyle/2020/01/24/surrogacy-is-misunderstood-unfairly-maligned-we-need-change-narrative/.

[6] Worldwide Surrogacy Specialists, The History of Surrogacy: A Legal Timeline, Worldwide Surrogacy Specialists LLC (Jan. 8, 2026), https://www.worldwidesurrogacy.org/blog/the-history-of-surrogacy-a-legal-timeline.

[7] See generally, Francoise Shenfield, et al., Ethical Considerations on Surrogacy, 40 Hum. Reprod. 420 (2025).

[8] European Parliament Resolution of 13 November 2025 on the Gender Equality Strategy 2025, Eur. Parl. Doc. 2024/2125 (INI).

[9] Experts Convene at European Parliament to Address Harms of Surrogacy, Following EU Resolution Condemning Practice, ADF Int’l (Nov. 19, 2025), https://adfinternational.org/news/experts-convene-at-european-parliament-to-address-harms-of-surrogacy#:~:text=Experts%20convene%20at%20European%20Parliament,%7C%20November%2019%2C%202025.

[10] U.N. Secretary-General, Violence Against Women and Girls, Its Causes and Consequences, U.N. Doc. A/80/158 (July 14, 2025), [hereinafter “The Report”]; Sarah A Topol, They Answered an Ad for Surrogates, and Found Themselves in a Nightmare, N.Y. Times (Dec. 14, 2025), https://www.nytimes.com/2025/12/14/magazine/fertility-surrogates-trafficking.html.

[11] The Report at 13–14.

[12] Id. at 11.

[13] Emi Nietfeld, The Baby Died. Whose Fault Is It?, Wired (Sept. 3, 2025, 6:00), https://www.wired.com/story/the-baby-died-whose-fault-is-it-surrogate-pregnancy/.

[14] Id.

[15] Nietfeld, supra note 13.

[16] The Report at 17–20, 22.

[17] The Best U.S. States for Surrogacy in 2026, Hatch Fertility (May 6, 2025), https://www.hatch.us/en/blog/best-states-for-surrogacy.

[18] Mohammed, supra note 1.

Legally Speaking, What Even Is a Gaming Console?

February 18, 2026
Video Games

Jacob Heimberger, MJLST Staffer

There is no shortage of ways to play Fortnite. The simplest way would be to play on a computer. If their PC meets the surprisingly reasonable system requirements to run the game, anybody could be blasting through walls and buildings as Sabrina Carpenter teamed up with Godzilla and Homer Simpson.[1] But maybe someone doesn’t own a computer that was made in the past two decades. Fortnite still has them covered. If they have gotten their hands on a relatively modern Xbox, PlayStation, Nintendo Switch, or Steam Deck, they’ll be driving Dodge Ram 1500 TRXs through the K-Pop Demon Hunters as Thanos or Hatsune Miku in no time.[2] If all else fails, the average layperson could even boot up Fortnite on their iPhone or Android.[3] On a cozy Friday night, anybody can cuddle up with their smartphone and drop out of a flying bus as Spider-Man and drop directly into Darth Vader’s martial arts dojo for a quick gunfight. Epic Games has ported their hit game to as many consoles as possible, allowing gamers to access Fortnite regardless of the technology they have on hand.

However, a more pedantic gamer would likely wince at the previous sentence. iPhones and Androids are not recognized as gaming consoles, although they can actually run games.[4] PC gamers are inclined to call sacrilege on anybody who dares propose that their gaming computers are even comparable to even high-performance consoles. This could be confusing to a non-gamer, because if all of these devices can run video games, then what even is a “gaming-console”?

The Ninth Circuit Court of Appeals tried to tackle this question over twenty-five years ago in Sony Computer Entertainment America, Inc. v. Bleem.[5] Here, to resolve a question of intellectual property, the court was challenged to determine what a console game market is composed of. The Ninth Circuit found “console games” distinct from other video games because they are played by loading a disk into a console which is then connected to a television.”[6] This is distinct from “computer games”, which the court defined as any game played by loading a disk into the CD drive of a computer.[7] These definitions were naive for the time, and even more so in the modern day, as games are playable on anything from a mobile to the seat screens on commercial airlines. Nintendo even released “Virtual Game Cards”, directly subverting the idea that video games require a physical disk or cartridge to be considered a console game.[8] Such a restrictive definition of gaming consoles prevents courts from properly identifying the scope of the console market, creating problems for large-scale antitrust litigation in the gaming sphere. For the sake of enforcing healthy competition in gaming markets, a more nuanced definition of a console is necessary.

A more modern legal definition for gaming consoles greatly broadened the scope of what devices may qualify. The Ninth Circuit recently ruled that physical consoles are devices that are designed for, and whose primary use is, to play video games.[9] However, certain PCs and even mobile phones are purchased for the sole purpose of playing games.[10] Despite the similarities, these devices are distinguishable from gaming consoles. Courts have found that gaming PCs typically have more advanced hardware to allow them to play more computationally demanding games.[11] Conversely, mobile games have lower levels of sophistication and graphics than PC or consoles.[12] Beyond its primary use, there seems to be a window of technological prowess that a device needs to fit into before being considered a console. It is easily inferred here that a game console is a device made with the primary purpose of playing video games, which is stronger than a mobile phone but weaker than the average gaming PC.

This is a generally satisfying definition, but a veteran gamer would recognize that a Nintendo Switch is functionally quite different from a modern Xbox or PlayStation. The Switch is portable, has its own screen, and is significantly less powerful hardware than its counterparts.[13] Differences between the three consoles does not matter. Whether a console is fully interchangeable with those of its competitors does not matter because perfect fungibility is not required.[14] Courts use the definition of consoles to help define the boundaries of the competition within video gaming markets.[15] A Nintendo Switch does not need to be replaceable by a PlayStation5 or Xbox in every respect. Rather, the relevant market encompasses the consoles and their respective companies whose presence drives competition, and whose foreclosure may disadvantage it.[16]

There is still room for improvement in this definition. The Steam Deck is functionally a computer which is in the shape of a handheld console.[17] They are widely considered to be PCs, regardless of the fact that they are made with the primary purpose of playing games and have gaming specs more comparable to high-performance gaming consoles like the Switch, Xbox, or PlayStation.[18] Despite checking every box, there is a serious contention that the Steam Deck is not a console.

It is reasonable to assume that as gaming consoles progress in technological prowess, gamers will show the courts which devices are in competition with one another through their purchasing habits. The definition of gaming consoles is in good hands, not necessarily with the courts, but with the gamers.

 

Notes

[1] What Are the System Requirements for Fortnite on PC?, Epic Games, https://www.epicgames.com/help/en-US/fortnite-battle-royale-c-202300000001636/technical-support-c-202300000001719/what-are-the-system-requirements-for-fortnite-on-pc-a202300000012731 (last visited Dec. 29, 2025).

[2] What Platforms or Devices are Compatible with Fortnite?, Epic Games,https://www.epicgames.com/help/en-US/fortnite-battle-royale-c-202300000001636/technical-support-c-202300000001719/what-platforms-or-devices-are-compatible-with-fortnite-a202300000012064 (last visited Dec. 29, 2025).

[3] See generally id.

[4] See Sony Comput. Entm’t Am., Inc. v. Bleem, LLC, 214 F.3d 1022 (9th Cir. 2000).

[5] See generally id.

[6] Id. at 1024.

[7] Id.

[8] Virtual Card Games, Nintendo, https://www.nintendo.com/us/gaming-systems/virtual-game-cards (last visited Dec. 29, 2025).

[9] FTC v. Microsoft Corp., 681 F. Supp. 3d 1069, 1077 (9th Cir. 2025).

[10] Razer, Razer Phone 2 – Flagship, Razer Newsroom (Oct. 10, 2018), https://www.razer.com/newsroom/product-news/razer-announces-the-razer-phone-2; Andrew E. Freedman, Best Gaming Laptops 2026: Tested and Reviewed, Tom’s Hardware (Jan. 9, 2026), https://www.tomshardware.com/laptops/gaming-laptops/best-gaming-laptops.

[11] Microsoft Corp., 681 F. Supp. at 1077.

[12] Id.

[13] Id. at 1086.

[14] Gorlick Distrib. Ctrs., LLC v. Car Sound Exhaust Sys., Inc., 723 F.3d 1019, 1025 (9th Cir. 2013) (citing United States v. E.I. du Pont de Nemours & Co., 351 U.S. 377, 394 (1956)).

[15] In the Matter of Illumina, Inc. and Grail, Inc., No. 9401, 2023 WL 2823393, at *20 (F.T.C. Mar. 31, 2023).

[16] Id.

[17] Tim Brookes, Should You Buy a Steam Deck if You Don’t Have a Gaming PC?, How-To Geek (Dec. 3, 2024), https://www.howtogeek.com/should-you-buy-a-steam-deck-if-you-dont-have-a-gaming-pc/.

[18] Marla Broadway, What Console Is Better Than the Steam Deck?, PC Guide (last updated Nov. 29, 2023), https://www.pcguide.com/steam-deck/what-console-is-better/.

Post-Laidlaw Civil Penalties: Circuit Split or Good-Faith Exception?

