NCL Issues a Second Alert to Heed Warnings About Unregulated Versions of GLP-1 Weight Loss Drugs

Media Contact: Lisa McDonald, Vice President of Communications, 202-207-2829 

Washington, DC – A year ago, the National Consumers League took the unusual step of flagging warnings from the Food and Drug Administration (FDA) and medical societies stating that compounded versions of GLP-1 (glucagon-like peptide-1 receptor agonists) weight-loss drugs are not FDA approved and may cause serious health problems. The purpose was to inform consumers about the potential harm posed by these drugs before Hims & Hers, a large telehealth company, aired a widely hyped television ad during the 2025 Super Bowl touting only the benefits of compounded GLP-1s.  

Now, NCL is raising alarm bells in advance of this year’s Super Bowl, where at least two telehealth companies – Hims & Hers and Ro – will use the Big Game to promote “personalized” compounded GLP-1s as a new trend in health care.  

Taking the form of microdosing injectable GLP-1s or as medications formulated with added ingredients such as B vitamins, these non-standard formulations are untested; lack FDA approval for safety, quality, or efficacy; and, according to the FDA, carry risks such as dosing errors and severe side effects.   

NCL’s consumer alert reflects a different market for compounded GLP-1 weight-loss drugs than what existed a year ago. At the time of the 2025 Super Bowl, there was a shortage of the branded GLP-1 drugs semaglutide (Ozempic© and Wegovy©) and tirzepatide (Mounjaro© and Zepbound©, which opened the door for compounding pharmacies to sell non-identical versions under specific FDA regulations. This dynamic produced a largely unregulated online marketplace where telehealth companies and other sellers mass-produced and widely promoted compounded GLP-1 drugs containing a different source of the active pharmaceutical ingredient (what drugs are made from), meaning the compounded versions were not the same and according to the FDA, could contain incorrect doses, too much or too little of the active ingredient, and possibly contaminants and bacteria.  

Underscoring the potential health consequences from dosing errors and exposure to the wrong ingredients, in September 2025, the FDA reported receiving 1,150 reports of adverse events associated with compounded GLP-1 drugs, including hospitalizations and some deaths. Additionally, poison control centers reported a nearly 1,500 percent increase in calls since 2019 due to overdose or side effects. In many of these cases, people reported dosing errors, sometimes taking 10 times the recommended dose, according to multiple poison control centers. 

Also of concern, the FDA and medical societies warned the public to be aware of illegal online pharmacies selling counterfeit GLP-1s and so-called GLP-1 products (patches, liquids, gummies) in forms that do not contain actual GLP-1 ingredients. Moreover, the FDA issued warnings about bad actors selling the active pharmaceutical ingredient (API) directly to consumers via the Internet, either in powder form labeled “not for human consumption” or in vials labeled as a “research chemical,” along with dosing instructions. This illegal practice is extremely dangerous, yet sellers advertised on social media that giving consumers access to the API is an easier, more affordable way to obtain GLP-1 drugs.  

The good news is that regulators are taking actions to address these problems. In March 2025, the FDA declared the end of the national shortage of approved GLP-1 drugs and gave online sellers until May 22 to withdraw mass-produced compounded versions from the market. Then, in September, the Trump Administration launched a crackdown on deceptive direct-to-consumer drug advertising, resulting in the FDA publishing over 55 warning letters to online sellers of compounded versions of GLP-1 medications that called for the removal of “false and misleading” promotional statements, claims of “clinically proven weight-loss treatments,” and using the words “FDA-approved” in advertising copy. 

However, even with these promising developments, the largely unregulated exploitative marketplace for selling GLP-1 products persists and now involves marketing “personalized” compounded GLP-1 weight-loss drugs, which can cause harm due to unknown formulations, dosing errors, and severe side effects.  

Therefore, NCL urges consumers to learn about the safety risks associated with non-standard forms of GLP-1s and to heed these warnings from the FDA and medical authorities: 

• Microdosing a GLP-1 drug means intentionally taking a smaller dose than what the FDA approved as the standard dosage levels for the treatment of obesity or diabetes based on clinical studies. Yet GLP-1s are designed to work at certain doses to achieve optimal results. This is why a primary concern with microdosing is that people may not obtain the necessary amount of the GLP-1 drug to have the desired therapeutic outcome, such as weight loss. 
• The FDA warns that microdosing is not an approved medical regimen and has issued specific alerts regarding the dangers of unregulated products marketed for this purpose. Specifically, the FDA states that microdosing “is not a regulated term” and there is no clinical evidence from large-scale trials demonstrating the safety and effectiveness of GLP-1 microdosing for mild appetite control, weight management, or longevity.
• According to published reports, microdosing GLP-1 drugs is associated with side effects and complications, such as dizziness; underdosing when patients do not get enough of the active ingredient for a therapeutic benefit, like stable blood sugar; and rebounding if the dose dips below the level the body needs and causes hunger or weight regain. 
• The FDA warns about the opposite of microdosing, when patients exceed the dosage levels of compounded semaglutide or tirzepatide products beyond what is in the FDA-approved drug label. As documented by the FDA, practices such as taking a higher amount of the drug in a single dose, taking doses more frequently, or increasing the amount of the drug more quickly can cause serious gastrointestinal problems, including nausea, vomiting, diarrhea, and abdominal pain. 
• Today, studies estimate that over 80 percent of the “personalized” compounded GLP-1 drugs now being marketed include added ingredients such as B vitamins (B6, B12, B3). Yet, the FDA cautions that the safety and effectiveness of combining a GLP-1 drug with additional ingredients, such as cyanocobalamin (Vitamin B-12) and pyridoxine (Vitamin B-6), have not been established. It is also worth noting that adding ingredients may affect the safety, absorption, or effectiveness of the GLP-1 medication. 

In light of this information, NCL offers this advice to consumers when considering GLP-1 treatment options: 

• Before seeking treatment with a GLP-1 drug, talk to your doctor or health provider to determine if you are a candidate for treatment based on your risk factors and degree of obesity. 
• When possible, the FDA recommends that patients opt for FDA-approved GLP-1 medications and fill prescriptions at a state-licensed pharmacy. 
• Because GLP-1 drugs are serious medicines that carry risks as well as benefits, it is best to obtain a prescription from your doctor or a health professional you know. 
• Be aware of the differences between FDA-approved GLP-1 drugs and products sold online that claim to be “the same” as these medicines, only cheaper and more convenient. Unlike FDA-approved medicines, compounded GLP-1 drugs and products promoted as alternatives to the FDA-approved versions – such as oral supplements and patches – do not go through the FDA’s rigorous review process to ensure safety, effectiveness, and quality. Moreover, there are differences in how these products are made, and the ingredients may come from undisclosed sources. The FDA warns that these products may be at different dosage levels, increasing the risk of dosing errors. 
• Before ordering a GLP-1 drug through an online pharmacy, follow the FDA’s tips to spot warning signs that the website may be unsafe, such as the online pharmacy being unlicensed in the US or by a state board of pharmacy, or offering deep discounts that seem too good to be true. 

### 

About the National Consumers League (NCL)      

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.