The 2012 elections are over! Celebrate or mourn. But either way, it’s now time to expect some stability and action as the sideshow comes to an end. As we predicted over the summer FDA did not release any of its new FSMA regulations before the election. In fact, the...
Generic drug manufacturers and certain others are subject to a new reporting requirement. It is perhaps buried in the Generic Drug User Fee Amendment (GDUFA), which was a part of the Food and Drug Administration Safety and Innovation Act (FDASIA) passed on July 9,...
If you distribute or import radiation-emitting electronic products, you may have already heard of FDA’s accession number system. However, we have found that many importers are perplexed when they are required complete Customs Form 2877 which, in part, asks the...
1. Does my product comply with federal law? The USDA administers the National Organic Program (“NOP”). NOP regulations set out the requirements for the handling, certification, processing, composition, and labeling of organic products. Products labeled as “organic”...
Customs brokers and importers who act as U.S. Agents on behalf of their foreign food manufacturing suppliers now face a new financial risk under the Food Safety Modernization Act. Before FSMA there was no such thing as an inspection fee for a foreign facility that...
FDAImports.com recently assisted a Chinese company with removal from FDA Import Alert 53-17, “Detention Without Physical Examination of Cosmetics Due to Microbiological Contamination.” This case is of particular interest, because it is a reminder that FDA makes...
FDAImports.com is pleased to announce 5 new labeling websites that we have developed in order to provide a fast, turn-key solution for preventing labeling errors before they happen. Our new label review websites allow users in any FDA-regulated industry to quickly...
The advent of Prop 37 portends great things for the small business organic and natural food industry, which has been forced until now to compete with big corporate agriculture. Prop 37 exempts from GMO labeling any food that is certified organic under the U.S....
Our friends at Food Chemical News are rolling out a brand-new conference this December – A conference solely aimed at addressing Food Safety Modernization Act issues relevant to food imports. Ben England, Founder and CEO of FDAImports.com, will be presenting on Day 1...
FDAImports.com Founder and CEO, Benjamin England, will present on FDA’s PREDICT system and issues affecting the distribution and importation of cosmetic, drug and combination products from an FDA regulatory perspective at this year’s 2012 Cosmetic Science Symposium in...
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