FDA Issues Warning Letter to Wellness Platform IBeautyStore

Ibeautystore.com, a company that sells beauty and wellness supplements, received a warning letter from the United States Food and Drug Administration (FDA) for violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.

FDA Letter Highlights

According to the FDA: “This letter is to advise you that the US 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.’

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).

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.

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 the products.

Read the full letter here.

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