On March 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration issued its weekly Enforcement Report for March 7 that lists the status of recalls and field corrections for food, drugs, biologics and devices. The report covers both domestic and foreign firms.

The Food and Drug Administration is proposing to find the European Union’s food safety system for bivalve molluscan shellfish intended for export to the U.S. is equivalent to the U.S. food safety system, it said in a notice. If finalized, the determination would allow importation of shellfish from certain areas in the EU and processed by establishments listed on FDA’s Interstate Certified Shellfish Shippers List, FDA said in a constituent update. Separately, the EU is in the process of finalizing a similar proposed equivalence determination that would allow export of certain EU shellfish to the EU, FDA said. Comments are due May 23.

The Food and Drug Administration posted a list of importers identified on entries of food subject to FDA’s Foreign Supplier Verification Program (FSVP) regulations. Required by the Food Safety Modernization Act, the list will be updated quarterly, FDA said on its website. It is currently is over 1,300 pages long, though some names of FSVP importers appear to be duplicates with minor differences in punctuation or spelling. “In the event a discrepancy is detected; the incident should be reported to FDA for further investigation and remedial action by emailing: ORAFSVPImporter@fda.hhs.gov,” FDA said.

On March 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On March 5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On March 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration recently issued a guide to assist small businesses in complying with changes to nutrition facts labeling rules announced in 2016 (see 1605200021). FDA’s small entity compliance guide explains “in plain language” who is, and what foods are, subject to the rules, how to comply with new serving size requirements and consequences for non-compliance with the regulations. The compliance date for the changes, which also affect the information that must be included on nutrition facts labels, serving sizes and labeling format, is currently unknown, with FDA proposing in 2017 to extend the deadline into 2020 at the earliest (see 1709290014). “A final determination regarding the compliance dates is pending,” FDA said in its guide.

On March 1 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration recently issued a draft guidance document clarifying certain product verification responsibilities for entities subject to the Drug Supply Chain Security Act (DSCSA). Under DSCSA, manufacturers, repackagers, wholesale distributors and dispensers of drugs must be able to identify a suspect product and make a determination about whether that product is an illegitimate product. Product may be considered suspect or illegitimate because it is counterfeit or diverted, subject to a fraudulent transaction or appears to be unfit for distribution, among other things. FDA’s draft guidance provides definitions for these terms to assist companies subject to DSCSA in complying with the verification requirement. Comments are due April 2, FDA said.