FDA Registration and Listing: Fact or Fiction?
Over the years we’ve worked with hundreds of companies to get their facilities registered and their products listed so they can meet their obligations, during which, we’ve come across a lot of misconceptions about registration. Here are some of the primary issues we...
FDA Implementing FSMA: Program Realignment Building a Firm Foundation
FDA is full-speed ahead with rolling out the Food Safety Modernization Act (commonly referred to as “FSMA”). With FSMA, FDA seeks to overhaul the U.S. regime for food safety – from a regime that reacted to safety outbreaks to one that seeks to preventive them. A key...
How Will FDA Handle Food Imports: Effects of FDA Program Alignment and FSVP
The U.S. relies heavily on imported food to meet our demand for international cuisine and fresh produce year round. In 2011 we reported that 20% of the food Americans eat each year is imported (How Much of U.S. Food Is Imported?). At that time FDA was just beginning...
Customs Sets Effective Date of ACE for Various Remaining Transactions
Customs and Border Protection (CBP) has announced and set July 8, 2017 as the effective date for reconciliation, duty deferral, drawback, collections and statement capabilities in the Automated Commercial Environment (ACE). Please be advised that the previously used...
Immediate Enforcement Crackdown on FSVP? Not so Fast
UPDATE 01-29-2018 : The next compliance date is March 19, 2018 for most food importers (who purchase food from foreign suppliers with fewer than 500 FTEs) . FDA’s Foreign Supplier Verification Plan (FSVP) first implementation date was May 30, 2017, which had...
Relief for Newly Deemed Tobacco Products: 3 Month Compliance Reprieve
In an email to stakeholders on May 1st FDA alerted the “deemed” tobacco products industry that FDA intends to delay enforcement of all compliance deadlines concerning newly deemed tobacco products for 3 months. Though, this did not come through the usual FDA channels,...
Seafood Regulation under the New Administration: Insights from our Government Panel at Seafood Expo North America
This year the FDAImports.com Government panel at Seafood Expo North America in Boston was again well attended, well reviewed and full of lively dialogue about where the Food & Drug Administration and U.S. Customs & Border Protection are going with respect to...
DUNS Numbers to Play Role in FSVP Compliance
UPDATE: Acceptable temporary Unique Facility Identifier FDA announced that FSVP Importers who do not yet have a DUNS number will be allowed to submit entries using "UNK" (unknown) following the May 30, 2017 compliance date. FDA is allowing this on a temporary basis...
FDA Law and Consulting Practices Expand to South Florida and Hire New Senior Attorney
FDAImports.com, A Fast Growing Consulting Practice Strengthens Resources Miami, FL – Consulting practice FDAImports (http://www.fdaimports.com) is pleased to announce that Roy León, has joined the firm to further develop our growing portfolio of regional and national...
This is a What … Unforeseen Pitfalls when Classifying a Medical Device
Editor’s note: This blog by affiliated attorneys John Johnson and Schevon Salmon was originally published by greenlight.guru. “This is a what” is not only a torturous summer-camp game, but an essential question when working to bring a medical device to market. An...