Does Shall mean Must and Is FDA “Release With Comment” Dead After Cook v. FDA?
A recent ruling by the DC Appellate court may have drastic implications for FDA’s ability to “Release with Comment” entries that contain FDA violations. In Cook v. FDA, prisoners on death row brought suit against FDA complaining that the Agency failed to refuse...
FDAImports.com at Mindanao Exporters Congress – Presentation, Consultation, and Opportunity
Rick Quinn, Partner at Maryland-based international FDA consulting firm FDAImports.com, will be attending and presenting at Mindanao Exporters Congress. The show will be held at the SMX Convention Center of the SM Lanang Premier, in Davao City, Philippines, from...
Exporting Papayas to the United States – Green Ticket Seminar
On July 19, in San Diego, Partner Rick Quinn of FDAImports.com will be offering a seminar, for growers, exporters, and importers of papaya from Mexico, teaching how to be added to the Green List for Import Alert 21-17 (Countrywide Detention Without Physical...
Centers for Excellence and Expertise: AAEI Brings the First Look
At the American Association of Exporters and Importers’ recent seminar called “Partnering with OGAs on Risk Management and Globalization,” attendees discussed FDASIA, the U.S.-E.U. Mutual Recognition Agreement, and Good Importer Practices – all things one would expect...
FDASIA’s Impact on Drug Imports: Give Feedback to FDA
The Food and Drug Administration Safety and Innovation Act (“FDASIA”), which was signed into law on July 9, 2012, has serious consequences for the drug industry, particularly in the import/export sector. Some of the changes upcoming from FDASIA include Increased...
Successful Release of Detained Dates with Fenvalerate
FDAImports.com successfully obtained an FDA Release of an entry of dates which contained an adulterating pesticide, even though the law technically prohibits bringing foods adulterated with pesticides into the United States. The Environmental Protection Agency...
FDAImports.com and Benjamin L. England and Associates Add Attorney, Regulatory Specialist, and Administrative Associates
FDAImports and Benjamin L. England and Associates, LLC continue to expand in their efforts to provide quick, competent, satisfying legal and regulatory counsel to FDA- and USDA-regulated companies around the world. Join us as we welcome an attorney, a regulatory...
Organic Products and GMOs – Oil and Water
USDA’s most recent installment in its series of blogs called Organic 101, which teaches readers about many different aspects of USDA Organic regulations, addresses the question of Genetically Modified Organisms (GMOs) in Organic products. For an establishment or...
Success Story: Removal from Import Alert 99-29
FDAImports.com again successfully obtained a Green Ticket for a manufacturer from Import Alert 99-29 (automatic detention of all vegetable protein products from China for melamine). The team of experienced regulatory professionals at FDAImports.com understood the...
Reflections from IFEX Philippines: A Bright Future
Ben England and Olivia Zuniga of FDAImports.com, an international FDA consulting firm, had a fantastic experience attending and presenting at IFEX Philippines. During the exhibition, Mr. England presented two expert trainings; on the first day, he spoke to industry...