February 10, 2026
Climate Change, Constitutional Law, Environmental Law, Litigation

Matthew Agurto, MJLST Staffer

Introduction

Congress enacted the Clean Water Act (“the Act”) in 1972 to restore and maintain the chemical, physical, and biological integrity of the nation’s waters.[1] The Act included remedies for violations, including citizen suits or a suit brought by a citizen alleging a defendant violates the Act, with all fees payable to the United States Treasury.[2] To show standing, a plaintiff must show injury in fact, causation, and redressability.[3] The injury must be to the plaintiff, not the environment or environmental group.[4] This is a low bar; the injury can be merely impeding the view or a bad smell.[5]

The Act authorizes three types of remedies for citizen suits: (1) injunctive relief, (2) civil penalties, and (3) attorneys’ fees.[6] The Act permits an entity to get a National Pollutant Discharge Elimination System (NPDES) permit, enabling it to discharge waste into navigable waters.[7] NPDES permits are issued by the Environmental Protection Agency or approved state agency.[8]

Before filing suit, a citizen must give the violator sixty days’ notice of their intent to file suit, affording an opportunity for the defendant to remedy the problem.[9] If the defendant remedies the problem before filing, the issue is moot.[10] If the violator comes into compliance post-filing, the case is not moot for purposes of attorney fees and civil damages.[11] In such an instance, injunctive relief fails to be an appropriate remedy. Although courts are divided on this issue, a closer examination of the cases suggests a “good faith” exception to the traditional rule for certain violations.

Friends of Earth v. Laidlaw Environmental Services

Laidlaw held that a suit under the Act was moot for injunctive relief if behavior sought to be remedied could not be expected to recur after remedied in the sixty-day notice period.[12] The U.S. Supreme Court left the civil penalties issue for post notice and filing compliance to the district court on remand.[13] Some suggest that a circuit split emerged, as circuits have ruled differently on whether civil penalties are moot for post-filing compliance.[14]

Circuits ruled on materially different issues. Specifically, the Eighth and Ninth Circuits hold that civil penalties are not distinct in cases where the defendant did not have an NPDES permit.[15] Five other circuits hold that civil penalties are distinct in cases where the defendant violated a valid permit.

The Five Circuits Holding Civil Penalties Distinct from Mootness

The Second, Fourth, Seventh, and Eleventh Circuits hold civil penalties distinct from mootness.[16] However, all these cases involve defendants who violated existing permits.[17]

For example, the Second Circuit, in Atlantic States Legal Foundation, Inc. v. Pan American Tanning Corporation, held civil penalties are not extinguished post compliance, as it diminishes the incentive to file a citizen suit.[18] The Second Circuit affirmed this holding post-Laidlaw on deterrence justifications.[19] The Third, Fourth, Seventh and Eleventh Circuits followed on similar grounds, holding that citizens suits lose their effectiveness and deterrence value without civil penalties being imposed for post-filing compliance.[20] This would create a pervasive incentive for violators to stall litigation as and come into compliance at their convenience, which is entirely against the spirit of the Act.

The Ninth and Eighth Circuits Hold a Violator Remedying the Issue Renders it Moot

The Ninth and Eighth Circuits hold civil penalties as distinct from mootness.[21] In Coastal Environment Rights Foundation v. Naples Restaurant Group, Naples Restaurant Group (“Naples”) hosted its Fourth of July Fireworks show, discharging fireworks over water.[22] Naples failed to pay the entire amount for a permit due to an administrative error and promptly remedied the error once notified.[23] The Ninth Circuit did not impose civil penalties against Naples.[24] Similarly, in the Eighth Circuit, in Mississippi River Revival v. City of Minneapolis, the City of Minneapolis applied for discharge permits for waste from its sewage system.[25] Due to administrative delay, the Minnesota Pollution Control Agency failed to provide its permit within a year to comply with the Water Quality Act of 1987.[26] Due to the “good faith” violations, the respective courts did not impose civil penalties on either defendant.[27]

Despite both cases being post-Laidlaw, the facts of these cases differ from the other circuits’ cases, holding civil penalties distinct from Mootness. In these two instances, neither defendant had a permit initially and came into compliance as soon as possible.[28] Violations were not expected to recur, and there was no deterrence benefit.[29]

  1. The Good Faith Exception

Reading the cases in conjunction, there is no circuit split on this issue. Rather, there is a good-faith exception to the rule of imposing civil penalties on entities complying with NPDES permits in the post-notice period. If a party is actively violating its permit, it will face civil penalties. As it serves as a strong deterrent for future violations, this is within the spirit of the Act. However, in cases such as the City of Minneapolis or Naples, there was no intent to pollute; administrative error and delay impeded their ability to comply. A deterrent civil penalty would do nothing to remedy these good-faith violations. Implicitly, courts adhere to the traditional rule of imposing penalties on violators but making an exception for “good faith” violations.

 

Notes

[1] Gwaltney of Smithfield, Ltd. v. Chesapeake Bay Found., Inc., 484 U.S. 49, 52 (1987).

[2] 33 U.S.C § 1365; see also Friends of the Earth, Inc. v. Laidlaw Env’t Servs. (TOC), Inc., 528 U.S. 167, 173 (2000); 33 U.S.C § 1320(d).

[3] Laidlaw, 528 U.S. at 174.

[4] Id. at 168–69.

[5] Id. at 181–82.

[6] Gwaltney, 484 U.S. at 54.

[7] 33 U.S.C. § 1344.

[8] 33 U.S.C. § 1342; NPDES Permit Basics, Env’t Prot. Agency, https://www.epa.gov/npdes/npdes-permit-basics#:~:text=An%20Operator%20must%20submit%20a,federal%20requirements%20at%20a%20minimum (last visited Jan. 23, 2026).

[9] Laidlaw, 528 U.S. at 174–75.

[10] Id. at 189–90 (discussing compliance within the notice period rendering the issue moot).

[11] Id.

[12] Id. at 193.

[13] Id. at 192–94.

[14] Quinn Wilson & Bernie Pazonowski, U.S. Law Week’s November 2025 Circuit Split Review: Labor Rights, Bloomberg L. (Dec. 4, 2025, 4:00am) https://www.bloomberglaw.com/product/blaw/bloomberglawnews/bloomberg-law-news/XEBP2ATO000000.

[15] Coastal Env’t Rts. Found. v. Naples Rest. Grp., LLC, 158 F.4th 1052, 1064 (9th Cir. 2025); Mississippi River Revival, Inc. v. City of Minneapolis, Minn., 319 F.3d 1013, 1018 (8th Cir. 2003) (discussing plaintiffs were not entitled to an award of civil penalties because the cities violation lacking a permit was unavoidable).

[16] Atl. States Legal Found., Inc. v. Pan Am. Tanning Corp., 993 F.2d 1017, 1021 (2d Cir. 1993) (discussing the weakened deterrent effect and diminished incentives for plaintiffs in civil suits under the Act); Nat. Res. Def. Council, Inc. v. Texaco Ref. & Mktg., Inc., 2 F.3d 493, 503 (3d Cir. 1993) (discussing a citizen suit losing its effectiveness and deterrent effect if penalty claims were mooted); Chesapeake Bay Found., Inc. v. Gwaltney of Smithfield, Ltd., 890 F.2d 690, 697 (4th Cir. 1989); Atl. States Legal Found., Inc. v. Stroh Die Casting Co., 116 F.3d 814, 820 (7th Cir. 1997); Atl. States Legal Found., Inc. v. Tyson Foods, Inc., 897 F.2d 1128, 1143 (11th Cir. 1990).

[17] Pan Am Tanning, 993 F.2d at 1018; Texaco Ref. & Mktg., 2 F.3d at 506; Gwaltney, 890 F.2d at 692; Stroh Die Casting, 116 F.3d at 817; Tyson Foods, 897 F.2d at 1142.

[18] Pan Am Tanning, 993 F.2d at 1021.

[19] Bldg. & Const. Trades Council of Buffalo, New York & Vicinity v. Downtown Dev., Inc., 448 F.3d 138, 152 (2nd Cir. 2006).

[20] Pan. Am. Tanning, 993 F.2d at 1021; Texaco Ref. & Mktg., 2 F.3d at 503; Gwaltney, 890 F.2d at 697; Stroh Die Casting, 116 F.3d at 820; Tyson Foods, at 1143.

[21] Coastal Env’t Rts. Found. v. Naples Rest. Grp., LLC, 158 F.4th 1052, 1061 (9th Cir. 2025); Mississippi River Revival, Inc. v. City of Minneapolis, Minn., 319 F.3d 1013, 1014 (8th Cir. 2003).

[22] Naples, 158 F.4th at 1055.

[23] Id. at 1060–61.

[24] Id. at 1061.

[25] City of Minneapolis, 319 F.3d at 1015.

[26] Id. at 1017.

[27] Id. at 1018; Naples, 158 F.4th. at 1064.

[28] Coastal Env’t Rts. Found. v. Naples Rest. Grp., LLC, 158 F.4th 1052, 1061 (9th Cir. 2025); Mississippi River Revival, Inc. v. City of Minneapolis, Minn., 319 F.3d 1013, 1017–18 (8th Cir. 2003).

[29] City of Minneapolis, 319 F.3d at 1017; Naples, 158 F.4th at 1064.

Proposed Rule of Evidence 707: Machine Experts

January 26, 2026
Artificial Intelligence, Evidence

Autumn Zierman, MJLST Staffer

Citing concerns about the lack of reliability and authenticity of machine-generated evidence, the Advisory Committee on Evidence Rules (“the Committee”) published its Proposed Rule 707 (“Rule 707”) last June. Rule 707 seeks to address those instances when AI evidence is presented in court without human expert accompaniment.[1] Rule 707 intends to hold artificial intelligence that created evidence to the same standards as human experts (the Daubert standard).[2] The proposed rule is: “When machine-generated evidence is offered without an expert witness and would be subject to Rule 702 if testified by a witness, the court may admit the evidence only if it satisfies the requirements of Rule 702(a)-(d).”[3] With the notice and comment period ending on February 16th, 2026, time remains to review (and comment on) the Committee’s plan.

