Health and filings round 4

5, 2021] - Registration Date 2021-03-19 - Hit 339002 [Press Release, Mar. 5, 2021 / Unofficial Translation] □ On March 5, at the Final Evaluation Committee meeting involving internal and external experts, the Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) granted marketing authorization to Pfizer Korea for its COVID-19 vaccine, COMIRNATY Inj., on condition that the final report of the currently ongoing clinical study be submitted. The pharmaceutical company filed for marketing authorization on Jan. 25, 2021. 1) Product Overview □ COMIRNATY Inj. is a COVID-19 vaccine jointly developed by U.S. pharmaceutical firm Pfizer and Germany’s BioNTech. It is a messenger RNA (mRNA) vaccine which induces immune response by inserting the antigen genes of SARS-CoV-2 into human cells in the form of mRNA for antigen protein synthesis. This triggers the production of neutralizing antibodies in the human body, leading to the neutralization of SARS-CoV-2 for destruction. ○ mRNA vaccines can be produced much faster in a larger scale than conventional vaccines. However, mRNA vaccines require ultra-cold chain storage to maintain its stability since mRNA, the major substance of the vaccine, can easily be degraded by RNase. ○ The Pfizer Korea COVID-19 vaccine is indicated for active immunization to prevent COVID-19 in individuals 16 years of age and older. It is administered as a series of two doses (0.3 mL each after dilution*) 3 weeks apart. The vaccine can be stored for 6 months in a temperature between -60˚C to -90˚C. *Each vial (0.45mL) is diluted with 1.8mL of 0.9% Sodium Chloride Injection. □ COMIRNATY Inj. is the first mRNA vaccine authorized in Korea and has been granted conditional marketing authorization or emergency use authorization by the WHO and 59 states and authorities including the EU (EMA), the U.S. and Japan. 2) Approval Procedure ○ The MFDS has secured as much time as possible to evaluate safety and efficacy data by starting a rolling review on available data even before the application is filed. ○The COVID-19 Vaccine/Treatment Review Task Force, composed of competent reviewers from the MFDS, was established to focus on review of non-clinical, clinical and quality data required for the approval. - Reviewed non-clinical data include the vaccine’s pharmacology (virus neutralizing titer, immune response and symptom, among others) in animal testing, pharmacokinetics and toxicity (repeated dose toxicity and reproductive toxicity, among others). - There have been submissions of data from two clinical studies including a clinical study conducted in Germany (phase I·II) and a multi-national clinical study carried out in six countries* (phase I·I·III) including the U.S. The safety and efficacy evaluation was based on the multi-national clinical study. * The U.S., Argentina, Brazil, Germany, South Africa and Turkey ● Immunogenicity Evaluation was carried out based on the phase I·II clinical studies conducted in Germany and the U.S. - Quality evaluation included a review on the submitted application, which comprises information such as manufacturing methods and standards, and test methods. The evaluation was also conducted on documents on foreign manufacturers’ compliance of Good Manufacturing Practice (GMP), which demonstrate whether the manufacturers have the facilities or management system that can guarantee the consistency of product quality. 3) 3-Tier Advisory Review □ In order to obtain expertise and maintain objectivity in the marketing authorization evaluation process for COVID-19 vaccines, the MFDS carries out the 3-tier advisory review composed of the meetings of the following advisory committees: 1) the COVID-19 Treatment and Vaccine Safety and Efficacy Assessment Advisory Committee (hereinafter the Advisory Committee); 2) the Central Pharmaceutical Advisory Committee, a legal advisory body of the MFDS in accordance with the Pharmaceutical Affairs Act; and 3) the Final Evaluation Committee. ○ The MFDS sought expert advice at the meetings of the Advisory Committee on February 22 and of the Central Pharmaceutical Advisory Committee on February 25, regarding the vaccine’s indications, safety, efficacy and post-authorization safety management plans based on the submissions from Pfizer Korea including the clinical data. ○ The Final Evaluation Committee meeting was held at the MFDS at 10 am on March 5, to make a final decision on the vaccine’s marketing authorization. -The meeting, which is the final step of marketing authorization of COVID-19 vaccines, was attended by three external experts including Chairman Oh Il-hwan of the Subcommittee on Biologics of the Central Pharmaceutical Advisory Committee and five members of the MFDS including the Minister of Food and Drug Safety. 