EllieMD Semaglutide Sublingual Drops

About one in eight U.S. adults report taking a GLP-1 drug used to treat type 2 diabetes and weight loss. Most GLP-1 drugs, like FDA-approved Ozempic and Wegovy, are injections. There is only one FDA-approved oral option, a pill that is only approved to treat diabetes.

Enter EllieMD’s semaglutide sublingual drops.

But first – what is EllieMD?

EllieMD is a telehealth company and subscription-based service that connects consumers to online medical providers for prescriptions to its customized medications. EllieMD also offers consumers the opportunity to receive “real earnings” selling its products to others, and recruiting others to do the same, under a multilevel marketing business model.

The company claims its semaglutide drops, which are applied under the tongue, contain the same active ingredient found in Ozempic and Wegovy – and provide “the powerful benefits of GLP-1 without injections.”

EllieMD further touts, under a “benefits” tab on the drops’ product page, that the drops offer “prescription appetite suppression” and are “scientifically backed” to help users lose weight, adding that the drops can help to lower blood sugar levels and “potentially reduce the risk factors associated with conditions like type 2 diabetes, high blood pressure and cardiovascular disease, which are often linked to diabetes.”

Meanwhile, a recent EllieMD Instagram post boasts about the “cardiovascular benefits” of its “GLP-1 medication,” including decreased risk of cardiovascular disease, heart attack and stroke.

But before you sign up for these drops, you should know that the FDA hasn’t had any say in whether they are safe or effective. That goes for all of the compounded medications found on EllieMD’s website.

EllieMD is part of an explosion of telehealth companies marketing compounded GLP-1 medications. Unlike generic drugs with the same active ingredient as FDA-approved drugs (or the FDA-approved drugs themselves), these types of medical products have not been approved by the FDA, a fact that EllieMD acknowledges in a disclaimer on the drops’ product page, which states in part:

Compounded medications are not FDA-approved, and their safety and efficacy have not been independently verified by the FDA.

Rather than rely on FDA approval, EllieMD appears to substantiate its health claims by listing five “scientific sources” about halfway down the drops’ product page:

However, four of the five sources listed are about the same study – the actual study, an article on the study, a summary of the study and a paper about the subgroups of people that were involved in the study. But the study didn’t examine sublingual drops at all; rather, it studied semaglutide injections.

The remaining “scientific source” listed on the EllieMD product page is a review of other trials that examined the efficacy and safety of several GLP-1 products but only in adults with type 2 diabetes. None of the GLP-1 products in the trials reviewed were sublingual.

As for potential side effects, these are relegated to an FAQ further down the product page (that consumers must click on to expand in order to read it) that states:

Semaglutide is generally safe when used under medical supervision. Common side effects include nausea, vomiting, diarrhea and constipation. Rare but serious risks include pancreatitis and kidney problems. Discuss potential risks with your healthcare provider.

The FDA notes that some patients who cannot be treated with an FDA-approved medication due to an allergy or difficulty swallowing pills can benefit from compounded drugs, which can be tailored to meet a patient’s specific medical needs. However, the agency also warns that trying to lose weight with an unapproved GLP-1 drug “can be risky for patients.”

Others have raised concerns regarding the safety of compounded weight-loss drugs, which can cost hundreds of dollars less than FDA-approved treatments.

EllieMD did not respond to TINA.org’s request for comment.

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