On May 23, 2022, the Food and Drug Administration’s (FDA) Center for Drug Evaluation & Research (CDER) issued a public warning letter to Grimann S.A. de C.V. concerning contradictory information between their product labeling and their electronic drug product...
On June 8, we reported that the Animal and Plant Health Inspection Services (APHIS) division of the United States Department of Agriculture (USDA) Plant Protection and Quarantine (PPQ) announced a new policy requiring those who import earthworms into the United States...
Update 06/09/2022 On June 9th USDA announced that they have again extended the deadline for earthworm importer compliance. Check back here for more updates. Original Post 06/08/2022 The Animal and Plant Health Inspection Services (APHIS) division of the United States...
During the 2020 biennial renewal period, the U.S. Food & Drug Administration (FDA) began requiring food facilities to include a unique facility identifier (UFI) on their registration. The required UFI must be a DUNS number obtained through a third-party company,...
On Tuesday, April 19, the U.S. Food & Drug Administration (FDA) published a draft guidance titled Evaluating the Public Health Importance of Food Allergens Outside of the Official List of Major Food Allergens Listed in the Federal Food, Drug, &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,...
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 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.”...
Update 06/03/2022: The next food facility registration renewal period begins October 1st and continues through December 31st. In preparation for this upcoming renewal season, FDA recently began validating the UFI status of existing registrations. The information...
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...
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...
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