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:

The Food and Drug Administration on Nov. 5 issued a new guidance document outlining its mandatory recall authority under the Food Safety Modernization Act. The guidance includes a series of questions and answers on the basis for the relatively new authority, the process followed, what foods may be subject to mandatory recalls and how FDA determines whether a recall is necessary. Under FSMA, the “responsible party” for carrying out a mandatory recall is the food facility required to register with FDA that manufactured, processed, packed or held the food. FDA will give facilities a chance to conduct a voluntary recall before it exercises its mandatory recall authority, the agency said.

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 on Nov. 2 issued new guidance documents to assist companies in complying with upcoming changes to nutrition facts labels. A final guidance document issued by the agency includes questions and answers to help manufacturers determine how to calculate added sugars in their products under certain circumstances. Other topics include compliance, label formats, and the declaration of quantitative amounts of vitamins and minerals. Another FDA draft guidance includes information on serving sizes under the new labeling framework, with information on the definition of a single-serving container, reference amounts customarily consumed, dual-column labeling and requirements relating to chewing gum and to multi-unit retail food packages. The new requirements start to take effect in 2020, with small businesses given until 2021 to comply (see 1805030053).

The Food and Drug Administration updated its policy of enforcement discretion for certain unique device identifier requirements for medical devices. In a guidance document that supersedes an earlier one issued in January that delayed UDI requirements for class I and unclassified devices (see 1801120017), FDA is adding new information on its compliance policy for devices that are manufactured before direct marking requirements apply but remain in inventory when those requirements take effect. For class III, LS/LS and class II devices, for which direct marking is already required, FDA will not enforce the requirements even after its three-year grace period if the device’s UDI can be derived from information directly marked on the device, such as catalog numbers, lot numbers or serial numbers. The same approach will apply to class I and unclassified devices once direct marking requirements for such devices take effect, FDA said.

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:

The Food and Drug Administration issued its weekly Enforcement Report for Oct. 31 that lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.

The Food and Drug Administration is amending its color additive regulations effective Dec. 4 to allow the expanded use of synthetic iron oxides in dietary supplement tablets and caplets, it said. That final rule follows another issued the previous day that barred the use of lead acetate in cosmetics intended for coloring hair on the scalp, effective Dec. 3. According to FDA, "new data available since lead acetate was permanently listed demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive."

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: