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In brief

Even though the term “cosmeceutical” is not new from the global market perspective, such products are considered relatively new from the Thai legal perspective. The Thai Food and Drug Administration (FDA) has been working on finding a new product category for herbal-based/herbal-related products with health claims for quite some time and has recently introduced the Herbal Product Act B.E. 2562 (HPA). The HPA will, generally speaking, regulate and manage the herbal drugs and herbal products which cosmeceutical is part of.


Herbal drugs, which include traditional drugs, used to be regulated by the Drug Act. Under the HPA, they may make claims for curing, treatment and relief of pain in humans, or prevention of diseases.

Herbal products or health supplements containing herbals used to be regulated by the Food Act as food supplements. Herbal products are defined to include health supplements such as nutraceutical, functional food and functional drink, as well as cosmeceuticals. Under the HPA, they may make claims such as “maintain good health” or “reduce risk factor in having a disease”. These products are limited to formulas containing herbal as active ingredients in accordance with the acceptable pharmacopoeias.

In short, most products under the HPA are not new but rather being “regrouped” based on their key ingredients, “herbal” and “health claims”. The only new product under this HPA is “cosmeceuticals” and this makes these products more interesting when it comes down to new business opportunities.

The term “cosmeceutical” is a new terminology for products which basically are a combination of cosmetics and pharmaceuticals. Possible claims for cosmeceuticals are, for example, hair treatment for scalp protection, hair treatment to prevent hair loss, probiotics, stem cells, anti-acne, anti-wrinkle, antioxidant, dark spot correction, keloid reduction, fine lines or wrinkles reduction. However, during the product registration, the manufacturer or product owner of health supplements and cosmeceuticals must submit sufficient supporting documents for the FDA’s review and evaluation if they can justify the claim.

Since the HPA is relatively new, the FDA has been providing guidance to business operators upon their request in order to assist them with the registration process and handling of applications. It is anticipated that additional guidelines and regulations about cosmeceuticals market authorization (including labeling and advertisement requirements) will be issued. We will keep you posted of any further developments.

For more information or assistance, please contact our team.

Author

Peerapan Tungsuwan is a corporate and M&A partner in Bangkok office with specialties in highly regulated industries, including the healthcare industry. She is currently Chair of the AEC Healthcare Harmonization Sub-committee of Baker McKenzie's Asia Pacific Healthcare Industry Group, of which she was head from 2007-2013. Within the Bangkok office, she heads the Healthcare Industry and Natural Resources Groups and co-leads the Mergers & Acquisitions practice group and Japan Advisory Group.

Author

Praween Chantanakomes is an associate at Baker & McKenzie’s Bangkok office. He was admitted in 2008. He is currently active in the Corporate & Commercial, Mergers & Acquisitions, Environment, Natural Resources, and Pharmaceuticals practice groups.