Susceptibility of Training Data to Flaws

The first flaw in Rule 707 is that it requires judges to become arbiter experts on the reliability of training data. The proposed rule requires courts to determine whether a machine can demonstrate reliability in how it is trained.[4] Problematically, most openly available machine learning tools or AI that may be used to generate court testimony are black box systems.[5]

The “black box” is the data set the AI is trained on to build a system capable of generating autonomous results or simulating thought.[6] It is, by design, impossible to explain how a black box system arrives at its decisions.[7] But black box systems are known to perpetuate the implicit bias of their creators because the data sets they are given to train from are inherently skewed.[8]

Certainly, the argument may be made that machines are less likely to be biased than their human expert counterparts. This argument misses a core objective of our adversarial system; juries are asked to evaluate evidence given in court for its reliability.[9] Experts may be impeached; but how do you impeach a system you know nothing about?

Possible Confrontation Clause Challenge

Considering the nature of the adversarial system, Rule 707 also raises questions regarding the Confrontation Clause. The Sixth Amendment guarantees the right of all accused to “be confronted with the witnesses against him.”[10] This manifests in a right of the accused to cross-examine the State’s witnesses against them, which requires the physical presence of a witness at the criminal trial.[11] This requirement extends, in many cases, to the experts the State relies upon in building its case.[12]

Imagine, then, the State seeks to introduce a composite sketch created by a machine with information given in witness interviews.[13] The sketch does not just assist in the investigation—it lends legitimacy to the investigation’s result. But, where a sketch artist may be cross-examined and evaluated in front of a jury, there is no way to examine the machine for the inherent bias it holds to create such a sketch. There is no way for a machine to present itself in fulfillment of the Confrontation Clause.

This flaw goes to the heart of the problem with Proposed Rule 707; it treats machines as replacements for human witnesses. Regardless of the potential machines hold for generating evidence, they cannot replace the human element that the trial system seeks to preserve.

Invitation Not a Warning

The Committee has prefaced Rule 707 as “not intended to encourage parties to opt for machine-generated over live expert witnesses.”[14] However, clever lawyers seeking a statistically based argument will view the rule as another means by which to support their client’s case. Thus, the proposed rule cuts with a double edge, either courts bury themselves having to test the reliability of each piece of AI evidence offered, or they will provide standards for broad acceptance, which opens the door to a surplusage of AI-generated evidence.

In its comment on the proposed rule, the Lawyers for Civil Justice opine that “[c]ourts and lawyers will read this as authorization, not as a hurdle or prohibition. The permissive language—‘the court may admit’—signals achievability, not restriction.”[15]

Conclusion

Rule 707 seeks to address a rising problem, reliability of AI evidence in the courtroom. But it relies on a human standard for a nonhuman problem—which opens the door to a plethora of problems arising at trial.

 

Notes

[1] Comm. on Rules of Prac. & Proc., Agenda Book, 76 (June 10, 2025), https://www.uscourts.gov/sites/default/files/document/2025-06-standing-agenda-book.pdf.pdf [hereinafter “Agenda Book”].

[2] Federal Rule of Evidence 702(a)-(d) is usually applied through Daubert analysis, which considers the following five factors: whether the theory/technique employed has (i) been tested; (ii) been subjected to peer review; (iii) an acceptable error rate; (iv) established standards controlling it’s application; and (v) is generally accepted in the scientific community. See generally Daubert v. Merrel Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).

[3] Agenda Book at 76.

[4] Id. at 77.

[5] Matthew Kosinski, What Is Black Box AI and How Does It Work?, IBM (Oct. 29, 2024), available at https://www.ibm.com/think/topics/black-box-ai.

[6] Id.

[7] Id.

[8] See James Holdsworth, What Is AI Bias?, IBM, https://www.ibm.com/think/topics/ai-bias (last visited Jan. 20, 2026); See also Lou Blouin, Can We Make Artificial Intelligence More Ethical?, Univ. of Mich.-Dearborn (June 14, 2021), https://umdearborn.edu/news/can-we-make-artificial-intelligence-more-ethical.

[9] Fed. R. Ev. 1008.

[10] U.S. Const. amend. VI.

[11] See generally Crawford v. Washington, 541 U.S. 36 (2004).

[12] See generally Bullcoming v. New Mexico, 564 U.S. 647 (2011) (requiring the lab technician responsible for generating a report to be present at trial for cross-examination).

[13] Kim LaCapria, Police Raise Eyebrows After Using ChatGPT to Create Composite Sketches of Suspects: ‘No One Knows How [It] Works’, The Cool Down (Dec. 10, 2025), https://www.thecooldown.com/green-business/ai-generated-police-sketch-chatgpt/.

[14] Agenda Book at 75.

[15] Lawyers for Civil Justice, Comment Letter on Proposed Rule to Proposed Rule 707 (Jan. 5, 2026), https://www.regulations.gov/comment/USC-RULES-EV-2025-0034-0013.

The Rise of the Tea App: What to Do if You’re Defamed

December 22, 2025
Internet, Social Media, Torts Law

Kate Neill, MJLST Staffer

Introduction

The Tea App has exploded in popularity in the past year as a place for women to anonymously share their experiences with men they have dated or matched with online. The app was launched in 2023 as a “women-only dating safety net” for those navigating the modern dating scene.[1] To gain access to the platform, users must first submit a photo as proof of their gender. Once approved, users can anonymously share photos of men, soliciting comments from other women warning them of potential “red flags.” Platforms allowing women to crowdsource information on potential partners are not a novel concept; in fact, Facebook groups such as “Are We Dating the Same Guy” have existed for years. However, the rapid-growing popularity of the tea app has raised legal controversy, and several law firms now advertise representation for men believing they have been targeted by defamatory posts.[2]

Why it Resonates: The Modern Dating Landscape

Information-sharing groups have grown out of necessity as dating has radically changed in the 21st century. Most people have seen a now-famous graph tracing how couples met over time: meeting through mutual friends used to dominate, while today that category has plummeted as dating apps have skyrocketed.[3] Putting aside whether this shift is good or bad, it undeniably changes the safety dynamics in dating. When your date came recommended by a friend, you had informal assurances about their character and background. Today, the norm is going out with someone who is, essentially, a complete stranger thanks to online dating. Whatever the benefits of digital dating, this erosion of social vetting introduces new vulnerabilities. With this new risk, it’s no surprise that women are turning back to the internet to find out who exactly they’re getting involved with.

Many women argue that anonymous platforms such as the Tea App create a necessary safe space to share about harmful dating experiences without fear of retaliation.[4] Considering online dating looks a lot like the wild west, this is an understandable perspective. However, anonymous information sharing through social media inevitably opens the door to ill-intended revenge plots and false rumors. The Tea App has just as quickly become a vehicle for defamatory statements that cause reputational harm.

Legal Stakes: When Posts Become Defamation

Posts that make a false statement of fact about an identifiable person that harms their reputation may rise to the level of defamation. Proving a post constitutes defamation requires (1) the statement is presented as a fact (not an opinion), (2) the post is conveyed to a third party (shared to the platform for other users to see), (3) made with some degree of fault (negligence for private individuals and “actual malice” for public figures), (4) and causes demonstrable reputational harm.

Therefore, posts that say “I felt unsafe on my date” are opinions, and not considered defamation. But, if a user makes an untrue factual allegation, there are potential legal ramifications. For example, multiple lawsuits arose in the state of Michigan after a young man was accused of rape on the Tea App.[5] Criminal allegations represent the type of posts ripe for litigation, though these lawsuits are generally considered an uphill battle for plaintiffs. The anonymity of the Tea App is an added barrier for proving defamation because it complicates the fault analysis.[6] Tracing the original poster can require cooperation from the platform or even subpoenas.

What to Do if You Believe You’ve Been Defamed

Section 230 of the Communications Decency Act provides broad immunity for online platforms for content posted by their users.[7] Section 230 provides an effective legal shield for the Tea App to avoid defamation lawsuits targeting the app. Despite the platform itself being protected, those harmed by content posted on the Tea App may be able to take legal action against the individual user who posted the harmful content to the protected app.[8]

If you believe you have been defamed on the Tea App, consider taking the following action:

  1. Preserve Evidence: Screenshot posts before they are deleted or removed. Evidence existing on social media can quickly vanish, so work with a trusted friend to gain access to the app (in the case of men unable to access the Tea App) and document everything including the harmful posts, users accounts, and timestamps.[9]
  2. Request Removal: File a removal request through the app’s reporting process. The Tea App has policies against defamatory content, and the platform purports to remove content that violates these guidelines.[10] If attempts directly through the app are unsuccessful, you can file a complaint directly through the Apple App Store.[11] Because posts often include photos taken from your social media accounts, this strategy involves a copyright infringement claim. Apple will in turn put pressure on the platform to remove the harmful or infringing content.[12]
  3. Consult an Attorney: Especially if posts allege criminal conduct, use your full identity, or cause employment or social consequences, consider seeking legal advice. Experienced attorneys can help ensure post removal and determine if posts meet the legal requirements for defamation.[13]
  4. Consider a Defamation Action: In serious cases, you may be able to assert your rights through a defamation lawsuit.[14] However, keep in mind that identifying users may require a time-consuming legal process and cooperation with the platform.

Conclusion

The rise of the Tea App reflects changes in how we date and how we protect ourselves in the real world. Crowdsourced information is important for protecting women, but information-sharing comes with responsibility. If something false and harmful is attached to your name, you are not powerless. Preserve evidence, request removal, and speak with counsel if necessary. Ultimately, the goal on all sides is to foster a safe, honest dating environment to bring back real-world connection in the digital age.

