The Food and Drug Administration on May 11 released a small entity compliance guide to help small businesses comply with newly extended deadlines under the Food Safety Modernization Act. The three-page document refers small businesses to a January guidance document on FDA’s decision to exercise enforcement discretion for written assurance requirements under FSMA, including the Foreign Supplier Verification Program regulations, for importers and other facilities relying on downstream customers to control food safety hazards (see 1801040035). The guidance also said FDA would not enforce certain requirements for food contact substances, some facilities that conduct farm-related activities but aren’t considered farms, as well as human food facilities that perform certain manufacturing and processing activities for "by-products" that will become animal food.

On May 10 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 will allow imports of Atlantic salmon and rainbow trout containing low amounts of the unapproved animal drug benzocaine, it said. Specifically, FDA’s Center for Veterinary Medicine set an import tolerance of 50 parts per billion of benzocaine in muscle with adhering skin for Atlantic salmon and rainbow trout. The import tolerance was requested by ACD Pharmaceuticals, FDA said. Under the Federal Food, Drug & Cosmetic Act, it is unlawful to import animal-derived food that bears or contains residues of an unapproved new animal drug unless an import tolerance has been established for residues of that drug and any residues do not exceed that tolerance, FDA said.

On May 9 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 soon will launch a pilot program to test product tracing requirements in the Drug Supply Chain Security Act set to take effect in 2023, it said in a notice of its request for Office of Management and Budget Approval of the pilot’s information requirements. Under the pilot, FDA will assess the ability of supply chain members, including authorized manufacturers, repackagers, wholesale distributors and dispensers, to satisfy DSCSA Section 582 product tracing requirements; identify, manage and prevent distribution of suspect and illegitimate products; and “demonstrate the electronic, interoperable exchange of product tracing information across the pharmaceutical distribution supply chain,” FDA said. FDA hopes to conclude its pilot within one year of the start date to give it time to consider results before it implements an actual electronic product tracing system in 2023, the agency said.

On May 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 on May 8 issued a draft guidance document detailing the process for obtaining exemptions from Drug Supply Chain Security Act (DSCSA) requirements. Under DSCSA, “trading partners,” including manufacturers, repackagers and wholesale distributors, can request waivers if DSCSA requirements cause undue economic hardship or a waiver is appropriate for emergency medical reasons, or exemptions in order to maintain public health. Manufacturers and repackagers can also request exemptions if the product is packaged in a container too small to bear information required by DSCSA. Comments are due July 9.

On May 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:​

On May 3 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 is amending its regulations on food additives permitted in feed and drinking water of animals to allow dried marine microalgae as a source of docosahexaenoic acid (DHA) for use in complete, dry foods for adult dogs, FDA said. DSM Nutritional Products filed the underlying petition. The final rule takes effect May 7.