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  5. SoloVital - 688046 - 08/27/2024
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WARNING LETTER

SoloVital MARCS-CMS 688046 —

Product:
Drugs
Recipient:
Recipient Name
German Alegre
SoloVital

2571 Mast Way #203
Chula Vista, CA 91914
United States

info@solovital.com
sales@solovital.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

WARNING LETTER

August 27, 2024

RE: 688046

Dear Mr. German Alegre:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.solovital.com/ in June 2024 and has observed that your website offers the product “Umary,” which is also referred to as “Umary Hyaluronic Acid” on your website, for sale in the United States. In addition, FDA has obtained samples and labeling of your “Umary” product. As described below, this product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, the product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352, 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 “Umary” contains undeclared diclofenac and omeprazole.1 Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). 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. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.

Omeprazole is a proton pump inhibitor (commonly referred to as PPI) used to treat gastric (stomach) acid-related disorders. PPI medicines may cause serious skin reactions, abdominal pain, diarrhea, nausea, and headache. This hidden ingredient may mask stomach issues such as erosions, ulcers, and stomach cancer, and it can also interact with other medications and should not be taken with certain medications.

Information on the label and/or labeling of “Umary” demonstrates that the product is marketed as a dietary supplement.2 Under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii), if an article is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized.

FDA approved diclofenac, under the trade name Voltaren, as a new drug on July 28, 1988. Given that diclofenac was not marketed as a dietary supplement or as food before Voltaren was approved, “Umary,” which contain diclofenac, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.

Unapproved New Drugs

Your “Umary” product is a drug as defined by 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 of claims from the labeling, including on your website https://www.solovital.com/, that provide evidence of the intended use of this product as a drug include, but may not be limited to, the following:

  • “Hyaluronic acid works as a cushion and lubricant in the joints and connective tissue. When joints are well lubricated they’re less likely to grind together. It has been known to reduce knee discomfort."

“Umary” is not generally recognized as safe and effective for the above referenced uses and, therefore, is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, a new drug may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for this product. Accordingly, the introduction or delivery for introduction into interstate commerce of this 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 “Umary” 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 “Umary” does not declare that the product contains the drug ingredients diclofenac and omeprazole. The failure to disclose the presence of diclofenac and omeprazole in the product’s labeling renders “Umary” misbranded under section 502(a) of the FD&C Act.

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).

A list of tainted products discovered by FDA can be found at https://www.fda.gov/consumers/health-fraud-scams/health-fraud-product-database.

Conclusion

This letter is 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 result in 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.

Sincerely,
/S/

CAPT Tina Smith
Director
Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

________________________

1 U.S. Food & Drug Administration, Public Notification: Umary contains hidden drug ingredients, (June 14, 2024), https://www.fda.gov/drugs/medication-health-fraud/umary-contains-hidden-drug-ingredients.

2 “Umary” is labeled as a supplement on the product packaging.

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