Dried Fish, Import Alert 16-74 & FDA
As a popular soup ingredient, dried fish is frequently imported to the United States – usually not eviscerated. Import Alert 16-74 is an Alert specifically focused on uneviscerated fish: the Alert instructs FDA’s compliance officers to detain (and ultimately refuse,...
Shrimp Importers: FDA Issues Countrywide Import Alert for Aquaculture Shrimp from Peninsular Malaysia
On Monday, April 18th, FDA published a new countrywide import alert (16-136) subjecting all aquaculture shrimp and prawns “from processors from Peninsular Malaysia” to FDA automatic detention (or detention without physical examination), alleging that all such product...
Dietary Supplement Importer Challenges an Unfair FDA Decision – And Wins
Recently, an importer sought help from our firm because FDA refused its shipment of an herbal supplement after FDA tested the product and alleged that the amount of a certain nutrient in the product was significantly lower than the amount declared on its Supplement...
USDA Regulating Catfish: Imports Implementation Delayed
In late 2015 the U.S. Department of Agriculture (USDA) issued the final rule for transferring jurisdiction for catfish from FDA to USDA. Given the burden of the new regime, the Final Rule includes an 18-month transitional period. USDA had planned to begin the...
Who‘s Who in FSVP: Importer, Foreign Supplier
Part 1 of this series discussed the first step of compliance with the Foreign Supplier Verification Program regulations: determining who needed an FSVP. In this blog, we will discuss identifying the key parties in FSVP: the “foreign supplier” and the “importer.” These...
Foreign Supplier Verification Program: Who Needs One?
FDA issued the final rule for the Foreign Supplier Verification Program (FSVP) last week. This final rule is the first step in implementing the Food Safety Modernization Act’s (FSMA’s) mandate that U.S. importers verify their foreign manufacturers’ compliance with...
Labeling For Medical Products Not Made With Natural Rubber Latex
Some manufacturers label or promote their products as “latex free” or “does not contain latex” to inform users that natural rubber latex in any of its forms was not used in their product. In a guidance document titled "Recommendations for Labeling Medical Products to...
Seafood and Juice Industry: Pay Attention, the HARPC Final Regulation Affects You Too!
The seafood and juice industry largely sat on the sidelines while FDA worked with the rest of the food industry to develop the recently finalized Hazard Analysis, Risk-based Preventive Controls (alternatively known as HARPC, Preventive Controls Rule, or PC Rule). This...
Renewal Season Starts October 1 – Are You Ready?
Between October 1 and December 31 every year, FDA-registered facilities around the world must submit renewals to their registrations (except registered food facilities, which must renew every even-numbered year). If your facility is registered with FDA, then this...
Preparing for FDA’s Final Ruling on the Foreign Supplier Verification Program (FSVP)
FDA plans to publish the final rule for the Foreign Supplier Verification Program (FSVP) on October 31, 2015 under the Food Safety Modernization Act (FSMA). This rule will require U.S. food importers to adopt an FSVP, verifying that the foods they import are safe and...