by JT DeGrinney, Associate Member, University of Cincinnati Law Review Vol. 93
I. Introduction
This year’s Super Bowl was a bust, at least for those awaiting a Chiefs three-peat, a Taylor Swift engagement, or even a real contest between two of the league’s titans. Yet for the drug industry, and many American consumers, the big game still featured a battle for the ages—to be waged over the airwaves rather than the gridiron. Among its usual array of commercials, which ranged from the goofy to the inspiring, to the outright weird,[1] the Super Bowl aired an ad from Hims and Hers Health, Inc. (“Hims & Hers”) about its new weight loss “treatment plans.”[2] The minute-long advertisement—still available on YouTube—aligns Hims & Hers with consumers by criticizing the American healthcare industry and touting the company’s “life-changing weight loss medications” as “the future of healthcare.”[3] Unsurprisingly, the ad drew criticism from the drug industry.[4] Even academics and lawmakers joined the fray to offer their critiques.[5]
This article will explore the legal background surrounding the Hims & Hers ad controversy. Section II will begin by describing the ad and its controversy more specifically. Section II then outlines the regulatory scheme for both the drugs at issue in the ad and the advertisements that promote those drugs. Section III will explore arguments for applying those schemes to the Hims & Hers ad and others like it. Finally, Section IV will briefly conclude by considering where else these titans of industry may have to wage Super Bowl LIX’s most compelling conflict.
II. Background
A. Hims & Hers’s Ad
Hims & Hers first launched its controversial ad on YouTube on January 28, 2025, in the weeks leading up to the climax of the National Football League’s 2024 season.[6] Even before the ad first aired during Super Bowl LIX, it made headlines.[7] Various factions weighed in on the ad, with varying degrees of concern and vigor. Academics, like Janelle Applequist of the University of Southern Florida, noted the timing of the ad—before millions of hungry Super Bowl watchers[8]—and its apparent lack of depth with respect to the typical disclosure consumers expect to accompany a typical drug ad.[9] Others noted the irony of the ad’s anti-establishment message in the face of the ad’s overall goal of establishing its proponent in the pharmaceutical marketplace.[10] One drug industry group called the ad “blatantly misleading,”[11] and another accused it of violating the Federal Food, Drug, and Cosmetic Act (“FDCA”).[12] Senators Dick Durbin (D-IL) and Roger Marshall (R-KS) also suggested that the ad is misleading.[13]
But, of course, there are two sides to every story. Scott Brunner, a drug-compounding industry leader, did not think that the ad was misleading.[14] Rather, in his view, the ad complied with the compounding industry’s self-imposed marketing guidelines, which the industry self-admittedly follows in an effort to minimize its regulatory profile.[15] Additionally, Hims & Hers itself responded to the criticism by contending that it “is complying with existing laws” and merely intended the ad as a “call[] for change” in the drug industry at large.[16]
Against the backdrop of this debate, this article seeks to analyze the controversial ad, starting from the ad itself. The ad is best understood as having three acts: the “criticize the industry” act, the “products pitch” act, and the “we’re a telehealth company, and this is a telehealth ad” act. The following subsections discuss them in turn.
