Conclusion on FDA, Swordfish, and Methyl Mercury
In April 2015, we commented on how FDA cancelled Import Alert 16-08 (Detention without Physical Examination of Swordfish for Methyl Mercury). This alert instructed FDA to automatically detain all swordfish imports unless the manufacturer was on FDA’s Green List....
Breakthrough in the Use of Symbols in Medical Device Labeling
The Food and Drug Administration (FDA) issued the final rule for using symbols in labeling of medical devices and certain biological products.[1] The rule will be effective mid-September 2016. Specifically, the new regulations allow symbols to “stand alone”, i.e.,...
Congress’ New Move on Catfish Inspection and the Implications
Recently, Congress made a new move to nullify the USDA rule published in December 2015 to establish a catfish inspection program under USDA's Food Safety and Inspection Service (FSIS). On May 25, 2016, the Senate passed a joint resolution to disapprove USDA’s...
What Will the Updated Nutrition Facts Panel Mean for the Food Industry?
UPDATE 6/5/2018: Editor’s Note: On May 4, 2018, FDA published a rule stating it will be extending the compliance dates for the Nutrition Facts panel and Serving Size Final Rules to January 1, 2020 for manufacturers with $10 million or more in annual food sales....
USDA Jurisdictional Transition over Catfish Imports Proceeds
As we’ve reported previously, the transition to U.S. Department of Agriculture (USDA)’s regulation of catfish imports was briefly delayed. However, jurisdiction for catfish imports has been moved from FDA to USDA effective April 15, 2016. On that same day FDA removed...
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...