Which 10 companies received the FTC/FDA joint warning letters in September 2021 and what changes did they make?
Executive summary
The U.S. Food and Drug Administration and the Federal Trade Commission announced in September 2021 that they jointly sent warning letters to ten companies for illegally marketing dietary supplements that claimed to treat or cure diabetes, and the agencies requested written responses explaining corrective actions within a short deadline [1]. Public documentation of which specific corrective steps each recipient took is limited because recipients’ responses to FTC/FDA warning letters are typically not published [2], so definitive lists of post-letter changes are not publicly verifiable from the supplied reporting.
1. What the agencies said they did in September 2021
The FDA and FTC issued a coordinated enforcement action in September 2021: the agencies sent joint warning letters to ten companies for marketing dietary supplements with claims that rendered those products unapproved drugs for diabetes and therefore in violation of the Federal Food, Drug, and Cosmetic Act and FTC advertising laws, and the FDA asked for written responses within 15 working days describing how the companies would address the violations [1].
2. Which companies were named in the agencies’ announcement — and what the available sources show
The FDA’s press announcement identifies that ten companies received joint warning letters but the excerpts provided here do not include the recipients’ names; the FDA page states the letters were sent and requests responses but the supplied snippet does not list the ten firms [1]. Independent summaries of other FDA/FTC joint letter campaigns (for COVID-19 products, delta‑8 products, or influencer posts) show that the agencies sometimes publish recipient names in full in other actions [3] [4] [5], but the materials supplied for this specific September 2021 diabetes action do not contain an itemized list of the ten company names.
3. What the agencies asked the companies to do and what agencies can do next
The FDA/FTC letters asked recipients to explain, within a defined period, the steps taken to stop unlawful marketing and how future violations will be prevented; the FDA’s typical practice is to give firms an opportunity to voluntarily correct violations but warns that failure to adequately respond can lead to civil penalties, seizures, injunctions, or other enforcement, and the FTC may seek injunctions or consumer redress if warranted [1] [6] [7]. The FDA also commonly requests that companies submit corrective plans, root‑cause analyses, and verification of corrective actions within the response window [6] [8].
4. What changes companies typically make after such letters — and why specific confirmations are scarce
Industry practice after warning letters often includes removing unapproved disease‑treatment claims from product labels and websites, revising marketing copy, updating disclaimers, and sometimes changing product formulations or distribution, but these are general patterns rather than documented facts for the ten September 2021 recipients; the FTC itself notes that recipients’ responses to warning letters are usually not public, which means independent confirmation of company‑level changes is frequently unavailable [2]. Legal commentators and enforcement records show regulators expect documented corrective actions and will escalate to formal enforcement if voluntary changes are not sufficiently prompt or complete [7] [6].
5. Bottom line and reporting limits
The agencies publicly stated that ten companies received joint FDA/FTC warning letters in September 2021 over supplements marketed as treatments for diabetes and requested prompt corrective responses [1]; however, the material provided here does not include the list of the ten company names nor public records of each company’s post‑letter changes, and the agencies’ practice of not publishing recipients’ responses means assertions about what each firm actually changed cannot be verified from the supplied sources [2]. Readers seeking company‑level follow‑up should consult the full FDA/FTC warning‑letter pages and archived press releases where recipient names and, on occasion, subsequent enforcement or settlement notices are published [1] [9] [10].