On Nov. 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 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 published two small entity compliance guides to help small businesses comply with new Food Safety Modernization Act regulations on preventive controls for human food (here) and animal food (here). Foreign and domestic human food facilities have been required to comply with certain provisions of the human food rule since Sept. 19, and must comply with the animal food rule beginning in September 2017, though small businesses have an additional one to two years to comply, depending on size. Importers must generally begin verifying their suppliers' compliance with these rules about six months after a supplier is required to comply, though no earlier than May 2017.
On Oct. 31 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 28-29 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The Food and Drug Administration issued draft guidance (here) on how to comply with Food Safety Modernization Act regulations that allow food facilities and importers to rely on downstream customers to control food safety hazards. Included under FSMA regulations on produce safety, preventive controls for human and animal food and the Foreign Supplier Verification Program, the regulations require a disclosure statement, in documents accompanying food, that certain hazards have not been controlled by the food facility or importer. According to the draft guidance, the statement may be provided using a “wide variety of types of documents that accompany the food, such as labels, labeling, bill of lading, shipment-specific certificates of analysis, and other documents or papers associated with the shipment that a food safety manager for the customer is likely to read,” though it is “not sufficient to reference a website in a document of the trade without including the disclosure statement, itself, in the document of the trade,” FDA said. In FSVP disclosure statements, importers may identify biological hazards using general terms (i.e., not describing the specific microbe), but chemical and physical hazards must be described specifically, the draft guidance said. Comments on the draft are due May 1, FDA said (here).
On Oct. 27 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 Oct. 26 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.
On Oct. 26 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 25 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: