FSVP Records Submission to FDA Now has a Portal on FURLS to Streamline Process
The Foreign Supplier Verification Program for Food Importers (FSVP) is one of the most significant Food Safety Modernization Act (FSMA) provisions and greatly impacted the food industry. On May 10, 2021, the Food and Drug Administration (FDA) opened a specific “FSVP...
Kratom-Navigating the Murky Regulatory Waters
On March 29, 2021, the Food and Drug Administration (FDA) updated and republished Import Alert 54-15, which allows for the detention without physical examination of dietary supplements containing Mitragyna Speciosa, otherwise known as Kratom. Kratom is a botanical...
Is Sesame Going to be a New Major Food Allergen?
Update 04/27/2021 On April 23, President Biden signed the FASTER Act into law, requiring that all packaged food labels disclose sesame ingredients beginning January 1, 2023. Orignal Post 04/05/2021 Sesame is a common ingredient in many of the foods in the U.S.,...
OTC Drug User Fees Officially Republished for FY 2021
On March 26, 2021, the Food and Drug Administration (FDA) republished the Over the Counter (OTC) Monograph Drug user fee rates for the fiscal year 2021 under the OTC Monograph Drug User Fee Program (OMUFA). While most OTC facilities will now be required to pay a...
Now is the Time to Reevaluate Your Foreign Supplier Verification Program
As an importer, once you have completed Foreign Supplier Verification Programs (FSVP) for each of your food items from your foreign suppliers, you can file away your documents until a time when the Food and Drug Administration (FDA) requests to conduct an inspection...
FDA’s New OTC Drug Facility User Fees Announced
Fee rates for OTC monograph drug facilities set by FDA.
FDA Initiates Grace Period for Providing Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Season
UPDATE 04/01/2021:On March 30, 2021, FDA announced that they are further extending the UFI deadline for Food Facilities until December 31, 2022. This is the second extension of this kind in response to industry concerns that food facilities were unable to obtain a UFI...
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) 2020 – Is your OTC Drug Company Ready?
UPDATE on Dec 30, 2020: FDA publishes new OTC drug user fees, read more here. Sep 9, 2020: On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to aid response efforts and ease the economic impact of COVID-19. In...
Food Facility Registration to Require DUNS Number and Renewal Season Approaches
Beginning October 1, 2020, FDA will require a unique facility identification (UFI) number when registering food production facilities. Right now FDA has only approved Data Universal Numbering Systems (DUNS) numbers for use as UFIs for food facility registration. DUNS...
FDA Announces New and Updated Drug and Medical Device User Fees
UPDATE Dec 30, 2020: FDA publishes new OTC drug user fees, read more here. Aug 27, 2020: FDA has officially announced the updated drug and medical device fees for the 2021 fiscal year (October 1, 2020 – September 30, 2021). This includes fees associated with the newly...