The popularity — and price — of brand-name injectable drugs like Ozempic, Wegovy, Mounjaro, and Zepbound has skyrocketed.

But the soaring demand for these drugs — used for weight loss as well as to control blood sugar levels and reduce the risk of heart disease — and the limited supply as well as lack of generic options has also led to a flood of non-brand alternatives in the market.

In a recent article for The Conversation, UConn expert C. Michael White, Distinguished Professor of Pharmacy Practice, issued a warning to consumers about the potential undisclosed risks of these off-brand products:

High demand is driving GLP-1 wannabes

The dietary supplement market has sought to cash in on the GLP-1 demand with pills, teas, extracts and all manner of other products that claim to produce similar effects as the brand names at a much lower price.

Products containing the herb berberine offer only a few pounds of weight loss, while many dietary supplement weight loss products contain stimulants such as sibutramine and laxatives such as phenolphthalein, which increase the risk of heart attacks, strokes and cancer.

The role of compounding pharmacies

Unlike the dietary supplements that are masquerading as GLP-1 weight loss products, compounding pharmacies can create custom versions of products that contain the same active ingredients as the real thing for patients who cannot use either brand or generic products for some reason.

These pharmacies can also produce alternative versions of brand-name drugs when official drug shortages exist.

Since the demand for GLP-1 medications has far outpaced the supply, compounding pharmacies are legally producing a variety of different semaglutide and tirzepatide products.

These products may come in versions that differ from the brand-name companies, such as vials of powder that must be dissolved in liquid, or as tablets or nasal sprays.

Just like the brand-name drugs, you must have a valid prescription to receive them. The prices range from $250-$400 a month – still a steep price for many consumers.

Compounding pharmacies must adhere to the FDA’s sterility and quality production methods, but these rules are not as rigorous for compounding pharmacies as those for commercial manufacturers of generic drugs.

In addition, the products compounding pharmacies create do not have to be tested in humans for safety or effectiveness like brand-name products do.

Proper dosing can also be challenging with compounded forms of the drugs.

Companies that work the system

For people who cannot afford a compounding pharmacy product, or cannot get a valid prescription for semaglutide or tirzepatide, opportunistic companies are stepping in to fill the void. These include “peptide companies,” manufacturers that create non-FDA approved knockoff versions of the drugs.

From November 2023 to March 2024, my team carried out a study to assess which of these peptide companies are selling semaglutide or tirzepatide products. We scoured the internet looking for these peptide companies and collected information about what they were selling and their sales practices.

We found that peptide sellers use a loophole to sell these drugs. On their websites, the companies state that their drugs are for “research purposes only” or “not for human consumption,” but they do nothing to verify that the buyers are researchers or that the product is going to a research facility.

By reading the comments sections of the company websites and the targeted ads on social media, it becomes clear that both buyers and sellers understand the charade. Unlike compounding pharmacies, these peptide sellers do not provide the supplies you need to dissolve and inject the drug, provide no instructions, and will usually not answer questions.

Peptide sellers, since they allegedly are not selling to consumers, do not require a valid prescription and will sell consumers whatever quantity of drug they wish to purchase. Even if a person has an eating disorder such as anorexia nervosa, the companies will happily sell them a semaglutide or tirzepatide product without a prescription. The average prices of these peptide products range from $181-$203 per month.

Skirting regulations

Peptide sellers do not have to adhere to the rules or regulations that drug manufacturers or compounding pharmacies do. Many companies state that their products are 99% pure, but an independent investigation of three companies’ products from August 2023 to March 2024 found that the purity of the products were far less than promised.

One product contained endotoxin – a toxic substance produced by bacteria – suggesting that it was contaminated with microbes. In addition, the products’ promised dosages were off by up 29% to 39%. Poor purity can cause patients to experience fever, chills, nausea, skin irritation, infections and low blood pressure.

In this study, some companies never even shipped the drug, telling the buyers they needed to pay an additional fee to have the product clear customs.

If a consumer is harmed by a poor-quality product, it would be difficult to sue the seller, since the products specifically say they are “not for human consumption.” Ultimately, consumers are being led to spend money on products that may never arrive, could cause an infection, might not have the correct dose, and contain no instructions on how to safely use or store the product.

Dr. C. Michael White is an expert in the areas of comparative effectiveness and preventing adverse events from drugs, devices, dietary supplements, and illicit substances.

Dr. White is available to speak with media — click on his icon now to arrange an interview today.