U.S. Food and Drug Administration (FDA) and FTC Warn Supplement Sellers Claiming to Treat Depression, Infertility and Diabetes (2021)

Between February and September 2021, the U.S. Food and Drug Administration (FDA) sent warning letters to 25 companies selling dietary supplements that were marketed as treating a disease: 10 over claims about depression and other mental health disorders, five over claims about infertility, and 10 over claims about diabetes. From May onward the letters were issued jointly with the Federal Trade Commission (FTC). In each round the U.S. Food and Drug Administration called the products “unapproved new drugs.” The conditions themselves are described on the site’s Depression, Infertility and Type 2 Diabetes pages.

This page reports what the U.S. Food and Drug Administration’s own documents say: the three rounds of letters and their dates, the legal rule the U.S. Food and Drug Administration applied, what the agency says it has not evaluated about these products, what a warning letter asks of a company, what the letters do not do, their status as of October 18, 2026, and how they fit later U.S. Food and Drug Administration supplement actions. No company, product, brand or ingredient is named here.

Table of Contents

  1. What the U.S. Food and Drug Administration Did in 2021
  2. February 19: Claims to Treat Depression and Mental Illness
  3. May 26: Claims to Treat Infertility, With the FTC
  4. September 9: Claims to Treat Diabetes, With the FTC
  5. Why a “Supplement” With a Disease Claim Is Treated as a Drug
  6. What the U.S. Food and Drug Administration Says It Has Not Evaluated
  7. What a Warning Letter Asks of a Company
  8. What the Letters Do Not Do
  9. Dates and Legal Status as of October 18, 2026
  10. How It Fits Later U.S. Food and Drug Administration Supplement Actions
  11. Primary Documents
  12. Key Research Papers
  13. Connections
  14. Featured Videos

1. What the U.S. Food and Drug Administration Did in 2021

The U.S. Food and Drug Administration announced three rounds of warning letters in 2021, each in a Constituent Update from its food and supplements program. The U.S. Food and Drug Administration’s “What’s New in Dietary Supplements” page lists all three among its 2021 items:

Together that is 25 companies. Each update lists the companies by name; this page does not. The updates explain that once a product is marketed to cure, treat, mitigate or prevent a disease, the law treats it as a drug (section 5).

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2. February 19: Claims to Treat Depression and Mental Illness

The Constituent Update dated February 19, 2021 states that the U.S. Food and Drug Administration “today posted warning letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health disorders.” It continues: “The dietary supplements discussed in these letters are unapproved new drugs and have not been evaluated by the U.S. Food and Drug Administration to be safe and effective for their intended use.”

The U.S. Food and Drug Administration described the harm it is concerned about in these words: “Consumers who rely on dietary supplements in lieu of discussing their symptoms with a health care professional could potentially suffer harm and may not receive appropriate therapies that have been determined to be safe and effective to treat depression and other mental health disorders.”

This first round was issued by the U.S. Food and Drug Administration alone; the update does not mention the FTC. The update points to a companion U.S. Food and Drug Administration press release, which could not be retrieved for this page, so nothing from it is quoted here.

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3. May 26: Claims to Treat Infertility, With the FTC

On May 26, 2021, the U.S. Food and Drug Administration and the Federal Trade Commission “issued warning letters to five companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent infertility and other reproductive health conditions,” according to the Constituent Update (content current as of May 28, 2021). The U.S. Food and Drug Administration’s press release of the same day uses the same wording and adds that the sales were “in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).” The individual letters linked from the update carry the date May 20, 2021.

The update gives the scale of the condition, citing the Centers for Disease Control and Prevention: “approximately six million American women of childbearing age face difficulties becoming or staying pregnant.” It states that consumers who rely on unapproved products “instead of seeking safe and effective therapies could potentially suffer harm and may not receive appropriate treatment.”

The press release quotes officials of both agencies:

The U.S. Food and Drug Administration also published a consumer page, “Unproven Infertility Supplements,” listing the five letters. It states that these products, “which are often sold online, have not been reviewed by the U.S. Food and Drug Administration and are not proven safe and effective to treat the diseases and health conditions they claim to treat,” and that they “may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment from a health care professional.”

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4. September 9: Claims to Treat Diabetes, With the FTC

The Constituent Update dated September 9, 2021 states that the U.S. Food and Drug Administration and the FTC “issued warning letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent diabetes,” and that “The products cited in these letters are unapproved new drugs and have not been evaluated by the U.S. Food and Drug Administration to be safe and effective for their intended use.”

