FDA
Up Inya Gear 6/7/18 June 7, 2018 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm610604.htm 未承認の医薬品、不正表示の問題。 KPC Products Inc 6/20/18 June 20, 2018 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/…
American Chinese Medicine Association 6/26/18 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm612377.htm アメリカ中国薬協会社？（一企業？） 各種がんを治すという製品の宣伝が未承認薬 （医者が見放したがんが治せる、5年生存率100%…
The American Chamber of Horrors Posted on June 29, 2018 by FDA Voice https://blogs.fda.gov/fdavoice/index.php/2018/06/the-american-chamber-of-horrors/ FDAの歴史館から 20世紀初頭、アメリカ人は効果がなく危険な医薬品と異物混入されて詐欺的表示…
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to advance health through improvements in nutrition under the agency’s Nutrition Innovation Strategy June 26, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnoun…
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to collaborate with internet stakeholders to stop the illegal sale of opioids online June 28, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612196.…
FDA Updates the Everything Added to Food in the U.S. Inventory June 26, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=104136&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=d8d08998c2014e8087ed06165921403c&elqaid=4059&elqat=1 更新…
FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy June 25, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm Epidiolex (カンナビジオール) [C…
Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply June 19, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc…
FDA Considering Revised Approach to Declaration of Added Sugars on Pure Maple Syrup and Pure Honey June 19, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=101615&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=96c13d065f3c47a4aec22…
FDA Issues Guidance, Science Review, and Citizen Petition Responses on Dietary Fiber June 14, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=99991&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=3ca1540bc5c940d2a0461a2e44e10138&elq…
FDA Announces Public Meeting to Discuss Foods Produced Using Animal Cell Culture Technology June 15, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=100491&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=e30959ac319b491b9992658c4e5f…
FDA Releases FSMA Draft Guidance on the Supply-Chain Program Preventive Control for Animal Food June 14, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=99967&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=3b3c83ce14074a44b0aede9e6…
Dave’s ペットフードは95%プレミアムビーフ缶詰ドッグフードを甲状腺ホルモン濃度が高い可能性があるため自主回収 Dave’s Pet Food Voluntarily Recalls 95% Premium Beef Canned Dog Food Due to Potentially Elevated Levels of Thyroid Hormone June 12, …
Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products June 7, 2018 https://www.fda.gov/NewsEvents/News…
FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers June 5, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609951.htm 食品の安全の監視をより強固により効…
FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales June 5, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609869.htm 合計で53ヵ所のウェブサ…
FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products June 5, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609862.htm 警告を受けたのは、liquidcaffeine.com社およびDual…
FDA Recognizes ACFS as Accreditation Body Under FSMA Program May 30, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=94462&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=54691e035f604ca7a998e01fb864e4e6&elqaid=3703&elqat=1 タイのバ…
Performance Nutrition Formulators LLC dba VMI Sports 5/18/18 https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm608716.htm アロマターゼ阻害剤(アンドロスタ-3,5-ジエン-7,17-ジオン)は食品成分ではない ダイエタリーサプリメントの宣伝…
Biotechnology Consultations on Food from GE Plant Varieties https://www.accessdata.fda.gov/scripts/fdcc/index.cfm?set=Biocon&id=IR-00GR2E-5 GR2Eコメ（ゴールデンライス） Letter May 24, 2018 https://www.fda.gov/downloads/Food/IngredientsPack…
As VQIP Application Period Expires, FDA Encourages Importers to Prepare Early for Next Year’s Cycle May 25, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=92856&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=b768aaa9ee6141ab88baf9…
New Guide Helps Small Food Facilities Register with FDA May 25, 2018 http://s2027422842.t.en25.com/e/es?s=2027422842&e=92676&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=03ca0071eced499995f67cc0cef2f694&elqaid=3663&elqat=1 連邦食品・医…
FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit May 23, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608325.htm FDAは生歯製品の販売中止を強く求める。他…
Merrick Pet Care Voluntarily Recalls Limited Amount of Good Buddy and Backcountry Treats Containing Beef Due to Potentially Elevated Levels of Thyroid Hormone May 23, 2018 https://www.fda.gov/Safety/Recalls/ucm608655.htm リコール対象は掲載…
Ethanol Extraction Recalls Alcohol Product Because of Possible Health Risk May 22, 2018 https://www.fda.gov/Safety/Recalls/ucm608579.htm 95%エタノール製品（エッセンシャルオイル抽出用）にメタノール混入の可能性 この製品には「飲むと危険。臓器…
Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens May 22, 2018 https://www.fda.gov/NewsEvent…
FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses May 22, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608447.htm 警告が発せられたのは…
FDA Extends Compliance Date for Certain Uses of Partially Hydrogenated Oils in Food; Denies Petition for Certain Uses of PHOs May 18, 2018 https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm608076.htm 米国FDAは、部分水素添加油（PHOs…
FDAは、若年者が電子タバコ製品に近づくことに関して懸念が持たれ続ける中、電子タバコメーカーに対し、FDAが若年者の使用や製品の誘引力を良く調べることができるように、重要な情報を提供するように要請した
FDA requires additional e-cigarette makers to provide critical information so the agency can better examine youth use and product appeal, amid continued concerns around youth access to products May 17, 2018 https://www.fda.gov/NewsEvents/N…
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