FDA Cracks Down on Weight Loss Drug Ads — Why Hims & Hers Is in the Spotlight

In 2025, the Food and Drug Administration (FDA) ramped up enforcement of laws and regulations governing how weight loss drugs are advertised — especially as demand for such drugs has surged. Among the companies now under scrutiny is Hims & Hers Health, a telehealth provider that has built a business around more affordable access to weight loss medications, including compounded versions of popular brand-name drugs like Wegovy and Ozempic. The FDA alleges that some of the company’s marketing is misleading — that it downplays or omits risks, overstates equivalence with FDA-approved drugs, or fails to maintain required balances in disclosure of benefits versus risks. This enforcement push reflects broader tensions in U.S. regulatory policy, public health, consumer protection, and telehealth’s evolving role.

What is going on, what Hims & Hers is accused of, what the regulatory and legal issues are, implications for patients/consumers, and possible next steps.

The Background: Weight Loss Drugs, Telehealth & Market Pressure

• GLP-1 drugs & weight loss boom: Drugs originally developed for diabetes, especially GLP-1 (glucagon-like peptide-1) receptor agonists, have gained popularity in recent years for weight loss. Medications like Wegovy and Ozempic (brand-name drugs), approved by the FDA for certain obesity or weight-management uses, have become highly sought after.
• Shortages, high cost, and compounded alternatives: Because of high demand, there have been supply shortages, and the cost of branded drugs is very high. Telehealth companies, compounding pharmacies, or other providers have offered compounded versions — these are custom-made formulations that aim to replicate active ingredients in smaller doses or in different formats. They usually come at lower cost but are not the same, in regulatory or safety oversight, as FDA-approved drugs.
• Rise of D2C / telehealth marketing: Alongside the rising demand, telehealth platforms (like Hims & Hers) have leaned heavily into marketing weight loss options directly to consumers, often via digital ads, social media, or high‐visibility campaigns (e.g. Super Bowl ads). The public interest in weight loss solutions, combined with the relative novelty and hype around GLP-1 drugs, has created fertile ground for aggressive marketing.

What the FDA Is Doing: New Enforcement & Regulations

• Warning letters & cease-and-desist orders: The FDA has recently issued more than 100 letters to companies (including telehealth and drug manufacturers) warning about misleading or false claims in advertisements. Some of the letters include explicit “cease and desist” language.
• Executive direction: A memo signed by President Donald Trump directed Health Department officials and the FDA to step up enforcement to ensure that pharmaceutical ads on television, social media, and websites are “truthful and non-misleading.” This political priority gives regulatory muscle to the FDA to scrutinize marketing more heavily.
• Focus areas: The FDA is especially concerned with:
  1. Compounded versions of GLP-1s being advertised as equivalent to approved brand-name drugs.
  2. Ads that highlight benefits heavily but omit risks or side effects (“fair balance” of risk vs benefit).
  3. The use of promotional language that could confuse consumers into thinking they’re getting an FDA-approved product when they are not.
  4. Marketing practices by telehealth companies and online platforms, which may fall into regulatory “gray areas.”
• Super Bowl ad by Hims & Hers: One high-profile example is Hims & Hers’ Super Bowl ad, which the FDA chief, Marty Makary, singled out as violating regulations because it presented benefits of GLP-1 weight-loss drugs without adequately mentioning side effects or risk information. The ad was criticized as lacking required “fair balance” between risks and benefits.