Citing the Centers for Disease Control and Prevention, the update says that “more than 34 million Americans have diabetes, which is the seventh leading cause of death in the United States,” and that “In just the last 20 years, the number of adults diagnosed with diabetes has more than doubled.” As in May, it states that consumers who rely on such products instead of seeking safe and effective therapies “could potentially suffer harm and may not receive appropriate treatment.”

This update also points to a companion U.S. Food and Drug Administration press release that could not be retrieved; nothing from it is quoted here.

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5. Why a “Supplement” With a Disease Claim Is Treated as a Drug

All three updates restate the same legal rule. In the February and May wording: “Under the Federal Food, Drug, and Cosmetic Act, products intended to cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements.” The September update uses the same sentence with one more word, covering products intended to “diagnose, cure, treat, mitigate, or prevent disease.”

The Federal Food, Drug, and Cosmetic Act (FD&C Act) is the federal law the updates cite. When the updates call these products unapproved new drugs, they add that the products “have not been evaluated by the U.S. Food and Drug Administration to be safe and effective for their intended use.” An unapproved new drug, in the sense the updates use, is a product that the law treats as a drug but that has not gone through the U.S. Food and Drug Administration’s drug approval. What turned these products into drugs, in the U.S. Food and Drug Administration’s reading, was the disease claim made for them: the letters rest on how the products were marketed.

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6. What the U.S. Food and Drug Administration Says It Has Not Evaluated

Each update contains the same sentence about what is unknown: “Unlike drugs approved by the U.S. Food and Drug Administration, the agency has not evaluated whether the unapproved products subject to the warning letters announced today are effective for their intended use, what the proper dosage might be, how they could interact with U.S. Food and Drug Administration-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.”

That sentence lists four open questions the U.S. Food and Drug Administration says it has not assessed for these products:

The May press release adds general statements from the U.S. Food and Drug Administration: that “consumers should be cautious of products marketed and sold online with unproven claims to prevent, treat, mitigate or cure diseases,” that “The U.S. Food and Drug Administration advises consumers to talk to their doctor, pharmacist, or other health care provider before deciding to purchase or use any dietary supplement or drug,” and that “Some supplements might interact with medicines or other supplements.” It also states that the U.S. Food and Drug Administration “encourages health care providers and consumers to report adverse reactions associated with U.S. Food and Drug Administration-regulated products” through MedWatch or the Safety Reporting Portal. These are the U.S. Food and Drug Administration’s statements, reported here as such.

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7. What a Warning Letter Asks of a Company

The three updates describe the same next step. “The U.S. Food and Drug Administration has requested responses from the companies within 15 working days stating how they will address these issues, or providing their reasoning and supporting information as to why they think the products are not in violation of the law.”

Each update then states: “Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.” The updates name seizure and injunction as possible later steps; they do not say that any was taken against these companies.

Put plainly, as these documents describe it, a warning letter is a written notice: the U.S. Food and Drug Administration states what it considers a violation, asks the company to answer within a set time, and names the legal steps that may follow if the violation is not corrected.

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8. What the Letters Do Not Do

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9. Dates and Legal Status as of October 18, 2026

Status as of October 18, 2026: advisory letters, no rule. Warning letters do not change any regulation, and their legal effect is the notice they give. What each company did afterward, and whether any letter was later closed out, was not checked for this page. A query of the Federal Register from February 19, 2021 through October 18, 2026 for U.S. Food and Drug Administration documents on dietary-supplement disease claims returned no document: none was found for the 2021 letters, and none that changes the rule they applied.

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10. How It Fits Later U.S. Food and Drug Administration Supplement Actions

The U.S. Food and Drug Administration’s “What’s New in Dietary Supplements” page lists one further 2021 item after the diabetes letters: in November 2021, “U.S. Food and Drug Administration Requests Information Relevant to the Use of N-acetylcysteine (NAC) as a Dietary Supplement.” That question, and the U.S. Food and Drug Administration’s 2022 decision on it, are reported on the page U.S. Food and Drug Administration Lets N-acetylcysteine Supplements Stay on Shelves While Ruling N-acetylcysteine Is Legally a Drug (2022).