[1] The Tea App: From Safety Haven to Legal Showdown, Henderson, Goldberg & DeMarco LLP, https://www.hgdlawfirm.com/blog/the-tea-app-from-safety-haven-to-legal-showdown/ (last visited Dec. 15, 2025).

[2] See, e.g., Minc Law, Tea App Defamation: What to Do If You’re Defamed on the Tea App, MincLaw.com, July 25, 2025, https://www.minclaw.com/tea-app-defamation/.

[3] Michael J. Rosenfeld et al., Disintermediating Your Friends: How Online Dating in the United States Displaces Other Ways of Meeting, 116 Proc. Nat’l Acad. Sci. 17753, Fig. 1 (2019), https://doi.org/10.1073/pnas.1908630116.

[4] See e.g., Jacqui Wakefield, My Ex Stalked Me, So I Joined a ‘Dating Safety’ App. Then My Address was leaked, BBC (Aug. 22, 2025), https://www.bbc.com/news/articles/ce87rer52k3o; Scarlett Dempsey, Tea Dating Safety App: Is it Really Worth Spilling the Tea?, Cardinal Times (Dec. 11, 2025), https://cardinaltimes.org/26725/news/tea-dating-safety-app-is-it-really-worth-spilling-the-tea/.

[5] Kara Berg, Tea App Dating Advice Users Face Defamation Lawsuits Over Posts, but Plaintiffs Face Uphill Fight, Detroit News (Aug. 18, 2025), https://www.detroitnews.com/story/news/local/michigan/2025/08/18/tea-app-dating-advice-users-face-defamation-lawsuits-over-posts-women-date-safely-men-insults/85615891007/?gnt-cfr=1&gca-cat=p&gca-uir=true&gca-epti=z117354p004850c004850d00—-v117354d–40–b–40–&gca-ft=208&gca-ds=sophi.

[6] Melisa Zukic & Abdurrahman Zukic, Defamation Law and Media: Challenges of the Digital Age, 5 Map Educ. & Human. 98, 105 (2024), https://scispace.com/pdf/defamation-law-and-media-challenges-of-the-digital-age-34zg2lhy2pks.pdf.

[7] Communications Decency Act of 1996, 47 U.S.C. § 230 (2025).

[8] Zukic & Zukic, supra note 6.

[9] Minc Law, supra note 2.

[10] Id.

[11] Id.

[12] Id.

[13] Id.

[14] The Tea App: From Safety Haven to Legal Showdown, Henderson, Goldberg & DeMarco LLP, https://www.hgdlawfirm.com/blog/the-tea-app-from-safety-haven-to-legal-showdown/ (last visited Dec. 15, 2025).

The EU’s Proposed Space Act Signals a New Era Controversial Space Regulation

December 9, 2025
EU Law, International Law, Space Law

Harper Bischoff, JLST Staffer

The European Union’s proposed Space Act has emerged as an early indicator of how the United States and Europe will approach the regulation of commercial space activity.[1] In public statements, the U.S. has expressed “deep concern” that the Act would create barriers for major American satellite operators and place a disproportionate burden on companies that deploy large constellations.[2] Several of the Act’s requirements would apply to any operator whose services reach users in Europe, even when the operator has no physical presence there.[3] As a result, American companies that dominate the market for large satellite networks, especially SpaceX and Amazon, would face new obligations that do not affect most existing European systems.[4] The Space Act represents a major shift in how commercial space activities are regulated, and the response by the U.S. and major corporate players will set the tone for a new era of regulation.

This growing divide places pressure on an international legal system that was not designed for today’s commercial environment.[5] The primary treaty governing space activities, the Outer Space Treaty (“OST”), was drafted in 1967 when only states launched satellites.[6] Its provisions focus on broad principles such as freedom of access, avoidance of harmful contamination, and state responsibility for national space activities.[7] The Liability Convention of 1972 expands on these duties, but it was also written for a world in which governments controlled nearly all space operations and private activity was rare.[8]

Contemporary space commerce looks nothing like that world. Modern operators manage thousands of satellites, engage in continuous launches, and pursue new activities such as commercial space stations, in-orbit servicing, resource extraction, and space tourism.[9] These developments expose the blatant gaps in the current treaty system. Concepts such as “damage” and “fault” lack detailed definitions for modern satellite operations, and the existing treaties contain no clear dispute resolution process for conflicts involving private companies.[10] The rapid growth of commercial activity has therefore outpaced the international rules that govern it, leaving states and operators to manage risks through national or regional regulation.[11]

The European Commission introduced the draft Act in June as a response to longstanding problems in European space regulation.[12] Today, satellite operators must contend with a fragmented set of national requirements for licensing, debris mitigation, and cybersecurity.[13] The Commission describes the new proposed legislation as an effort to promote “safety, resilience, and sustainability” across the European market by replacing this patchwork system with one coherent set of rules.[14] The goal is to establish consistent standards for operators that already view Europe as a unified market for broadband, navigation, and Earth observation services.[15]

Much of the United States’ concern centers on the Act’s treatment of what the Commission calls giga constellations.[16] These are systems with more than one thousand satellites, a category that the current market fills almost entirely with American operators.[17] Starlink has more than eight thousand active satellites and plans for far more, while Amazon’s Project Kuiper expects to deploy a constellation of several thousand satellites.[18] European constellations are far smaller.[19] The U.S. argues that the Act’s rules would therefore have a “selective effect” and risk limiting the competitiveness of American companies in Europe.[20]

Europe’s motivation is different. While the U.S. views these provisions as disproportionately burdensome, Europe approaches the issue from a different perspective. The Space Act is part of a broader effort to establish clear rules in sectors that are crucial to economic and strategic policy.[21] Recent European concerns about geopolitical uncertainty, including debates over U.S. security commitments and trade policy, have encouraged the Commission to strengthen European capabilities and reduce reliance on non-European providers.[22] In that context, the Space Act is both a regulatory project and a strategic one.

The draft Act introduces several requirements that drive this reaction. For instance, constellations with ten or more satellites must have propulsion or similar maneuvering capabilities that allow active collision avoidance.[23] This requirement reflects European concern about congestion in low Earth orbit.[24] Another concern is that operators planning to launch constellations between ten and ninety-nine satellites may apply for a single consolidated authorization, but only if every satellite is identical and launched under the same mission plan.[25] Modern American systems often rely on varied satellite designs and staggered launches, which makes it unlikely that they could use this streamlined pathway.[26]

The Act also extends to operators outside Europe whose services reach European users. These providers must obtain an EU license and designate a legal representative in Europe, even if the operator does not own the hosting satellite or ground systems.[27] As a result, hosted payloads arrangements and telemetry or tracking services fall within the Act’s reach, which complicates the allocation of compliance obligations between the payload operator and the owner of the satellite.[28]

The United States argues that these provisions create unnecessary barriers to an industry that is still being heavily developed.[29] In its consultation comments, the United States stated that the Act does “not take into account that space operations are still relatively new and novel” and that strict regulation could slow innovation at a time when the private sector is driving much of the growth in satellite technology.[30] American officials also warned that the Act could undermine cooperation within NATO by creating regulatory hurdles for United States commercial firms that currently support allied operations and communications.[31]

The EU Space Act should be understood in light of the preceding information. Europe is attempting to create a regulatory framework for a market that is expanding faster than the international legal system can accommodate.[32] The U.S., in turn, is seeking to protect the innovations of domestic companies from obligations that it views as costly and asymmetrical.[33] Both positions reflect legitimate concerns, yet without coordination, the result may be two divergent regulatory systems that shape how commercial operators design and deploy their satellites.[34]

What is clear is that the Space Act debate reveals a notable shift in the commercial space industry. Space governance is no longer driven exclusively by multilateral treaties. Instead, it is increasingly defined by regional regulatory choices that reflect different priorities for innovation, environmental protection, security, and market access. Whether this leads to cooperation or fragmentation will depend on whether the U.S and the EU can reconcile their approaches as commercial activity continues to expand.

 

Notes

[1] See Clément Evroux, Commission Proposal for EU Space Act, at 9, Eur. Parliamentary Rsch. Serv., June 25, 2025, https://www.europarl.europa.eu/RegData/etudes/BRIE/2025/775922/EPRS_BRI(2025)775922_EN.pdf (noting that U.S. analysts fear EU space law could set global standards affecting commercial operators; early scrutiny shows divergent regulatory approaches to orbit commercialization).

[2] Sam Clark, US Slams EU’s Proposed Space Law as ‘Unacceptable’, Politico, Nov. 5, 2025, https://www.politico.eu/article/us-slams-eus-proposed-space-law-as-unacceptable/.

[3] The Proposed EU Space Act: 10 Key Implications U.S. and Non-EU Satellite Operators Should Know, Cooley, July 24, 2025, https://www.cooley.com/news/insight/2025/2025-07-24-the-proposed-eu-space-act-10-key-implications-us-and-non-eu-satellite-operators-should-know.

[4] Tomorrow’s Aff. Ed. Bd., Space as a New Regulatory Dividing Line Between the EU and the US, Nov. 13, 2025, https://tomorrowsaffairs.com/space-as-a-new-regulatory-dividing-line-between-the-eu-and-the-us.

[5] See Inesa Kostenko, Current Problems and Challenges in International Space Law: Legal Aspects, 5 Adv. Space L. 48, 53–54 (“Today those founding treaties of Space Law find many issues unaddressed . . . the old rules and customs need their renewal today.”).

