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WARNING LETTER
•ibeautistore.com•April 1, 2026

ibeautistore.com – FDA Warning Letter, Apr 1, 2026

Record Details

The U.S. Food and Drug Administration (FDA) issued a warning letter to ibeautistore.com on April 24, 2026, following a review of the company’s website in March 2026. The investigation centered on a product sold as ‘New Hyaluronic Acid 850 mg Sealed 30 Caps,’ also labeled as ‘Umary.’ Laboratory analysis confirmed that the product contained three undeclared pharmaceutical ingredients: diclofenac (an anti-inflammatory drug), dexamethasone (a corticosteroid), and omeprazole (a medication for stomach acid). Under the Federal Food, Drug, and Cosmetic Act, the presence of these hidden drugs classifies the product as an unapproved new drug and a misbranded drug. The FDA noted that these ingredients pose severe health risks, including potential heart attacks, gastrointestinal bleeding, adrenal gland suppression, and the masking of serious stomach conditions. Furthermore, because these ingredients were approved as drugs before being marketed as food or supplements, the product cannot legally be sold as a dietary supplement. The FDA has required ibeautistore.com to respond within 15 working days, detailing the specific steps taken to correct these violations and prevent their recurrence. Failure to comply with these requirements may lead to legal action, including product seizures or injunctions to stop the company from distributing the product.

Company
ibeautistore.com
Inspection date
April 1, 2026
Product type
drugs
Office
Office of Unapproved Drugs & Labeling Compliance
Person
  • Tina Smith (Director)
View Company Profile

ID · a368ae3b-fe13-406b-9b30-61e5ffef7c64

Violation Codes10
FD&C Act 201(ff)(3)(B)(i)21 U.S.C. 321(n)21 U.S.C. 352(a)FD&C Act 50221 CFR 201.12821 U.S.C. 35521 U.S.C. 331FD&C Act 201(n)FD&C Act 201(p)(1)FD&C Act 201(g)(1)

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