Unapproved New Drug/Misbranded: FDA Warning Letter to Ray’s Vitamins, 2026-04-24
Letter issued · posted to fda.gov .
Subject as published: Unapproved New Drug/Misbranded
TL;DR
Here's the summary: FDA issued a Warning Letter to Ray’s Vitamins on 2026-04-24 citing: Unapproved New Drug/Misbranded. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rays-vitamins-726694-04242026
Argus analysis
Ray’s Vitamins (MARCS-CMS 726694) received an FDA Warning Letter dated April 24, 2026 from the Center for Drug Evaluation and Research (CDER). The letter cites: Unapproved New Drug/Misbranded. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on May 5, 2026.
Unapproved-drug letters cite 21 USC 355 (new drug application requirement) or 21 USC 331(d) (introducing an unapproved new drug into interstate commerce). FDA has increasingly applied these provisions to online sellers of homeopathic products, topical anesthetics, and supplement-adjacent SKUs making unapproved drug claims.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same unapproved new drug category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
Unapproved-drug letters cite 21 USC 355 (NDA requirement) or 21 USC 331(d) (introduction into interstate commerce). FDA increasingly applies these provisions to homeopathic products, kratom, and certain compounded preparations.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Ray’s Vitamins MARCS-CMS 726694 — April 24, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Rene Gonzalez Recipient Title Owner Ray’s Vitamins 6528 Greenleaf Avenue, Ste. 204 Whittier , CA 90601 United States Gonzalezr33@yahoo.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER April 24, 2026 RE: 726694 To Rene Gonzalez: This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://raysvitamins.com/ in April 2026. The FDA has observed that your website offers “Yeicob Ácido Hialurónico” for sale in the United States.1 In addition, FDA obtained a sample of “Yeicob Ácido Hialurónico” through your website, https://raysvitamins.com. Based on our review, this product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Furthermore, your “Yeicob Ácido Hialurónico” product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352, and introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a). FDA confirmed through laboratory analysis that a sample of your “Yeicob Ácido Hialurónico” product contains the undeclared active pharmaceutical ingredients diclofenac and dexamethasone. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. Diclofenac may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products. Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland. Abrupt discontinuation can cause withdrawal symptoms. In addition, the undeclared dexamethasone in “Yeicob Ácido Hialurónico” may cause serious side effects when combined with other medications. Your “Yeicob Ácido Hialurónico” product is marketed as a dietary supplement, according to information found on the labels and/or labeling of the product. However, under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i), a dietary supplement may not include an article that is approved as a new drug under section 505 of the FD&C Act unless that article…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has Ray’s Vitamins had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Ray’s Vitamins as of 2026-05-05. Argus ingests new FDA enforcement records daily.
- What FDA violations was Ray’s Vitamins cited for?
- The FDA Warning Letter to Ray’s Vitamins (issuing office: Center for Drug Evaluation and Research (CDER)) cites: Unapproved New Drug/Misbranded. Classification: Unapproved drug.
- When did FDA issue the warning letter to Ray’s Vitamins?
- FDA issued the letter (MARCS-CMS 726694) on 2026-04-24 and posted it publicly on fda.gov on 2026-05-05.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Unapproved New Drug/Misbranded: FDA Warning Letter to Ray’s Vitamins, 2026-04-24. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-ray-s-vitamins-2026-04-24-unapproved-drug
"Unapproved New Drug/Misbranded: FDA Warning Letter to Ray’s Vitamins, 2026-04-24." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-ray-s-vitamins-2026-04-24-unapproved-drug.
Argus HQ Research. "Unapproved New Drug/Misbranded: FDA Warning Letter to Ray’s Vitamins, 2026-04-24." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-ray-s-vitamins-2026-04-24-unapproved-drug.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_ray_s_vitamins_2026_04_24_unapproved_drug_2026,
title = {Unapproved New Drug/Misbranded: FDA Warning Letter to Ray’s Vitamins, 2026-04-24},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-ray-s-vitamins-2026-04-24-unapproved-drug},
note = {Accessed: July 13, 2026}
}