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
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...
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...
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,...
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On Tuesday, April 19, the U.S. Food & Drug Administration (FDA) published a draft guidance titled Evaluating the Public Health Importance of Food Allergens Outside of the Official List of Major Food Allergens Listed in the Federal Food, Drug, &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,...
Consequences of FSVP Non-Compliance…
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 Beverage Labeling: FDA or TTB?
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.”...
FDA Imposing Compliance Penalties Due to Inaccurate Food Facility Registrations
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...