Compounding

Lilly and Novo file 10 advertising challenges against compounded GLP-1 sellers

The challenges give the two drugmakers a faster path than litigation to change how compounded GLP-1s are advertised, which can affect what patients see but not whether a product can be sold.

By the Semaglutides news desk·

Eli Lilly and Novo Nordisk have filed 10 cases in the past year with the National Advertising Division, or NAD, a self-regulatory body run by BBB National Programs, as a faster alternative to lawsuits against compounders and telehealth companies selling unapproved versions of their GLP-1 drugs [1].

The NAD cases are a small piece of a larger enforcement effort. Novo says it has filed 130 federal lawsuits and five NAD challenges; Lilly has filed dozens of federal lawsuits and at least five NAD cases [1][2]. The NAD was founded in 1971 and settles disputes over advertising claims for products from bathroom cleaners to infant formula; the GLP-1 makers turned to it relatively recently [1].

The forum works differently from a courtroom. The NAD assigns an attorney to review a case, confers with the parties during a briefing period, and drafts a decision. The burden is on the advertiser to show it had a reasonable basis for the claim. Participation is voluntary, and advertisers are not required to follow recommendations. If a company does not comply, the NAD can refer the matter to the FDA, the Federal Trade Commission or state attorneys general, and can report the ad to the platforms where it ran [1].

"We're talking about a matter of months to get to a final resolution in the form of an NAD case decision," said Ricardo Carvajal, a director at Hyman, Phelps & McNamara P.C., who represents advertisers [1].

Two recent cases show the pattern. Novo's challenge against Willow Health Services, a Texas telehealth company, led the NAD in December 2025 to find that the company's safety, efficacy and superiority claims for its compounded semaglutide were unsubstantiated. Willow did not initially say whether it would comply, so the NAD referred the matter to the FTC, state attorneys general and the platforms where the ads ran. Willow later returned to the NAD, and in July 2026 the NAD confirmed the company had permanently discontinued all challenged claims covering weight loss support, comparability to FDA-approved semaglutide, and effectiveness without diet or exercise [1][2].

Lilly's May 2026 challenge against Noom targeted its "A Smaller Dose. A Smarter Start. Microdose GLP-1Rx Starts at $119" claim for compounded GLP-1s. The NAD found the claim conveyed an unsupported message that a smaller dose itself provided a measurable health benefit. Noom disagreed with the conclusion but agreed to comply, and said it was permanently discontinuing other challenged claims about dosing, efficacy and side effects, which the NAD did not review on the merits [1][2].

The NAD push largely began after the FDA determined that branded GLP-1s were available again following a shortage period, effectively prohibiting mass production of cheaper copies that had been used by at least a million patients. Compounders continue to make personalized versions [1]. Lilly's tirzepatide franchise, sold as Mounjaro and Zepbound, reached $40 billion in sales, and Novo's semaglutide products, sold as Ozempic, Wegovy and Rybelsus, generated $35 billion last year [1].

Federal regulators have not stopped their own efforts. The FDA has sent more than 100 warning letters in the past year over misbranded compounded GLP-1 claims, though the letters have stayed narrowly focused on issues such as active ingredients, branding and product performance [1][2]. "The enforcement has really been focused on what these websites shouldn't say, and that absolutely is needed," said Ashwin Chetty, a doctor of medicine candidate at Yale School of Medicine who studied compounded GLP-1 ads. "But there should also be some guidance and enforcement on what these websites should be saying as well" [1].

Court fights continue alongside the ad cases. Lilly sued Empower Clinic Services in New Jersey federal court in April 2025 and, in August 2026, sued six companies over alleged illegal sales of retatrutide, an experimental Lilly obesity drug that is not FDA-approved. In January 2026, Strive Compounding Pharmacy filed a federal antitrust suit in the Western District of Texas, alleging the two drugmakers used exclusive telehealth agreements to bar those platforms from working with compounding pharmacies [2].

Why it matters for patients

Claims that patients see while shopping for compounded GLP-1s can change or disappear because of these cases. An NAD decision addresses whether an advertiser backed up a claim; it is not a finding that a compounded drug works or does not work, and the NAD cannot ban a product or force compliance on its own [1]. The FDA's shortage determination is what limits large-scale compounding of copies, while personalized versions are still being made [1]. The access allegations in the Strive lawsuit are claims in a pending case, not established facts [2].

What happens next

No new hearing dates or deadlines in the remaining NAD challenges have been reported. Decisions can be appealed to a board of academics and brand representatives, and referrals to the FTC or state attorneys general can lead to enforcement the NAD itself cannot carry out [1].

Sources

  1. https://news.bloomberglaw.com/health-law-and-business/lilly-novo-amp-up-glp-1-fight-with-new-weapon-against-copycats
  2. https://www.beckershospitalreview.com/glp-1s/lilly-novo-nordisks-fight-against-glp-1-copycats/

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