• Title/Summary/Keyword: KFDA regulation

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Eye Irritation Test of Fel Ursi & Bovis Calculus Pharmacopuncture Solutions for Eye Drop (점안용 웅담.우황약침액의 안점막자극실험)

  • Seo, Hyeong-Sik
    • Journal of Pharmacopuncture
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    • v.11 no.3
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    • pp.99-104
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    • 2008
  • Objective: This study was done to investigate the safety of Fel Ursi & Bovis Calculus pharmacopuncture solution manufactured with freezing dryness method to use eye drop. Methods: The eye irritation test of this material was performed according to the Regulation of Korea Food & Drug Administration(2005. 10. 21, KFDA 2005-60). After Fel Ursi & Bovis Calculus pharmacopuncture solution was medicated in the left eye of the rabbits, the author observed eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Results: 1. After Fel Ursi & Bovis Calculus pharmacopuncture solution was medicated in the left eye of the rabbits, there wasn't physical problem at 9 rabbits. 2. After Fel Ursi & Bovis Calculus pharmacopuncture solution was medicated in the left eye of the rabbits, there wasn't eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Conclusions: I suggested that Fel Ursi & Bovis Calculus pharmacopuncture solution didn't induced eye irritation in rabbits.

Eye Irritation Test of Soyeom Pharmacopuncture Solution for Eye Drop (점안용 소염약침액의 안점막자극실험)

  • Seo, Hyeong-Sik
    • Journal of Pharmacopuncture
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    • v.11 no.2
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    • pp.75-79
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    • 2008
  • Objectives This study was done to investigate the safety of Soyeom pharmacopuncture solution manufactured with freezing dryness method to use eye drop. Methods The eye irritation test of this material was performed according to the Regulation of Korea Food & Drug Administration(2005. 10. 21, KFDA 2005-60). After Soyeom pharmacopuncture solution was medicated in the left eye of the rabbits, the auther observed eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Results 1. After Soyeom pharmacopuncture solution was medicated in the left eye of the rabbits, there wasn't physical problem at 9 rabbits. 2. After Soyeom pharmacopuncture solution was medicated in the left eye of the rabbits, there wasn't eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Conclusions I suggested that Soyeom pharmacopuncture solution didn't induced eye irritation in rabbits.

Eye Irritation Test of Bovis Calculus Pharmacopuncture Solutions for Eye Drop (점안용 우황약침액의 안점막자극실험)

  • Seo, Hyeong-Sik
    • Journal of Pharmacopuncture
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    • v.11 no.2
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    • pp.81-85
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    • 2008
  • Objective This study was done to investigate the safety of Bovis Calculus pharmacopuncture solution manufactured with freezing dryness method to use eye drop. Methods The eye irritation test of this material was performed according to the Regulation of Korea Food & Drug Administration (2005. 10. 21, KFDA 2005-60). After Bovis Calculus pharmacopuncture solution was medicated in the left eye of the rabbits, the auther observed eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Results 1. After Bovis Calculus pharmacopuncture solution was medicated in the left eye of the rabbits, there wasn't physical problem at 9 rabbits. 2. After Bovis Calculus pharmacopuncture solutionwas medicated in the left eye of the rabbits, there wasn't eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Conclusions I suggested that Bovis Calculus pharmacopuncture solution didn't induced eye irritation in rabbits.

Bambusae Caulis in Taeniam Applicable for Medical Indications Associated with Inflammation

  • Hyo Jae Choi;Yugyeong Gwak;Ji Yeon Lee;Min Jung Kwun;Jun-Yong Choi;Myungsoo Joo
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.37 no.1
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    • pp.14-18
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    • 2023
  • Jukyeo (竹茹; Bambusae Caulis in Taeniam: BCT) is an herbal medicine made from the inner part of the bamboo stem of Phyllostachys nigra Munro var. henonis Stapf ex Rendle or Phyllostachys bambusoides Siebold et Zuccarini. Although medical literature published in China and Korea decades ago introduced BCT as a remedy for reducing vomiting, fever, and hematemesis, decoctions containing BCT as a main herb (君藥) in Korea have been approved only for treating neurologic symptoms. Here, we discuss the anti-inflammatory function of BCT. Combined with the clinical usage of a BCT-containing decoction in treating inflammatory diseases in Japan, we raise the possibility of repurposing the BCT-containing decoctions for treating inflammatory diseases. The anti-inflammatory activity of BCT was mainly assessed by using RAW 264.7 cells. The regulation of NF-κB, Nrf2 and A20 activities was determined by western blot and quantitative RT-PCR. The list of decoctions containing BCT currently approved in Korea was obtained from the Korean Ministry of Food and Drug Safety (KFDA). BCT suppressed the activity of pro-inflammatory factor NF-κB elicited by LPS, activated an anti-inflammatory factor Nrf2, and induced A20 that is known to block several inflammatory pathways simultaneously, suggesting that BCT can suppress inflammation via at least 3 different pathways. KFDA approved 11 decoctions containing BCT as a major herb, including Gamiondam-tang (加味溫膽湯; GOT), for treating neurologic disorders. Interestingly, Jukyeoondam-tang (竹茹溫膽湯; JOT), whose composition is almost identical to GOT except for one herb, has been used to treat inflammatory pulmonary disorders including Covid-19 pulmonary infection in Japan Given the anti-inflammatory function of BCT evidenced by medical literature and experimental results and the clinical usage of JOT in treating inflammatory pulmonary disorders, we suggest a repurposing and extension of the BCT-containing decoctions approved in Korea to treating inflammatory diseases.

