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WARNING LETTER

ibeautistore.com MARCS-CMS 726302 —

Delivery Method:
Via Email
Product:
Drugs
Recipient:
ibeautistore.com

3042 Route 22 #38
Dover Plains, NY 12522-5920
United States

support@ibeautistore.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

WARNING LETTER

April 24, 2026

RE: 726302

To ibeautistore.com:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://ibeautistore.com/ in March 2026. The FDA has observed that your website offers “New Hyaluronic Acid 850 mg Sealed 30 Caps” for sale in the United States. In addition, FDA obtained a sample of “New Hyaluronic Acid 850 mg Sealed 30 Caps” through your website, https://ibeautistore.com/. The samples of your “New Hyaluronic Acid 850 mg Sealed 30 Caps” product were labeled as “Umary.” As such, this product will be hereinafter referred to as “Umary.”1

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 “Umary” 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 “Umary” product contains the undeclared active pharmaceutical ingredients diclofenac, dexamethasone, and omeprazole. 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 “Umary” may cause serious side effects when combined with other medications.

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. Omeprazole 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.

Your “Umary” 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, “Umary,” 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).

Unapproved New Drug

Your “Umary” 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://ibeautistore.com/product/new-hyaluronic-acid-850mg-sealed-30-caps/:

  • “What is hyaluronic acid?It [sic] is a polysaccharide found naturally in skin and cartilage cells. This crystalline substance has the function of hydrating the skin and joints, as it attracts and retains water molecules.”
  • “As the body ages, the presence of hyaluronic acid in our body decreases considerably. This translates into an aging of the skin that is losing firmness and volume and, of course, in the appearance of dreaded wrinkles.”

Your “Umary” 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 “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 your “Umary” product does not declare that the product contains diclofenac, dexamethasone, and omeprazole. As previously mentioned, these undeclared ingredients in your “Umary” 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 “Umary” 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).

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 “726302” 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 “Umary” product (see: https://www.fda.gov/drugs/medication-health-fraud-notifications/umary-contains-hidden-drug-ingredients).

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