On April 2, 2026, the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia, issued a statement advising the public to avoid purchasing and using two cosmetic products containing controlled substances. Currently, the sale of these two batches of cosmetic products has been prohibited in the Malaysian market.
Ingredients Detected
According to the NPRA test report, the following scheduled poisons were detected in the above products:
- Hydroquinone
- Tretinoin
- Betamethasone 17-valerate
- Mercury
Interpretation of Controlled Ingredients
Mercury: Mercury is strictly prohibited in cosmetics in Malaysia because it can be absorbed by the human body and cause damage to the kidneys and nervous system. In addition, mercury may interfere with brain development in young children or unborn fetuses. Mercury can also cause rashes, irritation, and other adverse skin reactions.
Betamethasone 17-valerate, Hydroquinone, and Tretinoin: Products containing betamethasone 17-valerate, hydroquinone, and tretinoin are classified as pharmaceutical products that must be registered with the Drug Control Authority (DCA) of Malaysia and should only be used under the advice of healthcare professionals. Use of cosmetic products containing these ingredients without the supervision of healthcare professionals may lead to the following adverse reactions:
- Betamethasone 17-valerate: Thinning of facial skin at the application site, increased susceptibility to irritation, acne, changes in skin pigmentation, and increased risk of absorption into the circulatory system, which may lead to harmful effects.
- Hydroquinone: May cause redness, discomfort, undesirable skin color changes, and skin hypersensitivity at the application site; can inhibit the pigmentation process (depigmentation), reducing the skin's protection against harmful UV radiation and potentially increasing the risk of skin cancer.
- Tretinoin: Redness, discomfort, burning, peeling, and photosensitivity at the application site.
Regulatory Action
NPRA emphasizes that the sale and distribution of these cosmetic products violate the Drugs and Cosmetics Regulations 1984. NPRA requires all sellers and distributors of these cosmetic products to immediately cease sales and distribution activities.
CIRS Reminder
CIRS reminds cosmetics companies to closely monitor regulatory changes, especially those related to controlled substances. It is crucial for companies to enhance their compliance management practices to ensure that their products meet all safety standards. By staying informed and proactive, companies can better navigate the regulatory landscape and maintain consumer trust in their products.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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