U.S. Department of Agriculture (USDA) officials testified before Congress on April 10, 2014 that the Department responsible for protecting agricultural interests in the U.S.A. will not meet the 60-day deadline to issue a proposed rule governing its new authority to...
The team at FDAImports.com successfully persuaded FDA to return an exporter to the Green List for Import Alert 16-131 (Detention Without Physical Examination of Aquacultured Catfish, Basa, Shrimp, Dace, and Eel from China- Presence of New Animal Drugs and/or Unsafe...
On February 7, 2014, the U.S. federal government enacted the Agricultural Act of 2014 (the “Farm Bill”). This bill gives USDA exclusive authority to regulate and inspect all farm-raised catfish sold in the U.S. In doing so, it removes FDA’s regulatory control over...
The Dietary Supplement and Nonprescription Drug Consumer Protection Act amended the FFDCA to subject those OTC drugs marketed without an approved NDA or ANDA to OTC drug reporting requirements, which had previously only applied to those OTC drugs with an approved...
The seafood industry should start preparing for greater FDA scrutiny and interference with seafood products from China. The industry is quite familiar with FDA’s Import Alert 16-131, which requires testing all aquaculture from China for unapproved veterinary drugs...
Intending to close the frequency gap between foreign and domestic inspections, FDA has been increasing its foreign inspections, especially at drug plants in India. India is FDA’s current top priority, as it has the largest number of drug manufacturers and is a major...
Device manufacturers take note: Changes in regulations accompanying the Unique Device Identifier (UDI) regulation took effect on December 23, 2013. The new UDI regulations reach far and wide. In addition to creating a new regulation at 21 CFR 830, changes also...
Approximately 90% of “antibacterial” or “antimicrobial” soaps currently on the market are made with the active ingredient triclosan, a chemical known to kill bacteria. For obvious reasons, consumers generally consider these soaps more effective than plain soap and...
FDAImports.com is excited to attend and participate in Natural Products Expo West again this year, meeting and talking with many industry members involved in bringing natural products to the United States market. We are looking forward to joining the discussion on...
Last month, FDAImports.com attended the Chennai Seafood Show, where we had the pleasure of meeting and talking with many members of the Indian seafood industry. The industry is very interested in finding clarification on duties, rebates, and preferential rates –...
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