4) Review Results of the Final Evaluation Committee □ Based on the results of the MFDS’s review on the application and the previous two committee meetings, the Final Evaluation Committee recommended granting marketing authorization to COMIRNATY Inj. on condition of submitting final results of clinical studies. ○ (Safety) The Final Evaluation Committee viewed that most of the reported adverse events were solicited adverse events following the vaccine administration and that they are in a range of acceptable level. - Most common adverse events were pain at the injection site, tenderness, fatigue, fever, chills, headache and muscle pain. These were mild to moderate symptoms and disappeared within a few days after the administration. - There was one report of drug-related hypersensitivity (urticaria) in vaccine recipients and no vaccine-related anaphylaxis reported during clinical studies. - Among a total of 43,448 participants enrolled in the study, serious adverse events have been reported in 0.6% (126 cases) of vaccine recipients and in 0.5% (111 cases) of placebo recipients. Among them, four serious adverse events were considered to be related to vaccine administration: lymphadenopathy, ventricular arrhythmia, shoulder injury and low back pain and bilateral lower extremity pain with radicular paresthesia. Patients with lymphadenopathy and ventricular arrhythmia have made recovery and the rest are currently recovering. - Based on the data, the Final Evaluation Committee concluded that the vaccine has met the safety standard for granting marketing authorization. Meanwhile, continuous monitoring is required even after the authorization regarding hypersensitivity including anaphylaxis. Further reports on adverse reactions will be reflected in relevant notifications including conditions of authorization. ○ (Efficacy) As the result of the previous two committee meetings, the Final Evaluation Committee concluded that the available data provides clear evidence of the Pfizer Korea COVID-19 vaccine’s effectiveness in preventing COVID-19. - Clinical study data showed that the vaccine is 95% effective in preventing COVID-19 among the participants with eight cases in the vaccinated group and 162 in the placebo group. - The effectiveness data is based on an analysis of the multi-national clinical study carried out in six countries including the U.S. on 36,523 participants (18,198 vaccine, 18,325 placebo) who had not been tested positive to SARS-CoV-2. ○ (Appropriateness for Use in Persons Aged 16 and Older) As the results of the previous two advisory committee meetings, the Final Evaluation Committee recommended granting marketing authorization for the vaccine to be used in persons 16 years of age and older considering the following: ▲ The vaccine has demonstrated meaningful preventive effect in individuals 16 years of age and older in clinical studies designed to evaluate its safety and efficacy in the age groups. ▲ Immune response in adolescents aged 16 and 17 is deemed to be similar to that of adults. ▲ Results from the clinical studies in adults can be used as reference. ▲ In multiple countries including the U.S., E.U.

Ministry of Food and Drug Safety>Information>News&Notice>News&Notice | Ministry of Food and Drug Safety [Press Release, Dec 31, 2020] COVID-19 vaccine developed in Korea approved for clinical trial (Phase I/II) - Registration Date 2021-01-07 - Hit 269 ... COVID-19 vaccine developed in Korea approved for clinical trial (Phase I/II) - 21 COVID-19 therapeutics and vaccines under clinical trial in Korea - □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) granted approval, on Dec. 31, for the clinical trial of GBP510, a vaccine developed by SK Bioscience in Korea. ○ 15 drugs (13 APIs) and 6 vaccines under development have received the approval for COVID-19-related clinical trials in Korea. □ The clinical trial of SK Bioscience’s vaccine is conducted in healthy adults to evaluate the safety and immunogenicity* of GBP510. Phase II clinical trial will follow after the completion of Phase I. * immunogenicity : the rate at which the amount of neutralizing antibodies that removes or reduces virus infectivity increases. ... One Life Science (GL ... -5310) I/II Recombinant vaccine (2) SK Bioscience (NBP2001) ... SK Bioscience (GBP510) I/II Viral vector vaccine (1) Cellid(AdCLD-CoV19) I/II

(ATTN: ADDS more details in paras 3, 10) By Kim Han-joo SEOUL, March 5 (Yonhap) -- South Korea's drug safety agency on Friday approved the vaccine for the novel coronavirus developed by U.S. pharmaceutical company Pfizer Inc. as the country is pushing for the COVID-19 inoculation campaign. The Ministry of Food and Drug Safety allowed use of Pfizer's two full-dose regimen following three separate independent evaluations on the efficacy and safety. The Pfizer vaccine is the second coronavirus vaccine approved here, following AstraZeneca developed by British-Swedish pharmaceutical giant AstraZeneca and Oxford University. Pfizer products for about 23 million people, under a direct contract between the pharmaceutical firm and the Seoul government, are expected to start arriving here later this month. The ministry said Pfizer's two full-dose regimen showed more than a 95 percent efficacy rate, including for people aged between 16 and 17, and aged 65 and older. ... Pfizer products through the COVAX earlier received "special import" approval from the ministry. The ministry also said it granted approval on the condition that the Pfizer vaccine be stored and transported at temperatures between minus 90 C and 60 C.

