Going back to the beginning, in 2022, studies showed that the FDA-approved GLP-1 drugs, semaglutide and tirzepatide, achieved significant weight loss. This news prompted high demand, which led to a national shortage of these drugs. Thus, to fill the supply gap, the FDA allowed compounding pharmacies to sell non-identical versions of GLP-1 drugs under specific FDA regulations until the shortage ended.
At the time, the FDA could not foresee that opening the market to compounders would create a gold rush situation for telehealth platforms and other sellers. Profits soared, and a largely unregulated market emerged where sellers hyped compounded GLP-1s as cheaper options with the same safety and efficacy as the branded drugs without disclosing the risks. Over time, this exploitative market expanded to include so-called GLP-1 products, such as gummies and patches, that do not contain GLP-1 ingredients. The market also includes online pharmacies selling counterfeit injectable GLP-1s and bad actors selling illegal research-grade raw GLP-1 ingredients online to consumers with dosing instructions.
This was the situation in February 2025, when the National Consumers League issued a national alert to relay the warning from the FDA that compounded GLP-1s are “risky for patients” because these drugs are not required to be tested, and are not reviewed and approved by the FDA. Then, on March 12, the FDA announced the end of the national shortage of semaglutide and tirzepatide, setting May 22 as the last day that mass-produced compounded GLP-1s drugs could be sold.
In advance of the deadline, NCL launched a national initiative, The Weight Truth, to help consumers learn about the differences between FDA-approved and compounded GLP-1s and identify fake and counterfeit products. The Weight Truth initiative is also the call-to-action for NCL to combat false and misleading advertising claims about GLP-1 drugs and press lawmakers to enforce existing laws that protect consumers from disinformation, take counterfeits off the market, and regulate compounding practices more aggressively.
Thus, on May 22, 2025, NCL and the patient safety community watched and waited. But what occurred was not the end of mass-marketed compounded GLP-1s. While some telehealth companies exited the market, most sellers evolved into promoting “personalized” compounded GLP-1s as microdoses or as GLP-1s in combination with other drugs, such as cyanocobalamin (Vitamin B-12). By February 2026, the hype about personalized compounded GLP-1s had reached a level where NCL felt the need to issue a second consumer alert in advance of the 2026 Super Bowl, where telehealth companies aired glitzy ads. The alert explained that these altered forms had not been tested in large clinical trials and may pose additional safety risks.
Then, the earth started to move, so to speak. The volume of misleading advertising claims, the audacious marketing of some telehealth companies, the story of a Kentucky woman who developed acute liver failure after receiving compounded tirzepatide combined with B12 and needed an emergency liver transplant, and the outcry from 38 state attorneys general to stop the illegal sale of research-grade GLP-1 ingredients all combined to get the attention of policymakers. Thus, lawmakers at the federal and state levels are taking increasingly meaningful steps to stop fraudulent advertising and crack down on illegal mass compounding.
What does change look like? In the year since the FDA declared the GLP-1 shortage resolved, there have been these developments:
- In September 2025, the FDA announced its intent to regulate compounded GLP-s more aggressively. Then, the FDA launched a crackdown on misleading advertising claims, sending warning letters to over 55 online sellers of compounded GLP-1 drugs, telling sellers that it is a breach of FDA regulations to tout the benefits of the weight-loss drugs without any mention of side effects.
- In December 2025, Congressman Rudy Yakym (R-IN-02) and Congressman André Carson (D-IN-07) introduced the “Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act of 2025” to protect patients from untested, unapproved, and potentially dangerous mass-compounded drugs. By February 2026, Senators Jim Banks (R-IN) and Martin Heinrich (D-NM) had introduced the bill in the Senate with the goal of closing regulatory loopholes and strengthening FDA oversight.
- In March 2026, Indiana Governor Mike Braun signed a bill into law establishing new state oversight requirements for drug compounding and med spas. This step sets the stage for other states to add guardrails that will protect patients and reinforce the boundaries of lawful compounding.
- In April 2026, FDA clarified its policies on GLP-1 compounding, stating that compounders should not assume that practices tolerated during shortage conditions are now acceptable. Soon afterward, the FDA issued a proposed rule to exclude three GLP-1 drugs – semaglutide, tirzepatide and liraglutide – from the 503B bulks list. In doing so, the FDA signaled that compounding is intended for limited purposes and not the permanent sale of mass-produced alternatives to FDA-approved medicines.
The National Consumers League celebrates these developments as a good start in improving the regulation of compounded GLP-1 drugs. A year after May 22, 2025, policymakers recognize that insufficient regulatory safeguards allowed an exploitative GLP-1 marketplace to flourish, putting the safety of consumers at increased risk. Now it is up to all of us – advocates, medical societies, public health leaders, and concerned citizens – to demand that policymakers keep moving forward to enforce existing laws and pass new ones that will keep consumers safe, combat fraud in the marketplace, and put patient safety first when implementing changes in compounding practices at the state level.