The disease-claim approach of 2021 continued the next year, when the U.S. Food and Drug Administration warned supplement sellers over claims about heart disease, reported on U.S. Food and Drug Administration Warns Supplement Sellers Over Untested Stimulants and Heart-Disease Cure Claims (2022). In 2023 the U.S. Food and Drug Administration opened a public directory of what it has said about supplement ingredients, reported on U.S. Food and Drug Administration Opens a Public Directory of What It Has Said About Supplement Ingredients (2023).

Background on how supplements can be contaminated or carry hidden drugs is on the site’s Dangerous Supplements page, and the checks a reader can make on a product are described on How to Verify a Supplement Before You Take It. Questions about any supplement, and about treatment for depression, infertility or diabetes, belong with a clinician.

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11. Primary Documents

  1. U.S. Food and Drug Administration. U.S. Food and Drug Administration Sends Warning Letters to 10 Companies for Illegally Selling Dietary Supplements Claiming to Treat Depression and Mental Illness. HFP Constituent Update, February 19, 2021 — fda.gov Constituent Update, Feb 19, 2021
  2. U.S. Food and Drug Administration. U.S. Food and Drug Administration and FTC Send Warning Letters to Five Companies for Illegally Selling Dietary Supplements Claiming to Treat Infertility. HFP Constituent Update, May 26, 2021 (content current as of May 28, 2021) — fda.gov Constituent Update, May 26, 2021
  3. U.S. Food and Drug Administration. FDA, FTC Warn Five Companies Illegally Selling Dietary Supplements Claiming to Treat Infertility. News release, May 26, 2021 — fda.gov press release, May 26, 2021
  4. U.S. Food and Drug Administration. Unproven Infertility Supplements. Health Fraud Scams consumer page, content current as of May 26, 2021 — fda.gov Unproven Infertility Supplements
  5. U.S. Food and Drug Administration. U.S. Food and Drug Administration and FTC Send Warning Letters to 10 Companies for Illegally Selling Dietary Supplements Claiming to Treat Diabetes. HFP Constituent Update, September 9, 2021 — fda.gov Constituent Update, Sep 9, 2021
  6. U.S. Food and Drug Administration. What’s New in Dietary Supplements. Program page listing the 2021 items — fda.gov What’s New in Dietary Supplements

No Federal Register document was found for these letters, so this action has no Federal Register citation or docket here. The individual letters are posted on the U.S. Food and Drug Administration’s warning-letter pages under each company’s name and are not linked here.

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Key Research Papers

  1. Geller AI, Shehab N, Weidle NJ, Lovegrove MC, Wolpert BJ, Timbo BB, Mozersky RP, Budnitz DS (2015). Emergency Department Visits for Adverse Events Related to Dietary Supplements. The New England Journal of Medicine 373(16):1531-1540 — PubMed PMID: 26465986
  2. Starr RR (2015). Too little, too late: ineffective regulation of dietary supplements in the United States. American Journal of Public Health 105(3):478-485 — PubMed PMID: 25602879
  3. Tucker J, Fischer T, Upjohn L, Mazzera D, Kumar M (2018). Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings. JAMA Network Open 1(6):e183337 — PubMed PMID: 30646238
  4. Cohen PA, Avula B, Katragunta K, Khan I (2022). Recalls, Availability, and Content of Dietary Supplements Following FDA Warning Letters. JAMA 328(4):393-395 — PubMed PMID: 35881132
  5. Samplaski MK, Clemesha CG (2018). Discrepancies between the internet and academic literature regarding vitamin use for male infertility. Translational Andrology and Urology 7(Suppl 2):S193-S197 — PubMed PMID: 29928617
  6. de Ligny WR, Fleischer K, Grens H, Braat DDM, de Bruin JP (2023). The lack of evidence behind over-the-counter antioxidant supplements for male fertility patients: a scoping review. Human Reproduction Open 2023(3):hoad020 — PubMed PMID: 37293243

The first paper is a U.S. national estimate of emergency department visits linked to dietary supplements. The second reviews how U.S. supplement regulation works. The third and fourth examine supplements that drew U.S. Food and Drug Administration warnings: the ingredients found in them and what happened to products after U.S. Food and Drug Administration warning letters. The last two look at fertility supplements: how claims online compare with the medical literature, and the evidence behind over-the-counter products sold to men with fertility problems.

PubMed Topic Searches

  1. PubMed: dietary supplements and FDA warning letters
  2. PubMed: dietary supplement disease claims
  3. PubMed: dietary supplement regulation in the United States

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Connections

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