1. The “Criticize the Industry” Act
The ad begins with a candid statement, spoken by a narrator who casts their voice as if venting to a friend a frustrating, yet familiar truth: “Obesity is America’s deadliest epidemic.”[17] To further the point, the biting, sarcastic hook from Childish Gambino’s “This is America” brashly interrupts the narrator after their first line, just before they start recounting various statistics to support their first point. The narrator then transitions to the next point. The system is broken, or—even worse—rigged against us, the American consuming public. It is predatory, the ad suggests, both visually, as it shows a clip of a lion taking her prey, and verbally, as the narrator describes how the weight loss industry “feeds on our failure.”[18] Designed to maximize emotional impact, the ad lingers in its first act; a full thirty seconds pass as the narrator builds to their final point: “A $160 billion industry . . . wasn’t built to help us. It was built to keep us sick and stuck.”[19] The narrator slams the alliterative staccato, and the two climactic words of the ad’s critique hang in big, bold block text for the final two seconds of the ad’s first act.[20]
2. The “Products Pitch” Act
Fortunately, however—as the change in the narrator’s tone of voice suggests—“Hims & Hers offers life-changing weight loss medications.”[21] The ad’s controversial second act thus begins. Immediately, while displaying a woman holding a pill—which resembles those represented on the company’s “Hers” website as those included as part of the company’s “Weight Loss Oral Medication Kits”[22]—the ad states that the medications are “affordable.”[23] The ad draws a clear contrast with the current drug industry’s offerings, which, according to the “criticize the industry” act, are “priced for profits, not patients.”[24] Then, while displaying vials identical to those represented on the company’s website as “compounded semaglutide,”[25] the ad claims that the medications are “doctor trusted.”[26] In the final selling point of the “products pitch” act, the ad notes that the medications advertised are “formulated in the USA.”[27]
Importantly, for about two-thirds of the “products pitch” act, the ad includes the first of two “required” disclosures relevant to this article.[28] In the classic, hard-to-read, “fine print” that one usually expects to accompany a drug ad, the ad includes a disclosure that reads: “Prescription required. Compounded drug products are not FDA approved. The FDA does not evaluate compounded drug products for safety, effectiveness, or quality.”[29] The disclosure first appears just as the word “affordable” appears in both the text and the narration.[30] The disclosure lingers only as long as the “affordable” and “doctor trusted” text—and the accompanying images of the pill and the vials described above—remain on the screen.[31] Notably, the disclosure abruptly disappears just before the text and narration plug that the drugs advertised originate in the United States.[32]
3. The “We’re a Telehealth Company, and This is a Telehealth Ad” Act
The ad concludes with a final description. On one view, the ad’s third act describes how consumers can get their hands on the drugs that Hims & Hers is advertising.[33] On another, the ad’s third act describes Hims & Hers’s actual service—that positions the company as a mere conduit which provides consumers with a prescription and access to the drugs they seek.[34] The service is individualized to each patient: “You get a treatment plan designed by a doctor to fit your body, goals, and lifestyle.”[35] The ad spins the service as bespoke and tailored to benefit consumers as it starts its conclusion, stating, “You deserve to feel great in your body.”[36]
The ad ends as it began, alluding to the first two acts, but with the third act’s twist: “This is the future of healthcare. This is Hims & Hers. Join us in the fight for a healthier America.”[37] A second disclosure accompanies the ad’s final statement, in the characteristic fine print. The disclosure notes that the service is not available in all fifty states and emphasizes that the “Weight Loss by Hims & Hers” service is a “holistic” one that could include a variety of different treatments depending on a medical provider’s determination of the patient’s needs.[38] It directs viewers to the Hims & Hers “website” for more details. The website to which the ad most specifically directs consumers—linked in the description of its YouTube video[39]—largely conflates its “treatment plans” with one product in particular: the compounded semaglutide featured in the ad’s “product pitch” act.[40]
B. Compounded Drugs and FDA Regulation
1. Background and History
The legal controversy surrounding the ad described above centers on a question about how “compounded drugs,” and consequently, ads promoting them, are or should be regulated. “Compounding” is a pharmacist’s original, traditional job: to mix the various ingredients that, when properly combined, “produce a finished, therapeutic substance.”[41] After the rise of mass-produced drugs, however, the main role of compounded drugs and their compounders was to create substitute drugs to meet specific patients’ individual needs that mass-produced drugs could not accommodate.[42] For example, a patient unable to properly swallow a pill might require a liquid equivalent compounded specifically to achieve the same effect in that patient as the basic pill otherwise would have.[43] Since drug compounding originated in small-scale, individualized production for patients with particular needs, compounding largely went unregulated at the federal level; however, when large-scale drug compounding started to become popular in the 1990s, Congress decided to regulate it.[44] Litigation followed in Thompson v. Western States Medical Center.[45]
