Approach to Responsible Product Representations

Basic Policy

In accordance with the Lion Group Charter for Corporate Behavior and Behavioral Guidelines, Lion complies with the Pharmaceuticals and Medical Devices Act, Act against Unjustifiable Premiums and Misleading Representations, Health Promotion Act and other related laws and regulations. Furthermore, Lion strives to consider customer perspectives in order to make accurate and reasonable product representations (such as labels and advertising) that will not lead to misunderstandings or negative customer experiences.

To improve the quality of representations about all the products it sells (including food and pharmaceutical products), Lion has clearly defined its basic approach to product representation and established a representation drafting manual, comprising guidelines for preparing precise, appropriate product representations at each step of product development under its Product Management System. These guidelines apply to all product packaging and presentation as well as the wording and expressions used in instructions, pamphlets, sales handbooks, advertisements and other representations (including those for samples).

In line with the guidelines for product representations, representations are subject to stringent checks by specialized staff as well as external experts (attorneys, etc.), as needed. Through this system of thorough management, we advance the use of representations that are clear and easily recognizable to customers.

Lion’s specialized representation checking staff strive to improve their expert abilities to ensure that they can make decisions and offer advice about representation quality that accurately reflect the latest legal interpretations, governmental tendencies and changes in society. To this end, they participate in lectures offered by governmental bodies and external seminars and, as needed, consult with external experts and governmental authorities.

Product Representations in the OTC Drug^* Business

The information displayed on pharmaceutical product labels is subject to the stipulations of the Pharmaceuticals and Medical Devices Act (statutory labeling). The laws and regulations regarding fairness and appropriateness in pharmaceutical product advertising include the Pharmaceuticals and Medical Devices Act and the Standards for Proper Advertisement of Pharmaceuticals, etc., while industry self-regulations include the Japan Federation of Self-Medication Industries’ Guidelines for the Proper Advertising of Over-the- Counter Medicines.

Pharmaceutical products serve to protect users’ lives and health. Advertisements for pharmaceutical products must therefore serve not only as marketing tools, but as information sources that encourage customers to use products correctly. Such advertisements must not encourage improper use, abuse or overuse due to insufficient caution.

Lion’s departments in charge of creating and checking product representations share pharmaceutical product information templates for statutory labeling and an advertising check sheet based on the Standards for Fair Advertising Practices concerning Pharmaceutical Products, etc., for advertisements. By ensuring that representations are created and managed based on a common understanding of the regulations stipulated in the Pharmaceuticals and Medical Devices Act, we strive to efficiently and accurately advance proper representations.

The Japan Federation of Self-Medication Industries has established an advertising screening committee, which evaluates pharmaceutical product advertisements after their publication. Comprising third-party and over-the-counter (OTC) drug manufacturer representatives, the committee works to ensure proper expressions in pharmaceutical product advertising and enhance confidence in such advertising. Lion participates as a corporate member, contributing to efforts to ensure proper OTC drug advertising.

Product Representations in the Food Product Business

The information displayed on food product labels is subject to the stipulations of the Food Labeling Act and the government’s Food Labeling Standards (statutory labeling). In addition, laws and regulations regarding fairness and appropriateness in the health food products^*1 that Lion offers include the Act against Unjustifiable Premiums and Misleading Representations and the Health Promotion Act, while regulations related to fair competition for such products include the Code of Fair Competition Regarding the Labeling of Food for Specified Health Uses and its enforcement regulations, and industry self-regulations include voluntary standards for the proper advertising of foods with function claims^*2.

Food products have three basic functions. The first and most important is nutrition (the primary function), the second is the sensory and enjoyment function (the secondary function) and the third is contributing to biological regulation to help maintain or improve health (the tertiary function). The food products that Lion sells are health food products that provide this tertiary function. While these products are thought to provide a health effect, it is important to ensure that they are properly marketed to avoid such misunderstandings as their being confused with pharmaceutical products or their effects being exaggerated.

Lion uses food product information templates for statutory labeling and an advertising check sheet based on related laws and regulations and voluntary industry rules for advertising. Furthermore, to ensure the provision of appropriate information to customers, we include a check by external experts (attorneys, etc.) as a third-party perspective during the food product advertising checking process.

The Japan Health and Nutrition Food Association, an industry organization, maintains a foods with function claims advertisement committee and foods with function claims advertisement screening committee, with the aim of enhancing the appropriateness of foods with function claims advertisements. The foods with function claims advertisement screening committee, which comprises third-party and manufacturer representatives, screens advertisements after their publication. Lion is a member of the foods with function claims advertisement committee, contributing to efforts to ensure appropriate representations of foods with function claims. Furthermore, Lion participates as a member of the operating committee and advertising study committee of the Foods for Specified Health Uses^*3 Fair Trade Council, contributing to the prevention of inappropriate representations and exaggerated advertisements for foods for specified health uses as well as ensuring fair competition between businesses in the industry.

Admonishment from the Consumer Affairs Agency Regarding Product Representations

Lion received an admonishment from the Consumer Affairs Agency regarding an advertisement for its product Tomato Su Seikatsu Tomato Su Inryo that ran from September 15 to November 27, 2015 in the Nikkei Shimbun on the grounds that said advertisement could be misunderstood by general consumers.

Lion takes this admonishment seriously. We have further reinforced advertisement submission management and are steadily advancing measures to prevent recurrences of such issues.

