• Interdisciplinary Bio Central
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• 제1권3호
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• pp.10.1-10.5
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• 2009

Toxicity is usually investigated using a set of standardized animal-based studies which, unfortunately, fail to detect all compounds that induce human adverse events and do not provide detailed mechanistic information of observed toxicity. As an alternative to conventional toxicology, toxicogenomics takes advantage of currently advanced technologies in genomics, proteomics, metabolomics, and bioinformatics to gain a molecular level understanding of toxicity and to enhance the predictive power of toxicity testing in drug development and risk/safety assessment. In addition, there has been a renewed interest, particularly in various government agencies, to prioritize and/or supplement animal testing with a battery of mechanistically informative in vitro assays. This article provides a brief summary of the issues, challenges and lessons learned in these fields and discuss the ways forward to further advance toxicology using these technologies.

• 월간포장계
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• 통권300호
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• pp.58-60
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• 2018

• 식품과학과 산업
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• 제49권3호
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• pp.55-61
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• 2016

Even though the food safety system in the United States is one of the best in the world, many millions of people become sick and thousands die from foodborne illnesses caused by any of a number of microbial pathogens and other contaminants. Large recalls of United States Department of Agriculture (USDA) and the Food Drug and Administration (US FDA)-regulated food products due to findings of E. coli O157:H7, Listeria, Salmonella, and other problems occur each year. As the US FDA Food Safety Modernization Act (FSMA) passed in 2011, FSMA will require food processing, manufacturing, shipping, and other regulated entities to conduct an analysis of the most likely safety hazards and to design and implement risk-based controls to reduce or eliminate these hazards. FSMA also mandates increased scrutiny of food imports, which account for a growing share of U.S. food consumption; food import shipments will have to be accompanied by documentation showing that they can meet safety standards that are at least equivalent to those in the U.S. On September 17, 2015, the US FDA published final rules for Preventive Controls for Human and Animal Food and, continuing into 2016, the US FDA intends to finalize the remaining five rules it has proposed to implement FSMA. Among these rules, this article will review and discuss Preventive Controls for Human Food Rule and its components, and suggest how to comply with these FSMA rules as foreign human food and ingredients suppliers to the US.

• 의료법학
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• 제15권2호
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• pp.63-89
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• 2014

In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

• 비만대사연구학술지
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• 제2권1호
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• pp.17-24
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• 2023

Obesity is a major public health problem worldwide, with several methods having been proposed as a means of weight loss. If diet, exercise, and medication are insufficient, a healthcare professional may suggest weight loss treatments, including bariatric surgery or medical devices. Antiobesity medical devices are an option for patients who do not want to undergo bariatric surgery. Compared with bariatric surgery, medical devices have the advantage of being reversible and easier to operate. The U.S. Food and Drug Administration (FDA) regulates medical devices, including those used for weight loss and weight management. This article provides an overview of the FDA-regulated weight loss and weight management devices.

• 무역학회지
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• 제48권3호
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• pp.131-150
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• 2023

본 연구는 한국 바이오헬스 산업에 대한 미국의 수입거부(Import Refusals) 대응 방안 모색을 목적으로 한다. 이를 위해 수입거부 품목과 유형에 대한 정보가 포함된 한국무역협회 통관거부사례 데이터베이스를 활용하여 팬데믹 시기의 동향 분석을 시행하였으며, FDA 위반코드(Violation Code)에 따라 거부사유까지 분석하였다. 추가적으로 단위거부율(URR)의 측정을 통해 수입거부 대응 수준도 파악하였다. 분석 결과, 한국 바이오헬스 산업에 대한 미국의 주요 수입거부 품목은 과거 콘택트렌즈에서 코로나-19 이후 진단키트와 의약품으로 확대된 것으로 나타났으며, 주요 수입거부 사유는 의료기기와 의약품 관련법의 규정 미준수와 제품 및 시설에 대한 FDA의 미승인으로 확인되었다. 한편 바이오헬스 주요 품목의 단위거부율은 산업 평균보다 높게 측정되어 미국 수입거부 대응 수준이 낮은 것으로 파악되었다. 또한 FDA 위반코드에 따라 품목별 수입거부 사유를 분석한 결과는 다음과 같다. 우선, 콘택트렌즈와 코로나바이러스 진단키트의 주요 위반사항은 부정표시(Misbranding)에 해당한다. 이는 FDA에 관련 통지나 정보가 규정대로 제공되지 않았거나, 시판 중인 기승인 의료기기(Predicate Device)와 비교하여 본질적 동등성을 입증하지 못한 경우가 많다. 반면, 의약품은 유효성 및 안전성 입증 관련 규정에 따라 신청서의 승인을 받지 못한 미승인 신약(Unapproved New Drug)에 해당한다. 결과적으로 바이오헬스 산업의 수입거부는 무역기술장벽(TBT)과 밀접한 관련이 있다.

