Sales of Medicube cream can resume, 2 batches found with minute amounts of prohibited ingredient will be recalled: HSA

UPDATE on Aug. 30, 1:35pm: This article has been updated with a statement from Medicube's parent company, APR.

Sales will continue for the Medicube PDRN Pink Collagen Capsule Cream in Singapore.

The Health Sciences Authority (HSA) said in an Aug. 28 statement that the prohibited ingredient Sudan IV was not detected in the samples submitted by two companies, APR SG Pte. Ltd. and Rirora International Pte. Ltd.

As such, the sale of the unaffected batches can resume.

Minute amounts of Sudan IV were found in only two samples of the Medicube product sold by Venus Beauty Pte. Ltd, and these batches will be recalled.

Suspension of sale lifted for APR

APR, Medicube's parent company, told Mothership it was officially informed by HSA that as of Aug. 26, 5:55pm, the suspension of the sale and supply of Medicube PDRN Pink Collagen Capsule Cream was lifted.

It added that all quantities of the Medicube PDRN Pink Collagen Capsule Cream currently stored in Singapore belong to the aforementioned batch.

Recall of two affected batches from Venus

Prior to this, HSA had directed the three companies marketing the Medicube cream to suspend sales of the product on Jul. 31 while it tested their product samples.

HSA told Mothership that its testing detected minute amounts of Sudan IV in two samples of the product sold by Venus Beauty Pte. Ltd.

On Aug. 26, HSA instructed the recall of these affected batches.

The two affected batches are 2E122I.2E117I and 2E191G.2E193G.

Product batch numbers can typically be found on the item's packaging or container.

Additional safeguard

As an additional safeguard, HSA has instructed the three companies to ensure that every batch of their Medicube PDRN Pink Collagen Capsule Cream products intended for sale in Singapore is tested by an accredited laboratory for the absence of Sudan IV.

This should be done before supplying the batches locally.

These companies must also provide HSA with their test reports of their products for local sale, the agency said.

Consumer advisory

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

Although the quantities detected in the affected batches are in minute amounts and are unlikely to pose any serious health risks from previous use, HSA warned consumers to stop using the affected products.

Those who have concerns related to refunds should also contact the seller.

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

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

HSA added that consumers should purchase from reputable retailers with an established presence in Singapore so that there is recourse if problems arise.

Sudan dyes not detected: APR

APR told Mothership in an Aug. 29 statement that according to the test results, Sudan I, II, III, and IV were not detected in the Medicube products tested.

It added that the findings are consistent with the results of its previous quality verification procedures and testing conducted by accredited laboratories.

APR added that a rigorous quality control (QC) system is maintained throughout the entire product lifecycle.

"We also comply with applicable standards and regulatory requirements in each market where our products are sold and continuously conduct necessary testing and verification procedures," APR said.

In addition to the latest results, multiple tests conducted to date have consistently confirmed that the substances in question were not detected, it said.

APR added: "Medicube will continue to strengthen its quality control and verification processes based on objective testing and scientific evidence, ensuring that customers around the world can use our products with confidence."

Counterfeit and unauthorised products

As Medicube continues to expand globally, APR said it has identified instances of counterfeit products and products being sold through unauthorised distribution channels in certain markets and online platforms.

It warned that the authenticity, storage and distribution conditions, or quality of products purchased outside Medicube's official distribution network cannot be verified or guaranteed.

"We therefore strongly encourage customers to purchase Medicube products only through our official online stores or authorised retailers and to verify the seller before making a purchase," APR stated.

It added that Medicube will continue to monitor and take appropriate action against counterfeit and unauthorised products while maintaining rigorous quality control and transparent communication with its customers worldwide.

Cosmetic product notification is not HSA approval

Cosmetic products are regulated under the Health Products (Cosmetic Products – ASEAN Cosmetic Directive) Regulations 2007, the agency said.

Under the regulations, dealers must notify HSA before any cosmetic products can be placed on the market.

The notification facilitates regulatory follow-up by HSA if safety concerns arise.

HSA pointed out that product notification is not a form of premarket approval and should not be construed as product certification or registration by HSA.

Dealers of cosmetic products must ensure that their products comply with the regulatory requirements.

This includes the prohibition and restriction of the use of certain ingredients, the reporting of serious adverse effects to HSA and product labelling.

Any person who supplies cosmetic products that do not comply with the regulatory requirements, including having prohibited ingredients in their products, may face enforcement action.

Anyone found to have supplied such products may face a fine of up to S$50,000 and/or up to two years' jail.