The authorization period for coronavirus vaccines and treatments will be reduced from 180 days to 40 days, under plans announced by the Ministry of Food and Drug Safety Sunday. After authorization, vaccines must receive another approval prior to sales of each batch — a system known as lot release, which is mandatory for biological products before market release. This step would be reduced to 20 days, from the usual two to three months, the ministry added. Altogether, Covid-19 vaccines may reach the market in around two months' time from the point the importer or manufacturer starts the process for government approval. The details were part of a set of guidelines published by the Drug Safety Ministry on Sunday in regards to Covid-1 ... As of Sunday, three vaccines developed by foreign pharmaceuticals were under previews for approval — AstraZeneca, Janssen and Pfizer. The government recently announced closing on deals to secure supplies of all three of them. Under Korean pharmaceutical regulations, a preview is a process in which an importer or manufacturer asks for an advisory review of clinical data and other documents before officially embarking on procedures to obtain government approval. ... authorization typically requires a long trail of paperwork that includes animal test results, clinical trial data to documents detailing mass production procedures and quality control standards. ... As of Sunday, five vaccines and 15 treatments were undergoing clinical trials in Korea to fight off the coronavirus.

[Australia] High-moderate risk changes to permissible ingredients - Caffeine (2019-09-03) ... The Therapeutic Goods (Permissible Ingredients) Determination ('the Determination') is a legislative instrument under section 26BB of the Therapeutic Goods Act 1989. This instrument specifies all of the ingredients that are available for use in listed and assessed listed medicines and their associated requirements. The Determination is continually reviewed by the TGA to ensure that all ingredients and their requirements are appropriate for use in low-risk medicines. Following a safety review, new requirements for caffeine and caffeine-containing ingredients within listed medicines are specified in the Therapeutic Goods Amendment (Permissible Ingredients) Determination (No. 1) 2019. A delay to implementation of these changes was considered likely to pose an imminent or serious safety risk to consumers (see High-moderate risk changes). As such, the Delegate of the Minister of Health has considered it appropriate to make this change to the Determination commencing 2 September 2019. [Background] The TGA wrote to sponsors of caffeine containing ingredients on 13 March 2018 and 17 May 2018 regarding changes relating to caffeine and caffeine-containing ingredients. Feedback from stakeholders at these times referenced a review of caffeine safety conducted by the European Food Safety Authority (EFSA) and the Health Canada (HC) monograph for caffeine. We also sought advice from the Advisory Committee on Complementary Medicines (ACCM) regarding requirements for caffeine in listed medicines in 2018. In June 2019, the TGA was contacted by the NSW Coroner's Court regarding the death of an individual associated with acute caffeine toxicity. The caffeine is suspected to have been ingested from an unlabelled pure or highly concentrated caffeine powder. Further, on 10 July 2019 Minister Colbeck and Minister Hunt wrote to Food Standards Australia New Zealand (FSANZ) to request a review of the safety of caffeine powders and high caffeine content products. The Ministers also requested that FSANZ engages with TGA to align therapeutic goods regulations with food regulation to the extent possible. Subsequently, the TGA reviewed the current toxicology data pertaining to caffeine and reconsidered the requirements for caffeine; as an individual ingredient, when present as a component of other herbal ingredients (e.g. Camellia sinensis), and when present from both these sources (i.e. total caffeine). [New requirements for the use of caffeine] Following consideration of options to manage the safety concerns with concentrated caffeine powders and other dosage forms, and taking into account the request from Minister Colbeck and Minister Hunt, and feedback from last year's review of caffeine, highly concentrated caffeine in any dosage form will become ineligible for listing. Caffeine as an individual ingredient remains