Counterfeit and Compounded GLP-1 Products Face Regulatory Crackdown

The Therapeutic Goods Administration (TGA) issued an updated safety advisory after testing confirmed counterfeit imported weight loss products falsely claiming to contain glucagon-like peptide-1 (GLP-1) receptor agonists or GLP-1 analogues. TGA laboratory testing of several imported unregistered products confirmed that the products contain no GLP-1 or any GLP-1 analogues, despite being labelled as such.

The products tested by the TGA are considered counterfeit under the Therapeutic Goods Act 1989 and are not included in the Australian Register of Therapeutic Goods (ARTG). Ten products were tested, including STDEI GLP-1 Weight Loss Oral Solution, BuildLeaf Tirzepatide GLP-1 Herbal Oral Liquid, HHVB GLP-1 Six In-One Health Solution Oral Liquid, EQVP GLP-1 Six In-One Health Solution Oral Liquid, Diapason GLP-1 Seven In-One Health Solution Oral Liquid, BuildLeaf GLP-1 Eight-In-One Fit & Vital Oral Solution, LERCEA GLP-1 Metabolic Balance Oral Ampoules, Croaie Tipoleptide GLP-1 + GIP Weight Management, HHVB-GLP-1 Nano Microneedle Patch, and HHVB GLP-1 Moringa Slimming & Health Boost Drops. All tested products showed no GLP-1 or analogues identified.

In the United States, regulatory authorities escalated enforcement efforts against compounded GLP-1 products. On February 9, Novo Nordisk initiated legal proceedings against Hims & Hers, accusing the telehealth provider of patent infringement by selling alternative versions of Wegovy. The lawsuit followed closely after Hims & Hers announced it would offer a compounded Wegovy pill at an introductory rate of $49 per month.

The telehealth company pulled its product just two days after its launch, after U.S. regulators vowed to take "decisive" action against its knockoff drug and others like it. Novo Nordisk representatives stated that the decision by Hims & Hers to introduce a pill form of Wegovy was the tipping point, emphasizing that there was never a shortage of the oral version, and thus no justification for a compounded alternative.

Originally, compounded drugs were meant to be widely available only during shortages of the branded medications. However, even after the Food and Drug Administration announced the end of the shortage in 2025, telehealth companies have continued to supply compounded anti-obesity drugs. The shortage has been officially over for more than a year for Zepbound, and nearly a year for Wegovy.

A compounded drug isn't subject to the same oversight as FDA-approved medications, meaning there's no guarantee it's as effective or safe as the original product. A compounded version of the Wegovy pill seems especially fraught because semaglutide, the active ingredient in Wegovy, is a peptide that historically has been difficult to turn into a pill. Peptides don't tend to survive the harsh environment of the human gastrointestinal tract.

The FDA escalated enforcement efforts, saying that in addition to cracking down on Hims & Hers and other compounders, the agency would take "steps to combat misleading direct-to-consumer advertising and marketing" by companies claiming to sell "generic" or equivalent products. Multiple sites claim to offer a pill version of tirzepatide, the active ingredient in Eli Lilly's Zepbound, though there is no approved oral version of tirzepatide.

According to the health policy organization KFF, approximately one out of every eight Americans uses a GLP-1 medication for weight management, diabetes, or related health issues. Many of these individuals face financial barriers because their insurance does not cover these drugs. A survey by Mercer found that 49% of large employers covered GLP-1 drugs in 2025, up from 41% in 2023.

Currently, Novo Nordisk is the sole company with FDA approval for an oral GLP-1 weight-loss medication. During a recent earnings call, executives highlighted the rapid uptake of their oral medication, with over 50,000 prescriptions being filled weekly and most early adopters paying cash. The starting price for the Wegovy pill is $149, which is about $200 less than the injectable version.

This exclusivity may soon end, as Eli Lilly's oral weight-loss drug, orforglipron, could receive FDA approval as early as April. Both Novo and Lilly have reduced prices for those paying cash. Lilly now offers a month's supply of 2.5 mg Zepbound vials for $299, down from $349, while the 5 mg vials are priced at $399. Novo Nordisk has lowered the cost of injectable Wegovy and most Ozempic dosages to $349 per month for customers purchasing directly or through partners, down from $499.

The TGA continues to monitor signals relating to harmful unregistered products and will notify the Australian Border Force to seize and destroy any of these products intercepted at the border. GLP-1 receptor agonists like semaglutide, tirzepatide, and liraglutide are prescription-only medicines in Australia and should only be used under medical supervision. Counterfeit products cannot be imported under the Personal Importation Scheme, and importing, supplying and giving away counterfeit therapeutic goods is illegal.

Hims & Hers reports having around 2.5 million subscribers across its health services, with GLP-1 users making up a small fraction of their customer base. The company continues to offer injectable GLP-1 medications and stated that effective obesity treatment requires individualized care.