Thailand Unveils Proposed Regulations for Cosmetics Containing Microneedles

On February 27, 2025, Thailand’s Food and Drug Administration (Thai FDA) published two draft regulations for a 14-day public consultation, aiming to introduce new rules for microneedle-based cosmetics. These proposed regulations seek to limit the production, import, and sale of specific microneedle products, while also requiring labelling for approved dissolving microneedle patches. Once finalized, the regulations will take effect the day after their publication in the Government Gazette. The Food and Drug Administration (FDA) recently held a meeting to create regulatory guidelines for microneedle patch products and those containing microneedle-like ingredients (Microspicules). The Cosmetic Standards Subcommittee decided that only dissolving microneedle patches with needle lengths of 100 micrometers (≤ 100 µm) or less will be accepted for cosmetic registration, specifically for facial and body use. These products are prohibited from being manufactured, imported, or sold. The following warnings were issued for the Dissolving Microneedle Patch cosmetic product:
•    May cause allergies or irritation; perform an allergy test before use.
•    Discontinue use if any issues arise and consult a doctor or pharmacist.
•    Avoid use on thin skin, sensitive areas, lips, or abnormal skin conditions like dermatitis, acne, open wounds, abrasions, or irritation.
•    Keep away from the eye area.
•    Not recommended for children under 15.
•    Not advised for daily use.