Hims is not FDA approved, because the FDA doesn’t approve telehealth companies. It approves specific medications. The real question is whether the drugs you’d get through Hims carry FDA approval, and the answer depends entirely on which product you’re looking at. Some medications Hims prescribes are fully FDA-approved generics. Others, particularly its compounded weight loss injections, are not FDA approved and have never gone through the agency’s review process for safety and effectiveness.
Why the FDA Doesn’t Approve Companies
The FDA approves individual drug products, not the pharmacies or platforms that sell them. Hims operates as a telehealth platform that connects you with licensed providers who write prescriptions, which are then filled by partnered pharmacies. There’s no FDA approval category for that type of business. So when people ask “is Hims FDA approved,” what actually matters is the regulatory status of each product in their catalog, and that varies significantly.
FDA-Approved Medications Hims Prescribes
Several core products on Hims are standard FDA-approved generic drugs that have been through the full approval process, including clinical trials demonstrating safety and efficacy.
For erectile dysfunction, Hims prescribes sildenafil (the active ingredient in Viagra) and tadalafil (the active ingredient in Cialis). Tadalafil was first FDA approved in November 2003 for erectile dysfunction, with an additional approval in 2008 for once-daily use. Both drugs are well-established generics with decades of clinical data behind them.
For hair loss, Hims offers finasteride, sold under the brand name Propecia. The FDA-approved dose is 1 mg taken once daily as an oral tablet. Minoxidil, another hair loss treatment available through the platform, also has FDA approval for that use. When you get these specific medications through Hims, you’re receiving the same FDA-approved drugs you’d get from any pharmacy.
Hims also prescribes certain medications off-label, meaning the drug itself is FDA approved but not for the specific condition being treated. Propranolol, for example, is FDA approved for high blood pressure, migraines, and essential tremor, but Hims prescribes it for performance anxiety, which is not one of its approved uses. Off-label prescribing is legal and common in medicine, though it means the FDA hasn’t specifically reviewed the drug’s safety and effectiveness for that particular purpose.
Compounded Weight Loss Drugs Are Not FDA Approved
This is where the distinction gets important. Hims gained major attention for offering compounded versions of GLP-1 weight loss injections, the same class of drugs as Ozempic and Wegovy. These compounded products use the same active ingredient (semaglutide), but they are not the same as the brand-name versions, and the FDA has been explicit about the difference.
As the FDA states plainly: “Compounded drugs are not approved by FDA. FDA-approved drugs go through FDA’s rigorous review for safety, effectiveness, and quality as part of the premarket approval process.” Brand-name Ozempic and Wegovy went through extensive clinical trials before receiving approval. The compounded versions sold through Hims did not.
Compounding pharmacies are allowed to mix custom medications under specific legal exemptions. Traditionally, compounding existed so pharmacists could tailor medications for individual patients, for instance, making a liquid version of a pill for someone who can’t swallow tablets. Two sections of federal law govern this. Section 503A applies to traditional pharmacies compounding individual prescriptions. Section 503B applies to larger outsourcing facilities that can produce compounded drugs in bulk but must register with the FDA and report adverse events.
Both types of compounders are exempt from the FDA’s standard drug approval requirements. That means no clinical trials proving the compounded version works as well as the approved one, and no FDA review of manufacturing quality under the same standards applied to approved drugs.
The GLP-1 Shortage Loophole Is Closing
Compounders were able to produce semaglutide and tirzepatide (the active ingredient in Mounjaro and Zepbound) because those drugs were on the FDA’s official drug shortage list. When a medication is in shortage, compounding pharmacies gain broader legal authority to produce copies. As supply has stabilized, the FDA has moved to restrict this practice.
Neither semaglutide nor tirzepatide currently appears on the FDA’s drug shortage list or on the 503B bulks list, which identifies ingredients compounders can use when there’s a recognized clinical need. The FDA’s guidance indicates that a compounded drug is considered an “essentially a copy” of a commercially available product when it contains the same active ingredient in the same or similar strength and uses the same route of administration. That description fits the compounded GLP-1 injections Hims has been selling.
For outsourcing facilities operating under Section 503B, the rules are now clear: they cannot compound drugs from bulk ingredients unless those ingredients appear on the 503B bulks list or the drug is on the shortage list. With semaglutide on neither list, the legal basis for large-scale compounding has narrowed considerably.
FDA Has Warned Hims Directly
In September 2025, the FDA issued a warning letter to Hims & Hers Health for making false or misleading claims about its compounded semaglutide products. The agency cited specific marketing language on the Hers website, including claims like “weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy” and “clinically proven ingredients.”
The FDA’s finding was direct: “Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading.” The agency determined the products were misbranded under federal law. This warning followed controversy around a 2025 Super Bowl ad from Hims that critics said inadequately communicated that its weight loss injections were compounded, not FDA approved.
Supplements Follow Different Rules Entirely
Hims also sells non-prescription products like biotin supplements, shampoos, and other wellness items. Dietary supplements occupy a completely separate regulatory category. The FDA does not approve supplements before they go to market. Under the Dietary Supplement Health and Education Act, manufacturers are responsible for ensuring their products are safe, but there’s no pre-market review process comparable to what prescription drugs go through. This applies to all supplement companies, not just Hims.
What This Means in Practice
If you’re considering Hims for a generic ED medication or finasteride for hair loss, you’re getting an FDA-approved drug dispensed through an online pharmacy. The medication itself has the same regulatory backing as what you’d pick up at a local drugstore. The telehealth model is the delivery mechanism, not the product.
If you’re looking at Hims for compounded weight loss injections, the situation is fundamentally different. Those products have not been through the FDA’s approval process, the legal basis for compounding them is shrinking, and the FDA has already taken enforcement action against the company for how it markets them. The active ingredient may be the same, but the final product has not been evaluated for safety, effectiveness, or manufacturing quality by the FDA.