Telos Trading Limited dba Alwinshop(729062)

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

June 17, 2026
 

WARNING LETTER

Reference Number: 729062

To Telos Trading Limited dba Alwinshop:

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://alwinshop.com in May 2026. We have also reviewed your TikTok shop at https://www.tiktok.com/shop/store/alwin-shop/7495713729295518702, where you offer the product to consumers for purchase. Based on our review, “Prostatitis Remission Cream” is an unapproved new drug and a misbranded drug 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 this product 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).

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 and TikTok shop, “Prostatitis Remission Cream” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is 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 this product as a drug include, but may not be limited to, the following:

On the webpage https://alwinshop.com/products/mens-treatment-cream-mens-body-treatment-relieves-discomfort-and-itching-daily-massage-treatment-cream-gentle-glycerin:

• “Improved Bladder Control”

• “Better Bladder Emptying”

• “Support Prostate Functions”

On your TikTok shop page, https://www.tiktok.com/shop/store/alwin-shop/7495713729295518702:

• “Treatment for Prostatitis Symptom Relief”

• “Improved Bladder Control”

“Prostatitis Remission Cream” is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its 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 application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Misbranded Drug Violations

“Prostatitis Remission Cream” is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the product label and/or website include statements that misleadingly suggest that the drug product is approved or endorsed by FDA in some way. For example, the website for “Prostatitis Remission Cream” includes an image of FDA officials standing with the FDA logo copied from FDA communications.1 Further, the product website includes the statement, “FDA certification means that the product has undergone comprehensive testing and meets the highest safety and effectiveness standards.” These assertions misleadingly suggest that “Prostatitis Remission Cream” is approved or endorsed by FDA in some way. “Prostatitis Remission Cream” is not the subject of an FDA-approved application nor is it endorsed by FDA. Therefore, this product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because its labeling is false or misleading. The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(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 “729062” in the subject line of the email.

If you have information that you believe demonstrates that your product is 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

cc:
Sandeep Grover
Global Head of Trust & Safety
TikTok Inc.
5800 Bristol Parkway, Suite 100
Culver City, CA 90230
legal@tiktok.com
info@tiktok.com

_________________________

1 See https://content.govdelivery.com/accounts/USFDA/bulletins/37ca6cc.