KOSEN 한인과학기술자네트워크

>1. FDA의 Final rule(dietary supplement)이란 무엇인가요? > > > >2. Final rule(dietary supplement)은 FDA에서 기능 및 안전성 측면을 모두 인정 하는 제도인가요? > > > >3. 제가 검색한 소재가 2002년에 “Interim final rule“ 이였다가, 2003년에 “Final rule“이라고 보고되었습니다? 무엇을 의미하는 것인지 설명 좀 해주세요! > > > >4. Final rule에 대한 자세한 자료가 나온 사이트를 알려주세요~! (한글 사이트면 더욱 좋구요~ㅋㅋ > > > >답변 좀 부탁드리겠습니다. > > > >감사합니다~! > > 아래가 설명 원문인데요, 건강보조식품도 cGMP수준의 퀄러티를 요구하는 내용인것 같습니다. FDA Issues Dietary Supplements Final Rule The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled. “This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,“ said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. “In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA.“ The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints. “The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,“ said Robert E. Brackett, Ph.D., director of FDA's Center for Food Safety and Applied Nutrition. Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded. The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling. The final rule includes flexible requirements that can evolve with improvements in scientific methods used for verifying identity, purity strength, and composition of dietary supplements. As a companion document, FDA also is issuing an interim final rule that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing of specific dietary ingredients used in the processing of dietary supplements. Under the interim final rule the manufacturer may be exempted from the dietary ingredient identity testing requirement if it can provide sufficient documentation that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient. FDA is soliciting comment from the public on the interim final rule. There will be a 90-day comment period, ending on September 24, 2007. Comments may be addressed to the Division of Dockets Management Branch at www.fda.gov/dockets/ecomments. The final CGMP and the interim final rule are effective August 24, 2007. To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with more than 500 employees have until June 2008 to comply, companies with less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

>1. FDA의 Final rule(dietary supplement)이란 무엇인가요? >2. Final rule(dietary supplement)은 FDA에서 기능 및 안전성 측면을 모두 인정 하는 제도인가요? >3. 제가 검색한 소재가 2002년에 “Interim final rule“ 이였다가, 2003년에 “Final rule“이라고 보고되었습니다? 무엇을 의미하는 것인지 설명 좀 해주세요! >4. Final rule에 대한 자세한 자료가 나온 사이트를 알려주세요~! (한글 사이트면 더욱 좋구요~ㅋㅋ >답변 좀 부탁드리겠습니다. >감사합니다~! http://www.fda.gov/bbs/topics/news/2007/new01657.html 위 사이트 참조하세요. 간략하게 설명하면 다음과 같습니다. * Proposed Rule – comment를 받기 위해 draft 형식을 공지 하는 것입니다. Proposed Rule 경우에는 comment 받는 기간을 정하고, comment 받는 후, FDA가 수정하고 Final Rule을 만든 수 있습니다. * Final Rule – 정식으로 공포하여 시행하는 version을 말합니다. 즉 Withdrawal 되는 일이 없는 규정입니다. * Direct Final Rule – 내부적으로 모든 검토과정을 거쳐 거의 완벽하다고 생각하여 comment를 받을 생각 없이 draft 형식을 공지 하는 것입니다. Direct Final Rule은 FDA가 간단한 내용으로 생각하거나 토론할 필요 없는 내용이라고 생각 하는 내용입니다. 그러나, 바로 시행하겠다는 것은 아니고, 언제 시행하겠다는 날짜를 미리 정하여 공포합니다. 만에 하나 시행 날짜 전에 “significant adverse comment”를 받는 경우에 Withdrawal를 할 수 있습니다. “significant adverse comment”가 없는 경우, 다시 공지할 필요 없이 바로 정해진 날짜로 시행하게 됩니다.