Investigation of Legal Regulation and Market Circumstances for Functional Dairy Products in Korea and Japan (일본과 한국의 기능성 유제품의 규격기준 및 시장현황에 관한 연구)

  • Bak, Da-Jeong;Lee, Dan-Won;Park, Jung-Min;Shin, Jin-Ho;Kim, Ji-Youn;Jeon, Sang-Rok;Song, Tae-Suk;Yoon, Sung-Sik;Kim, Jin-Man
    • Food Science of Animal Resources
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    • v.29 no.4
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    • pp.523-532
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    • 2009
  • Changing health awareness has had an important effect on the functional food industry and is creating greater market opportunities. Unfortunately, there is no statement on functional dairy products in the Processing of Livestock Products Act. As a result, there is confusion in the market and legal difficulties with regard to the advertising of functional dairy products. This study was carried out to improve the current standardization of functional dairy products by comparing the domestic Health/Functional Food Act with the Japanese Health Promotion Law, and by investigating scientific data and articles from various literature and the Internet. In Japan, the Ministry of Health, Labor, and Welfare (MHLW) officially presented the Food with Health Claims (FHC) system that consists of Food with Nutrient Function Claims (FNFC), and innovated Food for Specified Health Uses (FOSHU). In 2005, the FOSHU system was changed to include several new subsystems: Current, Standardized, Reduction of disease risk, and Qualified FOSHU. Finally, to manufacture FOSHU, scientific evidence pertaining to such products must be examined by MHLW. Since FNFC was allowed, only 12 vitamins, ${\beta}-carotene$, and five minerals were approved, though without scientific evidence of efficacy. The Korean Health/Functional Food Act requires that health/functional foods (HFFs) be marketed in measured doses. There are two types of HFFs: generic and product-specific. There are 67 ingredients listed in the act for generic HFFs, and if an HFF has a new active ingredient, it is considered a product-specific HFF. Product-specific HFFs must be approved by the Korean Food and Drug Administration (KFDA). With the present standards, it is impossible to label and advertise functional dairy products with health/functional claims. Government agencies must cooperate to solve this problem, and standardization should be carried out by considering existing health/functional products and claims/indications from other countries.

Evaluating Safety of Recycled and Non-recycled Paper-based Box for Food Packaging (식품 포장재로서 재활용 및 비재활용 종이 상자의 안전성 분석)

  • Oh, Jungmin;Shin, So-Hyang;Kwon, Sang-Jo;Cho, Ah Reum;Kim, Sung-Jin;Lee, Yun-Jeong;Jo, Heonjoo;Han, Jaejoon
    • KOREAN JOURNAL OF PACKAGING SCIENCE & TECHNOLOGY
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    • v.18 no.1_2
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    • pp.27-32
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    • 2012
  • There are many possibilities that recycled papers adulterate contaminants during the process. The objective of this research was to evaluate safety of paper-based packaging materials for food, especially commercial pizza boxes in Korea. Ultimately, we compared recycled and non-recycled commercial paper packaging materials. This study was based on Korean Food and Drug Administration (KFDA) regulation. PCBs were measured by GC-ECD. Arsenic and lead were analyzed using an ICP-MS. Formaldehyde was determined by LC-MS. Fluorescent materials were detected by UV lamp. The result of this study shows that non-recycled paper packaging materials meets all the tested hygienic specifications for food packaging materials, whereas recycled paper-based paperboard box may be contaminated by fluorescent whitening agent. Though these results need to be further studied, it is recommended to avoid using recycled paper in direct contact with food when used in food packaging.

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Prevalence of Nutrition Labeling and Claims on Processed, and Packaged Foods (시판 가공식품의 영양표시 실태 조사)

  • Kwon, Kwang-Il;Park, So-Hyun;Lee, Jun-Hyung;Kim, Jee-Young;Yoo, Kwang-Soo;Lee, Jee-Sun;Kim, Seo-Young;Sung, Hyun-I;Nam, Hye-Seon;Kim, Jong-Wook;Lee, Hye-Young;Park, Hye-Kyung;Kim, Myung-Chul
    • Korean Journal of Community Nutrition
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    • v.12 no.2
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    • pp.206-213
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    • 2007
  • This study investigated the prevalence of nutrition labeling and claims on processed and packaged foods. The final database consists of 1,287 foods, which were collected in two supermarkets in the Seoul area from September to November, 2006. An estimated 78% of KFDA-regulated processed, and packaged foods have nutrition labels. Nutrient content claims on food labels were identified in 21% of the foods which have nutrition labels. The prevalence of nutrition labels in this study is much higher than in previous studies due to the current expansion of the mandatory labeling regulation. However, false labeling and misleading contents claims were also identified. The food label is an important tool for enhancing the public's understanding of healthy choices of processed foods. Therefore, to maximize the benefits of the nutrition labeling regulation, industries, government agencies and health professionals should work together to help consumers make healthy dietary choices and improve their health.

