Ben England and Bill Nychis Present at FDA News virtual conference – FDA Import Holds
Benjamin England, FDAImports.com Founder and CEO, and Bill Nychis, Senior Regulatory Advisor, recently co-presented a webinar entitled “FDA Import Holds: New Powers to Control Products.” Mr. England provided an overview of FDA’s drug importation enforcement authority,...
Will the Bill on Drug Compounding Accomplish its Public Health Goal?
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...
FSMA Comment Period Extended – Again
As we predicted, FDA extended the comment periods for its proposed FSMA rules covering FSVP and the 3rd-Party Accreditation Program. The new deadline is January 27, 2014. These new food safety rules have significant implications for everyone in the food industry –...
FDAImports.com Saves Clients Thousands in Liquidated Damages
Whenever Customs issues a claim for liquidated damages, U.S. law gives the importer the right to petition for mitigation or cancellation of the damages amount. It is becoming increasingly difficult to persuade the government to mitigate or cancel these cases, because...
“De Facto” Asia-Wide Import Alert for Chinese Honey?
This year, FDA has published two Import Alerts to regulate unapproved veterinary drug use in imported honey. On May 23, Import Alert 36-04 published a Red List of manufacturers of honey and blended syrup whose products will be detained due to fluoroquinolones. On June...
Drug Quality and Security Act: New Federal Oversight of Compounding Pharmacies
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...
FDA Adding Companies to Import Alert 66-40 without Adequate Notice
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 Wants Your Comments!
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,...
Speech at Dalian Exhibition Center: Exporting Tilapia to the United States
Benjamin L. England, founder and CEO at FDAImports.com, honored to be invited as a recognized expert in the field of Tilapia, will be speaking on the expert panel in the 10th International Tilapia Industry Development Forum (Venue: Dalian Xinghai Convention &...
The Results Are In – Government Shutdown Proves No Obstacle for FDAImports.com
Shuttered up and closed - the government shutdown was painful for many U.S. businesses. This was especially true for any business having to deal with FDA. FDA lost over 50% of its employees during the shutdown. Many of those furloughed were investigators and internal...