FDA revokes famous herbal capsule registration after drug findings
Royal Gazette publishes FDA Order 21/2569 revoking Jiu Zheng Pu Shen Jiao Nang (G 427/52) after sildenafil and tadalafil were found
The Royal Gazette has published an order by Thailand’s Food and Drug Administration revoking the registration certificate for a herbal product formula, citing that it is unsafe for consumers.
On 22 January 2026, the Royal Gazette website published Food and Drug Administration Order No. 21/2569, titled “Revocation of the registration certificate for one herbal product formula.” The order was signed by Dr Roongruthai Mualprasitporn, Deputy Secretary-General of the Food and Drug Administration, acting on behalf of the Secretary-General of the Food and Drug Administration.
The order states that, based on inspection and laboratory analysis, the herbal product Pu Sen ginseng capsules, registration number G 427/52, was found to contain modern pharmaceutical substances— Sildenafil and Tadalafil. The product is considered to fall within the definition of a herbal product (or object) that is wholly or partly imitated in a way that could lead consumers to believe it is a genuine herbal product under Section 59(1), and a herbal product that is represented as being registered/notified with particulars that are not true under Section 59(5). It is therefore deemed unsafe for consumers and classified as a counterfeit herbal product under Section 58(1) of the Herbal Products Act B.E. 2562 (2019).
By virtue of Section 43(3) of the Herbal Products Act B.E. 2562 (2019), the Secretary-General of the Food and Drug Administration—upon approval of the Herbal Products Committee at meeting No. 6/2568 on 4 December 2025—ordered the revocation of the registration certificate for the herbal product formula Pu Sen ginseng capsules, registration number G 427/52.
If the registration certificate holder disagrees with the order, they may exercise the right to file a case with the Administrative Court by submitting a written complaint directly to the Central Administrative Court, or by sending it by registered post to the Central Administrative Court, within 90 days from the date of receipt of notification of this order.
The order takes effect from the date of publication in the Royal Gazette onwards.
