What regulatory actions have the FTC and FDA taken against supplements marketed for diabetes control?

1. Joint warning letters: a coordinated strike at unlawful diabetes claims

In September 2021 the FDA and FTC jointly sent warning letters to 10 companies for illegally selling dietary supplements that purported to cure, treat, mitigate, or prevent diabetes, telling those firms their products were being marketed as unapproved new drugs and publicizing the action to warn consumers ^{[1] [6]}. The agencies emphasized that consumers who substitute unapproved supplements for proven therapies risk harm and that the FDA had not evaluated those products for safety, dosing, interactions or effectiveness ^{[1] [2]}.

2. FTC’s evidentiary standard and cease‑and‑desist authority

The FTC’s communications in these coordinated actions make clear that any claim a product can prevent, treat, or cure diabetes must be substantiated by competent and reliable scientific evidence — specifically well‑controlled human clinical studies — and the Commission has issued cease‑and‑desist demands ordering companies to stop unsubstantiated claims or face legal action ^{[4] [2]}. The FTC framed enforcement as a consumer protection response to market conditions — including high insulin prices that the agency said drive consumers toward questionable products — and used its advertising authority to demand prompt corrective action ^[2].

3. FDA’s legal framing: disease claims reclassify supplements as drugs

The FDA’s portion of the enforcement applies the Federal Food, Drug, and Cosmetic Act (FD&C Act): products claiming to diagnose, cure, treat, mitigate, or prevent disease are drugs, not dietary supplements, and so are “unapproved new drugs” if not evaluated by the agency — a legal posture the FDA used in the joint letters to argue the products were misbranded and violative of the statute ^{[3] [2]}. The agency has repeatedly said it will alert the public and hold companies accountable when supplements cross that line, framing such actions as protecting patient safety ^[7].

4. History and pattern of coordinated actions

This is not new — the FDA and FTC have a history of joint campaigns against fraudulent diabetes therapies going back decades and have used coordinated notices, warnings and enforcement sweeps to target internet vendors and deceptive advertising for diabetes products ^[8]. Recent reporting and legal‑industry commentary shows these coordinated efforts have accelerated into non‑COVID areas and that regulators are increasingly comfortable announcing joint actions as a standard tool of oversight ^[4].

5. Enforcement scope expanding into influencers and 2026 priorities

Regulatory guidance and industry alerts warn companies that social‑media and influencer content is squarely in scope for both agencies, and the FTC‑FDA coordination is expected to continue as an enforcement mechanism into 2026, alongside other rulemaking and implementation priorities at the FDA ^{[5] [9]}. Legal observers note the agencies are shifting from rulemaking to vigorous implementation and enforcement of existing standards in the supplement and wellness space ^{[5] [10]}.

6. Industry response and political context

Trade groups remind members that supplements are regulated by both agencies and stress compliance with DSHEA and truth‑in‑advertising laws, while legal briefs and law‑firm analyses flag the risk of escalated enforcement and litigation; at the same time, observers note policy debates and congressional pushback on related food and supplement rules that can reflect competing industry and public‑health agendas ^{[11] [12]}. Reporting from law firms and trade observers suggests companies should assume intensified scrutiny and be prepared to substantiate claims with human clinical studies or face regulatory demands and potential removal from the marketplace ^{[4] [2]}.