FDA Pulls Registration of Herbal Capsules Over Drug Content

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The Thailand Food and Drug Administration (FDA) has annulled the registration certificate for Pu Sen ginseng capsules, declaring the herbal formula unsafe due to the presence of modern pharmaceutical substances. The revocation, published on January 22, 2026, on the Royal Gazette website, was authorized by Dr. Roongruthai Mualprasitporn, Deputy Secretary-General of the FDA. This decision follows findings that the product contains Sildenafil and Tadalafil, making it a counterfeit under the Herbal Products Act.

The FDA's decision stems from inspections and laboratory analyses demonstrating that Pu Sen ginseng capsules contained pharmaceutical ingredients. This contravenes Section 59 and Section 58(1) of the Herbal Products Act B.E. 2562 (2019), as the product is not purely herbal and misrepresents itself as registered. Such findings led to the Herbal Products Committee's approval to revoke the product's registration at their December 4, 2025 meeting.

The action implies significant consequences for the product's distributor and the herbal product industry, highlighting the FDA's strict regulations and commitment to consumer safety. Experts suggest this move could lead to increased scrutiny of other herbal products in the market. The FDA's decision sets a precedent and delivers a strong message about ensuring product integrity and consumer safety.

Looking forward, the registration certificate holder has the right to challenge the FDA's decision within 90 days by filing a complaint with the Central Administrative Court. The revocation order is effective immediately from its publication date, signaling an immediate halt to the product's distribution. The case underlines the importance of compliance with herbal product standards and regulatory vigilance, reported The Nation.

Key Takeaways

• Thailand FDA revokes certificate for Pu Sen ginseng capsules due to safety concerns.

• Product found to contain Sildenafil and Tadalafil, violating herbal regulations.

• Certificate holder can contest decision in court within 90 days.

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Adapted by ASEAN Now from The Nation 2026-01-22