only for oral use and at a maximum daily dose of 100mg. However, caffeine when present as a component of other herbal ingredients will now have dosage restrictions so that the medicine does not provide more than 400mg total caffeine per day. A maximum dose of 100mg per 3 hours will also be required. These limits consider consumption from other sources such as food, and the adverse effects which are seen with caffeine intake exceeding 400mg/day and more frequent dosing. The additional restrictions have been included to be consistent with all caffeine containing ingredients and cover routes of administration where caffeine is present from other ingredients. The warning statement (CAFF) has been adjusted to increase consumer awareness of caffeine intake. An additional warning statement of (CAFFPREG) addresses concerns for caffeine use in pregnancy and lactation. Caffeine as an individual ingredient currently has the requirement for a warning statement for 'Adults only'. The same concerns for caffeine intake for children apply to other ingredients containing caffeine and this statement has been applied to all caffeine containing ingredients above 10mg daily dose. For doses greater than 80mg/day (which equates to a cup of instant coffee), additional warning statements will be required to address specific safety concerns of inadvertent misuse, interactions with other medicines which may lead to increased caffeine plasma levels or interactions between medicines, and potential adverse effects due to high caffeine intake. A caffeine concentration of 1% in undivided preparations was considered acceptable given that 30 g (estimated equivalent of a heaped tablespoon) would deliver only 300 mg of caffeine, which sufficiently reduces the likelihood of inadvertent overdose. A concentration of 33% is considered acceptable in divided preparations that do not require the consumer to measure dosage. This is considered to pose a lower risk of inadvertent overdose and is in line with the highest caffeine concentration in existing OTC products. The new requirements for caffeine below will be applied to the following ingredients for internal use or oral application in listed medicines: - caffeine - Camellia sinensis - Coffea arabica - Coffea canephora - coffee - Cola acuminata - Cola nitida - Ilex paraguariensis - Paullinia cupana - Theobroma cacao The following requirements will have immediate effect: - Undivided preparations (e.g. bulk powders) must not contain a concentration of total caffeine greater than 4%. - Divided preparations (e.g. tablets) must not contain a concentration of total caffeine greater than 33%. For the following requirements, sponsors of existing listed medicines will have until 2 March 2021 to bring affected products into compliance, and any new listed medicines will need to comply immediately: - The maximum recommended daily dose must not provide more than 400mg of total caffeine from all ingredient sources. NOTE: The existing 100mg maximum daily dose limit for caffeine as an individual ingredient still applies. - Undivided preparations must not contain a concentration of total caffeine greater than 1%. - The maximum recommended dose must not provide more than 100 mg of total caffeine within a 3 hour period. - When the maximum recommended daily dose provides greater than 10 mg of total caffeine, the following warning statements are required: (ADULT) 'Adults only' (or words to that effect). (CAFF) 'Contains caffeine [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.'. (CAFFPREG) 'Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.'. - When the maximum recommended daily dose provides greater than 80 mg of total caffeine, the following warning statements are required: (CAFFLIMIT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'. (CAFFCYP) 'Caffeine interacts with the liver enzyme CYP1A2. Consult your health professional before taking with other medicines' (or words to that effect). [What the TGA will do] Following the expiration of the compliance transition period, the TGA will identify any listed medicines in the ARTG containing caffeine from any source and may initiate a review and cancel products that are not complying with the regulatory requirements that are in force at the time. If you have any concerns or would like to discuss this issue further, please do not hesitate to contact the Complementary and OTC Medicines Branch at complementary.medicines@tga.gov.au.

