What You Should Know about Telehealth Companies Selling Compounded Drugs

Hims claims in a national TV ad to offer a “safe and simple” way to get “doctor-trusted” ED medication. Willow suggests in a social media video featuring one of its “prescribing physicians” that its weight-loss medications can also address alcoholism. And Musely touts on its website that one of its “prescription-strength” creams treat wrinkles, while another both treats wrinkles and increases the production of collagen.

Hims, Willow and Musely are part of a recent explosion of telehealth companies marketing their own compounded drugs directly to consumers. The claims about these health products may be impressive but there’s often more to these types of customized medications than what is mentioned in ads like those above.

These products have not been approved by the FDA

For one, unlike brand-name drugs – or the generic versions of those drugs that have the same active ingredient – compounded drugs are not approved by the FDA (meaning that the FDA has not verified the safety or effectiveness of the products), a fact that can be buried in compounded drug ads, if disclosed at all.

For example, Hims notes in the quickly disappearing fine print of its TV commercial that products featured in the ad “include compounded products that have not been approved by the FDA.”

Among the compounded ED products Hims sells is a chewable made with sildenafil and tadalafil, the active ingredients in FDA-approved ED drugs Viagra and Cialis, respectively. Interestingly and potentially confusing for consumers, Hims also sells a generic Viagra product containing only sildenafil that the company says has FDA approval.

The Willow X post doesn’t mention that the company’s compounded GLP-1 injections and GLP-1 drops, which purportedly contain the same active ingredients in several FDA-approved GLP-1 drugs, specifically, semaglutide and tirzepatide, have not themselves been approved by the FDA.

As discussed in more detail below (see The rise of compounded drugs), the FDA allows compounded versions of FDA-approved medications to be manufactured during drug shortages. And up until late last year, FDA-approved GLP-1 drugs Ozempic, Wegovy, Mounjaro and Zepbound, were all in short supply. (While not unique to compounded drugs, the FDA also permits some unapproved prescription drugs to be marketed when health care professionals rely on the drug to treat serious medical conditions and there is no FDA-approved option.)

However, with regard to the Willow post, it’s worth noting that GLP-1 drugs have only been approved to treat diabetes or weight loss, not alcohol problems. In addition, while the company sells compounded GLP-1 drops primarily for weight loss, there is only one comparative FDA-approved GLP-1 drug that is taken orally, a pill that is only approved to treat diabetes.

With respect to Musely, while the company claims its ingredients are FDA approved, its products are not, which it doesn’t mention on product pages. And you might be interested to know that the FDA generally considers claims to treat or remove wrinkles and increase the skin’s production of collagen to be drug claims, which require the agency’s approval.

What are the health risks?

Another thing that can be missing from telehealth company ads for compounded drugs: information regarding health risks.

During the Super Bowl, Hims partnered with its sister brand Hers to run an ad called “Sick of the System.” The ad castigated the U.S. healthcare system for putting profits over patients while touting the brands’ compounded semaglutide injections, which start at $165 a month, as “affordable” and “doctor-trusted” alternatives to traditional weight-loss drugs.

But even before the ad aired, the spot faced backlash for exploiting a perceived loophole in federal law regarding promotions of compounded drugs by telehealth companies and omitting any safety or side effect information. The only indication that there may be risks associated with taking the companies’ products came in the last line of a long written disclaimer at the end of the ad: “See website for details and important safety information.” (A similar disclaimer appears at the end of the Hims’ ad focusing on its ED medication.)

Since the controversy over the Super Bowl ad, Hims and Hers have included a disclaimer in some of their ads regarding how their compounded weight-loss products have not been approved by the FDA and require an online consultation with a licensed provided who will determine if a prescription is “appropriate.” But the disclaimer doesn’t appear everywhere and it still refers consumers to a company website for “important safety information.”

As for the other telehealth companies mentioned earlier, Willow does not disclose any side effects associated with its compounded GLP-1 products in the social media post shown above and requires that consumers scroll more than halfway down product pages to learn about potential health risks. (Also, fun fact about that “prescribing physician” in the post – he actually has a larger role in the company as its chief medical officer.) And Musely doesn’t mention any side effects on the creams’ product pages, simply stating in an FAQ on one of the product pages that, “Your Musely board-certified dermatologist will guide you in a treatment plan regarding any skin concerns you may have.”

So, what are the potential side effects associated with these compounded products? Hims says its compounded ED medication may cause headaches, flushing, upset stomach, runny or stuffy nose, back and muscle pain, nausea, dizziness, rash and, in rare cases, changes in vision or loss of sight. Common side effects of Hims and Hers’ compounded semaglutide injections include nausea, diarrhea and vomiting. Similarly, Willow says people who take its compounded GLP-1 medications may experience stomach issues but also warns that pancreatitis and gall bladder disease are potential health risks. Lastly, one of the ingredients in Musely’s wrinkle creams, hydroquinone, can cause severe burning, itching, crusting or swelling of the treated area, among other potential side effects.

The rise of compounded drugs

A number of factors have helped contribute to the rise of compounded drugs, including cost, availability of FDA-approved medications and the ability to customize treatments.

For example, even with insurance, GLP-1 drugs can be difficult to afford. Without insurance, the cost of these FDA-approved medicines can be astronomical, approaching $1,300 for just a month-long supply, or more. In addition to their own compounded medications, Hims and Hers sells Ozempic for $1,799 a month.

By contrast, sellers of compounded GLP-1 products typically charge between $200 and $300 a month, and some less than that. Musely, meanwhile, claims that its compounded skin care products are 10 times more affordable than standard prescriptions.

Drug shortages have also played a major role when it comes to telehealth companies marketing compounded versions of FDA-approved drugs.

Under federal law, compounding pharmacies are allowed to make copycats of brand-name medications when the manufacturers of those medicines are unable to meet the demand for their products. Starting in 2022 and up until late last year, Ozempic, Wegovy, Mounjaro and Zepbound were all in short supply. Even as the FDA has raised dosing and other concerns with compounded semaglutide and tirzepatide, it has allowed the compounded medications to be manufactured during the drug shortages. Recently, however, those shortages were resolved, putting telehealth compounders on notice.

Some compounders have already pivoted to offering other types of treatments, such as hormone replacement therapy. Others have indicated they’ll continue to make compounded medications but shift to providing individualized doses that the pharmaceutical giants can’t produce.

But there are a variety of medications on the FDA’s drug shortages list across a range of therapeutic categories.

Perhaps most important, compounded drugs can be customized to meet a patient’s specific needs. For example, if a patient cannot be treated with an FDA-approved medication due to an allergy, compounding pharmacies can alter the ingredients of the drug to create a medication that is safe for the patient.

But as the FDA warns, “Although compounded drugs can serve an important medical need for certain patients, they also may pose a risk to patients.” And as shown in the examples above, these risks are not always disclosed in ads touting the benefits of compounded drugs.

In response to a TINA.org request for comment, Hims and Hers said the companies follow all laws and regulations that apply to telehealth platforms advertising access to medical treatments.

Willow and Musely did not respond to TINA.org’s requests for comment.

The bottom line

Consumers need to remember that compounded drugs have not been approved by the FDA and that these types of medications can carry risks, even if they aren’t disclosed in ads. As always, consumers should consult with a trusted healthcare provider when making any decision regarding their health.

Find more of our coverage on health claims.