FDA Warning Letter to ibeautistore.com (April 24, 2026) — Unapproved New Drug/Misbranded

FDA Warning Letter — Violations FDA cited at ibeautistore.com

WARNING LETTER ibeautistore.com MARCS-CMS 726302 — April 24, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters 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