FDA
Statement from FDA Commissioner Scott Gottlieb, M.D., on pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels March 15, 2018 https://www.fda.gov…
Oregon Food Bank Issues Alert on Foreign Material in Chia Seeds March 12, 2018 https://www.fda.gov/Safety/Recalls/ucm600756.htm フードバンクに寄付された22,201ポンドのチアシードにクラスIIリコール。ネズミの糞が混入している。 問題が発覚したの…
Carol Bond Health Foods 3/9/18 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm600398.htm ダイエタリーサプリメントCGMP違反、製品の宣伝が未承認医薬品 （ビンポセチンとか。CGMP違反の長い項目有り） Nutritional Engineering Inc 9/…
FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes March 6, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599560.htm この検査はBRCA遺伝子について…
PA Constans - Minnesota Emu 2/23/18 February 23, 2018 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm598478.htm エミュオイル等の各種ダイエタリーサプリメントの「抗炎症」や「かゆみや赤みに効いた」という個人の体験談の宣伝が未…
FDA warns of fraudulent and unapproved flu product March 2, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599223.htm 今シーズンのインフルエンザは米国各地で広く猛威をふるい、何百万人もの患者を出し、入院患者数は新記録と…
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s commitment to modernizing food and nutrition programs March 5, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599398.htm FDAは、FDAに振り分けられた新規およ…
FDA Releases Guidance on Fiber and Several Other Key Issues March 1, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=56737&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=e8bd315a77a6470191724ae3ec1e14b0&elqaid=2617&elqat=1 2016年5…
Terra Biological LLC 7/18/17 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm598171.htm CRONaxal（オキサロ酢酸）製品の宣伝が未承認医薬品あるいは医療用食品としての表示違反
Statement from Stephen Ostroff M.D., Deputy Commissioner for Foods and Veterinary Medicine, on National Toxicology Program draft report on Bisphenol A February 23, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm598100.h…
CFSAN Education Resource Library https://epublication.fda.gov/epub/ 約300の出版物（PDFから動画まで）ライブラリー
FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioid February 21, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm597649.htm クラトムを含むダイエタリー…
FDA, in Collaboration with American Medical Association, Releases Two Continuing Medical Education Videos: Identifying and Treating Foodborne Illness, and Talking to Patients About Food Safety https://www.fda.gov/Food/NewsEvents/Constituen…
Reishi D. International, Inc. 2/6/18 February 7, 2018 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm596320.htm ダイエタリーサプリメントの宣伝（中国伝統薬として数千年使われてきた、中国薬Chinese medicine（単語のみでアウト）…
女性向け：FDAは心疾患予防のためのコツを提供 For Women: The FDA Gives Tips to Prevent Heart Disease Updated: December 22, 2017 https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm353680.htm ・持病の管理 ・心臓発作の症状を認識して必要なら救…
Long Life Unlimited 1/31/18 January 31, 2018 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm595103.htm 各種ビタミンやその他ハーブ製品（サプリメントやクリーム）等の宣伝が未承認医薬品。個人の体験談も医薬品としての広告であり違…
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse February 6, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnn…
CFSAN’s Senior Science Advisor Aims to Build Bridges to Advance Produce Safety 02/05/2018 https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm595125.htm Jim Gorny博士がFDAに戻ってきた。彼は、米国食品医薬品安全局(FDA)が農産物の安全性向上に…
FDA, FTC warn companies for selling illegal, unapproved opioid cessation products using deceptive claims January 24, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm593602.htm FTCとFDA、オピオイド依存治療薬を販売したと…
Statement from Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on the recent National Toxicology Program draft report on radiofrequency energy exposure February 2, 2018 https://www.fda.gov/NewsE…
December 28, 2017J https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm592964.htm 未承認の医薬品、不正表示の問題。製品にシブトラミンを含む。
FDA recognizes first Accreditation Body under Accredited Third-Party Certification Program; launches Voluntary Qualified Importer Program January 31, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=46636 米国食品医薬品局(FDA)は、輸…
FDA Issues Guidance Documents to help Importers and Food Producers meet FSMA Requirements January 24, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=44314 米国食品医薬品局(FDA)は本日、5つのガイダンス文書を発表した。これらは、輸入業…
Magno-Humphries Laboratories, Inc., Issues Voluntary Nationwide Recall of Basic Drugs Brand of Senna Laxative Due to Mislabeling January 19, 2018 https://www.fda.gov/Safety/Recalls/ucm593150.htm#recall-photos Magno-Humphries Laboratories, …
USA Labs AKA Power Source Distributors, Inc AKA USA Sport 1/10/18 January 10, 2018 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm592691.htm 未承認の医薬品、不正表示の問題 Coenzyme A, Inc. dba Coenzyme-A Technologies, Inc. …
Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy steps for strengthening public warning and notification of recalls January 18, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592777.htm 先月は、FDAに…
FDA Releases Guidance Documents to help Importers and Food Producers meet new FSMA Standards January 24, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=44364 米国食品医薬品局は本日、5つのガイダンス文書を発表した。これらは、輸入業者…
FDA 2018 Shutdown Information https://www.fda.gov/aboutfda/workingatfda/ucm370999.htm 2018年予算が執行されるまでは緊急の脅威への対応や使用料ファンドにより賄われる活動などの範囲内で業務を継続する 1月21日、22日更新 お帰りみんな！1月23日から…
Hilgenkamp Farm Inc 11/15/17 November 15, 2017 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm586732.htm 違法医薬品の残留、不純品の問題。牛の腎臓から6.691ppmのデスフロイルセフチオフル、肝臓から0.213 ppmのフルニキシンが…
August 21, 2017 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm591097.htm 未承認の医薬品、ダイエタリーサプリメントのCGMP、表示違反、医薬品不正表示の違反。