[6] Treaty on Principles Governing the Activities of States in the Exploration and Use of Outer Space, including the Moon and Other Celestial Bodies, Jan. 27, 1967, 18 U.S.T. 2410 [hereinafter Outer Space Treaty or OST]. See also International Space Law Explained, United Nations, https://www.un.org/en/peace-and-security/international-space-law-explained, (last visited Nov. 16, 2025) (explaining that the OST was written during a period when space activities were exclusively conducted by nation-states, prior to the rise of commercial actors).

[7] See OST, supra note 6, art. IX. & VI. See also Kostenko, supra note 5, at 50 (“Outer space and celestial bodies are free for exploration, and use by all States in conformity with international law and are not subject to national appropriation.”).

[8] Trevor Kehrer, Closing the Liability Loophole: The Liability Convention and the Future of Conflict in Space, 20 Chi. J. Int’l L. 178, 188 (2019), https://cjil.uchicago.edu/print-archive/closing-liability-loophole-liability-convention-and-future-conflict-space (noting that the Convention was designed during a time when states, not private entities, dominated space operations).

[9] See Matthew H. Ormsbee & Harine Raaj, Precise Operations, Imprecise Laws: How Nebulous Laws Wreak Havoc in Outer Space, 20 Wash. J.L. Tech. & Arts 1 (2025) (explaining that “[t]he emergence of space tourism, proposals for asteroid mining, and plans for private space stations further underscore the expanding role of commercial entities in space”).

[10] See id. at 33–34 (describing how the OST and Liability Convention lack clarity on liability apportionment, supervision of private actors, and dispute resolution processes involving commercial space companies).

[11] Id.

v See Evroux, supra note 1, at 2–3 (explaining that the draft Act responds to fragmented national approaches to space law and aims to harmonize regulation across the EU).

vi See generally Ormsbee & Raaj, supra note 9 (noting that national regulations on commercial space activities are inconsistent across licensing, debris mitigation, and operational oversight).

[14] Tomorrow’s Aff. Ed. Bd., supra note 4.

[15] Id.

[16] Id.

[17] Id.

[18] Id.

[19] See Jean-Pierre Diris, IRIS2: Everything You Need to Know About This New European Constellation, Polytechnique Insights, Mar. 11, 2025, https://www.polytechnique-insights.com/en/columns/industry/iris2-everything-you-need-to-know-about-this-new-european-constellation/ (describing IRIS2, the EU’s flagship project that will deploy fewer than 300 satellites compared to Starlink’s tens of thousands and Kuiper’s projected 3,200).

[20] See Tomorrow’s Aff. Ed. Bd., supra note 4 (explaining that the Act’s technical requirements for large constellations apply almost exclusively to U.S. companies, which dominate that segment of the market).

[21] Id.

[22] See id. (citing recent EU efforts to promote “strategic autonomy” amid concern over shifting U.S. security and trade policies). See also Théophane Hartmann, From Iris2 to Starlink: A Taxonomy of Satellite Mega-Constellations, Euractiv, Aug. 26, 2025, https://www.euractiv.com/news/from-iris%C2%B2-to-starlink-a-taxonomy-of-satellite-mega-constellations/ (highlighting that initiatives like Iris2 serve both commercial and strategic purposes, aimed at securing sovereign communications in response to growing geopolitical instability).

[23] Cooley, supra note 3.

[24] See id. (“This obligation is closely linked to the elevated risk of orbital congestion and collision associated with the deployment of multiple, simultaneously operating satellites).

[25] Id.

[26] Jonathan O’Callaghan, What the Amazon versus SpaceX Satellite Mega Constellation War Means for Earth, Sci. Am., Apr. 28, 2025), https://www.scientificamerican.com/article/what-amazons-project-kuiper-vs-spacexs-starlink-satellite-mega-constellation/ (noting that U.S. constellations like Starlink and Kuiper use staggered, iterative deployment strategies, which renders them unlikely to qualify for EU streamlined licensing).

[27] See Cooley, supra note 3.

[28] Id.

[29] See generally Mija Aleksandraviciute et al., Industrial Policy for the Final Frontier: Governing Growth in the Emerging Space Economy, Brookings, Sept. 23, 2025, https://www.brookings.edu/articles/industrial-policy-for-the-final-frontier-governing-growth-in-the-emerging-space-economy/ (noting that the space economy remains in a formative stage, where unclear rules and premature regulation may impede innovation and undercut system-wide risk management).

[30] See Clark, supra note 2.

[31] See Theresa Hitchens, US Slams ‘Discriminatory’ Draft EU Space Law as Imperiling NATO Cooperation, Breaking Defense, Nov. 5, 2025, https://breakingdefense.com/2025/11/us-slams-discriminatory-draft-eu-space-law-as-imperiling-nato-cooperation/ (cautioning that the proposed regulation could obstruct NATO-aligned coordination by subjecting U.S. space providers to burdensome and discriminatory entry requirements).

[32] Cooley, supra note 3.

[33] See Douglas Gorman, US Echoes European Concerns on the EU Space Act, Payload, Nov. 7, 2025, https://payloadspace.com/us-echoes-european-concerns-on-the-eu-space-act/ (criticizing the EU Space Act for imposing “prohibitive costs” on startups and small companies that “drive innovation in space”).

[34] See Tomorrow’s Aff. Ed. Bd., supra note 4 (noting that both the EU and U.S. see the Space Act as serving critical interests, but are at odds over its extraterritorial effects and potential market consequences).

Examining the Constitutionality of Ohio’s New Obscene Material Age Verification Law

December 1, 2025
Data, First Amendment, Internet, Privacy

Fide Valverde-Rivera, MJLST Staffer

In September 2025, an Ohio law requiring websites that purvey obscene material to verify users’ ages went into effect.[1] Although this law sought to regulate pornographic material and platforms that distribute it, it erroneously exempts some of the largest pornographic websites from compliance while mandating compliance by regular social media sites. Because of this unintended consequence, this law is very likely unconstitutional.

 

General Overview of the New Law and Implementation Problems

Ohio’s new age verification law requires platforms that provide “any material or performance that is obscene or harmful to juveniles” to verify users’ ages.[2] The law exempts “providers of ‘an interactive computer service,’ which is defined . . . as having the same meaning as it does under federal law” from having to comply with the age verification requirements.[3] Federal law defines an “interactive computer service” to include “any platform where third parties can create accounts and can generate content, from social media sites to dating apps, message boards, classified ads, search engines, comment sections, and much more.”[4] Platforms like Pornhub and OnlyFans, two major pornography websites, arguably fall within this definition and qualify for the exemption.[5] Accordingly, Pornhub and OnlyFans are not conducting age verification for Ohio users.[6] However, general-purpose social media platforms like Bluesky—a type of platform lawmakers said would be outside of the law’s scope—have been mandated to begin age verification.[7]

 

Constitutional Considerations

The first step in evaluating the constitutionality of this law requires determining the appropriate level of scrutiny with which it should be examined. In Free Speech Coalition, Inc. v. Paxton, the Supreme Court held that “because accessing material obscene to minors without [age verification] is not [a] constitutionally protected [activity], any burden [an age verification law] imposes on protected activity is only incidental, and the statute triggers only intermediate scrutiny.”[8] It held that it was not subject to strict scrutiny because “speech that is obscene to minors is unprotected to the extent that [a] State imposes an age-verification requirement” and “where the speech in question is unprotected, States may impose ‘restrictions’ based on ‘content’ without triggering strict scrutiny.”[9]

Under intermediate scrutiny, the Supreme Court in Paxton found the Texas age-verification law constitutional for two reasons.[10] First, the law served an important government interest: shielding sexual content from children.[11] Second, the law was adequately tailored in that “the government’s interest ‘would [have been] achieved less effectively absent the regulation’ and the regulation ‘[did] not burden substantially more speech than is necessary to further that interest.’”[12] Age verification laws are a constitutionally-settled way to protect children from obscene material, and Texas’s preferred approach was valid.[13] The Supreme Court in Paxton also held the statute’s targeting of certain sites did not render it unconstitutional because “it [was] reasonable for Texas to conclude that websites with a higher portion of sexual content are more inappropriate for children to visit than those with a lower proportion.”[14]

 

Bottom Line

Here, Ohio’s age-verification law is very likely unconstitutional because it fails to shield children from sexual content. Because platforms with higher proportions of sexual content, the intended targets of this law, are outside of the scope of the law, the law is not adequately tailored to survive an application of intermediate scrutiny. Additionally, the law is overinclusive because social media sites on which obscene content generally represents a minority of the content are bound by the law. Based on these shortcomings, lawmakers and judicial officers alike should anticipate an interested party or parties advancing a facial challenge attacking the constitutionality of this law under the First Amendment. Further, platforms like Bluesky may attempt to advance an as-applied challenge by noting that the law—although written to target pornography websites without “ensnar[ing] social media platforms”—fails to achieve its articulated objectives.[15]

 

Notes

[1] Ohio Rev. Code § 1349.10(B) (2025).

[2] Id.

[3] Elizabeth Nolan Brown, Whoops—Ohio Accidentally Excludes Most Major Port Platforms from Anti-Porn Law, Reason (Oct. 6, 2025, 11:45 AM), https://reason.com/2025/10/06/whoops-ohio-accidentally-excludes-most-major-porn-platforms-from-anti-porn-law/.

[4] Id.

[5] Id.

[6] See id. (“I’m assuming that the exclusion of Pornhub was not intentional, given the way this law’s supporters talked about as a shield against Ohio minors being able to see any sexually oriented material online. One of the law’s biggest proponents, state Rep. Josh Williams (R-Sylvania), has talked about how it would not ensnare social media platforms even though they may contain porn, so perhaps the exclusion of interactive computer services was intended for that purpose. But most major web-porn access points, including OnlyFans and webcamming platforms, also fall under the definition of interactive computer service.”)

