Indiangoods.shop

WARNING LETTER Indiangoods.shop MARCS-CMS 729068 — June 17, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED Product: Drugs Recipient: Indiangoods.shop Plot No. 208 & 209, Kalyan Nagar Hyderabad 500045 Telangana India Issuing Office: Center for Drug Evaluation and Research (CDER) United States June 17, 2026 Plot 208, Kalyan Nagar, Yousufguda Hyderabad 500038, India WARNING LETTER Reference Number: 729068 To Indiangoods.shop: 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 Review Violations were identified and documented during a review of your website https://www.indiangoods.shop in May 2026. Based on our review, “Moon Herbal Josh Awar Khas,” “Kapiva Him Foods Testo Capsules,” and “Patanjali Youvan Gold Plus Capsule” are unapproved new drugs 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 these products 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). This review was conducted as part of FDA's public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs. Violations of the Federal Food, Drug, and Cosmetic Act The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations. Unapproved New Drug Violations Based on a review of your website, “Moon Herbal Josh Awar Khas,” “Kapiva Him Foods Testo Capsules,” and “Patanjali Youvan Gold Plus Capsule” 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: Moon Herbal Josh Awar Khas On the webpage https://www.indiangoods.shop/products/moon-herbal-josh-awar-khas: “For Stamina & Excitement” “Make Love Longer than ever” Kapiva Him Foods Testo Capsules On the webpage https://www.indiangoods.shop/products/kapiva-ayurveda-himfoods-testosterone-booster-capsules: “Helps increase testosterone levels” Patanjali Youvan Gold Plus Capsule On the webpage https://www.indiangoods.shop/products/patanjali-youvan-gold-capsule: “An authentic powder booster Ayurvedic Medicine useful in physical & sexual weakness which improves libido, vigour & vitality, sexual power. Keeps you always healthy, energetic & gives you total satisfaction of married life.” “Moon Herbal Josh Awar Khas,” “Kapiva Him Foods Testo Capsules,” and “Patanjali Youvan Gold Plus Capsule” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their 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 these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Conclusion As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure sustained compliance so that these violations and any others do not occur. Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “729068” in the subject line of the email. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. Please note FDA posts warning letters on www.fda.gov. Sincerely, /S/ Tina Smith, M.S. Captain, U.S. Public Health Service Director Office of Unapproved Drugs and Labeling Compliance Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration Content current as of: 06/23/2026 Regulated Product(s) Drugs