What Hims & Hers Is Being Accused Of

• Misleading equivalence claims: The FDA’s warning letter to Hims & Hers says that the company has used language on its website such as claiming its compounded products have the “same active ingredient” as FDA-approved drugs Wegovy and Ozempic. The agency asserts that such claims imply equivalence when that equivalence hasn’t been approved by the FDA.
• Downplaying risks, omitting side effects: The Super Bowl ad in particular is criticized for emphasizing benefits without giving appropriate prominence to risks. By not listing side effects or disclaimers, the ad may violate federal law requiring that prescription drug advertisements show a balanced view.
• Regulatory gray area: Compounded drugs & telehealth: Because Hims & Hers is offering compounded versions of GLP-1 medications, there is debate over how they should be regulated and what rules apply. These compounded products are not FDA-approved in the same way that branded drugs are, so they do not have the same labeling, standardized studies, or risk management protocols. But when they are advertised in ways that make them look like FDA-approved drugs, or implying similar safety/efficacy, regulators say that is misleading.
• Disclaimers and transparency: Hims & Hers claims to include disclaimers on its site and in customer-facing materials that compounded treatments are not evaluated by the FDA. However, the FDA’s position is that these disclaimers are insufficient in some cases (too small, too buried, not clear enough) or that they do not fully offset the misleading impressions given by other claims.

Legal & Regulatory Context

• Prescription drug advertising rules: Under U.S. law (the Federal Food, Drug, and Cosmetic Act, among others), advertisements for prescription drugs must not be false or misleading, must present a fair balance of information (benefits vs risks), and must include required information about side effects. These standards apply especially to FDA-approved drugs.
• Compounding pharmacies & regulations: Compounding is an allowed practice (under sections like 503A and 503B of FDCA) where pharmacists prepare customized medications under certain conditions (e.g., when an approved drug is not available in needed form or dose). However, compounded products do not undergo the same pre-market FDA review, standard labeling, or risk evaluations. The regulatory oversight for compounding is less strict and has some leeway — but that doesn’t mean no regulation.
• Telehealth companies & marketing: Telehealth providers are relatively new players in prescribing or arranging prescriptions, and their advertising practices are under more loose (or less tested) standards in many cases. Regulators are now pushing to hold them to the same standards as offline, brick-and-mortar drug companies. Some ads may fall under FTC oversight, others under FDA, depending on how they are structured.
• Policy shifts & political signals: The enforcement uptick follows recent executive orders and memos calling for stricter oversight of drug advertising. Also, regulators like FDA Commissioner Marty Makary have published opinion pieces criticizing current practices and calling for stronger enforcement. The political environment is more favorable to consumer protection in this area.

Why Hims & Hers Is Especially in the Spotlight

Several factors combine to put Hims & Hers at the center of this regulatory debate:

1. Business model reliant on affordability + compounding
   Hims & Hers has promoted compounded versions of GLP-1 drugs at lower cost, emphasizing price savings relative to brand-name treatments. This appeals to consumers but makes it vulnerable to claims that it is unfairly equating its offerings to approved drugs while not bearing the same regulatory burdens.
2. Visibility from major ad campaigns
   The company ran a high profile Super Bowl ad. That kind of exposure elevates public and regulatory scrutiny. Advertising benefits are larger, but so is the risk of regulatory backlash. The Super Bowl ad increased traffic to their platform dramatically (650% spike in site traffic after airing) but also drew critics.
3. Claims of equivalence in active ingredients
   Hims’s website reportedly used phrases like “same active ingredient as Ozempic and Wegovy” etc. While technically, some compounded versions use the same active molecule, they are not FDA approved, and can differ in formulation, dosing, quality assurance, etc. Implying equivalence can mislead consumers.
4. Regulators perceive imbalance in risk vs benefit messaging
   Hims’s ads have been criticized for focusing heavily on the positives (weight loss, lower costs, etc.) and less on side effects or possible risks. FDA rules require trade-offs (fair balance), so this kind of messaging is seen as problematic.
5. Regulatory changes & enforcement priorities align
   Changes in FDA enforcement posture, political push for more oversight of drug advertising, and recent executive orders make it more likely that companies like Hims will be held up as case studies. Being visible and being an early mover in compounded GLP-1s in the telehealth space means Hims & Hers is a natural target.

