Eli Lilly and Novo Nordisk have pursued a multiyear legal and regulatory campaign against compounders and telehealth companies selling unapproved versions of their GLP-1 drugs.
Novo has filed 130 federal lawsuits and five challenges with BBB National Programs’ National Advertising Division (NAD), a self-regulatory body that resolves advertising disputes faster than litigation. Lilly has filed dozens of federal lawsuits and at least five NAD challenges. The push comes even as the FDA has issued more than 100 warning letters over misbranded compounded GLP-1 claims in the last year, though enforcement has stayed narrowly focused on issues like active ingredients and product performance, leaving Lilly and Novo to lean more heavily on NAD and their own litigation.
Here’s a rundown of the litigation and regulatory actions to date.
The lawsuits
In January 2025, Novo Nordisk joined Eli Lilly in a legal challenge opposing the FDA’s 503B rules, taking legal action to block compounding of a key ingredient in its diabetes and obesity medications. That same month, Eli Lilly moved to join a lawsuit filed by a compounding pharmacy trade group, aiming to block the FDA’s determination that the Mounjaro and Zepbound shortage had ended, a designation that would otherwise allow compounders to keep selling unapproved versions of the drugs.
Lilly has since filed a string of lawsuits against specific compounding pharmacies. In April 2025, the company sued Empower Clinic Services in the District of New Jersey, alleging the compounder ran a nationwide scheme misleading consumers about product safety and efficacy in violation of state consumer protection law and the Lanham Act.
Most recently, in August, Lilly sued six companies — including compounding pharmacies, medical spas and online sellers — over alleged illegal sales of retatrutide, Lilly’s still-experimental obesity drug that has not yet been approved by the FDA.
However, the legal fight flipped direction in January 2026, when a compounding pharmacy sued Eli Lilly and Novo Nordisk over GLP-1 access. Strive Compounding Pharmacy filed a federal antitrust suit in the Western District of Texas, alleging the two drugmakers used exclusive agreements with telehealth platforms to bar those platforms from working with compounding pharmacies, restricting patient access to compounded versions of the drugs.
The NAD challenges
Over the past year, Lilly and Novo have also turned to NAD challenges as a new front.
In December 2025, Novo’s challenge against Willow Health Services led NAD to determine the Texas telehealth company’s safety, efficacy and superiority claims for its compounded semaglutide product were unsubstantiated. Willow did not provide a statement indicating it would comply with the recommendations, so NAD referred the matter to the Federal Trade Commission (FTC), relevant state attorneys general and the platforms where the ads ran. Willow later returned to NAD following discussion with the FTC, and in July 2026, NAD confirmed the company had permanently discontinued all the challenged claims covering weight loss support, comparability to FDA-approved semaglutide, and effectiveness without diet or exercise.
In May 2026, Lilly’s challenge against Noom resulted in a recommendation that the company modify or discontinue its “A Smaller Dose. A Smarter Start. Microdose GLP-1Rx Starts at $119” claim for its Microdose GLP-1Rx program. NAD found the claim conveyed an unsupported message that a smaller dose itself provided a measurable health benefit. Noom disagreed with NAD’s conclusion but voluntarily agreed to comply, and separately told NAD it was permanently discontinuing other challenged claims covering dosing, efficacy and side effects, which NAD did not review on the merits as a result.
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