Purpose: To investigate the form and level of daily caffeine intake recommended above 400 mg in medical students expected to consume caffeinated beverages to enhance their performance. Methods: From May to June 2023, freshman through senior medical students at a medical school in Korea were administered a seven-item questionnaire designed to measure the amount of caffeine-containing foods consumed, the weekly interval between consumption, the reason for consumption, and the level of caffeine-induced symptoms experienced. Results: Out of 443 students, 361 responded (81.5%). The most commonly consumed caffeine beverages were coffee (79.2%), followed by soda (33.2%), tea (27.4%), chocolate (25.2%), and energy drinks (20.5%). The estimated (average±standard deviation) daily intake was estimated to 274.6±276.5 mg, and they consumed caffeine on an average of 4.25±2.26 days per week. Students who consumed 400 mg or more of caffeine daily consumed 19.9%. The primary motivation for caffeine intake was "to improve academic performance" (60.9%) and "preferred food" (51.8%). Among the responders, 98% of them replied they had symptoms that could be caused by caffeine, in order of palpitations (47.4%), frequent urination (42.9%), anxiety (27.1%), indigestion (17.5%), and excitement (17.5%). A total of 45.7% reported two symptoms, and 24.7% reported three or more. Conclusion: Caffeinated beverage consumption was routine among current medical students, with 20% consuming more than the recommended daily amount. Most students experienced at least one caffeine-induced symptom, with two symptoms in half, suggesting the need for policy measures and warnings about caffeine-containing foods. ... As an attempt to reduce its reported toxicities, the Ministry of Food and Drug Safety recommends a maximum daily caffeine intake of 400 mg or less for adults, 2.5 mg/kg or less for children, and 300 mg or less for pregnant women [7] [8] [9] . In an average adult, 400 mg of caffeine per day would be exceeded by consuming four cups of Americano coffee or five cans of energy drinks [10] . Nevertheless, no studies have been reported that examine the extent and propensity to consume caffeine in contemporary college students, especially medical students, who are thought to be highly motivated to drink caffeinated beverages to enhance their academic performance. Substance addiction and abuse are common medical problems in modern times and can be a practical issue for medical students who will grow up to be healthcare providers. In this background, this study aims to investigate caffeine consumption among students in a single medical school in 2023 to understand their caffeine consumption behavior, thereby suggesting ways to consume caffeine more healthily. ... The type of caffeine-containing foods was categorized, and the subjects were asked whether they usually consumed each item. In order to estimate the caffeine intake per serving for each food, we set a daily serving size based on the caffeine-containing foods. The caffeine content of each food was calculated based on data published by the Korea Food and Drug Safety Evaluation Service in 2020 [6] . Participants were asked how many times per day they consumed each category of food, based on the number of servings, and multiplied by the number of servings to calculate their daily caffeine intake and the number of days per week they consumed caffeine. Also, the perception of caffeine consumption, reasons for caffeine consumption, and symptoms of caffeine consumption that can be associated with caffeine overdose were surveyed (Supplement 1). Multiple responses were allowed for all questions related to tastes and symptoms. ... Coffee was the most common food consumed by respondents, with 286 (79.2%) reporting that they usually drink coffee. This was followed by soda (120, 33.2%), tea (99, 27.4%), chocolate (91, 25.2%), and energy drinks (74, 20.5%). Based on this, the calculated average±standard deviation daily caffeine intake of all respondents was estimated to be 274.6±276.5 mg, and they consumed caffeine on an average of 4.25±2.26 days per week (Table 2 ). Students who consumed 400 mg or more of caffeine per day were 19.9% of the total, in order of first-year medicine (25.4%), first-year pre-med (26.3%), secondyear medicine (19.2%), second-year pre-med (15.6%), third-year medicine (15.1%), and fourth-year medicine students (12.5%). First-year medicine students had the highest average daily caffeine intake at 314.5±278.2 mg, and second-year medicine students consumed the most caffeine days per week at 4.94±2.49 days. ... The extent of caffeine-containing beverage con- The survey of our data had a high response rate of 81.5%, which ensured its reliability. In particular, the study was conducted among all grades, confirming the caffeine consumption needs of students in the familiar medical school environment. Regarding caffeine consumption among students, coffee was the most commonly consumed food, accounting for 79.2%. This may be attributed to the ease of access to coffee, as coffee franchises are widely located in and around schools. ... Among medical students, 98% have experienced abnormal symptoms after consuming caffeine, 49% have experienced two or more, and more than 25% have experienced three or more. Caffeine acts on ... stimulating