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# FDA, DoJ Expanding Enforcement Across Healthcare Ecosystem, Attorney Says
- URL: https://www.fdaweb.com/fda-doj-expanding-enforcement-across-healthcare-ecosystem-attorney-says/
- Published: 2026-07-20T12:00:00.000Z
- Updated: 2026-09-14T13:43:11.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161482

FDA and the Department of Justice are increasingly extending enforcement actions beyond traditional drug manufacturers to telehealth platforms, online marketplaces, compounders and other companies involved in distributing FDA-regulated products, according to a former DOJ official. During an episode of the *FDA Watch* [podcast,](https://fdawatch.net/2026/07/20/fda-legal-regulatory-compliance-issues-part-1-fda-doj-enforcement/?ref=fdaweb.com) **Gabriel Scannapieco**, a partner at Arnold Golden Gregory and former assistant director of the DOJ Consumer Protection Branch, said regulators are applying longstanding enforcement authorities — including misbranding, adulteration, unapproved drug promotion and manufacturing violations — to a broader range of entities than ever before.

"The headline is that anyone who touches an FDA-regulated product is no longer outside the enforcement perimeter," Scannapieco said.

Scannapieco said FDA's recent enforcement campaign against compounded GLP-1 weight-loss drugs illustrates the agency's broader approach to product integrity and consumer protection. Since late 2025, FDA has issued multiple waves of Warning Letters targeting compounders, telehealth providers, advertisers and digital health platforms marketing compounded GLP-1 products. According to Scannapieco, the agency has focused on promotional claims that could mislead consumers into believing compounded products are FDA-approved or equivalent to branded drugs.

He also pointed to FDA's proposed rule to remove semaglutide, tirzepatide and other GLP-1 drugs from the 503(B) bulks list, a move that could significantly limit large-scale compounding if finalized.

Another major enforcement trend involves online marketplaces that facilitate sales of FDA-regulated products. Scannapieco highlighted DoJ's recent $600 million non-prosecution agreement with Alibaba Group and its payment processor over allegations they facilitated tens of thousands of transactions involving illegal pharmaceuticals, counterfeit products and regulated chemicals.

He said the case builds on earlier enforcement against eBay and signals DoJ is expanding theories of liability to hold digital platforms accountable for products sold through their marketplaces. "The lens has broadened," he said. "If somehow you are an entity that makes money and helps put these products into commerce, you need to be familiar with what the FDA regulates, how they regulate it and the trends of what they're looking at."

Beyond GLP-1 products, Scannapieco said regulators are increasing scrutiny of skin substitutes, tissue allografts and peptides. He noted FDA continues to evaluate peptide substances for inclusion on the bulks list and suggested the category could become the agency's next major enforcement focus as consumer demand grows and products proliferate online.

Scannapieco also cited FDA's March Warning Letter to Novo Nordisk concerning pharmacovigilance practices as one of the year's most significant enforcement actions. A 1/13-2/7/2025 FDA inspection at the company’s facility in Plainsboro, NJ, identified serious violations of postmarketing adverse drug experience (PADE) reporting requirements. A 3/5 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novo-nordisk-inc-717576-03052026?ref=fdaweb.com) cited several examples of how Novo Nordisk failed to develop written procedures for the surveillance, receipt, evaluation, and reporting of PADEs. He warned that significant pharmacovigilance failures can progress beyond warning letters to consent decrees or even criminal investigations if patient safety is jeopardized.

Looking ahead, Scannapieco predicted continued FDA and DoJ attention on compounded GLP-1 drugs, peptide regulation, online platform liability and follow-up enforcement actions stemming from recent Warning Letter campaigns.

He advised companies to review promotional materials, ensure compounded drugs are clearly distinguished from approved products, verify the compliance of contract compounders, audit pharmacovigilance systems and strengthen compliance programs to identify potential issues before regulators do. He added that agencies increasingly expect companies to use advanced analytics and artificial intelligence to monitor compliance risks.