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The Constitution authorizes Congress to pass laws and the President signs the laws.Acts of Congress, e.g. Food, Drug and Cosmetic Act, are codified in the “United States Code,” (U.S.C.)The executive departments and agencies like U.S. FDA then promulgate “regulations.” Regulations are promulgated through a lengthy process called "Notice and Commentary," to satisfy the requirements of the Due Process Clause of the U.S. Constitution.
Proposed regulations, notices, public commentaries, agency responses to the commentaries, and eventually the final regulations are published in the “Federal Register”(FR) as they occur.
Title 21 of the CFR is reserved for the regulations of the Food and Drug Administration.
Melamine in pet foodIllegal antibiotics in aquacultureBetter detection of common pathogens, and strains of new pathogens.
Port-of-Entry inspections cannot handle the increase in imported foods (9,900,000 entries in 2010 / 27,000 per day). While we all know of the main ports, there are in fact over 300 ports-of-entry.
Covers most fruits and vegetables while in their raw or natural (unprocessed) state. Exemptions include agricultural commodities rarely consumed raw, those produced for personal or on-farm consumption, and those destined for commercial processing (such as canning).
Effective Date: 60 days after final rule is published and phased in based on business size
(FDA granted an extension in 2012 until January 31, 2013 due to technical glitches)
Prior to January 31, 2013, there were approximately 278,000 foreign food facility registrations (171,000 domestic)
No messages by FDA were sent to registrants explaining the requirement to renewFDA purged database starting in March 2013Numbers reduced to 74,000 foreign and 55,000 domestic
Many companies discover they have been purged only when shipment is trying to be cleared through PNSI or ABI
The entire detention period may not exceed 30 calendar days An administrative detention order is approved by the Director of the FDA District
All importers must establish, maintain, and follow a FSVP for each food it imports unless otherwise exempted.Importers must perform risk-based activities to verify that the imported food has been produced in a manner that provides the same level of public health protection as that required of domestic food producers
Import Alerts and OASIS are public records on the Internet. Your buyers will be privy to most issues FDA may have with you.
A DUNS number is issued by the private US company Dun and BradstreetFree of charge, but can take several weeksDun and Bradstreet offers other types of verification and financial services