[7] See Morgan Trau, Do You Live in Ohio? Do You Watch Porn Online? Your State Legislature Wants to See Some ID, Ohio Cap. J. (Oct. 1, 2025, 4:45 AM), https://ohiocapitaljournal.com/2025/10/01/do-you-live-in-ohio-do-you-watch-porn-online-your-state-legislature-wants-to-see-some-id/ (“[Rep. Josh] Williams said that this [law] won’t impact social media sites like X (formerly known as Twitter) and Reddit, even though both of those platforms contain easily-accessible pornography”); @psychic_twin, Reddit (Sept. 29, 2025, 2:00 PM), https://www.reddit.com/r/Ohio/comments/1ntqr4w/ohio_age_verification_notice_on_bluesky/ (sharing how Bluesky required Ohio users to complete age assurances because “[t]he laws in [the user’s] location require[d] [them] to verify [they’re] an adult before accessing certain features on Bluesky, like adult content and direct messaging”).

[8] Free Speech Coalition, Inc. v. Paxton, 606 U.S. 461, 483 (2025).

[9] Id. at 492.

[10] Id. at 495–96.

[11] Id. at 496.

[12] Id.

[13] Id. at 496–97 (“The specific verification methods that H.B. 1181 permits are also plainly legitimate. At present, H.B. 1181 allows for verification using government-issued identification or transactional data. Verification can take place on the covered website itself or through a third-party service. Other age-restricted services, such as online gambling, alcohol and tobacco sales, and car rentals, rely on the same methods. And, much of the online pornography industry has used analogous methods for decades . . . . H.B. 1181 simply requires established verification methods already in use by pornographic sites and other industries. That choice is well within the State’s discretion under intermediate scrutiny.” (internal citations omitted)).

[14] Id.

[15] Nolan Brown, supra note 3.

The Precarious Issue of Legally Creating Mashups Under the U.S. Patent System

November 24, 2025
Entertainment Law, Intellectual Property, Patents

McKenzie Alders, JLST Staffer

Ever wondered how your favorite DJs can legally incorporate those familiar beats and 2010 tunes into their own, new mashups? Apparently, the answer is not actually all that clear.

Copyright protection under federal law automatically applies to creative work once the work is fixed to something tangible.[1] Copyright law provides two protections for music: musical compositions and the recordings of those compositions.[2] Generally, this copyright grants the creator of the work an exclusive right to sell, make copies, and publicly perform the work for the life of the creator plus an additional 70 years.[3] Perhaps the best route for those who wish to use snippets of others’ works to create something uniquely their own is to obtain a license from each artist whose work they plan to use.[4] However, the licensing process is time-consuming, and, particularly for artists who will be using many short snippets of songs, this would be extremely expensive.[5] While this expense might be bearable by those who are at the top of the industry, it could have the effect of pricing out those hobby DJs or new talent looking to make their own name in the profession.

Thus, the question is raised: in lieu of obtaining a license, what options exist for those who wish to mash up the music of others? Historically, there have been two defenses available to those who would use small samples of another’s copyrighted material: de minimis and Fair Use.

 

Circuit Split Over the Use of the De Minimis Use Defense

In Bridgeport Music, Inc. v. Dimension Films, the Sixth Circuit held that, “A sound recording owner has the exclusive right to ‘sample’ [their] own recording . . . . Get a license or do not sample. We do not see this as stifling creativity in any significant way.”[6] In Bridgeport, various record companies brought copyright infringement claims against No Limit Films for their use of a sample from a composition and sound recording in a rap song, which was included in one of their movies.[7] The district court held that the infringement claim was de minimis and not actionable.[8] In reversing the district court’s holding in this case, the Sixth Circuit not only held that sampling was per se not permitted, but they made this holding extremely broad by doing so in a case where it had initially been held that the infringement claim was de minimis. Hence, at least in the Sixth Circuit, there is no defense to copyright infringement that the size of the sample was de minimis, and as such, a license is required to create a mashup.

In contrast, in Newton v. Diamond, the Ninth Circuit held that, after considering the facts and circumstances, the sampled portion of the composition was not a “quantitatively or qualitatively significant portion of the composition as a whole.”[9] Here, the copyright infringement claim arose out of the use of the recording of a live performance of a flutist that was then used in the Beastie Boys song “Pass the Mic.”[10] The Beastie Boys obtained a license to use the sound recording that was sampled, but not the underlying composition.[11] Thus, a claim for copyright infringement was brought due to the use of the underlying composition.[12] Quantitatively, the allegedly infringed upon sample represented six seconds or two percent of a four and a half minute recording, and the Ninth Circuit found that qualitatively the section of the work was no more significant than any other section.[13]

 

Since Newton, the Ninth Circuit has only made clearer its opposition to the holding in Bridgeport. In VMG Salsoul v. Ciccone, the Ninth Circuit explicitly disagreed with the Sixth Circuit by stating, “Congress did not eliminate the de minimis exception to claims alleging infringement of a sound recording.”[14] In VMG Salsoul, a claim of copyright infringement was brought against Madonna for the use of a portion of the song, Love Break, in her song Vogue.[15] The Ninth Circuit court held that, as a matter of law, “a general audience would not recognize the brief snippet in Vogue as originating from Love Break” and so any copying that was de minimis and did not amount to copyright infringement.[16] Therefore, the Ninth Circuit chose to preserve the de minimis defense that the Sixth Circuit had dismissed.

As a consequence of this circuit split, it is very hard to predict how a court will actually apply copyright law and the de minimis use defense to those who would create mashups without a use license for each of the songs that they choose to sample. Practically, in Sixth Circuit jurisdictional areas, sampling without a license should not be done at all. While the Ninth Circuit previously permitted sampling without a license under de minimis use, without a categorical rule, the application to the facts of any specific case makes it difficult to predict what the courts would rule.

 

Fair Use Defense

The fair use protections found in U.S.C. § 107 provide another avenue for artists looking to utilize another’s work. If a sample is deemed to be a fair use of another’s work, it is not considered copyright infringement.[17] Courts consider application of the U.S. Code Fair Use protection on a case by case basis, and the analysis utilizes four statutory factors: (1) the purpose and character of the of the use, focusing on “to what extent the new work is transformative” because it gives the original work something new; (2) “the nature of the copyrighted work”; (3) “whether ‘the amount and substantiality of the portion used in relation to the copyrights work as a whole’ are reasonable in relation to the copyright’s purpose”; (4) “the effect of the use upon the potential market for or value of the copyrighted work.”[18] In Campbell v. Acuff-Rose Music, Inc., the Supreme Court held that a commercial parody, essentially transforming another person’s work but maintaining the underpinnings of it so the original work remains recognizable for comedic purposes, can be considered Fair Use under the meaning of Section 107.[19]

In Campbell, the Court found that parodies utilize the underlying work to transform it into a meaningful comment about that work, creating an entirely new work in the process.[20] Addressing the second factor, the Court found that parodies almost always use publicly known works that are copyrighted.[21] The third factor was resolved in favor of Fair Use, because in this instance, the final product was distinctive and its lyrics had greatly departed from the original work.[22] Finally, the fourth factor was also resolved in favor of the parody creators, with the Court finding that there would likely be no significant market harm from the creation of this particular parody for the underlying copyrighted work.[23]

Theoretically, under the Campbell decision Fair Use doctrine could apply to protect those that mash up other artists’ work because—like a parody, their use of the copyrighted musical samples transforms them into something new and creative—is insubstantial in relation to the work as a whole and is unlikely to affect the market for the copyrighted work. It appears that, at least at the circuit court level, this defense has not been the basis for any decision. In district court, however, Campbell’s four-factor test was applied in Estate of James Oscar Smith v. Cash Money Records, Inc., et al., and the court held that rearranging and altering the message of the underlying copyrighted work was transformative because the purpose of creating the new song was markedly different from the purpose of creating the underlying work.[24]

This would seem to suggest that Fair Use can be a defense for mashup artists so long as the purpose in creating the DJ mashup was markedly different than that of the underlying song. However, given the fact that mashups generally directly take a clip from the underlying work rather than re-arranging the work to truly transform it, it seems like a Court would have to expand the breadth of the current law to find that such sampling qualifies as Fair Use under Campbell. As such, the actual outcome of such an argument is difficult to predict.

 

Conclusion

The state of copyright law as it relates to the sampling of short clips of copyrighted music in DJ booth mashups is anything but clear. Given the circuit split that exists on the availability of the De Minimis Use defense and the difficulty and unpredictability of the Fair Use defense, it seems that the best route of action for artists who seek to use copyrighted material is to obtain a license for both the composition and the right to the recording. Despite the need for licensing being costly and time-consuming, this route is likely cheaper than the alternative: battling it out with record companies and other owners of the originally copyrighted work in court.

 

Notes

[1] What Musicians Should Know About Copyright, U.S. Copyright Off. (last visited Nov. 9, 2025), https://www.copyright.gov/engage/musicians/.

[2] Id.

[3] How Long Does Copyright Protection Last?, U.S. Copyright Off. (last visited Nov. 9, 2025), https://www.copyright.gov/help/faq/faq-duration.html.

[4] See The Legal States of Mashup Music, OG+S (June 18, 2019), https://ogs.law/copyright/mashup-is-it-legal/ (discussing how mashup artists could obtain a license for each source of copyrighted material that they clip).

[5] Id.

[6] Bridgeport Music, Inc. v. Dimension Films, 410 F.3d 792, 801 (6th Cir. 2005).

[7] Id. at 795–96.

[8] Id. at 797.

