The Food and Drug Administration issued a new edition of its guidance document on medical foods (here). The second edition of its guidance titled “Frequently Asked Questions About Medical Foods” gives “responses to additional questions about the definition and labeling of medical foods, types of diseases and conditions that a medical food could be used to manage, and updates prior responses from the previous edition of the guidance,” said FDA in its announcement of the new guidance (here). Medical foods are “specially formulated and processed for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary food or certain nutrients, or who has other special medically determined nutrient requirements that cannot be met by modification of a normal diet alone,” said FDA.

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:

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:

On May 6 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 May 4 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.

The Food and Drug Administration will hold three one-day public meetings in June to discuss its implementation of “prevention-oriented import safety programs” under the Food Safety Modernization Act, it said (here). At meetings on June 7 in Costa Mesa, Calif., June 15 in Rutherford, N.J., and June 21 in Detroit, Mich., FDA will give importers the chance to have an “in-depth discussion” on implementation of the Foreign Supplier Verification Program (FSVP), regulations on third-party certification bodies, and the Voluntary Qualified Importer Program (VQIP). FDA officials and importers will discuss the “next phase” of implementation, “which includes establishing the operational framework for these programs and plans for guidance documents, training, education, and technical assistance,” said FDA. Registration is (here).

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:

On May 2 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 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.