On February 9, 2024, FDA issued “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s...
Imports
Cosmetic Regulation (Finally) Modernized…at Least in the Coming Years
After several decades, the U.S. Food and Drug Administration (FDA) will soon be required to update its regulation of cosmetic products following the amendment to Chapter VI of the federal Food, Drug, and Cosmetic Act (FDCA) as a part of the “Modernization of Cosmetics...
Seafood HACCP Implementation for Foreign Suppliers
The Food & Drug Administration’s (FDA) Hazard Analysis and Critical Control Points (HACCP) principles and practices started as a joint project between NASA and Pillsbury in the 1960s. The goal of HACCP was to ensure safe food for NASA’s astronaut program. Since...
MonkeyPox Declared as Public Health Emergency Medical Device companies Should Begin Preparing Now for EUA Submissions
The Biden administration has declared monkeypox to be a public health emergency in the United States. This is going to likely result in emergency use authorizations (EUAs) for medical products to diagnose and perhaps even reduce the symptoms related to the spreading...
FDA Calls on Companies to be “Recall Ready”…Are You?
On March 3, 2022, the U.S. Food & Drug Administration (FDA) issued a guidance, “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff,” to help companies prepare for voluntary recalls. Part 7 of Title 21 of the Code of...
WARNING: FSVP Importers, Time is Running Out
Beginning July 24, 2022, consistent with 21 CFR 1.509(a), food importers will be required to ensure that their valid, 9-digit DUNS number is provided in the Entity Number field. As an Importer, what does this mean for you and your operation? Simply...
Mandatory Product Listing For Dietary Supplements
The Food and Drug Administration (FDA) is getting closer to requiring manufacturers and distributors of dietary supplements to list their products on a public FDA electronic database. On Tuesday, June 14, 2022, the US Senate Committee on Health, Education, Labor, and...
Deadline for Earthworm Importers Extended: Act Now for Permit Application to Avoid Likely Setbacks
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...
USDA Updates Policy for Importing 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...
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,...