[9] Newton v. Diamond, 388 F.3d 1189, 1195 (9th Cir. 2004).

[10] Id. at 1192.

[11] Id. at 1193.

[12] Id.

[13] Id. at 1196.

[14] VMG Salsoul, LLC v. Ciccone, 824 F.3d 871 (9th Cir. 2016).

[15] Id. at 875.

[16] Id. at 874.

[17] Can I Use Someone Else’s Work? Can Someone Else Use Mine?, U.S. Copyright Off. (last visited Nov. 11, 2025), https://www.copyright.gov/help/faq/faq-fairuse.html.

[18] Campbell v. Acuff-Rose Music, Inc., 510 U.S. 569, 579, 585, 586, 590 (1994) (finding that a parody could qualify for the Fair Use defense and remanding for further consideration to the lower court).

[19] Id. at 594.

[20] Id. at 579.

[21] Id. at 586.

[22] Id. at 588–59.

[23] Id. at 591.

[24] Case Summary Estate of James Oscar Smith v. Cash Money Records, Inc., et al., U.S. Copyright Off. Fair Use Index, https://www.copyright.gov/fair-use/summaries/estate-of-james-oscar-smith-cash-money-records-no.1-14-cv-02703-2017.pdf (last visited Nov. 9, 2025).

Trump’s Shortsighted Proposal Would Shatter the Patent System

November 17, 2025
Administrative Law, Intellectual Property, Patents

Charlotte Lucas, JLST Staffer

The overall objectives of the U.S. patent system are to foster innovation, maintain inclusivity and fairness to all potential patent applicants, and achieve overall financial balance.[1] A patent, because it grants the patent holder a temporary monopoly of their invention, inherently has costs and benefits to society. Patent holders are able to face less competition for their product and thus make more money from it during the patent period, which incentivizes inventors to put time and money into developing new inventions that can benefit society.[2] However, the fact that patents create a monopoly on that invention, forcing consumers to spend more money than the market value to obtain a patented invention, is a cost to society.[3]

The patent system works by charging patent holders fees to obtain and maintain patents.[4] The fees cover the services that the United States Patent and Trademark Office (“USPTO”) provides.[5] Entities file for patents, and the size of that entity determines the fee amount.[6] The USPTO charges fees for filing and examining an application, for issuing a patent, and for maintenance during the 20-year life of the patent.[7]

The current fee system has multiple goals, one being to achieve financial balance for the USPTO by covering the costs of the patent process.[8] The discounts for small and micro entities are meant to foster innovation and increase fairness by lowering the barrier to obtaining and maintaining patents.[9] Additionally, charging maintenance fees will decrease the number of patents currently in effect, especially economically unviable ones, because not all entities will maintain all their patents.[10] Overall, the current fee model works, at least to make money for the USPTO. The USPTO estimated almost $4 billion in income from patent fees last year.[11] The USPTO does not cost taxpayers money and just runs on the fees paid by current patent holders.[12]

The Trump Administration is discussing charging patent holders fees equal to a percentage of their overall patent value.[13] The proposed percentage would be one to five percent.[14] The new fee system “would be a much more exorbitant cost for some patent holders that would function like a property tax.”[15] It would be a complete change to the 235-year-old patent system and a stark departure from the practices of any foreign country.[16] Whether the proposal would replace or add to the current fee system is unclear.[17]

The presidential administration suggests using the revenue to pay the national debt or for purposes in other areas of the government.[18] The administration is also considering a budget item for the USPTO that could transfer the extra money to other agencies of the government.[19] Trump nominated John Squires (“Squires”) to the position of USPTO director, and the Senate confirmed his appointment.[20] Squires, as a nominee and supporter of Trump, is expected to support the proposed fee system.[21] The USPTO’s authority to set its fees expires next year, and, therefore, Congress may change the way that the patent fee system works to be in line with the proposal, or Congress may prevent the USPTO from changing the system.[22]

Congress, and not the executive branch, has the power to levy taxes.[23] The USPTO has the right, granted by Congress, to charge fees to patent holders to pay for the services the USPTO provides.[24] However, charging patent holders a percentage of the overall patent value may constitute a tax more than a fee. The primary purpose of the proposed plan is to raise money for the government, generally to pay off the deficit or for services outside of the USPTO.[25] Such a goal is usually the purpose of a tax.[26] In contrast, the purpose of a fee is to pay for the cost of the specific services provided to the payer of the fee, such as the services the USPTO provides to patent applicants.[27] Additionally, the voluntariness of obtaining a patent and thus paying the proposed fees is not relevant to determining if the charge is a tax or a fee.[28] If someone voluntarily purchases alcohol at a store, they have to pay a sales tax, not a sales fee. The sales tax, although voluntary because no one has to purchase alcohol, still has the primary purpose of general revenue raising, not paying for a specific service. This would be the same as charging patent holders a percentage of the overall patent value, because, although voluntary, it would raise money, generally not just for the USPTO’s services.

In addition to the potential legal issues, several implementation and policy concerns exist. First, how or when the patent value will be assessed is unclear.[29] Patents can have commercial value but also hold value for the amount for which the patent owner could sell or license the patent. The commercial value of a patent is unknown at the time the patent is granted.[30] Even if the amount is assessed multiple times during the patent term, many different components go into how valuable a patent is.[31] For example, a patent granted to Apple to be used in an iPhone is working alongside hundreds of other patents in the phone. How would the government decide how the success of an iPhone is split among all the patents? Also, Apple’s branding, reputation, business model, and previous customer base are other factors contributing to an iPhone’s success. Would the government account for that, and if so, how?

If the government equates the overall patent value to the amount for which the patent owner could sell or license the patent, additional concerns are raised. How would the government determine that amount accurately? Especially because the patent owner may not want to sell or license the patent, or might not have any competitors interested in that specific patent on its own, despite being valuable.

If the government determines how to assess the patent value, the proposal might not even raise money for the government. First, many patents already do not have a significant amount of commercial value.[32] The holders of those patents sometimes let the invaluable patents lapse, but sometimes keep the patents active and pay the maintenance fees. The holders of commercially invaluable patents under the new system likely would not be paying that much in fees and would not make that much money for the government. Second, some potential patent holders may not even apply for a patent because of the possible taxes and instead rely on trade secret protection or first-to-market benefits. Not only would that mean that the USPTO would not get any revenue from that potential patent, but the potential decrease in patents would not encourage innovation or the distribution of knowledge. Third, large companies with many resources would likely find loopholes or reorganization tricks to limit the value of their patents.[33] Companies would be spending money and time on avoiding or limiting the tax rather than on R&D, thus limiting and discouraging innovation and not truly raising money for the government.[34] Fourth, the government would have to create a system to determine the value of the 3.5 million active U.S. patents, which would be very expensive.[35] Additionally, patent holders upset at the valuations could try to contest the amount, leading to a significant amount of litigation.[36] Therefore, the plan would raise operating costs for the USPTO and not lead to more money to pay off the government deficit.

The proposed plan would likely achieve the opposite of the USPTO’s goals. Any money that companies make from the patents they own is already taxed on the federal and state levels. More money that companies have to pay under the proposal to maintain patents would take money away from their profits and reduce investment into R&D, therefore decreasing innovation. Small businesses and start-ups would be the most impacted. They have the least amount of money to pay any patent fees, and often they hold patents as their primary assets. Forcing them to pay more to maintain would decrease the likelihood of innovation. It would not encourage fairness, and it would increase the barrier to entry for gaining a patent, the opposite of what the current system attempts to achieve with its tiers of patent fees.

Overall, the proposed system would discourage innovation, decrease fairness, and be difficult to implement. The system probably would not even achieve the goal of raising money for the government due to the increased costs of implementing the system. Additionally, legal challenges and backlash from patent-holding companies are likely. The proposal would be a drastic shift in how the patent system works and would make the U.S. a significant outlier in the world.

 

Notes

[1] Gaétan de Rassenfosse & Adam B. Jaffe, Framework for Analysis of U.S. Patent Fee Structure Options 2 (Dec. 2024),  https://www.uspto.gov/sites/default/files/documents/UAIA_Fee_Study_Framework_for_Analysis.pdf.

[2] Id. at 10–12.

[3] Id.

[4] Id. at 2.

[5] Id.

[6] 37 C.F.R. § 1.16.

[7] 37 C.F.R. §§ 1.16, 1.17, 1.18, 1.20.

[8] De Rassenfosse & Jaffe, supra note 1.

[9] Id. at 16–18.

[10] Id. at 18–19.

[11] United States Patent and Trademark Office, Fiscal Year 2025 Congressional Submission 3 (Mar. 2024), https://www.uspto.gov/sites/default/files/documents/fy25pbr.pdf.

[12] Id.

[13] Amrith Ramkumar, Trump Administration Weighs Patent System Overhaul to Raise Revenue, Wall St. J., July 28, 2025, https://www.wsj.com/politics/policy/patent-system-overhaul-18e0f06f?gaa_at=eafs&gaa_n=AWEtsqcrNTdIjXDybihSzFhBXwdMfKp1P3twYDq3pdyZ1O9OqaQjMcPsCTRSSd162eE%3D&gaa_ts=69167aa4&gaa_sig=sn7mig18LPadrQwSl70zopRzxIWhd-iGUBVS5lUE7D6lZS-f4l7FaJOwcYTLujXukFEKbMBrfD0SCOOLFvxJhw%3D%3D.

[14] Id.

[15] Id.

[16] Id.

[17] Id.

[18] Id.

[19] Id.

[20] Press Release, United States Patent and Trademark Office, USPTO Welcomes New Director John A. Squires (Sept. 22, 2025), https://www.uspto.gov/about-us/news-updates/uspto-welcomes-new-director-john-squires.

