The Food and Drug Administration is amending standards for general biological products to remove outdated and duplicative requirements, it said in a direct final rule (here). Among other changes, the agency is changing standards relating to dating periods and removing some provisions on standard preparations and limits of potency, it said. The direct final rule takes effect Sept. 16, 2016, unless FDA receives comments opposing the changes and withdraws the amendments. FDA also issued an identical proposed rule (here) it will consider if it withdraws the direct final rule.

The Food and Drug Administration recently updated its compliance policy guide (here) for FDA staff on when seizure and import refusal is appropriate for crabmeat that is contaminated with e. coli bacteria. According to the updated guide, seizure and import refusal is automatic if sampling detects e. coli at levels of 3.6 MPN/g or greater in two of six subsamples. An FDA officer may recommend seizure or import refusal if e. coli is detected at levels of 3.6 MPN/g in only one of six subsamples but other evidence also suggests inadequate cooking or contamination after cooking.

The Food and Drug Administration outlined factors it will consider when deciding whether to enforce drug application and registration requirements for cat and dog food that purports to treat disease, in a recently published compliance policy guide (here). According to the document, dog and cat food intended to treat and prevent disease are animal drugs subject to listing, registration and current good manufacturing practice requirements, but FDA has generally not enforced these requirements even though it considers dog and cat food that doesn’t meet them adulterated and misbranded. FDA has said it has seen an increase in non-compliant dog and cat food, and directed its officers to follow a set of criteria outlined in the guide when deciding whether to initiate enforcement action, including ingredients, labeling, safety risks and whether the animal food is distributed by veterinarians.

On April 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On April 28 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 April 27 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 April 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 is asking for comments on a proposal to withdraw provisions of its food additive regulations that allow for the use of two perfluoroalkyl-containing substances as water and oil repellants for paper and paperboard in contact with aqueous and fatty foods (here). The proposal is based on a petition from 3M, which says the substances are no longer used for that purpose. Comments are due June 28, and should address whether these uses have been completely abandoned, “such as information on whether food-contact paper and paperboard containing the two respective substances are currently being introduced or delivered for introduction into the U.S. market,” said FDA.

On April 26 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

During the week of April 18-24, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of: