[Press Release, April 27, 2020 / unofficial translation] Personalized Health Functional Foods Can Now Be Purchased - Selected for special regulatory sandbox, test operation of personalized health functional foods - □ The Ministry of Food and Drug Safety (Minister Lee Eui-Kyung) announced that “recommendation and sales of personalized health functional foods” applied by seven businesses* including the Pulmuone Health & Living Co., Ltd was selected as the subject of special regulation at the Special Regulation Discussion Committee held today, and it will be operated as a regulatory sandbox trial business for the next 2 years. * Pulmuone Health & Living Co., Ltd., Amorepacific, Amway Korea, COSMAX NBT, Herbalife Korea, Bigsome, Mono labs ○ Through this special regulation, sales of divided health functional foods and non-medical consultation based on an individual’s lifestyle habits, health status, and genetic information become possible, - Consumers can purchase personalized products made by the combination of multiple products, based on specialist’s recommendation. □ So as to maintain the level of effectiveness and quality of health functional food products as same as the previous one and to guarantee the highest level of consumer safety, ○ Sales of divided products are restricted to six food forms* which rarely change in quality after opening and are allowed only if the stores are equipped with hygienic division and packaging system. * tablet, capsule, pill, flake, bar, jelly ○ Furthermore, to secure consumer confidence, product recommendations through health and nutrition consultations can only be performed by specialists such as pharmacists and nutritionists in the store. □ The MFDS projects personalized health functional foods will take root as a system that fulfills demand for daily well-being in the aging society as well as reflects the latest consumer trends, centered on user, not supplier. ○ It also announced that personalized health functional foods are expected to protect consumers from over-consumption and abuse of the foods and contribute to the creation of new jobs. ○ Furthermore, the Ministry also announced its determination to do its best to ensure the system settle down well by carefully examining whether there are any things to be improved to protect consumer safety during this trial operation process and reviewing whether there are still any unnecessary procedural regulations. (Example) A woman in her 50s felt uneasy about her blood pressure and cholesterol level after getting a medical check-up, although it wasn’t that serious. So she visited a health functional food store to take care of her health in advance. ☞ ① Consultation: She presented her eating habits and medical check-up results to the counselor in the store. ☞ ② Product recommendation: The counselor recommended “Coenzyme Q10” which is helpful for reducing blood pressure and “Oat fiber” that can improve the levels of cholesterol in the blood. ☞ ③ Divided packaging: The two health functional foods are subdivided into individual packing, with one pill (capsule) of each product in each bag. ☞ ④ Increased Consumer satisfaction: The consumer found the products easy to carry when traveling or going outside, wouldn’t forget taking the pill and didn’t have to buy unnecessary products and over-consume them. 1. Personalized Health Functional Food Q&A Q1. What are personalized health functional food recommendations/sales? ○ Personalized health functional foods refers to a service where health functional foods are recommended/subdivided/sold by taking into account nutrients the consumer needs to have supplemented determined by reviewing the individual’s health status, dietary habits, and direct-to-consumer (DTC) genetic test results, which is undergoing trial operations, reflecting expansion trends in the personalization market. Q2. Why are we pushing the demonstration of subdivision/sales which were previously prohibited? ○ Recently, in alignment with tendencies of consumers to take care of their own health (self-medication) and the expansion of genetic analysis, the demand for personalization to one’s own bodily conditions is growing. ○ The MFDS as well has been planning system reform since 2019, and if it is confirmed that safety/quality is secured through this demonstration exception, it will be able to increase the speed of system reform. Q3. What is the content of the applications made by the seven businesses that applied for demonstration? ○ The demonstration target/content and territory/scale differ depending on the business. ○ What they all have in common is that they are services that, based on a foundation of scientific/objective data such as regarding eating habits, exercise and DTC genetic testing, it helps to recommend nutritional components with deficiency, and divides/packages only the health functional foods that are necessary for the consumer. Q4. What qualifications do the personalized health functional food counseling personnel hold? ○ Personal nutritional/health consultation requires providing professional service that the consumer can trust, and so it can be performed by pharmacists/nutritionists in the stores. Q5. Is there any possibility of changes in quality due to subdivision/packaging? ○ For this demonstration, the consumption formats that are allowed to be subdivided are limited to six types which are resistant to any change in quality: tablets, capsules, small pills, flakes, bars, and jelly. Furthermore, we are requiring machinery/instruments that can perform subdivision/packaging hygienically, and thereby are ensuring that changes in quality do not occur doing the subdivision/packaging process.