As, Cd, Pb, Co, Cr Concentration and Property Evaluation in Frequently Using 16 Oriental Herbal Medicines -Mainly Average, Lowest, Highest Concentration and Percent Exceeding Value of Legal Allowance in Korean and Chinese Origines- (16종 다용한약재의 산지별 As, Cd, Pb, Co, Cr 농도 및 특성고찰 -한국과 중국산의 평균농도, 최소-최대농도와 법적 허용농도초과비율을 중심으로-)

  • Kim, Kee-Dong;Park, Hae-Mo;Seo, Yong-Chan;Lee, Sun-Dong
    • Journal of Society of Preventive Korean Medicine
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    • v.16 no.3
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    • pp.167-183
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    • 2012
  • Objective : Average, lowest, highest concentration and exceeding value of legal allowance of As, Cd, Pb, Co, Cr in frequently using 16 oriental herbal medicines in korea(Astragali Radix, Ginseng, Citri Unshii Pericarpium, Aurantii Fructus Immaturus, Angelicae Gigantis Radix, Cnidii Rhizoma, Paeoniae Radix, Rehmanniae Radix Preparata, Zingiberis Rhizoma Crudus, Zizyphi Fructus, Atractylodis Rhizoma Alba, Hoelen, Dioscoreae Rhizoma, Corni Fructus, Schisandrae Fructus, Lycii Fructus) was evaluated according to their origines (korea, china) and property was also discussed according to the medicinally active part and individuals regardless origines. Method : Korean and Chinese herbal medicines were evenly sampled from corresponding country nationwide. Pre-treatment was executed according to the KFDA(Korea Food and Drug Administration) regulation and analysis was performed according to the Korean Environmental Analysis QA/QC. Result : Not much difference was observed according to their origines. However, lowest, highest and percent exceeding value of legal allowance was showed some consistent differences according to the medicinally active part and individuals. Co and Cr was can not be evaluated since their legal regulation was not established yet. Conclusion : The average concentration of As, Cd, Pb, Co, Cr in frequently using 16 oriental herbal medicines in korea showed no noticeable difference according to their origines. Regardless the origin, some consistent differences were observed according to the individuals and medicinally active parts.

Eye Irritation Test of Fel Ursi, Bovis Calculus & Moschus Pharmacopuncture Solutions for Eye Drop (점안용 웅담.우황.사향 약침액의 안점막자극실험)

  • Seo, Hyeong-Sik
    • Journal of Pharmacopuncture
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    • v.11 no.3
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    • pp.105-111
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    • 2008
  • Objective: The aim of this study is to investigate the safety of Fel Ursi, Bovis Calculus & Moschus pharmacopuncture solution manufactured with freezing dryness method to use eye drop. Methods: The eye irritation test of this material was performed according to the Regulation of Korea Food & Drug Administration(2005. 10. 21, KFDA 2005-60). After Fel Ursi, Bovis Calculus & Moschus pharmacopuncture solution was applied eyewash in the left eye of the rabbits, the author observed eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Results: 1. After Fel Ursi, Bovis Calculus & Moschus pharmacopuncture solution was applied eyewash in the left eye of the rabbits, there wasn t physical problem at 9 rabbits. 2. After Fel Ursi, Bovis Calculus & Moschus pharmacopuncture solution was applied eyewash in the left eye of the rabbits, there wasn't eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Conclusions: In this study, it was observed that Fel Ursi, Bovis Calculus & Moschus pharmacopuncture solution didn't induced eye irritation in rabbits.

Hazardous Effect of Dietary Trans Fats on Human Health and Regulations (인체에 미치는 트랜스지방의 위해와 규제현황)

  • Gil, Bog-Im;Rho, Jeong-Hae
    • Korean journal of food and cookery science
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    • v.23 no.6
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    • pp.1015-1024
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    • 2007
  • Trans-fatty acids (TFAs) are defined as the sum of all unsaturated fatty acids that contain one or more non-conjugated double bonds in a trans configuration. Dietary trans- fatty acids originate from commercially hydrogenated oils and from dairy and meat fats. From the perspective of the food industry, partially hydrogenated vegetable oils are attractive because of their long shelf life, stability during deep-frying, and semisolidity, which can be customized to enhance the palatability of baked goods and fried foods. Although no definite differences have been documented so far between the metabolic and health effects of industrial and ruminant TFAs, the intake of industrially produced TFA has declined, and in Europe, the majority of TFAs are of ruminant origin. Due to the scientific evidence associating TFA intake with increased risk of coronary heart disease (CDH), the Korea Food and Drug Administration (KFDA) issued a final rule that requires the amount of trans fat present in foods to be declared on the nutrition label, by December 1, 2007. In addition, many food manufacturers who use partially hydrogenated oils in their products have developed, or are considering ways, to reduce or eliminate trans-fatty acids from certain food products.