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Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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).