On Dec. 13 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 Dec. 13 that lists the status of recalls and field corrections for food, drugs, biologics and devices. The report covers both domestic and foreign firms.

The Food and Drug Administration on Dec. 12 issued a draft guidance document on labeling of drugs that have gluten-containing ingredients or are gluten-free. Though FDA said it is not currently aware of any, FDA says any oral drug products that use wheat gluten, wheat flour or wheat starch as an intentionally added ingredient should be labeled to indicate its presence. Ingredients derived from wheat starch or fermented from wheat likely have very low levels of gluten, FDA said. Unintentional contamination of drugs by wheat-derived ingredients would likely result in very low amounts, but such drugs may nonetheless be subject to enforcement action due to violations of current good manufacturing practice (CGMP) requirements, FDA said. Comments on the draft are due Feb. 12.

The Food and Drug Administration on Dec. 11 issued a new draft guidance document explaining its authority to refuse entry to food from factories and countries that have not permitted or refused FDA inspections, as provided for by the Food Safety Modernization Act (see 11010426). FDA will refuse admission to food from foreign food facilities that refuse or impede an FDA inspection, placing them on Import Alert 99-32, and may place entire countries on that import alert if it finds the country is refusing FDA inspections for all food establishments. Comments are due Feb. 26.

On Dec. 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Dec. 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 issued its weekly Enforcement Report for Dec. 6 that lists the status of recalls and field corrections for food, drugs, biologics and devices. The report covers both domestic and foreign firms.

On Dec. 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Dec. 5 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 extending until Feb. 5, 2018, the period for comments on existing FDA regulations and related paperwork requirements that could be modified, repealed or replaced to reduce burdens on industry, it said. The effort is part of implementation of recent executive orders issued by President Donald Trump on reducing and reforming regulations, FDA said. The agency issued notices in September seeking comments on regulations and paperwork requirements related to biologics, medical devices, drugs, foods, tobacco products and veterinary medicines, as well as regulations and paperwork requirements that may cut across several of its product-based centers (see 1709070029).