Increase in Organic Product Sales Will Likely Lead to Increased FDA Regulations, Costs
The demand for organic products is on the rise, despite higher prices, according to a recent report from the TABS Group, Inc. The Annual Organic Product Study for 2011 showed an estimated 15-20% growth in sales for organics products, for both foods and cosmetics. The...
China International Aquatic Products Network Welcomes Ben England and ExportToUsa.com.cn as FDA Resource
FDAImports.com and ExportToUsa.com.cn Founder and CEO, Benjamin England, was recently invited to join the China International Aquatic Products Network as an official expert resource for FDA regulation and imports to the United States. In this capacity he will assist...
USA Losing its Foothold? Ben England Presents on FSMA and Imports at 2012 FDLI Conference
FDAImports.com Founder and CEO, Benjamin England, recently spoke at the Food and Drug Law Institute’s Annual Conference on the Food Safety Modernization Act and imports. During the presentation, “How FSMA Changed the Game on Imports,” Mr. England discussed, along...
FDA, is That Your “Final Answer?” Never Say Never When it Comes to Reversing FDA Import Refusals
If you remember only one thing about FDA-related legal matters involving imported products it should be this: Even if FDA issues a “final” FDA refusal on a legal matter, it is still possible to 1) prove that the FDA got it wrong, and 2) convince FDA to reverse...
Prop 65 Press Releases Are Blood in the Water for California Plaintiff’s Attorneys
Cue the soundtrack from Jaws. Earlier this month, the California Department of Toxic Substances Control (DTSC) issued a press release alleging that several nail polish manufacturers failed to declare the presence of potentially dangerous cosmetic ingredients, Toluene,...
Just Like Fake Avastin, Pending Counterfeit Drug Legislation Doesn’t Do Anything Either
In February 2012, news of fake Avastin in the United States hit the news wires. Cancer patients were being administered water while under the impression that it was the actual cancer treatment drug, Avastin. People were outraged. Weeks later, another shipment of...
The Food Safety Modernization Act: The Sound of Silence
What happened when observers pointed out that the Congressional Budget Office estimated it would cost $1.4 billion over 5 years to implement FSMA even though Congress only gave FDA a $50 million boost for this year? Silence. What happened when industry and consumers...
We’ve Moved!
FDAImports.com and Benjamin L. England & Associates have officially moved and are now in our new office space. Please note our change of address and new phone number below. Our email, website and fax information will remain unchanged. 810 Landmark Drive Suite 126...
Medical Device 513g Requests: FDA vs. FDAImports.com, The Battle Rages On
FDA recently issued new guidance regarding how FDA responds to device classification questions submitted under Section 513(g) of the Federal Food, Drug, and Cosmetic Act. In short, a 513(g) Request for Information must be submitted in writing to FDA, must be for a...
50 People at FDA Oversee the Entire Cosmetics Industry? Believe it
The FDA has “a total of about 50 full time equivalents to regulate a very large and growing industry,” said Michael Landa, Director of the Center for Food Safety and Applied Nutrition at the FDA in a statement made during a Senate hearing on the safety of cosmetics a...