In Western States, the Court considered the Food and Drug Administration’s (“FDA”) first foray into compounded drug regulation in the context of a First Amendment challenge to an FDCA provision that prohibited drug compounders from advertising their products.[46] Prompted by the FDA’s concerns that certain “establishments” were mass-producing compounded drugs under traditional pharmacy licenses to avoid regulation under the FDCA, Congress included the relevant provisions in its amendments to the FDCA in the Food and Drug Administration Modernization Act of 1997 (“FDAMA”).[47] A group of licensed pharmacists who specialized in drug compounding challenged the provisions as an unconstitutional restriction of commercial speech under the First Amendment.[48]
The district court found the advertising restriction unconstitutional but left the other provisions intact.[49] Accordingly, after the district court’s ruling, drug compounders could still compound drugs if they compounded the drugs 1) only in “limited quantities” for individual patients within an established pharmacist-patient relationship, 2) using ingredients meeting certain FDA safety and efficacy standards, 3) without producing “inordinate amounts” of products that were “essentially copies” of commercially available products, 4) without producing products identified as presenting “demonstrable difficulties” for safe or effective compounding, and 5) without producing “inordinate amounts” according to the respective state’s compounding agreement with the FDA, if one existed.[50] When the Government appealed, the Ninth Circuit agreed with the district court’s First Amendment conclusion but found that the other provisions listed above were not severable from the unconstitutional advertising restriction. Accordingly, the Ninth Circuit found all the provisions unenforceable.[51] The parties did not petition for certiorari on the severability issue, so the Supreme Court also treated all the provisions as rising or falling with the advertising restriction.[52]
To defend the provisions, the Government cited the need to preserve the “effectiveness and integrity of the FDCA’s new drug approval process” as a “substantial government interest” grounded in the fundamental interest of protecting public health.[53] The Court agreed with the Government’s logic: If requiring rigorous premarket review for all generally available drugs is the best way for the government to guarantee that those drugs are safe and effective, the government cannot allow an exception to that rule for entities capable of producing drugs on such a scale as to make their own unreviewed and untested products generally available.[54] On the other hand, the Court recognized that the virtues of traditional drug compounding are incompatible with the type of regulation suitable for the drug industry at large.[55] Such wide-ranging regulation lacks the flexibility that individual patients with unique needs will always require.[56] After weighing the two hefty interests behind the provisions, the Court ultimately held that the provisions were unconstitutional because the Government could have served its “substantial government interest” by non-speech-related means.[57]
2. Regulation Today
As the drug industry’s response to Hims & Hers’s ad suggests,[58] Western States did not end the compounding industry’s regulatory story. In 2012, an outbreak of fungal meningitis infected hundreds of people and killed sixty-four.[59] The Centers for Disease Control and Prevention traced the outbreak back to the New England Compounding Center (“NECC”), a licensed compounding pharmacy in Massachusetts that was not following standard sanitary protocols.[60] NECC had been compounding drugs in bulk and had avoided the FDA’s reach in the wake of Western States.[61] The following year, in response to the incident with NECC, Congress passed the Compounding Quality Act (“CQA”), the relevant provisions of which are still in force today.[62]
The FDCA provisions added by the CQA that are relevant here—according to their more popular FDCA section numbers—are section 503A, which was struck down in Western States and then amended and reinstated in the CQA, and section 503B, which was added fresh by the CQA.[63] Section 503A remains largely unchanged from its initial form as scrutinized in Western States, except that the unconstitutional restraint on advertising is now omitted. Accordingly, the FDA still requires traditional compounders to follow the same restrictions listed above by the Court in Western States.[64]
Section 503B governs “outsourcing facilities,” a category of drug compounders created specifically by the CQA. Under section 503B, a “facility” may employ licensed pharmacists or individuals directly supervised by licensed pharmacists to compound drugs under specified circumstances.[65] Outsourcing facilities must register with the FDA, send various reports to the FDA, and permit periodic FDA inspections.[66] Most importantly for the Hims & Hers ad, section 503B(a)(2) permits outsourcing facilities to compound using “bulk drug substances”—defined elsewhere as “active pharmaceutical ingredient[s]”[67]—only when they are on either a “clinical need” or a “drug shortage” list established by the FDA.[68] Outsourcing facilities may compound using FDA-approved drugs only when they appear on the FDA’s drug shortage list or are compounded for an individual patient to produce a demonstrable clinical difference from the approved drug.[69]
