The recent controversy surrounding Hims & Hers’ Super Bowl advertisement has thrust FDA drug promotion rules into the spotlight, particularly regarding compounded medications. The U.S. Food and Drug Administration (FDA) Commissioner Martin Makary publicly stated that the ad breached federal drug promotion laws by highlighting the benefits of weight-loss drugs without adequately disclosing associated risks and side effects. This ad promoted compounded versions of semaglutide-based drugs like Ozempic and Wegovy without clarifying that these compounded drugs lack FDA approval. The omission of critical safety and regulatory information raised regulatory alarms and questions about compliance with the Federal Food, Drug, and Cosmetic Act (FDCA) and FDA advertising guidelines.
This article unpacks the regulatory framework implicated by the ad, explores the implications for Hims & Hers and the broader pharmaceutical and telehealth industries, and discusses how evolving enforcement trends may shape future drug promotion practices.
Surprisingly, despite the high stakes of pharmaceutical advertising, compounded drug ads like Hims & Hers’ can sometimes skirt rigorous FDA approval requirements, creating a complex compliance landscape that regulators are increasingly scrutinizing.
Regulatory Landscape
FDA drug promotion rules are designed to ensure that prescription drug advertisements present a fair balance of information, including both benefits and risks. Under 21 CFR 202.1(e)(7)(viii), advertisements must not omit side effects and contraindications and must present this information with prominence comparable to the presentation of drug effectiveness. The Hims & Hers Super Bowl ad’s failure to adequately disclose the lack of FDA approval for its compounded drugs and omit detailed risk information runs afoul of these requirements.
Compounded drugs, by definition, are medications mixed or altered by pharmacists or outsourcing facilities to meet unique patient needs and are exempt from the standard FDA approval process. However, FDA expressly cautions that compounded drugs are not FDA-approved and may pose risks due to the absence of rigorous safety and efficacy evaluations. Advertising compounded drugs as safe and effective without disclaimers violates FDA and FDCA standards.
Moreover, the Federal Food, Drug, and Cosmetic Act prohibits false or misleading drug promotion. The ad’s emphasis on affordability and accessibility, while omitting safety disclosures, creates an unbalanced and potentially deceptive message. The Federal Trade Commission (FTC) also oversees advertising practices, requiring truthful, non-misleading claims, which compounds the regulatory scrutiny on such ads.
Government sources such as the FDA’s Prescription Drug Advertising guidelines and the Pharmaceutical Compounding regulations provide detailed frameworks that Hims & Hers’ ad arguably failed to meet.
Why the Controversy
The Hims & Hers ad controversy stems from the company’s business model of offering compounded versions of popular weight-loss drugs at lower prices via telehealth channels. The ad sought to position Hims & Hers as a disruptor in the weight-loss medication market, criticizing the high cost of FDA-approved brand-name drugs and promoting compounded alternatives as affordable and accessible.
However, compounded drugs are legally distinct from FDA-approved medications and do not undergo the same rigorous evaluation for safety and efficacy. The ad’s omission of this critical distinction and lack of prominent risk disclosures led regulators and lawmakers to view the promotion as misleading and non-compliant with drug promotion laws.
This situation highlights tensions between innovation in telehealth and compounding pharmacy practices versus established regulatory safeguards designed to protect patients from unapproved or insufficiently tested therapies.
Impact on the Company & Individuals
For Hims & Hers, this controversy exposes significant regulatory and reputational risks. Non-compliance with FDA drug promotion rules can lead to enforcement actions, including warning letters, fines, mandated corrective advertising, and potential legal liabilities. The company’s use of compounded drugs, which do not have FDA approval, increases scrutiny and may complicate marketing strategies.
Individual healthcare providers and consumers are also affected. Providers must navigate prescribing compounded medications with awareness of their regulatory status, while consumers risk exposure to drugs without fully vetted safety profiles. The FDA’s emphasis on fair balance in advertising aims to ensure consumers make informed decisions based on transparent information.
