Products containing rhododendrol have been banned following complaints from consumers about depigmentation of the skin after they had used a product produced by Kanebo Cosmetics, the Food and Drug Administration (FDA) said on Tuesday last week.
The administration said that it had received many complaints from consumers that a Kanebo product containing rhododendrol had caused temporary depigmentation in the form of spots that appeared on their skin.
Kanebo is the only cosmetic company known to have used the substance in its products and following complaints the company’s Taiwan branch started a general recall of its products in Asia on July 4. By the end of last month, a total of 63,784 bottles, or about 99 percent of the product, had been recalled, the agency said.
Kanebo said the product contains natural minerals that help in the repression of melanin production, adding that the company spent 11 years researching the product.
The company also said that the product had passed a Japanese Ministry of Health, Labor and Welfare inspection.
Dermatologists said the depigmentation may have been due to an unforeseen allergic reaction to rhododendrol or simply because the substance is too effective.
The repression of melanin production by rhododendrol is 25 times that of vitamin C and as the substance is “toxic” to melanin, the depigmentation may simply be excessive repression, dermatologists said.
Food and Drug Administration medical supplies and cosmetic equipment division chief Lu Li-fu (呂理福) said the agency had received 354 complaints, with about 276 of those suspected of exhibiting depigmentation of the skin due to the use of the Kanebo product.
The other 47 were diagnosed as having depigmentation caused by other chemical substances, Lu said.
The depigmentation should disappear as long as patients diagnosed with the condition cease to use the product, Lu said, adding that some may require a brief period of medication before the effects of the depigmentation wear off.
The agency said that after extensive research into rhododendrol, it has banned its use in cosmetic products.
The agency said products containing the substance can no longer be imported or manufactured.
Additional reporting by Hung Su-ching