On Dec. 22 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 announced revisions to its Compliance Policy Guide on labeling of processed and blended seafood products made primarily with fish protein (here). Changes to the guide, which is used by FDA staff, include revisions for “clarity and format, with new sections on regulatory action guidance and specimen changes.
The Food and Drug Administration is finalizing guidance on the labeling of beers that are subject to FDA jurisdiction (here). Certain beers, which are not made from both malted barley and hops but are instead made from substitutes for malted barley (such as sorghum, rice, or wheat) or are made without hops, do not meet the definition of a “malt beverage” under the Federal Alcohol Administration Act. Such products (other than sake, which is classified as a wine under the FAA Act), are not subject to the labeling provisions of the Alcohol and Tobacco Tax and Trade Bureau, and instead must follow FDA labeling regulations. FDA’s guidance explains the application of its labeling regulations to non-TTB regulated beers.
On Dec. 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 18 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. 17 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 Dec. 17 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 Dec. 18 issued guidance on standards for children’s toy laser products while the agency’s own rules are in development. In 2013, FDA proposed a rule to define children's toy laser products and require them to be within the International Electrotechnical Commission (IEC) Class 1 emission limit. While it works on the final rule, FDA is recommending that manufacturers keep children’s toy laser products within the FDA Class I or IEC Class 1 emission limits, it said in the guidance (here). However, because IEC Classes 1M and 2M “do not have comparable analogs in FDA’s classification system,” manufacturers should not conform to these standards unless they also comply with FDA performance standards, said FDA.
On Dec. 16 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 Dec. 8-14, 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: