HACCP Plan: all domestic and foreign facilities who produce, process, pack, distribute, receive, hold or import are required to assess all hazards that could affect food, implement risk-based preventative controls, and maintain records that must be stored and shown to FDA inspectors upon request. This must be done according to a standard HACCP (Hazard Analysis Critical Control Points), which must include documents related to food allergens and recall procedures.
Importer Liability: As of October 2011, importer are required to verify the product safety of all their foreign supplier (Foreign Supplier Verification Program) based on the supplier’s risk profile. Each shipment must be accompanied by a safety audit certification that needs to be checked and verifies by the importer. Importers who sell food without verifying their safety may be subject to injunction or criminal prosecution.
Grey Market Imports:The new law (Sec. 309) requires the FDA to “develop and implement a strategy to better identify smuggled food and prevent entry of smuggled food into the United States. “Smuggled food” means “any food that a person introduces into the United States through fraudulent means or with the intent to defraud or mislead” FDA is particularly concerned about adulterated or misbranded food (for example missing allergen declarations) and can order an immediate recall solely based on suspicion that a food may be harmful to consumers. Grey market importers certainly will face a higher financial risk if their products are not labeled correctly.