USFDA Warns Hyderabad Firm Over Sale of Unapproved Ayurvedic Sexual Wellness Products
New Delhi: The United States Food and Drug Administration (USFDA) has issued a warning letter to Hyderabad-based online retailer Indiangoods.shop, citing significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for marketing and selling three Ayurvedic products in the US as unapproved new drugs with claims related to sexual performance and testosterone enhancement.
The warning letter, issued by the Center for Drug Evaluation and Research (CDER), bears Reference Number 729068 and was addressed to Indiangoods.shop, Plot No. 208 & 209, Kalyan Nagar, Hyderabad 500045, Telangana, India.
According to the FDA, the agency conducted a review of the firm's website, https://www.indiangoods.shop, during May 2026, and identified violations involving three products—Moon Herbal Josh Awar Khas, Kapiva Him Foods Testo Capsules, and Patanjali Youvan Gold Plus Capsule. Based on the review, FDA concluded that these products are unapproved new drugs under Section 505(a) of the FD&C Act (21 U.S.C. 355(a)). The agency stated that 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)).
The FDA stated that the violations were documented during its review of the company's website and cautioned that the warning letter does not represent an exhaustive list of violations that may exist in connection with the firm's products or operations.
The regulator directed the company to promptly address the violations without delay, ensure that adequate resources are allocated to fully resolve the issues, and implement measures to prevent recurrence. It also reminded the company that it is responsible for ensuring compliance with all applicable federal laws and FDA regulations.
The agency warned that failure to adequately address the violations could result in regulatory or legal action without further notice, including seizure and injunction.
According to the FDA, the products are considered 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 are intended to affect the structure or function of the human body. The agency said the intended uses are evidenced by statements appearing in the products' labeling on the company's website, as defined under 21 CFR 201.128.
For Moon Herbal Josh Awar Khas, the FDA cited promotional claims including:
"For Stamina & Excitement"
"Make Love Longer than ever"
For Kapiva Him Foods Testo Capsules, the agency pointed to the claim:
"Helps increase testosterone levels"
For Patanjali Youvan Gold Plus Capsule, FDA highlighted the following promotional statements:
"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."
The FDA further stated that the three products 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 their labeled conditions of use.
The agency explained that, except for limited exceptions that are not applicable in this case, a new drug cannot be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect under Section 505(a) of the FD&C Act.
According to the warning letter, no approved applications under Section 505 are in effect for any of the three products. Consequently, the FDA concluded that the products are unapproved new drugs, and their introduction or delivery for introduction into interstate commerce violates Sections 301(d) and 505(a) of the FD&C Act.
In the concluding portion of the warning letter, the FDA instructed Indiangoods.shop to investigate and determine the root causes of the violations and implement corrective and preventive actions to ensure sustained compliance and prevent similar violations in the future.
The agency directed the company to submit a written response within fifteen (15) business days of receiving the warning letter by emailing FDAAdvisory@fda.hhs.gov. The response must include:
- The specific corrective actions taken to address the violations;
- An explanation of the steps being implemented to prevent recurrence; and
- Copies of supporting documentation.
The FDA also instructed the company to include Reference Number "729068" in the subject line of its response email.
Additionally, the regulator stated that if the company believes its products do not violate the FD&C Act or FDA regulations, it should submit supporting information for the agency's consideration.
