FDA Warning Letter to Ray’s Vitamins (April 24, 2026) — Unapproved New Drug/Misbranded

FDA Warning Letter — Violations FDA cited at Ray’s Vitamins

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 was marketed as a dietary supplement or food before its approval as a drug. FDA approved diclofenac under the trade name Voltaren as a new drug on July 28, 1988, and approved dexamethasone under the trade name Hexadrol, as a new drug on December 21, 1960. Given that diclofenac and dexamethasone were not marketed as dietary supplements or as a food before Voltaren and Hexadrol were approved, “Yeicob Ácido Hialurónico,” which contains diclofenac and dexamethasone, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i). Moreover, we note regardless of whether your “Yeicob Ácido Hialurónico” product is excluded from the definition of a dietary supplement, it is a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for, among other things, use as an arthritis treatment. Unapproved New Drug Your “Yeicob Ácido Hialurónico” product is a drug under section 201(g)(1) of the FD