While generic drug laws and policy have brought down the cost of Rx drugs for many Americans, recent legislation, such as the Generic Drug User Fee Amendments of 2012 (GDUFA) is reversing that trend and significantly increasing the cost of generic drugs. GDUFA added...
Chinese companies exporting foods, drugs or medical devices to the USA: be aware! FDAImports.com has recently learned China’s FDA inspections include verifying the U.S. FDA registrations of Chinese manufacturers. China FDA is not just verifying companies have valid...
FDAImports.com recently obtained removal for a manufacturer from Import Alert 66-41 (automatic detention of unapproved new drugs promoted in the U.S.). Under this Import Alert FDA detains all products it deems “unapproved new drugs” – even if they’re merely cosmetics...
Benjamin England, FDAImports.com Founder and CEO recently presented a webinar with FDANews, entitled “Thinking Ahead of FDA: Preventive care tips for your FDA import compliance program.” Mr. England said, “Up to now, FDA has been mostly reactionary in its enforcement...
UPDATE 03/02/2017 FDA’s Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates are out for FY 2017. The domestic reinspection rate was not changed from the 2016 rate. Surprisingly, the foreign reinspection rate, which has been...
Benjamin England, FDAImports.com Founder and CEO recently presented a webinar with Eurofins Scientific, entitled “Switching Sweets: Economic Adulteration in Sugar-Rich Foods.” The webinar addressed the issue of producers substituting cheap ingredients and advertising...
ExportToUsa.com.cn attended the 15th SIAL China Show in Shanghai on May 13-15. Many food suppliers gathered together in Shanghai, looking for opportunities. ExportToUsa.com.cn spoke with many food suppliers regarding various problems that might occur if they want to...
FDA and the cosmetic industry recently separated ways as their talks to modernize how FDA regulates cosmetics collapsed. In March, FDA expressed a “profound disappointment” with the legislation proposed by the cosmetic industry and implied that FDA would proceed...
Last month, FDA issued a new Draft Guidance, requiring the labels of honey products to declare sweeteners in the statement of identity. This sounds ridiculous. Consumers have accepted that honey marketers routinely mix honey and sweeteners – for example, sugar or corn...
The news media is flooded with stories about FDA proposing to regulate electronic cigarettes (e-cigs) for the first time, according to the proposed rule published on April 24. Despite the news stories and FDA’s talking points, the proposed rule talks very little...
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