• 한국수산과학회지
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• 제26권3호
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• pp.205-213
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• 1993

APHA-MPA(American Public Health Association-Most Probable Numbers)은 환경수중에 존재하는 위생지표세균 추정에 사용되는 미국 FDA의 유일한 공인방법이기는 하나 결과를 얻기까지 많은 시간, 인력 및 경비가 소요될 뿐 아니라 일반적으로 정밀도도 낮다는 결점이 있다. 이러한 문제를 극복하기 위하여 개발된 막여과 방법중 mTEC(membrane thermotolerant E. coli)은 분변계대장균 및 E. coli의 회수율이 좋을 뿐 아니라 경비도 절약할 수 있는 방법으로서 알려져 있어, 미국 Rhode Island주의 Greenwich Bay의 위생조사를 통하여 MPN과 비교하여 보았다. 그 결과 mTEC의 분변계 대장균 및 E. coli 회수율은 MPN보다 평균치로써 각각 1.08 및 1.27배 높게 나타나, MPN의 대체 방법으로서의 가능성이 확인되었으며, 따라서 이 방법이 앞으로 위생지표세균의 검출방법으로서 공인된다면 우리나라 수출용 패류생산 지정해역의 관리는 물론 패류양식장의 위생학적인 분류도 효율적으로 할 수 있으리라 기대된다.

• Nutrition Research and Practice
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• 제1권2호
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• pp.89-93
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• 2007

Many countries such as The Republic of Korea have established their own nutritional standards, collectively termed Nutrient Reference Values (NRVs), and they vary due to the science which was reviewed, the purposes for which they are developed, and issues related to nutrition and food policy in the country. The current effort by the Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses (CNFSDU) to update the NRVs that were established following the Helsinki Consultation in 1988 represents an opportunity to develop a set of reference values reflecting current scientific information to be used or adapted by many countries. This paper will focus on possible approaches to selecting or developing reference values which would serve the intended purpose for nutrition labeling to the greatest extent possible. Within the United States, the Food and Drug Administration (U.S. FDA) is currently reviewing regulations on nutrition labeling to better address current health issues, and is expected to enter into a process in the next few months to begin to explore how best to update nutrient Daily Values (DVs), most of which are still based on the Recommended Dietary Allowances (RDAs) of the Food and Nutrition Board, U.S. National Academy of Sciences, last reviewed and revised in 1968. In this presentation, I review the current purposes in the U.S. for nutrition labeling as identified in the 1938 Food, Drug, and Cosmetic Act as amended, the scientific basis for current nutrition labeling regulations in the United States, and the recommendations made by the recent Committee on Use of Dietary Reference Intakes in Nutrition Labeling of the Institute of Medicine (2003) regarding how to use the DRIs in developing new DVs to be used on the label in the United States and Canada. Based on these reviews, I then provide examples of the issues that arise in comparing one approach to another. Much of the discussion focuses on the appropriate role of nutrient labeling within the Nutrition Facts panel, one of the three major public nutrition education tools in the United States (along with MyPyramid and Dietary Guidelines for Americans).

• 한국어업기술학회:학술대회논문집
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• 한국어업기술학회 2000년도 춘계수산관련학회 공동학술대회발표요지집
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• pp.233-234
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• 2000

Formalin, 37% formaldehyde, has been employed as a chemical for controlling ectoparasites and aquatic fungi responsible for infectious fish of diseases in hatcheries and culture facilities (Roberts, 1978; Schnick, 1991; Rach et al., 1997). Regarding the commercial usage of formaldehyde in the aquaculture industry, the U.S. Food and Drug Administration (FDA) approved three commercial products as parasiticides in a species-specific manner: Paracide-F and Formalin-F for bluegill, catfish, largemouth bass, salmon, and trout and Parasite-S for all finfish (FDA, 1998). Withdrawal time for these products was legally zero when used as permitted under the regulations. With the increased production of cultured fish in Korea, such as olive Hounder Paralichthys olivaceus and black rockfish Sebastes schlegeli, application of formalin to diseased fish has become more frequent. Moreover, there is still some concern about environmental exposures caused by effluents from fish culture facilities. The purpose of the present study was to evaluate residues in fish resulting from therapeutic usage of formalin in the aquaculture industry and to document the rate of disappearance of formaldehyde in seawater treated with formalin. (omitted)

• 한국연초학회지
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• 제31권2호
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• pp.107-114
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• 2009

In this study, we investigated the existence of melamine and cyanuric acid in cigarette smoke because leaf tobacco contains lots of nitrogen compounds and they are capable of pyrolytic synthesis while smoking. The extraction and derivatization conditions of two compounds were performed according to the procedure of U.S. Food and Drug Administration(FDA). Ky3R4F as reference cigarette was smoked on ISO condition(Puff volumne : 35 ml, duration : 60 sec, Interval : 2 sec). Compared with the results Ky3R4F and standard solution, retention time of two compounds was not corresponded. As a result, we concluded that melamine and cyanuric acid were not existed in cigarette smoke.