Sections 503A and 503B thus align with Congress’s initial purpose as outlined in Western States and expanded upon in the wake of the Framingham incident: to craft a regulatory scheme that encourages the compounding industry’s virtues while reining in its apparent vices.[70] Section 503A continues to outline “traditional” compounding, with its pros and cons.[71] Section 503B permits larger-scale compounding only if it is employed to meet individual patients’ needs—like traditional compounding—or, in a pinch, to help alleviate drug shortages.[72] Compounders producing drugs according to the limits outlined in sections 503A and 503B are exempt from various other provisions in the FDCA, including sections 501(a)(2)(B), 502(f)(1), and 505, for section 503A-compliant drugs,[73] and sections 502(f)(1), 505, and 582 for section 503B-compliant drugs.[74] Accordingly, in exchange for the benefits that inure from limited drug compounding practices, large and small, sections 503A and 503B exempt compounded drugs from some of the costliest, most stringent provisions of the FDCA that otherwise govern commercial drug manufacture and distribution.[75]
C. Drug Ad Regulation
While most of the regulatory controversy surrounding the practice of drug compounding is in the past for now, the regulatory controversy surrounding marketing compounded drugs is ongoing, as the Hims & Hers ad’s commentators suggest.[76] The controversy centers around a split between the FDA’s regulatory authority and that of the Federal Trade Commission (“FTC”). When it comes to advertising, according to a memorandum of understanding between the two agencies, the FDA is responsible for regulating prescription drug advertisements.[77] The FTC takes responsibility for regulating advertising for all other foods, drugs, devices, and cosmetics.[78] Accordingly, to determine who, if anyone, should have done anything about the Hims & Hers ad, or should do something about similar ads in the future, the question is whether the ad is best characterized as an ad for prescription drugs or something else.
The FDA’s authority to regulate compounded drugs stems from section 502 of the FDCA. Under section 502(bb), a compounded drug is “misbranded” if it is “false or misleading in any particular.”[79] The FDCA’s “false or misleading” language explicitly contemplates that an advertisement’s omissions may also render its drug misbranded when they are material to the drug’s ordinary use:
If an article is alleged to be misbranded because the . . . advertising is misleading, then in determining whether [it is] misleading there shall be taken into account not only representations made or suggested . . . but also the extent to which the . . . advertising fails to reveal facts material . . . with respect to consequences which may result from the use of the article to which the . . . advertising relates under the conditions of use prescribed . . . or under such conditions of use as are customary or usual.[80]
On the other hand, the FTC’s general authority concerning advertising derives from the Federal Trade Commission Act (TCA), 15 U.S.C.A. § 52. Section 52 prohibits false advertising that affects interstate commerce.[81] Under section 52, courts consider advertisements “in their entirety,” according to the “net impression” that they create in viewers’ minds.[82] Courts apply a three-part inquiry in assessing whether an ad, based on its “net impression,” is deceptive, asking: 1) what the ad claims or omits; 2) whether those claims or omissions are false or misleading; and 3) whether the identified claims or omissions are material to prospective customers.[83]
III. Discussion
As noted above, the question about which regulatory agency, if any, should be primarily responsible for ensuring the Hims & Hers ad complies with its respective statute likely turns on whether one reads the ad as a “prescription drug ad” that falls to the FDA or some other type of ad, for which the FTC should be responsible. The ad itself—arguably intentionally—complicates the issue.
A. The FDA Could Regulate, but Probably Shouldn’t
The ad’s second act, the “products pitch” act, most resembles a typical drug advertisement. There, as noted above, the ad makes three distinct claims about the “life-changing” medications the company offers.[84] Beyond the sneaky “life-changing” assertion, the ad also asserts that the drugs are “affordable,” “doctor-trusted,” and “formulated in the USA.”[85] Without more, these three assertions are probably not “misleading in any particular” to render the ad’s products “misbranded” under the FDCA. The “life-changing” assertion is likely vague enough to be read as mere puffery rather than a concrete claim of efficacy.[86] The “affordable” and “doctor-trusted” claims are similarly vague and effectively self-evident: Hims & Hers can afford to offer its products at cheaper prices due to its reduced regulatory burden,[87] and Hims & Hers’s drugs are all “doctor-trusted” insofar as the ad’s disclosure notes that the company will only distribute its products under a doctor’s valid prescription manifesting that trust.