Risks & Consequences for Hims & Hers and Others

• Regulatory penalties, warning letters: The company has already received warning letters and been asked to remove misleading statements. Failure to comply may lead to stronger enforcement, possible fines, or even legal action.
• Reputation risk: Allegations of misleading advertising can harm trust from consumers and health professionals. If people believe the company is exaggerating claims, it can affect uptake, reviews, partnerships, etc.
• Stock price / investor impact: There have already been observable impacts. For example, after the FDA warning letters, Hims & Hers stock dropped.
• Market changes: As the FDA tightens rules, companies in similar spaces (telehealth, compounding, etc.) may need to adjust their marketing, disclosures, pricing, etc. This may increase costs, reduce margins, or slow growth.
• Consumer risk: For consumers, misleading advertising could lead to misuse, underestimation of risks, inadequate consultation, or choosing compounded drugs when a more proven, FDA-approved option would have been safer. Also, quality and consistency of compounded drugs can vary. Regulatory oversight exists but is less standardized.

Broader Significance & Policy Implications

• Consumer protection in age of online/telehealth ads: As more health services, prescribing, and pharmacies go digital, regulation of drug ads is becoming more complex. Ensuring transparency and veracity when messages are pushed via social media, streaming ads, influencer marketing, etc., is a growing challenge for regulators.
• Compounding pharmacy oversight: The trend toward compounded versions of drugs—especially high-profile, expensive brand-name drugs—puts spotlight on regulatory gaps around compounding. What quality control, dosage standardization, and safety oversight do these compounding providers have? Are consumers adequately informed?
• Access vs safety trade-off: Part of the push for compounded, lower-cost options comes from concerns about access—cost, supply shortages, etc. Regulators and policymakers need to balance enabling access (especially for patients who can’t afford brand-name drugs) with ensuring safety.
• Regulatory modernization: The legal frameworks for drug advertising were largely developed in a different era (pre-digital, pre-social media, pre-telehealth). Adapting regulation (in rulemaking, guidance, enforcement) to modern realities is a policy imperative.
• Legislation & oversight: There are proposals in Congress and among regulators to more explicitly bring telehealth companies and online-based drug marketing under stricter guidelines, especially for prescription drugs and even compounded versions. Enforcement may involve not just FDA, but also the FTC, state boards of pharmacy, etc.

What Could Happen Next: Scenarios & Possible Outcomes

1. Hims & Hers revises its marketing: The company may remove or alter any language that implies equivalence with approved drugs, clarify disclaimers, emphasize side effects and risk, adjust ad content to ensure “fair balance.”
2. Increased enforcement / penalties: If Hims & Hers (or others) do not comply, the FDA may escalate — more warning letters, possible injunctions, fines, or other sanctions.
3. Rulemaking or guidance updates: The FDA might issue new guidance clarifying how compounded drugs can be advertised, what constitutes misleading claims, what disclaimers are sufficient, particularly for telehealth‐led marketing.
4. Legislation clarifying oversight: Congress may pass laws to close loopholes, clearly assign responsibility (FDA vs FTC vs states) for oversight of advertising by telehealth/compounded drug providers.
5. Industry response & shift: Telehealth companies may adjust business models, reduce reliance on compounded drugs, or partner with established drug manufacturers. They may invest more in clinical trials, more rigorous disclosures, better quality assurance to reduce risk of regulatory backlash.
6. Consumer awareness & behavior: As the controversies gain media attention, consumers may become more skeptical; they may demand greater disclosures, question claims of equivalence, or prefer FDA-approved options despite cost.

Conclusion

The FDA’s recent crackdown on misleading advertisements for weight loss drugs is not just about one company — but reflects structural changes in how medicines are marketed, how new channels (telehealth, online platforms) operate, and how consumers and regulators navigate safety, transparency, cost, and access.

Hims & Hers finds itself under particular focus because its model bridges deep cost incentives (compounded, telehealth-based alternatives) with high visibility advertising. When claims are made that suggest equivalence to well-known FDA-approved drugs without the same regulatory vetting, or when risks are under-emphasized, regulators see red flags.

For consumers, this raises important questions: How to verify what they are being sold; whether compounded drugs meet the same standards; how side effects are disclosed; whether cheaper options are always safer or adequately regulated; and where to find reliable information.