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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...
FDA Orders Juul E-Cigarettes Off the Market, Citing Insufficient and Conflicting Data
On Friday, June 24, 2022, the U.S. Food and Drug Administration (FDA) denied an application to continue selling menthol and tobacco-flavored e-cigarette cartridges manufactured by Juul Labs Inc. FDA ordered the removal of these products from the market, citing these...
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...
FDA Proposes Collection of Information on Structure/Function Claim Notification Procedures
Structure/function claims commonly appear on dietary supplement labeling, both as a marketing tool and as a means of conveying the benefits of the supplement. Structure/function claims are claims that describe the role of a nutrient or dietary ingredient intended to...
FSIS Recalls Siluriformes Imported from China, Consumers Potentially Still in Possession
Earlier in June, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) and Yumei Foods USA, Inc., announced a recall of over 9,000 pounds of processed Siluriformes imported from the People’s Republic of China. China is eligible to import raw...
CDER Issues Warning Letter on Drug Product Listing
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...
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...
FDA Issues Notices to Food Facilities with Inadequate UFI Status
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,...