Indeed, the ad’s disclosures assert its most “particular” claims. While the first relevant disclosure seems to concede that all the drugs the ad promotes are prescription drugs—which arguably triggers an FDCA provision independent of § 502(bb)[88]—it also clearly specifies that the products promoted have not been proven safe or effective by the FDA. Since the ad represents so little about the drugs’ use and disclaims so much, the ad probably neither represents nor omits facts material “with respect to consequences which may result from their use.”[89]
B. The FTC Probably Should Regulate, but Probably Won’t (And Didn’t This Time)
The ad’s third act offers a potentially more persuasive line of attack from the FTC’s perspective. As noted above, in that act both the ad’s narrator and a disclosure emphasize that Hims & Hers offers a service—that might include the prescription of various medications—that is distinct from the medications the ad appears to promote.[90] From a casual viewer’s perspective, the ad’s maneuvering probably does not matter much. The ad’s second act is the focal point. However, from a regulatory perspective, the ad’s third act arguably functions to categorize the ad as a telehealth ad rather than a drug ad, to be regulated under the FTC’s general authority to regulate false and misleading advertisements, rather than the FDA’s prescription drug-specific authority.
Under section 52’s standards, the Hims & Hers ad was deceptive—and future ads following its strategy will be, too.[91] The ad made a key omission, especially in light of its “net impression,”[92] which includes the notion that its service is “the future of healthcare.” The ad failed to represent that its service was necessarily subject to a harsh time limit. Hims & Hers is not a traditional drug compounder; rather, to achieve production levels commensurate with “the future of healthcare,” its drugs are surely compounded by a larger-scale section 503B outsourcing facility. Accordingly, whether Hims & Hers itself compounds the drugs it purports to offer or has arranged to receive them from another entity, Hims & Hers’s business is subject to section 503B’s limits. Hims & Hers can only market drugs compounded from bulk drug substances on the FDA’s clinical need list or drug shortage list. The ad heavily featured “compounded semaglutide,” which Hims & Hers’s deliberately placed in direct comparison with its branded counterparts which are “priced for profits.”[93] Semaglutide only appeared on the FDA’s drug shortage list and not on the clinical need list.[94] Accordingly, as soon as semaglutide dropped off that list, Hims & Hers—and its customers—were out of luck.
The failure to include this detail is a material omission that rendered the ad “deceptive” under section 52. The ad’s invitation to participate in “the future of healthcare” implies that the service it offers will be a long-lasting one. Moreover, the ad’s accompanying website encourages customers not to stop medicating, at least without first consulting a doctor.[95] The website states explicitly: “Medication is a long-term use weight loss treatment not meant for short-term use. When you stop taking it, the triggers that previously drove unhealthy eating behaviors may return. Always speak with a licensed medical provider before stopping treatment.”[96] If the company’s “affordable,” “life-changing” medications are meant for long-term, rather than short-term use, that the company knows it can only offer the medications for a limited time—perhaps, as here, for only a few weeks or months—is material to a reasonable consumer’s decision to purchase its services.
IV. Conclusion
Though this Super Bowl’s most controversial ad may fade into distant memory like the game itself, now that the shortage it sought to exploit has been resolved, drug compounding regulation leaves the door open for similar ads in the future. The ad’s critics may have been stretching to argue that the ad was misleading under the FDCA’s specific provision for compound drug advertising, but the FTC may have compelling arguments to make. Furthermore, an even more compelling First Amendment may yet lurk. If Western States is any example, the Court is open to First Amendment challenges by compounders against those who seek to keep them down. One reading of the ad—perhaps a future topic to explore—would be to highlight the ad’s call to action against the drug industry. How might the First Amendment apply, where the ad functions both to align its proponent with the people against “the system,” which might include not only the expensive drugs it decries but also the regulatory scheme that contributes to those high prices? And how would the First Amendment apply where the ad seeks to plant its policy seed not only by placing its message in the marketplace of ideas but also by ensnaring its vulnerable constituents with the promise of needed drugs at affordable prices?
