FDA-Banned Underarm Whitening Cream May Contain a Controlled Ingredient with Serious Side Effects if Improperly Used
8 September 2024, Quezon City. Aside from highly toxic mercury, an imported cosmetic for whitening the underarm contains a controlled ingredient for pharmaceutical products that can result in a host of serious side effects if inappropriately used, warned the watchdog group EcoWaste Coalition
Citing information from Hong Kong’s Department of Health (DH), the environmental and health watchdog group revealed that 88 Total White Underarm Cream, which the Food and Drug Administration (FDA) banned in 2021 for being sold without the necessary market authorization, contains a controlled ingredient called betamethasone valerate.
Taking its cue from FDA Advisory No. 2021-1187, the EcoWaste Coalition in 2022 analyzed samples of “made in Thailand” 88 Total White Underarm Cream, which were then found to contain mercury up to 3,130 parts per million (ppm). The ASEAN Cosmetic Directive bans mercury as an ingredient, and sets a maximum limit of one ppm for mercury as a contaminant in cosmetics.
Based on the information published by Hong Kong’s DH last September 3, the product contains betamethasone valerate as analyzed by the Government Laboratory. Under the special administrative region’s Pharmacy and Poisons Ordinance, the said compound is a “Part 1 poison.” 88 Total White Underarm Cream is also “suspected to be an unregistered pharmaceutical product.”
According to Hong Kong’ DH, “betamethasone valerate is a steroid substance for treating inflammation."
"Inappropriate application of steroids could cause skin problems and systemic side effects such as moon face, high blood pressure, high blood sugar, skin atrophy, adrenal insufficiency and osteoporosis,” the agency pointed out.
“Products containing betamethasone valerate are prescription medicines that should be used under a doctor's directions and supplied in a pharmacy under the supervision of a registered pharmacist upon a doctor's prescription,” it emphasized.
Hong Kong’s government (like in the Philippines) requires all pharmaceutical products to be registered with the Pharmacy and Poisons Board (equivalent to the FDA) before they can be placed in the market. The unlawful sale of unregistered pharmaceutical products or Part 1 poisons in Hong Kong is considered a criminal offence punishable with a fine of HK$100,000 (or about P720,000) for each offence and two years' imprisonment.
Consumers were advised by the Hong Kong government not to buy or use products of doubtful composition or from unknown sources. People who have purchased 88 Total White Underarm Cream were further advised to immediately stop using it and to consult healthcare professionals if in doubt or feeling unwell after use.
In light of the above warning by Hong Kong’s DH, the EcoWaste Coalition appealed to the national and local government authorities to strictly enforce FDA Advisory No. 2021-1187 and stop the ongoing importation, distribution and sale of 88 Total White Underarm Cream in physical and online stores.
The group also appealed to all consumers to steer clear of this unauthorized product containing betamethasone valerate and/or mercury for their health and safety.
Reference:
https://www.info.gov.hk/gia/
https://www.fda.gov.ph/wp-
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