FDA
FDA Expands Data Dashboard to Include FSMA May 16, 2018 https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm607534.htmData Dashboard https://www.fda.gov/AboutFDA/Transparency/InspectionComplianceDataDashboard/default.htm
Shoreside Enterprises 社は7K と Poseidon 4500 (Extreme 1000 Mg)を表示されていないシルデナフィルとタダラフィルを含むため全国リコール Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to P…
Baker's Best Health Products, Inc. 4/25/18 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm606875.htm 各種ダイエタリーサプリメントの宣伝が未承認医薬品、成分表示が中身と違う（ニンジンがPanaxではなくシベリアニンジンEleutheroco…
FDA Extends Nutrition Facts Label Compliance Dates May 3, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=83066&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=de684f93121b4f45bcf9dd8dd45fa211&elqaid=3382&elqat=1 年間1千万ドル以上の…
FDA Finalizes Guidance to Help Food Establishments Meet Menu Labeling Requirements May 7, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=84219&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=8388c977d8f04e319509303f2698867c&elqaid=…
FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan May 10, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607327.htm 先週FTCと共同で…
Chi's Enterprise Inc 4/30/18 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm606528.htm ダイエタリーサプリメントCGMP違反（各種具体的記載有り） （Myomin はエストロゲンを減らす（アロマターゼ阻害）中国伝統ハーブと称するものらし…
FDA seeks permanent injunctions against two stem cell clinics May 9, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607257.htm 本日FDAは連邦裁判所に、FDAの認可無しに幹細胞製品を宣伝販売している二つの幹細胞クリニックへの…
New Web Page Focuses on the Foods and Veterinary Medicine Program’s Science and Research to Support Food and Feed Safety http://s2027422842.t.en25.com/e/es?s=2027422842&e=82615&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=fc8edf0cbca341…
若年者をニコチンやタバコ製品の危険から保護する合同活動の一環として、また若年者をタバコから保護するFDAの新計画の一環として、警告文書を送達 FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice …
Statement from FDA Commissioner Scott Gottlieb, M.D., on new enforcement actions and a Youth Tobacco Prevention Plan to stop youth use of, and access to, JUUL and other e-cigarettes April 24, 2018 https://www.fda.gov/NewsEvents/Newsroom/Pr…
製品のラベルミスによる表示されていないピーナツアレルゲンが含まれる可能性があるためHappy Harvestほうれん草の缶詰の自主回収 Voluntary Recall Notice of Happy Harvest Canned Spinach Due to Potential Undeclared Peanut Allergen from Product Misl…
Amerigo Labs LLC 4/4/18 April 4, 2018 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm604177.htm 各種ダイエタリーサプリメントの疾患治療宣伝等各種違反
Triangle Pharmataturalsはサルモネラ汚染の可能性があるためクラトム製品をリコール Triangle Pharmataturals Recalls Kratom Products Due to Potential Salmonella Contamination April 17, 2018 https://www.fda.gov/Safety/Recalls/ucm604880.htm （強…
Statement by Dr. Susan Mayne on FDA efforts to reduce consumer exposure to arsenic in rice April 17, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604807.htm （食品安全･応用栄養センター(CFSAN)のセンター長であるSusan Ma…
FDA takes step to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine April 13, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604485.htm FDAは、20…
'Rhino 69 Extreme 50000'は有効成分「タダラフィル」を含むためリコール 'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil' April 12, 2018 https://www.fda.gov/Safety/Recalls/ucm604633.htm FDAの検査で検出された
FDA to Extend Comment Period on Draft Guidance Regarding Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products April 13, 2018 https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm604605.htm 期間延長要請に応…
Ironed Out Posted on April 12, 2018 by FDA Voice By: Vanessa Burrows https://blogs.fda.gov/fdavoice/index.php/2018/04/ironed-out/ 20世紀の初めの頃、科学的知見が増えてある種の病気はビタミンやミネラルの欠乏により引き起こされるということが、…
FDA Working to Protect Consumers from Toxic Metals in Foods April 11, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=73853&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=f2a3a54396b5435abde1830d88d49899&elqaid=3126&elqat=1 私たち…
Cache Commodities Incorporated 3/23/18 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm603731.htm ペットフードのCGMP違反、治療目的用飼料CGMP違反 Gate Gourmet Inc. 3/29/18 https://www.fda.gov/ICECI/EnforcementActions/WarningL…
Schmidt, James 3/26/18 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm602777.htm 乳牛の残留動物用医薬品デスフロイルセフチオフル
Triangle Pharmanaturals社は、FDAに自主的リコールを再三促されたにもかかわらず、それを拒否 FDA orders mandatory recall for kratom products due to risk of salmonella Triangle Pharmanaturals refused to cooperate with FDA despite repeated attem…
FDA Commissioner Scott Gottlieb Delivers Nutrition Speech at National Food Policy Conference March 29, 2018 https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm603090.htm FDA長官Scott Gottlieb氏は、ワシントンDCで開かれた国家食糧政策…
未公表の医薬品成分を含む製品をダイエタリーサプリメントとして販売 Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs Products marketed as dietary supplements contained undisclosed …
Biotek, Inc. 3/13/18 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm602236.htm 各種サプリメントの宣伝（免疫系改善、病気への抵抗性を増す、血中トリグリセリド濃度を改善する、など）が未承認医薬品、CGMP違反（項目多数、査察とそれ…
Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce tobacco use, especially among youth, by exploring options to address the role of flavors ‒ including menthol ‒ in tobacco products March 20, 2018 https://www.fda.go…
FDA Takes Steps to Make the Importation of Certain Live Animals Less Burdensome March 21, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=64432&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=e2d498519ab74276ae2a5bf7e1eb6ced 米国食…
FDA Helps Businesses Determine Their Size Under FSMA Preventive Controls Regulations March 19, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=63101&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=cc1923def418422e878a46b66604608a&el…
FDA Investigates Multistate Outbreak of Salmonella Infections Linked to Products Reported to Contain Kratom March 15, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=62483&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=726bfcafbfef…
