Sale of unaffected batches of Medicube capsule cream can resume: HSA

SINGAPORE: The sale of unaffected batches of Medicube PDRN Pink Collagen Capsule Cream may resume after testing found no traces of the banned Sudan IV dye, the Health Sciences Authority (HSA) said on Friday (Aug 28).

HSA had on Jul 31 directed three companies marketing the product in Singapore - APR SG, Venus Beauty and Rirora International - to suspend sales while it tested product samples.

Its testing detected minute amounts of Sudan IV dye in two samples sold by Venus Beauty. HSA subsequently ordered a recall of the affected batches on Wednesday.

Sudan IV was not detected in samples submitted by APR SG and Rirora International, and the companies may resume sales of their unaffected batches, HSA said.

The affected batches sold by Venus Beauty are batch numbers 2E122I.2E117I and 2E191G.2E193G.

Sudan Red dyes, including Sudan IV, are not permitted for use in cosmetic products. 

The group of dyes is normally used to colour plastics and other synthetic materials, and has been found to have carcinogenic effects, according to the European Commission. The dyes also pose a potential risk of genotoxicity, meaning they may damage genetic material.

"Although the quantities detected in the affected batches are in minute amounts and are unlikely to pose any serious health risks from previous use, consumers should not continue using the affected products and should contact the seller if they have concerns related to refunds," HSA said.

"HSA has not received any local reports of adverse events associated with the product to date."

As an additional safeguard, HSA has instructed the three companies to ensure every batch of the product intended for sale in Singapore is tested by an accredited laboratory for the absence of Sudan IV before supplying it locally.

The companies must also provide HSA with the test reports for products intended for sale here.

"HSA will continue to monitor the situation closely," it said.

Consumers are advised not to purchase or use cosmetic products from dubious or unfamiliar sources, particularly where the source or quality cannot be verified.

They should buy from reputable retailers with an established presence in Singapore so there is recourse should problems arise, HSA said.

Anyone found to have supplied cosmetic products that do not comply with the regulatory requirements, including having prohibited ingredients in their products, faces a fine of up to S$50,000 (US$39,300), a jail term of up to two years or both.