Indiangoods.shop
FDA issued a warning letter to Indiangoods.shop (Hyderabad, Telangana, India) on Jun 17, 2026, citing 21 CFR 201.128. Subject: Unapproved New Drugs, Misbranded.
From the letter: ““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).”
At a glance
What a reviewer notes before reading: findings, citations, the response deadline and what the letter warns of.
- Violations
- 3 findings · 2 issue types
- Cited
- 21 CFR 201.128
- Response due
- Fifteen (15) business days of receipt
- FDA asks for
- 2 actions
- Named as possible actions
- Seizure, injunction
- Issued by
- Center for Drug Evaluation and Research
- Published status
- No close-out recorded
AI assisted findings
Model-assisted reading of each issue. Open one to see the FDA text it comes from, and check it against the full letter.
01Registration, listing & premarketProducts are unapproved new drugs introduced into interstate commerce without an approved application.
“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).
02Labeling, claims & marketing · 21 CFR 201.128Products are drugs under section 201(g)(1) based on labeling claims of intended use.
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.
03Registration, listing & premarketProducts are new drugs not generally recognized as safe and effective, lacking approved applications.
“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).
What FDA requested
- 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.
- 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.
FDA Warning Letter
31 paragraphs · 8 sectionsText as published on FDA.gov, retrieved Sep 8, 2026. Layout added for reading; the wording is FDA’s. View on FDA.gov (opens in a new tab)
1Introduction
1 paragraph
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.
2FDA Review
2 paragraphs
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.
3Violations of the Federal Food, Drug, and Cosmetic Act
1 paragraph
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.
4Unapproved New Drug Violations
1 paragraph
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:
5Moon Herbal Josh Awar Khas
3 paragraphs
On the webpage https://www.indiangoods.shop/products/moon-herbal-josh-awar-khas:
“For Stamina & Excitement”
“Make Love Longer than ever”
6Kapiva Him Foods Testo Capsules
2 paragraphs
On the webpage https://www.indiangoods.shop/products/kapiva-ayurveda-himfoods-testosterone-booster-capsules:
“Helps increase testosterone levels”
7Patanjali Youvan Gold Plus Capsule
3 paragraphs
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).
8Conclusion
4 paragraphs
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.
Citations and trends
Each 21 CFR section, ISO 13485 clause and issue type in this letter, how often it appears across all letters, and its trend by the year FDA issued the letters. 2026 runs to Nov 3, 2026, compared with the same dates last year. Select a row or a bar to see those letters in Letters. As cited in this historical letter, not a statement of current requirements.
Regulations
Issue types
Record details
- Issuing center
- Center for Drug Evaluation and Research
- Issuing office
- Center for Drug Evaluation and Research
- Location
- Hyderabad, Telangana, India
- Letter posted date
- Jun 23, 2026
- Letter issue date
- Jun 17, 2026
- Addressed to
- Not recorded
- Inspection dates · model-assisted
- May 1, 2026 to May 31, 2026
- Response window
- 15 business days after receipt of this letter
Read the source clause
Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter.
- Record length
- 750 words · 0 recorded redactions
- Published status
- No published close-out
- FDA reference
- 729068
- Original letter
- View on FDA.gov (opens in a new tab)
- Dataset last checked
- Nov 11, 2026 · How this is built
A response window is not a calculated due date. Source excerpts are selected passages. Finding interpretations and categories are model-assisted. Verify the original letter before relying on a finding.