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...
The Food & Drug Administration (FDA) has begun to apply Import Alert 99-29, "Detention Without Physical Examination of All Vegetable Protein Products From China for Animal or Human Food Use Due to the Presence of Melamine and/or Melamine Analogs," to imported...
FDA has officially announced the updated medical device fees for the 2022 fiscal year (October 1, 2021 – September 30, 2022). All medical device manufacturers, importers, and distributors must pay an annual establishment registration fee to FDA. Please do not wait...
On Friday, July 23rd, a bipartisan group of Senators introduced legislation that, if enacted, would require the manufacturers of e-cigarettes, vaping products, and other forms of electronic nicotine delivery systems (ENDS) to pay annual user fees to the Food and Drug...
Our team has noted a recent and significant uptick in the Food and Drug Administration’s (FDA) enforcement with respect to seafood imports. Specifically, FDA has been heavily encouraging the use of the draft guidance document entitled “Reconditioning of Fish and...
In 2012 FDAImports represented a Chinese primary vegetable protein processor to obtain the first Green Ticket from the Food and Drug Administration's (FDA) Import Alert (IA) #99-29. Since then, multiple other Chinese vegetable protein processors have obtained a Green...
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...
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...
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.,...
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...
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