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Thailand Further Revises Notification Standard for Products Used in Intimate Areas

The revised standard introduces additional provisions regarding physical characteristics, product formulations, and naming regulations for products used in intimate areas.

Following the revision of the Criteria for Reviewing Notification of Products Used in Intimate Areas in April 2024, the Thai Food and Drug Administration (FDA) released another update to this standard on September 24. The latest version, titled Guidelines for Evaluating the Notification of Products Used in Intimate Areas (Revised Edition July 2024) (the revised Guidelines), builds on the previous April 2024 edition. While maintaining the overall structure—covering definitions, formulations, efficacy claims, naming rules, and documentation requirements, the new version introduces additional provisions regarding physical characteristics, product formulations, and naming regulations.

Key changes are as follows:

1. Physical Characteristics

In the physical characteristics part of the revised Guidelines, new provisions are added for non-aerosol sprays used in intimate areas, as shown in the below Table.

Revised Edition, April 2024

Revised Edition, July 2024 (the text in red indicates changes to the previous version)

Cosmetics for intimate areas must avoid certain physical characteristics that could pose risks or lead to misuse. Products designed in shapes that could be mistaken for vaginal insertion, such as stick-shaped or suppository-like items, are prohibited due to potential safety concerns. Similarly, aerosol sprays applied directly to intimate areas are banned. If the application method doesn't involve direct spraying onto intimate areas, the product will be evaluated on a case-by-case basis. Moreover, the product’s physical features should not cause confusion or imply sexual enhancement properties.

  • Cosmetics for intimate areas must avoid certain physical characteristics that could pose risks or lead to misuse. Products designed in shapes that could be mistaken for vaginal insertion, such as stick-shaped or suppository-like items, are prohibited due to potential safety concerns. Similarly, aerosol sprays applied directly to intimate areas are banned. If the application method doesn't involve direct spraying onto intimate areas, the product will be evaluated on a case-by-case basis. Moreover, the product’s physical features should not cause confusion or imply sexual enhancement properties.

  • In the case of products used in the intimate area in the form of non-aerosol sprays, such as antiperspirants/deodorants and skin care products, instructions for direct application in the intimate area should be provided. These instructions should state “For external use only. Do not use on broken, irritated, or itching skin. If any abnormalities occur, stop using and consult a doctor immediately” or other similar text.

2. Product Formulation

Revised Edition, April 2024

Revised Edition, July 2024 (the text in red indicates changes to the previous version)

Intimate area products must meet ingredient list regulations prescribed by the Cosmetic Act B.E. 2558 (2015). If they include ingredients that might irritate the skin of intimate areas, compliance with the Cosmetic Notification Review Standards (2021 Edition) is necessary. For instance, products added with AHAs (Glycolic Acid, Lactic Acid, Tartaric Acid, Citric Acid, Malic Acid, Mandelic Acid), BHA (Salicylic Acid), PHA (Gluconolactone), and alcohol may need to be attached with additional documentation like irritation test reports and pH value testing for review.

  • Intimate area products must meet ingredient list regulations prescribed by the Cosmetic Act B.E. 2558 (2015). If they include ingredients that might irritate the skin of intimate areas, compliance with the Cosmetic Notification Review Standards (2021 Edition) is necessary. For instance, products added with AHAs (Glycolic Acid, Lactic Acid, Tartaric Acid, Citric Acid, Malic Acid, Mandelic Acid), BHA (Salicylic Acid), PHA (Gluconolactone), and alcohol may need to be attached with additional documentation like irritation test reports and pH value testing for review.

  • Tranexamic acid and hydrogen peroxide are not permitted as ingredients in the product.

3. Product Efficacy Claim and Naming

The revised Guidelines also introduces new naming rules for intimate area products, as shown in the below Table.

Revised Edition, April 2024

Revised Edition, July 2024 (the text in red indicates changes to the previous version)

Certain terms are strictly prohibited for use in product efficacy claims and naming, including:

  • Terms implying healing, relief, treatment, and prevention effects, such as: reducing vaginal dryness symptoms, reducing itching symptoms, reducing leucorrhea secretion, reducing irritation, reducing redness, reducing inflammation, etc.

  • Terms related to sexual intent, implying the promotion of sexual performance, or making consumers misleadingly believe the product has sexual nourishing effects, such as: aphrodisiac, changing the size of the genitals, delaying ejaculation, tightening the vagina, etc.

  • Terms indicating the product’s application in abnormal circumstances, for example: suitable for people with irregular menstruation, suitable for private parts that are rubbed after exercise, suitable for private parts that are easily irritated, suitable for private parts after laser treatment, etc.

  • Terms suggesting effects on body structure and/or function, such as regulating the pH value inside the vagina, affecting normal flora, increasing blood circulation in the genital area, etc.

Certain terms are strictly prohibited for use in product efficacy claims and naming, including:

  • Terms implying healing, relief, treatment, and prevention effects, such as: reducing vaginal dryness symptoms, reducing itching symptoms, reducing leucorrhea secretion, reducing irritation, reducing redness, reducing inflammation, etc.

  • Terms related to sexual intent, implying the promotion of sexual performance, or making consumers misleadingly believe the product has sexual nourishing effects, such as: aphrodisiac, changing the size of the genitals, delaying ejaculation, tightening the vagina, etc.

  • Terms indicating the product’s application in abnormal circumstances, for example: suitable for people with irregular menstruation, suitable for private parts that are rubbed after exercise, suitable for private parts that are easily irritated, suitable for private parts after laser treatment, etc.

  • Terms suggesting effects on body structure and/or function, such as regulating the pH value inside the vagina, affecting normal flora, increasing blood circulation in the genital area, etc.

  • For rinse-off and leave-on products used in the intimate area, terms such as "whitening," "lightening," or "brightening", or similar terms are permitted to be used as part of the product name to describe the product’s properties, provided that the formulation contains approved whitening agents in line with cosmetic notification evaluation criteria. However, sunscreen agents are exempt from this requirement, as they are deemed unsuitable for intimate areas, which are typically covered by clothing. Additionally, translating cosmetic names into Thai is not allowed; instead, transliteration must be used. If the product contains potentially irritating ingredients such as AHAs or BHAs, it must be in line with the formulation requirements outlined above.


Recommended Resources

On October 30, 2024, ChemLinked will host a free webinar featuring expert legal consultants from Tilleke & Gibbins, specializing in cosmetics regulations. The session will delve into Thailand’s Cosmetic Regulations, covering essential topics such as cosmetic registration, labeling, claims, and ingredient compliance. Participants will also gain insights by comparing these requirements with the ASEAN Cosmetic Directive (ACD). Attendees will leave with a comprehensive understanding of how cosmetics are regulated in Thailand and how to ensure compliance with the Cosmetics Act. Registration is open now!

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