Jing Cheong Asia Inc. dba New York Tong Ren Tang

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October 26, 2026

WARNING LETTER
Reference Number: 738200

To Timothy Chuang:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https://nytrt.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.

Your “Ofloxacin Eye Drops” product discussed below is especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.

FDA Review

Violations were identified and documented during a review of your website https://nytrt.com/ in September 2026. Based on our review, “Ofloxacin Eye Drops,” “Jingzhi Niuhuang Jiedu Pian,” and “Gui Pi Wan” 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.

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, “Ofloxacin Eye Drops,” “Jingzhi Niuhuang Jiedu Pian,” and “Gui Pi Wan” 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:

Ofloxacin Eye Drops
On the webpage https://nytrt.com/products/ofloxacin-eye-drops-5ml (translated from Chinese):

• “This product is indicated for external ocular infections, including bacterial conjunctivitis, keratitis, corneal ulcers, dacryocystitis, and post-operative infections.”

Jingzhi Niuhuang Jiedu Pian
On the webpage https://nytrt.com/products/jingzhi-niuhuang-jiedu-pian-cholinex?_pos=5&_sid=6791608a5&_ss=r:

• “May assist with high fever aggravated by constipation. May be useful in treating children's fever, including fevers due to measles, mumps, and tonsillitis.”

Gui Pi Wan
On the webpage https://nytrt.com/products/gui-pi-wan-240pills?_pos=3&_sid=8a48de578&_ss=r:

• “For heart shen disorders due to deficiency of qi and blood, poor memory, excessive dreaming, dizziness, palpitations, or anxiety. Use for blood deficiency disorders including aplastic anemia and thrombocytopenic purpura.”

“Ofloxacin Eye Drops,” “Jingzhi Niuhuang Jiedu Pian,” and “Gui Pi Wan” 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).

We also observed that your website https://nytrt.com offers “Notoginseng Formula Special Gout Granule” for sale to consumers in the United States. Previous FDA lab analyses of the product similarly named to “Notoginseng Formula Special Gout Granule” sold on your website revealed the product contained undeclared drug ingredients.¹ While the Agency has not sampled and tested this product variation from your inventory to date, this letter expresses our serious concern about the safety of this product. We emphasize that it is your legal responsibility under federal law to ensure that products you sell do not contain any undeclared or potentially harmful ingredients, and that they are marketed in compliance with applicable laws.

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 “738200” 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

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1 See https://www.fda.gov/drugs/medication-health-fraud/notoginseng-formula-special-gout-granule-contains-hidden-drug-ingredients.