Thailand Introduces Draft Regulations for Microneedle-Based Cosmetics

On February 28, 2025, Thailand’s Food and Drug Administration (Thai FDA) released two draft announcements for a 14-day public consultation, introducing new regulations on microneedle-based cosmetics. These proposed rules aim to restrict the production, import, and sale of certain microneedle products while mandating labeling requirements for permitted dissolving microneedle patches. Once adopted, both regulations will take effect the day after publication in the Government Gazette.

Key Highlights of the Draft Announcements

1. Ban on Most Microneedle-Based Cosmetics

The first draft, titled Draft Announcement of the Ministry of Public Health on the Specification of Cosmetics in the Form of Small Needles or Microneedles that are Prohibited from Manufacture, Import, or Sale B.E. ...., proposes a strict prohibition on most microneedle-based cosmetics.

Under the new regulation, only dissolving microneedle patches with needle lengths not exceeding 100 micrometers (≤100 µm), intended for facial and body skin use, will be eligible for cosmetic notification. All other microneedle-based cosmetics, including those containing microneedle-like crystalline structures (microneedle-like ingredients), will be banned from production, import, and sale.

To support compliance, the Thai FDA will issue guidelines or a manual on the notification process for permitted microneedle-based cosmetics, ensuring clarity for industry stakeholders.

2. Mandatory Warning Labels for Dissolving Microneedle Patches

The second draft, titled Draft Announcement of the Cosmetics Committee on the Display of Warnings on the Labels of Cosmetics in the Form of Small Needles or Microneedles B.E. ...., focuses on labeling requirements for these approved microneedle-based cosmetics, mandating specific warning statements on product labels.

Key warnings include:

• This product may cause allergic reactions or irritation. Perform an allergy test before use.

• If any abnormalities occur after use, discontinue use and consult a physician or pharmacist.

• Do not use on thin skin, intimate areas, lips, or abnormal skin conditions such as inflamed skin, acne, open wounds, irritated or abraded skin, etc.

• Avoid the eye area.

• Do not use on children under 15 years of age.

• Not recommended for daily use.

Manufacturers, importers, and contract manufacturers who have already received notification receipts for microneedle-based cosmetics with pre-existing labels before the finalized announcement takes effect must update their labels within 180 days of the announcement’s enforcement date.