More broadly, this case signals to telehealth companies and pharmaceutical compounders that regulatory compliance in advertising is non-negotiable, influencing operational decisions, risk management, and marketing approaches across the industry.
Industry Concerns
The Hims & Hers incident exemplifies growing regulatory enforcement focus on compounded drug promotion and telehealth advertising. Industry experts note increased FDA vigilance regarding ads that blur lines between FDA-approved drugs and compounded alternatives. Advocacy groups, including pharmaceutical manufacturers and compounding associations, have voiced concerns about misleading claims and patient safety.
Market analysts observe that telehealth companies are under pressure to balance innovative delivery models with compliance rigor. The controversy has sparked bipartisan congressional attention, with senators urging the FDA to enforce consistent advertising standards across all drug types.
Companies are increasingly adopting internal compliance protocols, enhanced legal reviews, and transparent communication strategies to mitigate risks. The trend suggests a tightening regulatory environment where misleading or incomplete drug promotion, especially during high-profile media events like the Super Bowl, will face swift consequences.
Compliance Requirements
To align with FDA drug promotion rules, companies like Hims & Hers must ensure that their advertisements:
- Clearly disclose whether drugs are FDA-approved or compounded and explain the implications.
- Present side effects, contraindications, and risks with prominence and readability comparable to efficacy claims.
- Avoid misleading or unbalanced claims that could deceive consumers about safety or effectiveness.
- Comply with both FDA and FTC advertising regulations, ensuring truthfulness and substantiation of claims.
- Include comprehensive risk information in a manner consistent with 21 CFR 202.1(e)(7)(viii) and the FDCA.
Common mistakes to avoid include burying disclaimers in fine print, omitting risk disclosures entirely, or implying equivalency between compounded and FDA-approved drugs without evidence.
Future Outlook
The Hims & Hers Super Bowl ad controversy is likely a harbinger of more rigorous regulatory scrutiny on compounded drug promotion and telehealth advertising. The FDA appears poised to enforce stricter compliance with drug promotion laws, particularly in high-visibility campaigns.
Telehealth and compounding sectors may face evolving standards requiring greater transparency, more robust risk communication, and possibly new regulatory frameworks addressing compounded drug marketing. Companies that proactively enhance compliance programs and engage with regulators constructively will be better positioned to navigate this shifting landscape.
In this evolving environment, clear, balanced, and truthful drug promotion is not only a legal obligation but a strategic imperative to maintain consumer trust and avoid costly enforcement actions.
FAQ
1. What specific FDA rules did the Hims & Hers Super Bowl ad violate?
Ans: The ad violated FDA rules requiring fair balance in prescription drug advertising, specifically 21 CFR 202.1(e)(7)(viii), which mandates that side effects and risks be presented with prominence comparable to efficacy claims. It also breached the Federal Food, Drug, and Cosmetic Act by promoting compounded drugs without disclosing their unapproved status.
2. Why are compounded drugs treated differently under FDA regulations?
Ans: Compounded drugs are made by pharmacists or outsourcing facilities to meet unique patient needs and are exempt from the standard FDA approval process. Because they do not undergo FDA’s rigorous safety and efficacy review, they must be marketed with clear disclaimers about their unapproved status and potential risks.
3. What are the consequences for companies that violate FDA drug promotion rules?
Ans: Companies may face FDA enforcement actions such as warning letters, fines, mandated corrective advertising, and legal liabilities. These actions can damage reputation and lead to increased regulatory scrutiny.
4. How does this controversy affect consumers using compounded medications?
Ans: Consumers may be exposed to medications without fully established safety and effectiveness profiles, increasing health risks. Lack of clear risk disclosures in advertising can lead to uninformed decisions.
5. What steps can telehealth companies take to ensure compliance in drug advertising?
Ans: Telehealth companies should clearly disclose drug approval status, present balanced risk and benefit information, comply with FDA and FTC regulations, conduct thorough legal reviews of ads, and avoid misleading claims to ensure compliance and protect consumers.