[1] See Liam McKeone, Ranking the Top 5 Commercials From Super Bowl LIX, Sports Illustrated (Feb. 10, 2025), https://www.si.com/nfl/ranking-the-top-5-commercials-from-super-bowl-lix [https://perma.cc/J7ET-5PCJ].
[2] hers, Hims & Hers Big Game Commercial: “Sick of the System”, YouTube (Jan. 28, 2025), https://www.youtube.com/watch?v=l5l6QMNnqoc [https://perma.cc/5EUY-AE22].
[3] Id.
[4] Nick McGee, Major Drug Compounder is Spending Millions on Misleading Super Bowl Ad, PhRMA (Feb. 5, 2025), https://phrma.org/blog/major-drug-compounder-is-spending-millions-on-misleading-super-bowl-ad [https://perma.cc/P38Q-AKF3].
[5] Dani Blum, Millions Will See This Super Bowl Ad. Health Experts (and Two Senators) Aren’t Pleased, N.Y. Times (Feb. 7, 2025), https://www.nytimes.com/2025/02/07/well/hims-hers-health-super-bowl-ad.html?searchResultPosition=1.
[6] hers, supra note 2.
[7] See, e.g., Blum, supra note 5; Nyah Phengsitthy, Super Bowl Ad Selling Weight Drug Shows Wild West of Copycats (1), Bloomberg Law (Feb. 7, 2025, 10:40 AM EST) https://www.bloomberglaw.com/product/health/bloomberglawnews/health-law-and-business/BNA%2000000194dcf0d9afad94fdfd2a2a0000?bna_news_filter=health-law-and-business [https://perma.cc/ZW54-BPU5].
[8] Phengsitthy, supra note 7. See also Uber Eats, A Century of Cravings – Extended Cut | Uber Eats, YouTube (Feb. 4, 2025), https://www.youtube.com/watch?v=YYb6erM8z8w [https://perma.cc/5J9R-8W7M].
[9] Phengsitthy, supra note 7.
[10] Blum, supra note 5 (“‘They try to present themselves as anti-establishment,’ said Dr. Scott Hagan, an assistant professor of medicine at the University of Washington . . . . But the company represents the ‘cutting edge of, basically, capitalism in this space,’ he added.”).
[11] Shabbir Imber Safdar, Letter to FDA’s Office of Prescription Drug Promotion, CDER Re: Irresponsible Super Bowl Commercial by Hims & Hers Health, The Partnership for Safe Medicines (Feb. 5, 2025), https://www.safemedicines.org/2025/02/letter-to-fdas-office-of-prescription-drug-promotion-cder.html#_ftn3 [https://perma.cc/TQ3P-3ZT5].
[12] McGee, supra note 4.
[13] Blum, supra note 5; Sen. Richard Durbin and Sen. Roger Marshall, M.D., Senators Marshall, Durbin Put FDA on Notice for Misleading Drug Commercial Set to Run During Super Bowl, Doc Marshall: U.S. Senator For Kansas (Feb. 7, 2025), https://www.marshall.senate.gov/newsroom/press-releases/senators-marshall-durbin-put-fda-on-notice-for-misleading-drug-commercial-set-to-run-during-super-bowl/.
[14] Phengsitthy, supra note 7. The distinction between the drug industry at large and the compounded drug industry is an important one that this article will address in greater detail in Section II.B. In this context, they are not necessarily the same industry. The drug industry might, like other critics, characterize a drug compounding “industry” to be a “regulatory loophole” for competing with the drug industry at large. Durbin and Marshall, supra note 13.
[15] Phengsitthy, supra note 7; Alliance for Pharmacy Compounding, Best Practices for Marketing Compounded Medications, Compounding Best Practices (Oct. 9, 2024), https://join.a4pc.org/hubfs/PDFs/2024-10_Best-Practices-for-Marketing-Compounded-Drugs.pdf?hsLang=en [https://perma.cc/2G4W-A479].
[16] Blum, supra note 5.
