Thailand Revises Notification Review Standard for Products Used in Intimate Areas

On April 23, 2024, the Thai Food and Drug Administration (Thailand FDA) unveiled a revised version of the Criteria for Reviewing Notification of Products Used in Intimate Areas (the Criteria). This revision, built upon the previous "Notification Standards and Requirements for Products for Cleansing Intimate Areas" within the Cosmetic Notification Review Standards (2021 Edition), further refines and enhances regulations pertaining to the definition, formulation, efficacy claims, naming rules, container characteristics, and notification documentation requirements for products used in intimate areas.

Key highlights of the revised Criteria include:

1. Regulatory Scope

The Criteria now clearly defines products intended for use in intimate areas as those applied to the external genital area and falling within the cosmetic definition in Thailand. Products meant for internal vaginal or anal use, or for lubricating these areas, are not classified as cosmetic products, which means they are not covered by the Criteria.

Moreover, the Criteria expands the categories of products eligible for notification to include soap, skin care, and deodorant products, in addition to the previously accepted intimate area cleaning and tampon products. 

2. Physical Characteristics

Cosmetic products with physical characteristics that pose risks of vaginal insertion, or those that may be mistaken for use inside the vagina and pose risks when used externally, such as stick-shaped products or products resembling vaginal or rectal suppositories, are prohibited. Additionally, products designed for direct spraying onto intimate areas (aerosol sprays) are not allowed. However, if the application method doesn't involve direct spraying onto intimate areas, the product will be subject to case-by-case discussion.

Moreover, the physical characteristics of cosmetic product must not create confusion regarding its intended purpose or imply sexual enhancement properties. Any other product forms that could pose risks due to incorrect usage will be considered on a case-by-case basis to ensure consumer safety.

3. Product Formulation

Products used in intimate areas must be in line with the requirements of the ingredient lists prescribed by the Cosmetic Act B.E. 2558 (2015). If the product formula contains ingredients that may irritate the skin of intimate areas, the compliance with the Cosmetic Notification Review Standards (2021 Edition) is necessary. For instance, if a product contains substances like AHAs (Glycolic Acid, Lactic Acid, Tartaric Acid, Citric Acid, Malic Acid, Mandelic Acid), BHA (Salicylic Acid), PHA (Gluconolactone), and alcohol, the notification reviewer may request additional supporting documents for review, such as product irritation test reports, pH value testing and other documents.

4. Container Characteristic

The Criteria prohibits the use of containers in the form of syringes, ampoules, vials, as well as container forms that may lead to misuse, including misuse inside the vagina, such as containers with tubes, containers with long ends, and containers with applicators. In addition, any other container that poses potential risks to consumers due to misuse is also prohibited and subject to case-by-case discussion.

5. Product Efficacy Claim and Naming

The Criteria imposes restrictions on the usage of certain terms in product efficacy claims and naming. The following terms are strictly prohibited:

• 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: changing the size of the genitals, delaying ejaculation, tightening the vagina, aphrodisiac, 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.

6. Documentation Requirements

During the notification process, enterprises are required to submit specific documents for review. These include:

• Images of the actual products available for sale, which clearly shows the actual container that the product is filled in;

• Images of labels on each side of the products for sale, including box labels and product labels. It is essential to ensure that the text and pictures on the labels do not lead to misunderstandings about the nature of the cosmetics or contain any of the prohibited expressions mentioned above. If the product is imported, the label of the original product must also be attached for review.

• A company-director-signed letter of guarantee, promising that the product's promotion will not include any of the prohibited expressions listed above.

• Additional supporting documents, such as irritation test reports, pH value testing and other documents. These may be requested by the notification officers if they have further inquiries or require additional clarification about the product.