Initiatives to Ensure Proper Use

Lion’s food products, particularly its processed food products in tablet form, are easy to consume and therefore present the potential risk of excessive intake. By such means as displaying recommended intake amounts in large print on the front of packages, Lion strives to provide clear labeling so that consumers can use its health food products appropriately.

Allergen Labeling

Lion requires its raw ingredient manufacturers and suppliers to provide information about their use of the seven ingredients that under the Food Labeling Standards are required to be listed on food product labels as allergens, as well as the 21 ingredients recommended for such labeling. In particular, we carry out tests as appropriate to ensure appropriate labeling regarding functional substances (used as ingredients in foods with function claims) and substances with specified uses (used in foods for specified health uses).

Seven raw ingredients required to be listed as allergens: Eggs, milk, wheat, buckwheat, peanuts, shrimp and crab 21 raw ingredients recommended to be listed as allergens: Apples, oranges, soy, sesame, etc.
Lion shares information about revisions to allergy labeling regulations and other such developments internally, mainly through a food safety team.

Raising Awareness of Balanced Dietary Habits

Exercise, rest and a balanced diet are all important to maintaining and improving health. Japan’s Food Labeling Standards require the packaging of foods with function claims, foods for specified health uses and foods with nutrient function claims^*4 to display text reminding users of the fundamental importance of dietary balance based on different food groups. All of Lion’s food products, including its general health food products, carry this text to enhance awareness of healthy dietary habits.

Labeling in the Languages of the Places Where Products Are Sold

To ensure that customers can accurately understand the features of our products, our product labels, including usage instructions and ingredient lists, are presented in the official languages of the places where they are sold.

KireiKirei Hand Soap labels

Participation in Pharmaceutical Product Safety Initiatives

Pharmaceutical Product Safety Activities

In Japan, under the Pharmaceuticals and Medical Devices Act, businesses must obtain a marketing license to manufacture and sell pharmaceutical products and quasi-drugs. Per this law, businesses must conduct appropriate management and supervision by establishing and properly operating systems of quality assurance and post-marketing safety control for such products and appointing a general marketing director, quality assurance director and safety control director.

As a company that manufactures and sells pharmaceutical products, quasi-drugs, cosmetics and medical devices, Lion complies with such legal requirements and operates an appropriate marketing framework. Lion has created a manual for compliance with the GVP Ordinance for use in safety control. Safety control is carried out in accordance with this manual and managed by the safety control director. Furthermore, the safety control director manages the safety control divisions, and the general marketing director provides oversight to ensure proper operations and conducts post-marketing safety control. The safety control divisions operate according to internal manuals, including implementing post-marketing safety measures for the products Lion sells, collecting and evaluating safety data about pharmaceutical and other products, and, as needed, implementing safety measures.

Twice a year, the safety control divisions provide education and training to divisions that implement safety control to better promote the proper use of pharmaceutical and other products.

Participation in Industry Groups

To further enhance the safety of the pharmaceutical products it sells, Lion has been a member of the Japan Self-Medication Industry, an organization of OTC drug manufacturers, since 1978. As of May 2021, Itsuo Hama, the Chairman of Lion’s Board of Directors, serves as a vice chair of said organization. The Japan Self-Medication Industry works to provide information about the correct use of OTC drugs and examines all kinds of issues related to OTC drugs, for example, researching how to make drug instructions easier to read and understand.

Lion’s safety control director regularly takes part in the organization’s committee meetings to gather the latest information about pharmaceutical product safety for use in safety control.

In addition, to increase the safety of pharmaceutical products, Lion has been involved in creating shared guidelines for preparing product instructions and warnings in multiple languages. These guidelines help companies meet the needs of non-Japanese speakers by offering product inserts in English, Chinese and Korean.

In addition to the Japan Self-Medication Industry, in the area of pharmaceutical products, Lion is a member of the Pharmaceutical Manufacturers’ Association of Tokyo, and in the areas of quasi-drugs and cosmetics, Lion participates in the activities of the Japan Dentifrice Manufacturers’ Association (JDMA) and the Japan Cosmetic Industry Association. Through such participation, Lion suggests research initiatives and measures related to regulations and conducts educational programs for customers about correct product use with the aims of promoting the manufacturing and quality control of pharmaceutical and other products as well as post-marketing safety management and correct product use.

Animal Testing Policy

The Lion Group adheres strictly to the international principles of the 3Rs for animal testing (Replacement, Reduction, Refinement) and supports the philosophy of animal welfare.

We proactively work to thoroughly ensure the safety and enhance the functionality of our wide range of products and services to better serve our customers. In developing cosmetics (including medicated cosmetics), we do not use animal testing apart from exceptional circumstances in which it is required to ensure safety or satisfy legal requirements. Similarly, in developing other products, we employ alternative methods as long as the accuracy and replicability of the scientific data used as the basis for evaluating products are not negatively affected. When no alternative methods are available and we must use animal testing, we strive to do so properly and in line with the principles of the 3Rs and the laws of relevant countries.

Lion Corporation has long focused efforts on related research through participation in the Long-range Research Initiative of the Japan Chemical Industry Association and the Japanese Society for Alternatives to Animal Experiments. We will continue actively developing alternatives to animal testing and advancing business activities that contribute to both the health of our customers and animal welfare.