the release of norepinephrine, which sensitizes dopamine receptors [13] . This process causes ... body to block signals from the brain that it needs to rest, and blood pressure and heart rate increase. Beyond ... short-term discomfort of performing daily activities, these symptoms can lead to problems such as anxiety, digestive issues, restlessness, and even death [14] [15] [16] [17] . These side effects and overconsumption have led to the establishment of a recommended daily allowance for caffeine in Korea, but 20% of medical students consume more than the recommended amount. This suggests that most students continue to consume caffeine despite experiencing adverse symptoms. There is a need for policy research and procedures to prevent caffeine overuse and abuse, such as awareness of the amount of caffeine consumed by individuals and information and education on the recommended intake. According to data from the Ministry of Food and Drug Safety of Korea, the average daily intake of caffeine per person in Korea over the past 3 years (2015-2017) was 65.7 mg, which is 17.6% higher than the maximum recommended daily intake of 400 mg [18] . In addition, according to a previous study on the consumption of high-caffeine beverages by college students, the average daily intake of caffeine from high-caffeine beverages was 13.81 mg, and sumption among medical students known for their heavy academic workload has been scarcely reported. The first data was published based on a cross-sectional study investigating caffeine use for "academic purposes" by first -to third-year medical students at the University of the Free State of South Africa in 2006 [11] . The second cross-sectional report was published based on 400 medical students of the Dao University of Pakistan in 2016 [12] .Unlike the West, where coffee and other beverages are commonplace, these countries have been drinking caffeine-containing beverages since the 20th century, like South Korea, so comparing their data with ours is helpful, especially in the early 21st century, when caffeinated drinks are more readily available and exposed in the media globally. the average daily intake of caffeine from caffeinecontaining drinks such as coffee, excluding high-caffeine beverages, was 75.19 mg among the 291 college students who participated in the study. The average daily caffeine intake from energy drinks during the trial was 30.00 mg, group of students who participated in the Good Will project, a medical humanities class conducted as part of the fourth-year medical student class at Yeungnam University in 2023.

High caffeine warnings: South Korea enforces mandatory warning labels and tightens rules for coffee and tea ... The South Korean Ministry of Food and Drug Safety (MFDS) has introduced mandatory warning labels and tightened regulations governing ‘high caffeine’ beverages, including coffee and tea products. ©Getty Images ## The South Korean Ministry of Food and Drug Safety (MFDS) has introduced mandatory warning labels and tightened regulations governing ‘high caffeine’ beverages, including coffee and tea products. This was announced as part of the latest amendment to the Enforcement Regulations of the Act on Labeling and Advertisement of Food under Prime Minister Decree No. 1642, and will formally enter into force after December 31 2021. “The packages of all liquid foods containing 0.15mg or more caffeine per ml will be required to display a warning label mentioning ‘high caffeine content’ as well as the phrase ‘Total Caffeine Content OOO mg’ (sic, OOO being the amount of caffeine present),” said MFDS. ... In addition, once the total caffeine content is printed on the label, the range of actual caffeine content found in the product will not be allowed to vary by more than 10% from the number displayed. This means that a product that declares 100mg per ml caffeine must contain not less than 90mg and not more than 110mg if tested in order to avoid any penalties. “Coffees, teas or other liquid beverages made from coffee and tea ingredients [will be given slightly more leeway on the upper limit] and allowed to go up to 20% above the displayed caffeine content before being penalised,” added MFDS. These labelling rules will apply to both locally produced and imported products – importers would be expected to attach the relevant warning labels to any high caffeine imports on the main display side of the product. ... South Korea has a history of paying special attention to regulations governing caffeine consumption in the country because local students tend to rely heavily on caffeine in order to study through the night, even though excessive intake could cause palpitations, nausea, and sleep disorders. Back in 2016, MFDS issued a ban on media ads for all high caffeine foods and drinks which covered television, radio and print media advertisements and also involved foods and snacks like caffeinated ice cream. ... South Korea has also banned high caffeine drinks sales to students in schools since 2013, but tightened this in 2018 by also banning coffee vending machines (previously still made available for teachers) after realising that students had been making use of these. According to Euromonitor data, South Koreans drink an average of 181 cups of coffee a year – the highest consumption amongst Asian countries.

