Update On DUNS Requirement for 2022 Food Facility Registrations
In October of 2020, the Food and Drug Administration (FDA) introduced the requirement for all food facility registrations to include a UFI (Unique Facility Identifier). Currently, FDA has only approved Data Universal Numbering Systems (DUNS) numbers for use as UFIs...
FDA Draft Guidance for Nonprescription Drugs Should Improve Labeling Consistency to Empower Consumer Choice
During the first full week of September, the Food & Drug Administration (FDA) released a draft guidance titled “Statement of Identity and Strength–Content and Format of Labeling for Human Nonprescription Drug Products.” This guidance outlines suggestions for...
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...
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...