US FDA Issues Warning Letter to Indiangoods.shop Over Sale of Unapproved Drug Products

The United States Food and Drug Administration (US FDA) has issued a warning letter to Hyderabad-based online retailer Indiangoods.shop for alleged violations of the Federal Food, Drug, and Cosmetic (FD&C) Act.

The warning letter, issued by the Center for Drug Evaluation and Research (CDER), carries Reference Number 729068 and was addressed to Indiangoods.shop, located at Plot No. 208 & 209, Kalyan Nagar, Hyderabad, Telangana.

According to the FDA, the agency reviewed the company's website during May 2026 and identified multiple regulatory violations involving products being offered for sale to consumers.

Three Products Identified During Website Review

During its review of the website, the FDA identified three products that it considers to be unapproved new drugs:

• Moon Herbal Josh Awar Khas
• Kapiva Him Foods Testo Capsules
• Patanjali Youvan Gold Plus Capsule

The agency stated that these products are considered unapproved new drugs under Section 505(a) of the FD&C Act because they are being marketed without an FDA-approved application.

As a result, the FDA said introducing or delivering these products into interstate commerce violates Sections 301(d) and 505(a) of the FD&C Act.

Why the FDA Took Action

According to the warning letter, the products are classified as drugs because the claims made on the company's website suggest they are intended to diagnose, cure, mitigate, treat, or prevent diseases or affect the structure or function of the human body.

The FDA said these intended uses were evident from the promotional statements displayed on the product pages.

For Moon Herbal Josh Awar Khas, the website included claims such as:

• "For Stamina & Excitement"
• "Make Love Longer than ever"

For Kapiva Him Foods Testo Capsules, the agency highlighted the claim:

• "Helps increase testosterone levels"

For Patanjali Youvan Gold Plus Capsule, the FDA pointed to promotional statements claiming the product is useful for physical and sexual weakness while improving libido, vigor, vitality, sexual power, and overall married life satisfaction.

According to the regulator, these types of therapeutic and body-function claims bring the products under the definition of drugs under the FD&C Act.

FDA Says Products Are Not Approved

The FDA also stated that the three products qualify as "new drugs" because they are not generally recognized as safe and effective for their labeled uses.

The agency explained that, except for limited exemptions that do not apply in this case, new drugs cannot be legally marketed in the United States without an approved application under Section 505(a) of the FD&C Act.

According to the warning letter, no approved applications are currently in effect for any of the three products identified during the review.

Because of this, the FDA concluded that marketing or shipping these products into interstate commerce violates federal law.

Agency Warns of Possible Legal Action

The FDA emphasized that the warning letter does not necessarily include every possible violation related to the company's products or operations.

The agency instructed Indiangoods.shop to promptly correct the identified violations, dedicate adequate resources to resolve the issues, and establish measures to prevent similar problems in the future.

The FDA also reminded the company that it is responsible for ensuring compliance with all applicable federal laws and FDA regulations.

The warning letter further states that failure to adequately address the violations could lead to regulatory or legal action without additional notice. Such actions may include product seizure or injunction.

FDA Requests Corrective Action Within 15 Business Days

The regulator has directed Indiangoods.shop to investigate the root causes behind the violations and implement corrective and preventive actions.

The company has been asked to submit a written response within 15 business days after receiving the warning letter by emailing FDAAdvisory@fda.hhs.gov.

According to the FDA, the response should include:

• Details of the corrective actions already taken.
• An explanation of the measures being implemented to prevent similar violations in the future.
• Supporting documents that demonstrate compliance efforts.

The agency also instructed the company to include Reference Number 729068 in the subject line of its response.

If the company believes that its products do not violate the FD&C Act or FDA regulations, it has been invited to provide supporting information for the FDA's review.

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