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WARNING LETTER

Ray’s Vitamins MARCS-CMS 726694 —

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&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.

Examples from your product labeling, including on your website that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:

On the webpage https://raysvitamins.com/product/yeicob-acido-hialuronico/:

  • “How This Supplement Can Help You: Supports ligament and tendon function, lubricating and cushioning joint areas. Provides nutrients for joint health, including the cartilage [sic] and menisci. Helps adjust moisture absorption in the skin, preventing dehydration. Often used for joint or muscle pain related to arthritis.”

Your “Yeicob Ácido Hialurónico” product is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Misbranded Drug

Your “Yeicob Ácido Hialurónico” product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for your “Yeicob Ácido Hialurónico” product does not declare that the product contains diclofenac and dexamethasone. As previously mentioned, these undeclared ingredients in your “Yeicob Ácido Hialurónico” product may pose serious health risks because consumers with underlying medical issues may take the product without knowing that it can cause serious harm or interact in dangerous ways with other drugs they may be taking. The failure to disclose these ingredients in the product labeling renders your “Yeicob Ácido Hialurónico” product misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). The introduction or delivery for introduction into interstate commerce of this misbranded drug is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

We also observed that your website https://raysvitamins.com/ offers “RM Joe”2 and “RMSOL GRACIAN”3 for sale to consumers in the United States. Previous FDA lab analyses of products similarly named to those sold on your website revealed these products contained undeclared drug ingredients. While the Agency has not sampled and tested these product variations from your inventory to date, this letter expresses our serious concern about the safety of these products. We emphasize that it is your legal responsibility under federal law to ensure that products you sell do not contain any undeclared or potentially harmful ingredients, and that they are marketed in compliance with applicable laws.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “726694” in the subject line of the email.

Sincerely,
/S/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

_________________________

1 FDA issued a warning to consumers not to use your “Yeicob Ácido Hialurónico” product (see: https://www.fda.gov/drugs/medication-health-fraud-notifications/yeicob-acido-hialuronico-may-be-harmful-due-hidden-drug-ingredients)

2 https://www.fda.gov/drugs/medication-health-fraud-notifications/rm-joe-may-be-harmful-due-hidden-drug-ingredients

3 https://www.fda.gov/drugs/medication-health-fraud/rmsol-gracian-contains-hidden-drug-ingredient

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