[17] hers, supra note 2.
[18] Id.
[19] Id.
[20] Id.
[21] Id.
[22] Hims & Hers Health, Inc., Weight Loss Oral Medication Kits, Hers Blog, https://www.forhers.com/weight-loss/oral-weight-loss-medication-kits (Last visited Feb. 16, 2025).
[23] hers, supra note 2. The ad notes makes this point first and foremost about Hims & Hers’s new weight loss products, both visually, by placing a single word on the screen in large, friendly, lower-case font, and verbally, through the narrator’s cheerful tone.
[24] Id.
[25] Hims & Hers Health, Inc., Compounded Semaglutide, Hers Blog, https://www.forhers.com/weight-loss/compounded-semaglutide (Last visited Feb. 16, 2025).
[26] hers, supra note 2.
[27] Id.
[28] Id. The ad also includes disclosures stating “actor portrayal” and “simulated interaction” in its first and third acts, respectively, that are not material to this article’s discussion.
[29] Id.
[30] Id.
[31] Id.
[32] Id.
[33] Id.
[34] Id.
[35] Id.
[36] Id.
[37] Id. (emphasis added).
[38] Id.
[39] Id.
[40] Id. The disclosure’s text does not provide a URL for the website it refers to; rather, it merely states “See website for details and important safety information.” The Hims & Hers full sites reflect the variety of treatment options suggested by the ad’s third act. See Hims & Hers, Inc., Weight Loss, Hims Blog, https://www.hims.com/blog/weight (Last visited, Feb. 16, 2025); Hims & Hers, Inc., Weight Loss, Hers Blog, https://www.forhers.com/blog/weight-loss (Last visited Feb. 16, 2025). On the other hand, the website linked in the description of the YouTube video corresponding to the Super Bowl ad does not. See hers, supra, note 2. It clearly emphasizes one treatment above the rest—showing images of its “compounded semaglutide” and referring to it explicitly several times. Healthier America, Hims & Hers, https://www.forhers.com/healthier-america (last visited Feb. 25, 2025).
[41] C. James Watson et al., Pharmaceutical Compounding: A History, Regulatory Overview, and Systematic Review of Compounding Errors, 17 J. Med. Toxicology 197, 199 (2021).
[42] See Id. at 198-99.
[43] Id. at 198. See also U.S. Food and Drug Admin., Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry (2018).
[44] Watson et al., supra note 41, at 200.
[45] Id.; Thompson v. W. States Med. Ctr., 535 U.S. 357 (2002).
[46] W. States Med. Ctr., 535 U.S. at 366.
[47] Id. at 363-64.
[48] Id. at 365.
[49] Id.
[50] Id. at 364.
[51] Id. at 366.
[52] Id.
[53] Id. at 368.
[54] Id. at 369.
[55] Id.
[56] Id. at 369-70.
[57] Id. at 372.
[58] See McGee, supra note 4 (suggesting that the ad is misleading under the Food, Drug, and Cosmetic Act).
[59] Watson et al, supra note 41 at 199.
[60] Id.
[61] Id.
[62] Id.; See 21 U.S.C. §§ 353a-353b.
[63] Compare Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, § 127(a), 111 Stat. 2296, 2328-330 (1997) with Drug Quality and Security Act, Pub. L. No. 113-54, § 102(a), 127 Stat. 587-93 (2013).
[64] See Thompson v. W. States Med. Ctr., 535 U.S. 364 (2002); see also 21 U.S.C. 353a(b)(1)(A)-(D).
[65] 21 U.S.C. § 353b(a).
[66] 21 U.S.C. §§ 353b(b)(1), 353b(b)(2), 353b(b)(4).
[67] 21 C.F.R. § 207.3 (2025).
[68] 21 U.S.C. §§ 353b(a)(2)(A)(i), 353b(a)(2)(A)(ii).
[69] Athenex Inc. v. Azar, 397 F. Supp. 3d 56, 70 (D.D.C. 2019).
[70] See Thompson v. W. States Med. Ctr., 535 U.S. 357, 369-70 (2002); see also Watson et. al., supra note 41 at 200.
