Unapproved New Drugs/Misbranded: FDA Warning Letter to Lus Essentials LLC, May 14, 2026

FDA Warning Letter — Violations FDA cited at Lus Essentials LLC

WARNING LETTER Lus Essentials LLC MARCS-CMS 728783 — May 14, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: 728783 Product: Drugs Recipient: Lus Essentials LLC 605 Ravoux Road Chaska , MN 55318 United States ningdeleon482@gmail.com info@lusessentials.store Issuing Office: Center for Drug Evaluation and Research (CDER) United States May 14, 2026 WARNING LETTER To Lu’s Essentials: This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. FDA has observed that you offer products marketed on your firm’s website as skin treatment and skin lightening products, including, but not limited to, “Dr. Yanhee Acne Treatment Set (Green)” and “Dr. Yanhee Cream Set (Pekas & Melasma Treatment) – Blue” (hereinafter “your products”) for sale in the United States. Additionally, FDA obtained a sample of these products and has serious safety concerns about them. FDA confirmed through laboratory analysis that these products contain high levels of mercury. Applying products that contain mercury to the skin repeatedly can allow mercury to be absorbed into the bloodstream, potentially causing serious and permanent health problems, including kidney damage and neurological damage. Children and pregnant individuals face heightened risks and should avoid exposure to these products. FDA Review Violations were identified and documented during a review of your website https://lusessentials.store in April 2026. Based on our review, your products are unapproved new drugs and misbranded drugs under sections 505(a) and 502(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 352(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(a), 301(d), and 505(a) of the FD&C Act, 21 U.S.C. 331(a), 331(d), and 355(a). This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor-quality drugs. Violations of the Federal Food, Drug, and Cosmetic Act Unapproved New Drug Violations The following are violations identified during our review. As a reminder, this is not an allinclusive list of violations that may exist in connection with your products or operations. Based on a review of your website, your products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are 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 these products as drugs include, but may not be limited to, the following: Dr. Yanhee Acne Treatment Set (Green) On the webpage https://lusessentials.store/products/dr-yanhee-acne-treatment-setgreen?variant=45027938828483: “Reduce acne, freckles, dark spots and tighten pores.” “Benefits: [t]reatment for [p]imples and [s]ever [sic] acne problems, [d]ark spots, reduce visible scars.” “Protects skin from the sun and skin whitening.” Dr. Yanhee Cream Set (Pekas & Melasma Treatment) - Blue On the webpage https://lusessentials.store/products/dr-yanhe