JIHFS 日本健康食品規格協会



		（1）米国FDAにおけるGMP策定作業が終了、制度化に向けて前進待たれていた米国の健康食品GMPは、FDAにおける作業が終了し、制度化の最終ステップに入りました。最終ステップの検討はOffice of Manage and Budget (OMB)で行われ、問題があれば、通常90日以内にFDAに差し戻し、問題がなければ最終的な制度化となります。米国の業界筋では、OMBでの作業は2006年の春までずれ込む可能性が高いとみているようですが、いずれにしても米国での健康食品ＧＭＰ制定化の最終段階に入ったことは確かなようです（IADSA「News flash　10月号」より）。（2）グルコサミンの介入試験結果米国NIHによるグルコサミン/コンドロイチンの関節炎に対する多施設協同介入試験（GAIT）の結果、この2剤の組み合わせは、骨粗しょう症による中等度から重症の膝の痛みに対して、有効であることが示されました。また、ヨーロッパにおける多施設協同臨床試験（GUIDE）でも、グルコサミンの変形性膝関節症に対する有用性が示唆されています（IADSA「News flash　10月号」より）。英語版（1）PUBLICATION OF DIETARY SUPPLEMENT GMPS IMMINENT? Publication of the Food and Drug Administration’s (FDA) final regulation on good manufacturing practices (GMPs) for dietary supplements moved a step closer to completion this week. The regulation was recently sent to the Office of Management and Budget (OMB) for review. As part of the executive branch of government, the OMB conducts in-depth regulatory analyses and can be the last stop in the rule-making process. The regulation, which is considered a “major” rule, could routinely take as long as 90 days to be reviewed. Once OMB has reviewed the rule, it has the option of sending it back to FDA for additional changes.While the industry has remained hopeful that a regulation could be finalized by year-end, many experts are now predicting that the rule will not be finalized until early 2006. （2）POSITIVE TRIAL RESULTS FOR GLUCOSAMINE The recently-released first results of the multi-centre Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT), carried out by the US government-funded National Institutes of Health, has found a combination of the two substances to be effective in treated moderate to severe knee pain due to osteoarthritis. Now, the efficacy of Glucosamine in the treatment of osteoarthritic pain has been further confirmed by the results of another multi-centre study carried out in Europe. The GUIDE trial compared a daily dose of l500mg glucosamine sulphate with an OTC painkiller and placebo ? and concluded that ‘… it might be the preferred symptomatic medication in knee osteoarthritis’.