In recent years, innovative cosmetics have been increasingly emerging, such as those in the form of microneedles. 

Common types include derma rollers, microneedle patches, and microneedle serums, with efficacy claims often involving 

promoting ingredient penetration, anti-aging, repair, and other beauty effects. When microneedles act on the epidermal layer (without penetrating the dermis) and are intended for "beauty care," they are classified as cosmetics. If the efficacy claims include "scar treatment, deep repair," or other medical effects, they need to be categorized as medical devices. On February 28, 2025, the Thai Food and Drug Administration (Thai FDA) released two draft announcements to establish regulatory guidelines for microneedle patches and products containing microspicules. A 14-day public consultation was conducted, and once formally approved, these regulations will take effect the day after their publication in the Government Gazette.

Here is an explanation of the main principles or key issues of the bill or law currently under public hearing:

Product Scope and Restrictions

• Applicable Products: This regulation primarily targets cosmetic products in the form of dissolvable microneedle patches used on facial and body skin, with needle lengths not exceeding 100 micrometers (≤ 100 μm).

• Prohibitions: The production, import, and sale of other forms of microneedle or microneedle-like cosmetics are prohibited.

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Safety and Consumer Protection Measures

• Allergy and Irritation Warnings: Products may cause allergies or irritation, and an allergy test is recommended before use.

• Adverse Reaction Handling: If any abnormalities occur after use, discontinue use immediately and consult a doctor or pharmacist.

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Usage Restrictions and Specific Warnings

• Prohibited Areas: Avoid use on thin skin, concealed areas, lips, and abnormal skin (e.g., dermatitis, inflammatory acne, open wounds, abrasions, or irritated skin).

• Avoid Eye Area: Avoid contact with the eye area.

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

• Usage Frequency: Daily use is not recommended.

Consumer Safety: By restricting the types of microneedle products and implementing stringent labeling requirements, the aim is to minimize the risk of adverse skin reactions and ensure that only products strictly compliant with safety standards can enter the market.

Market Regulation: Prohibiting the production, import, and sale of non-compliant microneedle products helps encourage innovation in cosmetic technology while safeguarding public health.

This regulatory framework was developed following discussions and public hearings organized by the Food and Drug Administration (FDA) and relevant cosmetic standards committees, reflecting a balance between encouraging innovation and ensuring consumer safety.

To regulate the market, the Thai Food and Drug Administration (FDA) has drafted the following two announcements:

1. Draft Announcement of the Ministry of Public Health, Thailand – Prohibiting the production, import, or sale of certain cosmetics with microneedle characteristics.

2. Draft Announcement of the Cosmetics Committee – Requiring warning information to be labeled on microneedle-based cosmetics.

   
   

This initiative aims to ensure product safety, reduce risks consumers may face due to improper use, and standardize industry development.

1. Interpretation of the Ministry of Health Draft: Restrictions on Production, Import, and Sale of Cosmetics Containing Microneedles

This draft, issued by the Ministry of Public Health of Thailand, includes the following key points:

Legal Basis and Effective Date

• Based on relevant provisions of the Cosmetics Act (Article 5, Paragraph 1 and Article 6(1)), the announcement will take effect the day after its publication in the Royal Gazette.

Scope of Application and Prohibitions

• The production, import, and sale of cosmetics with microneedle characteristics or containing microneedle-like components are strictly prohibited.

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• Exceptions:

• The sale of "Dissolving Microneedle Patches" is permitted, provided that the needle length does not exceed 100 micrometers and the product is exclusively for facial and body skincare use.

Follow-up Actions

• Reference will be made to the guidelines or operational manuals developed by the Food and Drug Administration to help relevant businesses understand and comply with the regulations.

2. Interpretation of the Cosmetics Committee Draft: Mandatory Labeling and Warning Requirements

This draft, issued by the Thai Cosmetics Committee, includes the following key points:

Legal Basis and Effective Date

• Based on Article 22, Paragraph 3 of the Cosmetics Act, the announcement will take effect the day after its publication in the Royal Gazette.

Warning Label Requirements

• All cosmetics with microneedle characteristics must include the following warning information on their labels:

• The product may cause allergies or skin irritation. An allergy test is recommended before use.

• If any abnormal reactions occur after use, discontinue use immediately and consult a doctor or pharmacist.

• Prohibited for use on certain areas, such as concealed areas, lips, and abnormal skin conditions (e.g., inflammation, acne, open wounds, abrasions, or existing irritation).

• Avoid use around the eye area.

• Not for use on children under 15 years of age, and daily use is not recommended.

Compliance Deadline

• For products already registered and labeled before the announcement takes effect, the labels must be updated to comply with the new regulations within 180 days after the announcement's effective date.

These two drafts collectively reflect the strict regulatory approach of Thai authorities toward cosmetics containing microneedle components:

1. Safety Risk Control: By restricting the production, import, and sale of non-compliant products and mandating clear usage warnings, the aim is to reduce the risk of allergies or skin irritation caused by improper use of such products.

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3. Clear Product Categorization: Only dissolvable microneedle patches meeting specific conditions are permitted in the market, ensuring product safety and suitability.

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5. Transition Period Arrangement: A 180-day adjustment period is provided for businesses to ensure that existing products on the market can update their labels in a timely manner to comply with the new regulations.

Overall, these measures are designed to further standardize the market, safeguard consumer health and safety, and provide clear regulatory guidance for businesses.