APR(278470)'s flagship brand Medicube "PDRN Pink Collagen Capsule Cream" has been halted from sale or recalled in key Asian markets including Hong Kong and Singapore. The two governments said they detected Sudan Red, a banned colorant, in products distributed on the market. In Korea, however, the same product remains on regular sale on grounds that there is no issue domestically.
Sudan Red is an industrial azo synthetic dye that imparts a red color to plastics, waxes and inks. It is banned in foods and cosmetics worldwide because it is known to break down in the body into harmful substances that can damage genetic material or increase the risk of cancer. The issue this time involves Sudan IV, a member of the Sudan Red series.
◇ After Hong Kong, Singapore… successive brakes in Asia
According to the industry on the 8th, the incident began in Hong Kong. On July 24, Hong Kong Customs announced that, after conducting roving inspections and purchasing products off the shelf for testing and commissioning the Government Laboratory, Sudan Red was detected in the cream. It urged consumers to stop using it and ordered retailers to immediately pull it from shelves. APR halted sales right away. Hong Kong Customs did not disclose the lot numbers of the detected products or how they were obtained, nor has it notified the company of additional measures. As a result, sales of the cream have not resumed to date.
Singapore's Health Sciences Authority (HSA) then moved proactively to verify this. On July 31, HSA ordered three companies marketing the product locally—APR's Singapore subsidiary, Venus Beauty and Reora International—to halt sales, then tested all samples obtained from them.
Of these, two samples sold by Venus Beauty tested positive for trace amounts of Sudan IV, and on Aug. 26 a recall was ordered for the two lot numbers (2E122I·2E117I, 2E191G·2E193G). A lot number is assigned to a production unit made at one time with the same raw materials to ensure uniform properties, also called a batch number. Founded in 2002, Venus Beauty is a well-known retail chain operating around 30 stores across Singapore. It serves as the local distributor for various imported brands and also runs its own online mall. No detection was found in submissions from APR's local subsidiary and Reora, so sales of the remaining batches were resumed. As an added safeguard, however, HSA required all three companies to have every batch intended for sale in Singapore tested by an accredited institution before supply and to submit the test reports.
◇ APR: "We manufactured it, but there is no export record"
APR said there is no issue with the Sudan Red controversy. On the 3rd and 4th, it issued clarifications on two consecutive days, asserting that tests by institutions in Korea, China, Taiwan and Singapore all showed non-detection of Sudan Red. It also said additional tests of the implicated lot numbers showed non-detection.
The Ministery of Food and Drug Safety also tested products distributed domestically after the incident. An official said, "We tested products currently on the market and confirmed non-detection," adding, "We are not planning follow-up measures because there is no issue with products distributed domestically." However, the testing targets were limited to finished goods already released to the market. Asked whether an inspection of the overall production facilities had been conducted, the official said, "We reviewed the products."
The crux of the company's explanation is the distribution route. A company official said, "It is true that we manufactured products with the implicated lot numbers," but added, "We have never officially exported them to Singapore." The official also stressed that Venus Beauty, which sold the detected products, is not an official sales channel. This is why some suggest the possibility of counterfeits with forged lot numbers. Regarding Hong Kong, however, the official said, "Customs authorities have not disclosed how they obtained the products, so we do not know whether they came through official channels."
Industry watchers say that, given the nature of consumer goods sold through diverse channels, distribution management must be airtight. It means products made by the company ended up on overseas shelves through routes unknown even to the company. APR manufactures all its cosmetics through OEM/ODM outsourcing without its own production facilities and distributes them through local subsidiaries and intermediary wholesalers. Contract manufacturers include Nodinary and Hankook Cosmetics Manufacturing.
Raw material management is another point to examine. APR also faced trouble over Sudan dyes late last year. Sudan IV was detected in a red raw material from its then-supplier, the Singapore-based dye company Chemcolor Research, leading to an international issue. An APR official said, "At the time, tests by the international certification body (KOTITI) showed non-detection, but we proactively switched to alternative raw materials because consumers might feel uneasy." Despite the company's explanation, some users on local communities and social media (SNS) continue to ask which route their purchased products came through and whether there is a way to verify authenticity.