Ong Tien USA LLC

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October 26, 2026

WARNING LETTER
Reference Number: 737352

To Ong Tien USA LLC:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https://ongtienlinhchi.com/, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them 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 any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.

Additionally, FDA purchased “Sâm Xương Khớp Tế Bào Gốc Linh Chi Ông Tiên” from your website, but instead received a product labeled as “Sâm Xương Khớp Ông Tiên.” We have serious safety concerns about this product. FDA confirmed through laboratory analysis that your product labeled as “Sâm Xương Khớp Ông Tiên” contains piroxicam and dexamethasone phosphate. Piroxicam is a type of pain and inflammation reliever known as an NSAID. NSAIDs can increase the risk of serious heart problems, such as heart attack and stroke, and can cause serious gastrointestinal problems, such as bleeding, ulcers or life-threatening tears in the stomach or intestinal lining. Piroxicam can interact with other medications, especially other NSAID-containing products, and may significantly increase the risk of these serious side effects. Dexamethasone is a steroid medication commonly used to reduce inflammation. However, it can weaken the immune system, making it harder for the body to fight infections. It also can cause high blood sugar, muscle damage and mental health problems.

FDA Review

Violations were identified and documented during a review of your website https://ongtienlinhchi.com in April 2026. In addition, FDA attempted to purchase “Sâm Xương Khớp Tế Bào Gốc Linh Chi Ông Tiên” through your website, https://ongtienlinhchi.com, but instead received a product labeled as “Sâm Xương Khớp Ông Tiên.” Based on our review, “Sâm Xương Khớp Tế Bào Gốc Linh Chi Ông Tiên,” “Sâm Xương Khớp Ông Tiên,” and “Cao Đông Trùng Hạ Thảo Tế Bào Gốc Linh Chi” 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). Further, “Sâm Xương Khớp Ông Tiên” is misbranded under 502(a) of the FD&C Act, 21 U.S.C. 352(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(a), 301(d), and/or 505(a) of the FD&C Act, 21 U.S.C. 331(a), 331(d), and/or 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 and product label, respectively, “Sâm Xương Khớp Tế Bào Gốc Linh Chi Ông Tiên,” “Sâm Xương Khớp Ông Tiên,” and “Cao Đông Trùng Hạ Thảo Tế Bào Gốc Linh Chi” 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:

Sâm Xương Khớp Tế Bào Gốc Linh Chi Ông Tiên
On the webpage https://ongtienlinhchi.com/products/ong-tien-linh-chi:

• “[D]esigned to relieve joint pain, reduce inflammation, and support musculoskeletal health. It enhances joint mobility, strengthens connective tissues, and promotes healing, providing relief from symptoms of gout, arthritis, and other joint-related issues.”
• “Relieves joint pain and back pain safely.”
• “Health Benefits
  o Support and disease prevention
  o Gout
  o Body aches
  o Osteoarthritis”

Sâm Xương Khớp Ông Tiên
On the product label:

• “[G]out, joint pain, pain in the elderly, and general body aches.”

Cao Đông Trùng Hạ Thảo Tế Bào Gốc Linh Chi
On the webpage https://ongtienlinhchi.com/products/sam-te-bao-goc-bao-tu-nam-linh-chi:

• “Health Benefits
  o Joint and Back Pain Relief . . .
  o Anti-Inflammatory Effects . . .
  o Anti-Cancer and Anti-Tumor Properties”

“Sâm Xương Khớp Tế Bào Gốc Linh Chi Ông Tiên,” “Sâm Xương Khớp Ông Tiên,” and ““Cao Đông Trùng Hạ Thảo Tế Bào Gốc Linh Chi” 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 drugs 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

“Sâm Xương Khớp Ông Tiên” is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for your “Sâm Xương Khớp Ông Tiên” product does not declare that it contains piroxicam or dexamethasone phosphate. As previously mentioned, FDA confirmed through laboratory analysis that your product contains piroxicam and dexamethasone phosphate. Consumers may purchase and use this product without knowing that it contains these potent pharmaceutical drug ingredients, which may cause serious harm or interact dangerously with other medications the consumer may be taking. The failure to disclose piroxicam and dexamethasone phosphate in the product labeling renders “Sâm Xương Khớp Ông Tiên” misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).

The introduction or delivery for introduction into interstate commerce of this misbranded drug product is a prohibited act 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 future and 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. 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. Identify your response with reference number “737352” in the subject line of the email.

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