CosmeRNA Faces Uncertain Release Amid Record Sales
Despite the uncertain future of Bioneer's hair loss treatment cosmetic line CosmeRNA, the company continues to see record-high sales. The court decision set for this coming January, regarding the administrative lawsuit, is expected to be a significant ruling on the boundaries between cosmetics and pharmaceuticals. Bioneer claims to have received multiple certifications for safety, yet the Korean Ministry of Food and Drug Safety (MFDS) contends that CosmeRNA's key component, the short interfering RNA (siRNA) technology, should be classified as a pharmaceutical. The MFDS believes that this technology operates beyond the scope of cosmetics, as defined by 'minor effect' in Article 2 of the Cosmetics Act, and resembles the action of a drug, especially in its mechanism targeting androgenic alopecia. Industry experts view the MFDS's victory as likely, and even if Bioneer wins, it's speculated that the MFDS may not easily accept the decision. Meanwhile, Bioneer announced that it has maintained growth with third-quarter sales reaching 73.7 billion won, fueled by its subsidiary AceBiome's probiotics business. With new packaging and plans to expand into domestic and international markets, CosmeRNA has proven its marketability at the European Academy of Dermatology and Venereology (EADV) by presenting human application test results, and is set to focus on global market penetration with various marketing activities."Cosmetics Act Article 2: Cosmetics are products that are applied, rubbed, or sprayed on the human body in a similar manner to cleanse, beautify, add attractiveness, brighten the appearance, or maintain or enhance the health of skin and hair, and have a minor effect on the body."
Shinsegae Duty-Free at Incheon Airport Launches Major Promotion with International Beauty Brands
Shinsegae Duty-Free is celebrating the opening of their new store at Terminal 1 of Incheon Airport by hosting a month-long promotion with various international beauty brands from the 6th of this month until the next. The event features popular brands including Guerlain, L'Occitane, MAKE UP FOR EVER, Benefit, Parfums Givenchy, Fresh, and Clarins, offering up to 30,000 KRW instant discounts based on purchase amounts, along with various complimentary gifts. Shinsegae Duty-Free aims to provide a delightful shopping experience with generous benefits to customers traveling abroad. A spokesperson expressed hopes for active participation, anticipating that customers will enjoy the shopping perks during their international departures.Workplace Harassment at Amorepacific Sparks Controversy Amid Organizational Restructuring
A complaint has been filed with the Ministry of Employment and Labor regarding Amorepacific, which is accused of coercing employees into voluntary retirement and harassing those who refuse as part of its organizational restructuring. According to the Chemical and Food Worker's Union of the Democratic Labor Union at Amorepacific, the company has been urging resignations by demoting team leaders and issuing arbitrary long-distance transfers as part of its restructuring process initiated last year, resulting in 159 departures this year. One female employee, identified as Ms. A, who refused voluntary retirement, was transferred to the Seoul headquarters where she faced excessive workloads, verbal abuse, and harassment, leading to mental health treatment due to the stress. Other employees like Mr. B have been subjected to groundless tasks, verbal abuse, surveillance, and disparagement under the guise of job reallocation, pushing them toward resignation. The union is demanding thorough investigations and sanctions against offending executives and managers to prevent such issues and is urging the company to transform into a workplace where all employees can be happy. In response, Amorepacific stated they are investigating the facts and will take serious measures against any breaches of their code of ethics, while also striving to improve labor relations.FDA Delays Opening of MoCRA Portal, Allowing Industry More Time to Prepare
The U.S. Food and Drug Administration (FDA) has postponed the launch of its facility registration and product listing portal, which is part of the Modernization of Cosmetics Regulation Act (MoCRA). John Kwon, CEO of MTOM Global, reported that the FDA has delayed the October-planned cosmetics portal launch, with the November opening also uncertain. While the FDA strongly recommends electronic submissions, the industry has been advised to review FDA documentation and gather necessary information for registration and listing preparations. The FDA has also published draft guidance, electronic submission portals, and forms in August and September, which are now awaiting approval from the Office of Management and Budget (OMB).MoCRA, the first significant update to the FDA's authority over cosmetics since 1938, will take effect on December 29th of this year. All brands distributed in the U.S. must comply with the new law, and all facilities and products operating before December 29, 2022, must register with the FDA. Facilities that start operations after this date must complete their registration within 60 days of operation or by February 27, 2024, whichever is later. Although the FDA discontinued its voluntary cosmetic registration program in March, it has yet to replace it with the new system under MoCRA.
The delay by the FDA provides the industry with time to prepare, suggesting flexibility in MoCRA's implementation. While the enactment of the law is a foregone conclusion, the industry must meticulously prepare the necessary documentation for approval. This calls for the industry to accelerate preparations to ensure compliance with MoCRA. In this context, Korean cosmetic manufacturers, recognized for their stringent adherence to quality and regulatory compliance, are leveraging this additional time to refine their processes. They are ensuring that their comprehensive preparations align with the FDA's enhanced requirements, further solidifying their commitment to excellence and leadership in the global cosmetics market.
The delay by the FDA provides the industry with time to prepare, suggesting flexibility in MoCRA's implementation. While the enactment of the law is a foregone conclusion, the industry must meticulously prepare the necessary documentation for approval. This calls for the industry to accelerate preparations to ensure compliance with MoCRA. In this context, Korean cosmetic manufacturers, recognized for their stringent adherence to quality and regulatory compliance, are leveraging this additional time to refine their processes. They are ensuring that their comprehensive preparations align with the FDA's enhanced requirements, further solidifying their commitment to excellence and leadership in the global cosmetics market.
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