Benjamin England Presents on FDA Import Enforcement Changes for Chinese Seafood Exporters
FDAImports.com Founder and CEO Benjamin England recently presented on “FDA Import Enforcement Changes for Chinese Seafood Exporters” at the 10th International Tilapia Industry Development Forum, which was held concurrently with the Dalian (China) Seafood Show. His...
FDAImports.com and ExportToUsa.com.cn Team Third Showcase at Dalian China Seafood Show
2013 marks the third consecutive year that FDAImports.com has been showcased at the China Fisheries and Seafood Expo. This year Benjamin England, Rick Quinn, John Wu, Shelly Li, and Ge Song attended the show, November 5 to 7, 2013 in Dalian, to meet and connect with...
Import Alert Listings: Not Just for Tested Product Anymore
Look out, industry: there’s a new way to get put on Import Alert. FDA is beginning to place firms on import alert based on traceability data collected by FDA and the Center for Disease Control and Prevention (CDC). Firms used to think they would only end up on...
The Myths and Truths of the Bill on Drug Compounding
Myth 1: DQSA grants the FDA sweeping authority in determining what pharmacies can compound. Compounding sophisticated, difficult-to-produce drugs will not be prohibited. Traditional compounding pharmacies – those small operations which compound drugs that fill...
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...