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HOME > Sympathy and response to vitiligo-like symptoms experienced by some customers of Kanebo Cosmetics products containing the quasi-drug ingredient “Rhododenol”

Sympathy and response to vitiligo-like symptoms experienced by some customers of Kanebo Cosmetics products containing the quasi-drug ingredient “Rhododenol”

Regarding Kanebo Cosmetics products that contained the quasi-drug ingredient “Rhododenol,” we at the Kao Group offer our sincerest sympathies for the trouble and worry caused to customers who have experienced vitiligo-like symptoms and everyone else who has been affected.
Kanebo Cosmetics is continuing its voluntary product recall and is placing top priority on the recovery and treatment of customers who experienced symptoms, while the Kao Group is making concerted Group-wide efforts to investigate the cause and prevent a recurrence.

Overview

Of the brightening products manufactured and sold by Kanebo Cosmetics, some customers who used products containing the quasi-drug ingredient “Rhododenol”* 4-(4-hydroxyphenyl)-2-butanol reported the appearance of white, vitiligo-like blotches on their skin.
Upon learning of these cases, Kanebo Cosmetics began a voluntary recall on July 4, 2013.
Kanebo Cosmetics employees are personally visiting customers who have experienced vitiligo-like symptoms to offer their sympathies and provide information on treatment and other matters. As of April 30, 2016, the number of people confirmed to have vitiligo-like symptoms was 19,584 in total. Of these people, 11,872 have made a complete or almost complete recovery (based on examinations by doctors or reports from the customers themselves). Settlements have been reached with 15,350 people, and a total of 702,497 products have been collected.
Outside Japan, product recalls are being conducted in the countries and regions following the policy of the respective pharmaceutical authorities. As in Japan, Kanebo Cosmetics is providing care for customers who have experienced vitiligo-like symptoms until they have recovered.

  • *Rhododenol
    Rhododenol is the name Kanebo Cosmetics gave to the chemical compound 4-(4-hydroxyphenyl)-2-butanol. Rhododenol is a quasi-drug ingredient approved by the Ministry of Health, Labour and Welfare that works by binding with and inhibiting the activity of the enzyme tyrosinase involved in melanin synthesis.

Response to customers experiencing symptoms in Japan

  • Basic policy

    Kanebo Cosmetics is providing care for customers who have experienced vitiligo-like symptoms after use of products containing Rhododenol until they have completely recovered.

  • Action policy
    1. Efforts to investigate the cause and establish treatment methods
    2. Support in daily life for affected customers
    3. Fair compensation
    1. Efforts to investigate the cause and establish treatment methods

      A project team comprising Kao Group researchers is conducting research that is relevant for investigating the cause and establishing treatment methods, and shares such information with groups including the Japanese Dermatological Association and the Ministry of Health, Labour and Welfare. Kanebo Cosmetics has provided grant funding totaling 60 million yen to the Fund for Research into Vitiligo-like Symptoms Experienced by Some Users of Products Containing Rhododenol for eight projects over its two years of operation from January 23, 2014 to March 31, 2016. The findings of research conducted by the Japanese Dermatological Association, research groups and many research institutes, including treatment methods, have been published and incorporated in the FAQ published on the Japanese Dermatological Association’s website (revised August 7, 2015). We will continue to fully cooperate with development of treatment methods at research institutes.

    2. Support in daily life for affected customers

      Customer Care Centers have been set up at the Head Office and branches of Kanebo Cosmetics throughout Japan. A dedicated team of about 400 staff assigned to each region of Japan is visiting customers on an ongoing basis and providing information on treatment and skin condition checks. The team also provides special coverage make-up and make-up advice for customers at their request.

      Special coverage make-up

      Special coverage make-up

      We have developed special coverage make-up products that bring the affected areas closer in appearance to the skin’s natural color. Liquid, concealer, and powder type foundations, BB cream, color powder, and loose powder are available, depending on the location and size of the area to cover. As individual skin condition varies, customers are asked to first see their dermatologist about using special coverage make-up products. After receiving the dermatologist’s consent, Kanebo Cosmetics staff visit the customer to confirm the skin condition and provide information and products based on symptoms and usage needs. Kanebo Cosmetics has published and provides the Skincare Advice Book, and staff also provide daily skin care advice tailored to customer needs.

    3. Fair compensation
      ①Basic approach

      Appropriate compensation will be offered to customers who have experienced vitiligo-like symptoms after use of products containing Rhododenol manufactured and sold by Kanebo Cosmetics.

      ②Details of the compensation

      ・Medical and travel costs
      Kanebo Cosmetics will pay the actual medical and travel costs incurred to receive treatment for vitiligo-like symptoms. Specifically, the company will reimburse treatment-related costs covered by the health insurance system and costs incurred through use of public transportation to receive treatment.