[21] Ramkumar, supra note 13.

[22] Id.

[23] U.S. Const. art. I, § 8, cl. 1.

[24] De Rassenfosse & Jaffe, supra note 1, at 2.

[25] Ramkumar, supra note 13.

[26] Nat’l Cable Television Ass’n, Inc. v. United States, 415 U.S. 336, 340–41 (1974).

[27] Id.

[28] See generally, Nat’l Fed’n of Indep. Bus. v. Sebelius, 567 U.S. 519 (2012) (determining that the individual mandate penalty was a valid tax, even though it was a voluntary choice for citizens to not purchase insurance and thus pay the individual mandate penalty).

[29] Rodrigo Balbontin, Taxing Patent Value Is a Patently Bad Idea, Info. Tech. & Innovation Found. (Aug. 4, 2025), https://itif.org/publications/2025/08/04/tax-on-patent-value-is-a-patently-bad-idea/.

[30] Id.

[31] Id.

[32] Sujai Shivakumar & Chris Borges, Don’t Tax Invention: The Risks of a Patent Tax, Ctr. for Strategic & Int’l Stud. (Sept. 4, 2025), https://www.csis.org/analysis/dont-tax-invention-risks-patent-tax.

[33] Balbontin, supra note 29.

[34] Id.

[35] Shivakumar & Borges, supra note 32.

[36] Id.

The [In]adequate Provision Loophole: The Future of Drug Advertisements

November 10, 2025
Administrative Law, Food and Drug Law, Telecommunication

Caelen Caspers, MJLST Staffer

The television shows a sunny day, birds chirping, and kids skipping. A journal staffer attempts to join in, but winces in remembrance of cite checks. The narrator sighs and explains that life’s moments should not be interrupted by the discomfort of bluebooking. Loudly, the narrator cuts in, “That’s why there’s LawRizzy—clinically proven to relieve the racking pain of cite checks.” The narrator directs you to talk to your healthcare provider and rambles off a few side effects.

Sound familiar? Direct-to-consumer (“DTC”) drug broadcasts have become prolific on our television, social media, podcasts, etc. The rise of DTC advertising is attributed mainly to the “adequate provision loophole”[1]—a regulatory text utilized by drug companies to minimize risk disclosures and instead refer viewers to a secondary source for additional information.[2]

On September 9, 2025, the Food and Drug Administration (“FDA”) announced plans to rescind the loophole.[3] Without it, pharmaceutical companies would have to provide a disclosure of all necessary information related to a drug’s side effects and contraindications in their advertisements.[4] Controversy has since ensued.

 

Statutory Context

Currently, the law requires that broadcast advertisements must include a “major statement” of “information relating to major side effects and contraindications . . . of the advertised drugs.”[5] Additionally, the advertisements must contain a “brief summary of all necessary information related to [the major statement], unless adequate provision is made for dissemination of the approved or permitted product labeling in connection with the broadcast presentation.”[6]

The provision did not garner loophole status until 1997, following guidance by the FDA,[7] wherein a drug company provides an adequate provision by presenting “reasonably convenient access” to the product’s labeling.[8] This can be accomplished by disclosing a toll-free number, print page, webpage, and a directive to speak to a medical professional.[9] Lucy Rose, a former FDA employee involved in drafting the guidance, explained that the purpose of the is regulation not as a loophole, but rather to balance “the demands for marketing new drugs and informing patients.”[10]

 

The Controversy

Indeed, there are many persuasive arguments in favor of the adequate provision loophole. First, proponents argue that it is essential to avoid burdening the consumer with bulky risk information.[11] The mass of information merely functions to fearmonger, desensitize, and dilute more serious risks among minor issues.[12] Second, proponents underscore the benefits to public health, such as public awareness and market competition.[13] Moreover, standards for disclosure and fair balance are well-established, hence, if the administration were to enforce the existing law, then there would be no need for eliminating the provision.[14] Finally, proponents warn that the FDA’s proposed action will have a chilling effect on drug companies’ First Amendment rights.[15]

Those adverse to the provision argue that it is “used to conceal critical safety risks in broadcast and digital ads, fueling inappropriate drug use and eroding public trust.”[16] The FDA contends that DTC ads lead to more prescription requests and inappropriate prescribing.[17] FDA Commissioner, Marty Makary, stressed that the 25% of drug companies’ budget towards advertising could be “better spent on lowering drug prices for everyday Americans.”[18] Furthermore, the FDA admitted to difficulty in regulating DTC advertising in social media, making it “increasingly difficult for patients to distinguish between evidence-based information and promotional material.”[19]

 

The Future

It is easy to envision the provision in practice, given the unavoidability of DTC advertisements on our screens. You anticipate the statement “ask your health provider about LawRizzy! Side effects include panic attacks, failing journal, or dizziness.” Without it, advertisers would be required to include a “brief summary of all necessary information related to the major side effects and contraindications.”[20]

But what constitutes a brief summary? Health and Human Services (“HHS”) Secretary Robert F. Kennedy proclaimed “[o]nly radical transparency will break the cycle of over-medicalization that drives America’s chronic disease epidemic.”[21] Thus, on one extreme, it appears that the purpose of the rescission is part of a larger effort to ban DTC drug advertisements altogether.

Is it realistic that the FDA can curtail all drug advertisements? Before to 1997, drug advertising in the United States was virtually non-existent.[22] However, given that DTC ads have become industry standard, it might be too difficult to put the mouse back in the bag. And, Big Pharma is unlikely to go quietly, likely to give rise to immense litigation.[23]

The FDA has yet to release guidance on what constitutes presentation of a “brief summary.”[24] One might expect subsequent guidance from the FDA, as done prior with “major statement” in 2023[25] and “adequate provision” in 1999.[26] Until it does, the future landscape of DTC drug advertising will remain uncertain.

 

Notes

[1] U.S. Dep’t Health & Hum. Servs., HHS, FDA to Require Full Safety Disclosure in Drug Ads (Sept. 9, 2025), https://www.hhs.gov/press-room/hhs-fda-drug-ad-transparency.html.

[2] See Login H. Merril, The FDA Just Killed Big Pharma’s Favorite Loophole, Freedom (Sept. 20, 2025), https://www.freedommag.org/news/the-fda-just-killed-big-pharmas-favorite-loophole-d87bf6 (explaining the adequate provision).

[3] U.S. Food & Drug Admin., FDA Launches Crackdown on Deceptive Drug Advertising (Sept. 9, 2025), https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising.

[4] Id.

[5] 21 C.F.R. 202.1(e)(1)(i)(A).

[6] 21 C.F.R. 202.1(e)(1)(i)(B) (emphasis added).

[7] U.S. Food & Drug Admin., Guidance for Industry: Consumer Directed Broadcast Advertisements 2–3 (Aug. 1999), https://www.fda.gov/media/75406/download.

[8] Id. x

[9] Id.

[10] See Annalee Armstrong, In New DTC Ad Crackdown, FDA Trying to Close a Loophole That Isn’t, Biospace (Sept. 17, 2025), https://www.biospace.com/policy/in-new-dtc-ad-crackdown-fda-trying-to-close-a-loophole-that-isnt (citing Lucy Rose, A Response and Suggested Path Forward to FDA’s Fact Sheet, LinkedIn (Sept. 15, 2025), https://www.linkedin.com/pulse/response-suggested-path-forward-fdas-fact-sheet-ensuring-lucy-rose-jrple/?trackingId=h8%2BVIWXVSpKr4lMOeqQnQA%3D%3D).

[11] See James A. Boiani, et al., HHS, FDA Target Direct-to-Consumer Drug Advertising: A Paradigm Shift in Patient-Focused Communications, 15 Nat’l L. Rev. 278, 278 (Sept. 29, 2025), https://www.healthlawadvisor.com/hhs-fda-target-direct-to-consumer-drug-advertising-a-paradigm-shift-in-patient-focused-communications (explaining the importance the adequate provision).

[12] Id.

[13] Id.

[14] Id. (discussing enforcement of existing law).

[15] Joanne S. Eglovitch, FDA Cracks Down on Drug Ads, Promises to End the Adequate Provision ‘Loophole’, Regul, Focus (Sept. 10, 2025), https://www.raps.org/news-and-articles/news-articles/2025/9/fda-cracks-down-on-drugs-ads,-promises-to-end-adeq (“[T]ruthful and non-misleading DTC advertising is protected under the First Amendment and has documented evidence of advancing patient awareness and engagement.”)

[16] U.S. Food & Drug Admin., supra note 3 (citing Mor, et. al., Pharmaceutical Industry Promotional Activities on Social Media: A Scoping Review, 15 J. Pharm. Health Servs. Rsch. 1 (2024)).

[17] Id.

[18] Id.

[19] Id.

[20] 21 C.F.R. 202.1(e)(1)(i)(B).

[21] U.S. Food & Drug Admin., supra note 3 (emphasis added).

[22] Boiani, supra note 11.

[23] See Eglovitch, supra note 15 (discussing potential litigation on First Amendment grounds).

[24] See HHS and FDA Declare “Crackdown” on Drug Advertising and Promotion, King & Spalding (Sept. 10, 2025), https://www.kslaw.com/news-and-insights/hhs-and-fda-declare-crackdown-on-drug-advertising-and-promotion (“[The FDA] has not specifically addressed the presentation of the ‘brief summary’”).

[25] Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format, 88 Fed. Reg. 80958 (Nov. 21, 2023) (to be codified at 21 C.F.R. pt. 202).

[26] U.S. Food & Drug Admin., supra note 7.

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