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...
FDA has recently begun applying Import Alert 99-30 to breaded seafood from China. That import alert relates to melamine in dairy products and foods with dairy-based ingredients. This is an unprecedented action. FDA has previously only applied Import Alert 99-30 to...
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...
FDA recently issued a Warning Letter to a seafood facility in Hawaii, citing five major issues that the firm must address: controlling pathogenic bacteria growth resulting from time/temperature abuse, controlling allergens at the packing/wrapping stage, having an...
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...
FDAImports.com recently attended and presented at the 2014 India International Seafood Show in Chennai. Principal Rick Quinn and India Country Director Shanmugam Jayakumar met with processors, exporters, and industry members at the FDAImports.com booth, discussing the...
For decades, FDA and the States’ jurisdiction over compounding were at odds. Compounding has traditionally been governed by the States, and pharmacists could supply patients with compounded drugs without needing FDA’s approval. The controversial Drug Quality and...
An outbreak of fungal meningitis, traced to contamination in compounded injectable steroids, jump-started the movement to increase federal authority over compounding operations. Now, federal oversight is about to increase, with the President expected to sign into law...
Is it ever legitimate for FDA to add companies to an FDA import alert without notice? No. Does FDA do this anyway? Yes, and frequently. In April 2013, many Chinese OTC drug manufacturers fell victim to FDA’s caprice. In 2012, FDA conducted a series of surprise...
FDA may be having some trouble with its regulations.gov website, but it still wants to hear from industry on proposed rules. FDA had extended the comment period for the FSMA proposed rules for produce safety and preventive controls for human foods to November 15th,...
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