Is It, or Isn’t It? Should FDA Add Other Food Allergens to the Major Food Allergen List for Labeling?
On Tuesday, April 19, the U.S. Food & Drug Administration (FDA) published a draft guidance titled Evaluating the Public Health Importance of Food Allergens Outside of the Official List of Major Food Allergens Listed in the Federal Food, Drug, & Cosmetic Act,...
Consequences of FSVP Non-Compliance…
Did you know that your imported entry of food can be refused admission into the United States if it appears that you failed to comply with the requirements of the Foreign Supplier Verification Program (FSVP)? Over the course of the last five years, FDA’s mantra has...
Alcoholic Beverage Labeling: FDA or TTB?
Alcoholic beverages are an area of equal, albeit for somewhat separate reasons, interest for both the Food and Drug Administration (FDA) and the Tax and Trade Bureau (TTB). By law, FDA has jurisdiction over “any article used as food or drink for man or other animals.”...
FDA Imposing Compliance Penalties Due to Inaccurate Food Facility Registrations
The U.S. Food & Drug Administration (FDA) recently increased its focus on auditing and imposing penalties for food companies who registered with FDA using misleading and/or inaccurate information. Entities engaged in food manufacturing, processing, packing, and...
FSVP – Five Years After Roll Out, Importers Receive A Failing Grade
It has been nearly five years since FDA began inspections under the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP) regulations. Based on inspectional data from FDA’s Data/Compliance Dashboard for the last three years (2019-2022...
US Senator Requests Immediate Action on Food Safety Efforts from FDA Commissioner
Chairperson of the Senate Health, Education, Labor, and Pensions (HELP) Committee, U.S. Senator Patty Murray (D-WA), recently sent a letter to the Food and Drug Administration (FDA) Commissioner, Robert Califf, insisting on action following a report from Politico...
FDA Now Requiring Annual Report of Drug Product Manufacturing Volumes for 2020, 2021 and Beyond
In March of 2020, the US Congress and President Trump signed into law the Coronavirus Aid, Relief, and Economic Security (CARES) Act to help mitigate the economic and health consequences caused by the COVID-19 pandemic. One requisite of the CARES Act was to heighten...
FDA has Revoked Three EUAs for Medical Devices that Detect/ Diagnosis COVID-19
In July and August of 2021, the Food and Drug Administration (FDA) announced the revocation of the Emergency Use Authorizations (EUAs) for Gravity Diagnostics, LLC for the Gravity Diagnostics COVID-19 Assay, Materials and Machines Corporation of America for the...
FDA’s New OTC Drug Facility User Fees Announced – OMUFA Fee Not Tied to Registration Renewal Season
In March of this year, the Center for Drug Evaluation and Research (CDER) branch of the Food and Drug Administration (FDA) implemented a new fee under the OTC Monograph User Fee Program (OMUFA). The fee was required of all facilities that produced OTC monograph drugs...
CDER Now Requiring Confirmation of U.S Agency for NDC Labeler Code Requests
Effective summer 2021, the Center for Drug Evaluation and Research (CDER) requires confirmation of U.S. Agency assignments for National Drug Code (NDC) drug labeler code requests submitted to the Food and Drug Administration (FDA). If the U.S. Agent has not been...