Delivery Method: Via Email Product: Drugs Recipient:

Recipient Name

Anthony Trinh

123Herbals

7214 Berne St
Rosemead, CA 91770
United States

hello@123herbals.com Issuing Office: Center for Drug Evaluation and Research (CDER)

United States

WARNING LETTER

November 13, 2025

RE: 719198

Anthony Trinh:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.123herbals.com from July 2025 to November 2025. The FDA has observed that your website offers various products including, “SILINTAN,” “Ganoderma Huo Luo Dan,” “Hong Kong Vail Bon Tong,” “SAM NHUNG BO THAN,” “TDCARE,” and “Vall Boon Antacid” for sale in the United States. In addition, FDA has obtained a sample of your “SILINTAN” product. Based on our review, these products 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). Furthermore, your “SILINTAN” product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352, and introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

FDA confirmed through laboratory analysis that a sample of your “SILINTAN” product contains the undeclared active pharmaceutical ingredient meloxicam. Meloxicam is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.

Unapproved New Drugs

Based on a review of your website, your “SILINTAN,” “Ganoderma Huo Luo Dan,” “Hong Kong Vail Bon Tong,” “SAM NHUNG BO THAN,” “TDCARE,” and “Vall Boon Antacid” products 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:

SILINTAN

On the webpage https://123herbals.com/collections/frontpage/products/silantin-gout-joint-arthritis-supplements?variant=48198515425580:
• “SILINTAN 100% natural herbal to relief gout, joint, arthritis body aches [sic].”

Ganoderma Huo Luo Dan
On the webpage https://123herbals.com/collections/frontpage/products/ganoderma-huo-luo-dan-arthritis-stiff-joints-gout-hot-item:
• “Ganoderma Huo Luo Dan for relief of Rheumatism, Gout, Arthritis, Stiff Joints, Back Pains.”

Hong Kong Vail Bon Tong
On the webpage https://123herbals.com/collections/frontpage/products/hong-kong-vail-bon-tong-cough-herbals-capsules:
• “Non Drowsy Treatment of acute or chronic bronchitis, Coughs due to colds, chronic coughs, sore throats, excessive sputum or phlegm.”

SAM NHUNG BO THAN
On the webpage https://123herbals.com/collections/frontpage/products/kian-pee-wan-appetite-stimulant:
• “SAM NHUNG BO THAN herbal supports kidney tonic to nourish blood to improve physiological functions. Improve the symptoms of numb limbs, back pains, relief knee pain due to kidney failure. Relief of Urinary Tract Infection(UTI) symptoms. Support kidney health and limit urged to urinate at night.”

TDCARE
On the webpage https://123herbals.com/collections/frontpage/products/korean-red-ginseng-made-in-korea-buy3-get1-more-free-plus-free-shipping:
• “TDCARE helps to lower blood glucose and cholesterol. Prevents diabetic complications by lowering blood glucose. Lowers cholesterol to prevent cardiovascular disease.”

Vall Boon Antacid
On the webpage https://123herbals.com/collections/frontpage/products/antacid-tablets-606:
• “VALL BOON ANTACID herbals For Use: Gastric pain, Dyspepsia, Bloating, Flatulence, Heartburn, Indigestion.”

Your “SILINTAN,” “Ganoderma Huo Luo Dan,” “Hong Kong Vail Bon Tong,” “SAM NHUNG BO THAN,” “TDCARE,” and “Vall Boon Antacid” products 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 above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, new drugs 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).

Misbranded Drug

Your “SILINTAN” product 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 “SILINTAN” product does not declare that the product contains meloxicam. As previously mentioned, this undeclared ingredient in your “SILINTAN” product may pose serious health risks because consumers with underlying medical issues may take the product without knowing that it can cause serious harm or interact in dangerous ways with other drugs they may be taking. The failure to disclose this ingredient in the product labeling renders your “SILINTAN” product misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).

Your “SILINTAN” product is not the first product found by FDA to contain hidden ingredients. You previously sold the product “Vail-Bon Jie Yang Wan,” which FDA laboratory testing identified as containing undeclared dexamethasone and chlorpheniramine.1 In addition, you market other products on your website that are intended for pain relief, similar to “SILINTAN.” While the Agency has not sampled and tested these products from your inventory to date, this letter is to 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

The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “719198” in the subject line of the email.

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
Food and Drug Administration

____________________

1 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/123herbals-llc-123herbalscom-issues-voluntary-nationwide-recall-vail-bon-jie-yang-wan-capsules-due

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