An improved method for the analysis of caffeine in foods by HPLC was validated by measuring several analytical parameters. The caffeine contents of 1202 products available from Korean markets were analysed. A consumption study was conducted by using data from the Korea National Health and Nutrition Examination Survey (KNHANES), 2010-12, to estimate the caffeine intakes of the Korean population. The mean intakes of caffeine from all sources in the general population and consumers were 67.8 and 102.6 mg day(-1) for all age groups, respectively. The 95th percentile intakes of the general population and consumers were 250.7 and 313.7 mg day(-1), respectively. In those aged 30-49 years, the caffeine intakes of the general population and consumers were highest at 25.5% (101.8 mg kg(-1) day(-1)) and 36.6% (0.9 mg kg(-1) day(-1)), respectively, compared with the maximum recommended daily intake (400 mg day(-1)) for adults. In the general population, the main contributors to the total caffeine intake were carbonated beverage for the younger age groups and coffee for the adults. These data provide a current perspective on caffeine intake in the Korean population. ... - Coffee research and ... - Tea Polyphenols and Effects - Nutrition, Health and Food Behavior ... Yu‐Mi Lee, Byung-Jin Na, Yu-Si Lee, Shin Young Park, Myung‐Sub Chung, Young‐Soo Chang, et al. Exposure ... of caffeine in children’s snacks ... Food Science and Biotechnology. 20 ... 3;22(3):865 ... 869 ... doi:10.1007/s10068-013- ... -y.

Caffeine is widely contained in favorite foods for children such as chocolate, caffeinated snacks, breads, and milk as well as soda like coke. However, as caffeine content labeling is inappropriately kept, children and pregnant women, who are sensitive to caffeine consumption, cannot aware how much caffeine is taken from food. Therefore, they are facing high possibility to over-consume the recommended daily allowance for caffeine. ... In conjunction with the Korea Food and Drug Administration, the KCA made a proposal to the industry to adopt voluntary product labeling for caffeine contents to prevent caffeine over-consumption. Meanwhile, the KCA continued to request parents to keep kids’ consumption of chocolate-containing foods, caffeinated foods, and caffeinated soda to a minimum, considering that children can be sensitive to caffeine. ※ Caffeine is a substance widely found in coffee, green tea, cocoa, and chocolate. When taken in moderation, caffeine may help to restore energy, ward off drowsiness, and get rid of body wastes through a diuretic effect. Yet, when taken in excess, side effects may include: anxiety, irritation, jitteriness, excitement, and insomnia. In particular, the vulnerable such as children and pregnant women may face comparatively severe side effects from caffeine over-consumption. ... According to the recent results from the KCA and the Korea Food and Nutrition Foundation, caffeine was widely contained in favorite foods for children. ... Processed milk (containing coffee) ... In 2007, the Korea Food and Drug Administration presented daily caffeine intake guidelines for children (no more than 2.5 milligrams per one kilogram of body weight), pregnant women (no more than 300 milligrams), and adults (no more than 400 milligrams) There is a possibility for children to over-consume the recommended daily allowance for caffeine when repeatedly taking foods containing coffee (mentioned in the above table). ... There is no current labeling standard for caffeine contents in foods. It is stipulated that liquid foods use a ‘Highly-caffeinated’ label if containing more than 0.15 milligram of caffeine per one milliliter. Yet, as tea, coffee, and other products using ‘coffee’ or ‘tea’ as part of its name do not have to adopt the labeling, there are scarcely any products with caffeine content labeled in reality. ... The KCA made a proposal to the industry to label whether caffeine is contained as well as how much caffeine is contained in the product and use decaffeinated coffee for raw material to enable consumers to select low caffeinated products. In conjunction with the Korea Food and Drug Administration, the KCA made a proposal to the industry to adopt voluntary product labeling for caffeine contents to prevent caffeine over-consumption. Furthermore, the KCA plans to make a request for introducing a mandatory labeling system to the KFDA if the voluntary labeling is unsatisfactory. Meanwhile, the KCA continued to request children to keep kids’ consumption of chocolate-containing foods, caffeinated foods, and caffeinated soda to a minimum, considering that children can be sensitive to caffeine.

in those regions ... and SSS (Shanghai) and SSCX (Xian ... Production sites for finished products include SSEC (Suzhou) and semiconductor production facilities are located in SCS (Xian) among others. The Company in 2023 recorded total revenue of KRW 258,935.5 billion, a decrease of 14.3% year-on-year. Major customers (listed in alphabetical order) included Apple, Best Buy, Deutsche Telekom, Qualcomm, and Verizon. ... In 2023, reported revenue was KRW 169,992.3 billion (65.7% of total net sales) for DX; KRW 66,594.5 billion (25.7%) for DS; KRW 30,975.4 billion (12.0%) for SDC; and KRW 14,388.5 billion (5.6%) for Harman. ... 5 5 ... transactions.

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