FDA
FSMA Collaborative Training Forum Page Last Updated: 01/08/2018 https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm590444.htm
Wellness Resources, Inc. 11/30/17 November 30, 2017 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm587384.htm 未承認の医薬品、ラベル表示、不正表示の問題 Bedessee Imports, Inc 12/1/17 December 1, 2017 https://www.fda.go…
FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product, Atcell January 4, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm591371.htm (FDAは新たな政策枠組みにより未…
Explaining How the Voluntary Qualified Importer Program Will Work January 2, 2018 https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm590803.htm VQIP (Voluntary Qualified Importer Program: 任意適格輸入事業者プログラム)は、有料で実施…
Statement from FDA Commissioner Scott Gottlieb, M.D. on efforts to support more efficient and effective food recalls December 26, 2017 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm590423.htm 要旨 FDA (United States Food an…
Maine Natural Health, Inc. 12/19/17 December 19, 2017 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm590003.htm ダイエタリーサプリメントのCGMP違反、不純品、不正表示の問題。 (魚油が炎症を抑制する、という宣伝は医薬品に…
Marmex Corpは表示されないシルデナフィルのためBlue Pearl All Natural Male Enhancement サプリメントを全国的に自主回収 Marmex Corp Issues Voluntary Nationwide Recall Of Blue Pearl All Natural Male Enhancement Supplement, Due To Undeclared Sil…
GnuPharma Corp. 12/13/17 December 13, 2017 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm588915.htm ダイエタリーサプリメントの未承認の医薬品、不純品、不正表示の問題。 Professional Botanicals, Inc. 7/6/17 July 06, 2017…
FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs December 18, 2017 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm589243.htm 2017年12月18日、FDAは…
FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs December 18, 2017 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm589243.htm あとで
Medications and Gluten https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/ucm410373.htm 経口薬の多くはグルテンを含まないか実質的に含まない。FDAは、”draft guidance on Gluten in Drug Produ…
FDA’S PREDICTIVE TOXICOLOGY ROADMAP December 2017 https://www.fda.gov/downloads/scienceresearch/specialtopics/regulatoryscience/ucm587831.pdf グローバリゼーション、急速に進化する技術、新たな学問分野の積み重なる影響は、FDAにとってかつてない…
What Do We Mean by ‘Refusal of Inspection’? FDA Explains December 11, 2017FSMA (Food Safety Modernization Act: 米国食品安全近代化法)により、FDA (Food and Drug Administration: 米国食品医薬品局)は、外国の食品製造企業が査察を受けることを許可…
フッ化物添加の乳児用飲料水の回収措置を消費者に警告する FDA Alerts Consumers to Recall of Certain Comforts FOR BABY Water with Fluoride December 4, 2017 https://www.fda.gov/Safety/Recalls/ucm587618.htm Kroger社の検査により、アオカビのタラロ…
Talking FSMA in the Land of Cotton and Looking for Middle Ground November 27, 2017 https://blogs.fda.gov/fdavoice/index.php/2017/11/talking-fsma-in-the-land-of-cotton-and-looking-for-middle-ground/ (FDAの食品獣医局副長官Stephen Ostroff医学…
Ihm Farms 10/27/17 October 27, 2017 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm583099.htm 新動物医薬品、不純物の問題。セフチオフル塩酸塩の過剰投与。 B & H Foods Inc 11/14/17 November 14, 2017 https://www.fda.gov/IC…
Information About Self-Administration of Gene Therapy 11/21/2017 https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm586343.htm 自分に投与するための遺伝子治療製品やDIYキットが販売されているが、これらは違法である (バ…
The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication November 28, 2017 https://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm586505.htm 対象者:ビオチン、ビタミンB7、サプリメントを使っているあるいは使お…
Laser Toys: How to Keep Kids Safe Updated: November 24, 2017 https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm363908.htm たくさんの子ども(とその親)はライトセーバーでダース・ベーダーと戦うルーク・スカイウォーカーを見てレーザーはかっこ…
No Bones (or Bone Treats) About It: Reasons Not to Give Your Dog Bones Updated: November 21, 2017 https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm208365.htm 犬の飼い主の多くは鶏やシチメンチョウの骨を犬に与えてはいけないと知っている。こ…
Questions and Answers on Glyphosate (農薬モニタリング報告の一部) Last Updated: 11/06/2017 https://www.fda.gov/Food/FoodborneIllnessContaminants/Pesticides/ucm583713.htm グリホサートは特定の雑草や草を除去できる除草剤で、広範に使用されてい…
Mannatech Incorporated 11/14/17 November 14, 2017 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm585515.htm 未承認の医薬品、ダイエタリーサプリメントのCGMP違反、製造、包装、表示及び衛生管理、不純品、不正表示の問題。 (要…
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom November 14, 2017 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584970.htm ◇要約 FDAは、クラトム(kratom)の使用で…
August 7, 2017 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm584710.htm ダイエタリーサプリメントの不正表示違反、虚偽及び誤解を招く宣伝表示の問題。マグネシウム77.5mg/serving (申告の62%)、マンガン0.255mg/serving (申告の…
Pesticide Residue Monitoring Program Questions and Answers Last Updated: 11/06/2017 https://www.fda.gov/Food/FoodborneIllnessContaminants/Pesticides/ucm583711.htm 米国連邦政府の各当局は、食品中または表面上の農薬化学物質残留物を監視する責任…
FY 2015 Pesticide Analysis Demonstrates Residue Levels Remain Low November 6, 2017 https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm583717.htm 本日公表された報告書によると、米国食品医薬品局は2015年度に検査された国内食品の98%と輸入…
FDA Issues Menu Labeling Guidance, Utilizing Q&A Format and Graphics to Address Concerns, Offer Solutions, and Provide Flexibility November 7, 2017 米国食品医薬品局(Food and Drug Administration: FDA)はこの日、『メニュー表示についての業界向…
Create-A-Pack Foods, Inc. 11/2/17 November 2, 2017 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm583979.htmダイエタリーサプリメントのCGMP違反、製造、包装、及び衛生管理、不純品の問題。 Bluegrass Proteins, Inc. 10/26/17…
FDA Issues Guidance to Allow “Co-Manufacturers” Additional Time to Implement Certain Supply-Chain Program Requirements November 3, 2017 http://s2027422842.t.en25.com/e/es?s=2027422842&e=14706 米国食品医薬品局(Food and Drug Administration: …
FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer November 1, 2017 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583295.htm 米国食品医薬品局(Food and Drug Administra…