      ・Compensation for emotional distress
      In principle, compensation for emotional distress incurred as a result of vitiligo-like symptoms is based on a standard determined through consultation with legal experts with reference to judicial precedent. Separate sums are calculated and paid to each affected customer in accordance with the length of time required until recovery, the nature of the symptoms experienced, and other relevant factors.

      ・Compensation for time taken off work
      Kanebo Cosmetics will pay compensation to customers who lost income as a result of time off from work caused by vitiligo-like symptoms. Customers forced to leave work for hospital visits will be paid according to Kanebo Cosmetics’ own standards based on documentation confirming both the customer’s hospital visits and the time away from work. When vitiligo-like symptoms result in absences from work not entailing hospital visits, Kanebo Cosmetics will pay the actual sum of lost income after confirming that the customer was obliged to take time off work due to the nature of symptoms and the content of the work. To receive this compensation, the customer must present documentation indicating the day or days of absence from work and the amount of income lost.

      ・Compensation similar to damages payable for aftereffects
      Kanebo Cosmetics will pay compensation similar to damages payable for aftereffects, as a compensation for customers who have not recovered from vitiligo-like symptoms after using Rhododenol-formulated products at a certain point in time.* The amount of this compensation to the customers who desire to receive this, will be determined based on the standards used by Japanese courts and standards applied to accidents in the workplace by considering the affected area of the body, the size of the affected area, contrast between the affected area and the surrounding areas, presence or absence of a recovery trend and other factors. Kanebo Cosmetics will in principle determine whether a customer has recovered or not based on the diagnosis by a medical doctor. Customers who received compensation similar to damages payable for aftereffects will not receive any further compensation of any kind, although Kanebo Cosmetics will continue to inform such customers when a new effective treatment method has been established in the future.

      • * “Certain point in time” refers to the time when said information is provided by Kanebo Cosmetics as described in paragraph ③ “Compensation similar to damages payable for aftereffects.”

      ③Dates of payment

      ・Medical and travel costs
      Medical and travel expenses are paid on an as-needed basis.

      ・Compensation for emotional distress and for time taken off work
      Compensation for emotional distress and for time taken off work is paid at the time a settlement is reached.

      ・Compensation similar to damages payable for aftereffects
      Kanebo Cosmetics started by contacting customers whose vitiligo-like symptoms continued to exist over a large area of the face from December 2014, and since July 2015 has been working to contact all other customers who have not yet recovered. Compensation will be paid to customers who request it and who meet the conditions for compensation similar to damages payable for aftereffects at the time a settlement is reached together with compensation for emotional distress and for time taken off work.

Steps to ensure a similar situation does not happen

  1. Product manufacturing based on Kao Group safety standards

    In April 2014, the Kao Group introduced more rigorous and broader cosmetics safety standards to verify safety. Kanebo Cosmetics also conducts product manufacturing based on these new standards.

    Kanebo Cosmetics’ Safety Standards

    1. ①Strict selection of safe materials

      The safety of materials is thoroughly assessed using safety information from a broad range of fields and even more rigorous conditions and testing methods than in the past. Materials are also selected based on how gentle they are to people and the environment.

    2. ②Verification of formulation safety

      The absence of skin reactions is verified using patch tests or other methods for all products developed.

    3. ③Verification through a variety of use tests

      Before products are launched, use tests using monitors are conducted for a longer time and on a larger scale than in the past to verify that the products do not cause skin problems.

    4. ④Customer counseling

      While verifying individual customers skin problems and skin conditions, we offer advice on recommended products, how to use them, and how to care for skin. For customers with concerns about the use of cosmetics, we also provide a “skin and cosmetics compatibility check” that customers can do on their own.

    5. ⑤Continual safety inspections after market launch
      The details of every report received from customers and medical institutions are verified individually and used in safety inspections. At stores we listen intently to our customers. Opinions and requests from customers are used in improvement activities.
  2. Promotion of “Listening to the Voices of Customers” Activities
    To improve our ability to hear directly from customers, we placed postcards at stores from late May 2014 to December 2015 to obtain customers’ opinions and requests. We also opened the Kanebo Cosmetics Skin Consulting Center in July 2014, where customers can receive advice about make-up at their convenience.
  3. Internal mindset reforms (to continue our quality management organization with the participation of all employees)
    We have created a system to collect feedback related to products from employees in real time. All information received from customers, medical institutions, employees, and other stakeholders is verified by the Quality Improvement Study Meeting with involvement by the Kanebo Cosmetics management team and corrective actions examined.
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