[71] Cf. W. States Med. Ctr., 535 U.S. at 370; 21 U.S.C. § 353a.
[72] W. Thomas Smith et al., There is No Such Thing as a Compounding Manufacturer! (Or is there?), 27 Health Law., no. 5, June 2015, at 1, 8, n. 67.
[73] 21 U.S.C. § 353a(a). Exemption from § 501(a)(2)(B) protects § 503A compounded drugs from liability for being “adulterated” under the FDCA for failing to comply with “current good manufacturing practice” safety and efficacy standards. 21 U.S.C. § 351(a)(2)(B). The § 502(f)(1) exemption protects § 503A compounded drugs from “misbranding” liability for failures to include adequate directions for use on product labels. 21 U.S.C.A. § 352(f)(1). The § 505 exemption means that § 503A compound drugs do not need to comply with the extensive premarket FDA review process. 21 U.S.C. § 355.
[74] 21 U.S.C. § 353b(a). Accordingly, § 503B compounded drugs are also exempt from premarket review and “misbranding” liability for inadequate directions on product labels. See supra note 73. Section 503B drugs are also exempt from the requirements in § 582, which outlines the logistical requirements that govern the drug industry’s distribution process. 21 U.S.C. § 360eee-1.
[75] Cf. U.S. Food and Drug Admin., Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry (2018) at 4 (Sponsors would be less likely to invest in, and seek approval of . . . medications if an outsourcing facility could . . . compound “substitutes” that may be less expensive because they have not gone through the drug approval process.).
[76] See Phengsitthy, supra note 7.
[77] Fed. Trade Comm’n, Memorandum of Understanding Between the Federal Trade Commission and the Food and Drug Administration (1971) (FDA-225-71-8003).
[78] Id.
[79] 21 U.S.C. § 352(bb).
[80] 21 U.S.C. § 321(n).
[81] 15 U.S.C. § 52(a)
[82] Aronberg v. FTC., 132 F.2d 165, 167 (7th Cir. 1942); Charles of the Ritz Distribs. Corp. v. FTC., 143 F.2d 676, 679 (2d Cir. 1944).
[83] Kraft, Inc. v. FTC, 970 F.2d 311, 314 (7th Cir. 1992); see also FTC v. Simeon Mgmt. Corp. 391 F. Supp. 697, 702 (N.D. Cal. 1975).
[84] hers, supra note 2.
[85] Id.
[86] See Bland v. Abbott Lab’ys, Inc., No. 3:11-CV-430-H, 2012 WL 32577, at *3 (W.D. Ky. Jan. 6, 2012).
[87] See U.S. Food and Drug Admin., Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry, supra note 75 and accompanying text.
[88] See 21 U.S.C. § 352(n).
[89] Id.
[90] See hers, supra note 2.
[91] Since the ad aired, and since this piece’s author began researching this piece, a critical fact changed. The FDA removed “semaglutide injection” from its drug shortage list after a shortage lasting from August, 23, 2022 until February 21, 2025 was resolved. FDA Drug Shortages, U.S. Food and Drug Administration (Feb. 21, 2025), https://dps.fda.gov/drugshortages/resolved/semaglutide-injection. While the change effectively moots this piece’s argument as to the actual Hims & Hers ad that aired during Super Bowl LIX, the argument retains its force generally and would apply to similarly-situated future ads. Accordingly, this piece continues to use the ad and the circumstances under which it first aired—before the shortage was resolved—as a model for analyzing the ad and its overall strategy.
[92] Charles of the Ritz Distribs. Corp. v. FTC, 143 F.2d 676, 679 (2d Cir. 1944).
[93] See hers, supra note 2; Compounded Semaglutide, supra note 25.
[94] 503B Bulk Drug Substances List, Food and Drug Administration (Aug. 21, 2023), https://www.fda.gov/drugs/human-drug-compounding/503b-bulk-drug-substances-list; FDA Drug Shortages, supra note 91.
[95] Healthier America, Hims & Hers, https://www.forhers.com/healthier-america (last visited Feb. 25, 2025).
[96] Id.
Cover Photo by Kateryna Hliznitsova on Unsplash.
