FDA consulting firm, FDAImports.com, has won another substantial victory for a client on FDA Import Alert, this time for Import Alert 53-17, Detention Without Physical Examination of Cosmetics Due to Microbiological Contamination. A Chinese company bringing in eye...
Law & Regulatory
Will FDA Meet its July 4 FSMA Deadline? Don’t Hold Your Breath
It’s that time of year again… Time for another FSMA deadline! The pressure is on for the U.S. Food and Drug Administration to meet yet another critical date with multiple deadlines imposed by the Food Safety Modernization Act (FSMA). Every 6 months a deadline rolls...
How an FDA Inspection Can Fuel a Consumer Lawsuit
The following is a letter from FDAImports.com Founder and CEO, Benjamin England: As you may know, Diamond Pet Food Processors issued multiple product recalls over the last two months. On April 12, only six days after Diamond's first recall, FDA conducted a weeklong...
FDA and Nanotech Regulation: The Smaller it is, the Longer it Takes
Apparently, the smaller something is, the longer it takes to talk about. This is the axiom currently employed by FDA, illustrated by the agency’s recently published guidance on nanomaterials in cosmetics and foods (5 years in the making). While the European Union...
Rick Quinn & John Johnson Author FDLI Article, “FDA’s Illegal Treatment of Brazilian Orange Juice During the Carbendazim Incident”
Did the U.S. Food and Drug Administration act illegally, capriciously and arbitrarily in its treatment of imported orange juice during the carbendazim incident? This is the question that FDAImports.com Principal, Rick Quinn, and Associate Attorney, John Johnson,...
Benjamin England Presents on FSMA Time Bombs: The Sleeper Provisions in FSVP, Bioterrorism, Import Alerts, HARPC and International Trade
FDAImports.com Founder and CEO, Benjamin England, recently presented a webinar with FXConferences entitled “FSMA Time Bombs: The Sleeper Provisions and How to Prepare.” This webinar addressed numerous provisions within the Food Safety Modernization Act that are not...
No More Crying Over Pacifiers: FDAImports.com Persuades FDA to Change ABI System
FDAImports.com achieved a major victory this month, making life easier for importers of pacifiers. The Automated Broker Interface utilized for making entry with U.S. Customs and Border Protection was originally set-up to force importers to notify and submit...
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...
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,...