FDAImports.com Brings on Two Attorneys, Adds Staff to California and Maryland Offices
The FDAImports.com team has added two new attorneys to its staff, expanding its team of affiliated regulatory attorneys. Associate Attorney Mr. Fournier practices in the area of Food and Drug Law. He previously completed a summer position with the firm before joining...
How Will Election Results Impact FSMA, Imports, Other Food Safety Trends?
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...
Attention! All Involved With Generic Drugs: Due Soon – A New Reporting Requirement
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,...
Looking for the FDA Accession Number Database? It Doesn’t Exist so Read This Carefully
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...
10 Things To Think About Before You Put “Organic” on Your Label
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 Acting as U.S. Agents Face New Financial Risks Under FSMA
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...
Import Alert 53-17 Success Story Reminds us that FDA Makes Mistakes Too
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...
What’s Important to the Organic Community? GMOs, Creativity, Start Up Culture & Health Claims: Observations from Expo East 2012
The FDAImports.com team has wrapped up another intensive exhibiting experience at Natural Products Expo East 2012 – the East Coast’s premier event for organic manufacturers, distributors, buyers and press to connect, network and discuss trends and issues affecting the...
FDAImports.com Announces 5 New Labeling Websites For Fast and Easy Label Reviews
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...
Prop 37: A Two-Edged Sword for Small Businesses
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....