The Food and Drug Administration is proposing to reclassify rapid influenza detection test systems from class I to class II. The reclassification would apply to antigen-based rapid influenza virus antigen detection test systems used to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents. It would make the test systems subject to premarket notification, and would designate special controls the agency deemed necessary for safe use. FDA would also change the name of the products to "influenza virus antigen detection test systems.” Comments on the reclassification are due by Aug. 7.
On May 20 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 19 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 will allow use of the high-intensity sweetener advantame as a food additive, except in meat and poultry, it said in a final rule that takes effect May 21. The free-flowing, water soluble, white crystalline powder can now be used as a general-purpose sweetener and flavor enhancer in baked goods, non-alcoholic beverages (including soft drinks), chewing gum, confections and frostings, frozen desserts, gelatins and puddings, jams and jellies, processed fruits and fruit juices, toppings and syrups, it said. FDA says it evaluated a variety of animal and human studies, and found the additive to be safe. Advantame is the sixth high-intensity sweetener approved by FDA, it said in a concurrent constituent update (here). Objections and requests for a hearing on the final rule are due June 20.
During the week of May 12-18, 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:
On May 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
Two fish importers in New York have been put on notice by the Food and Drug Administration that their products may be refused admission at the border. Galil Importing Corp. of Syosset (here) and Eddie's Place (dba Esther Kwakyewa) of the Bronx (here) were each recently sent warning letters detailing alleged violations of seafood hazard analysis and critical control point (HACCP) regulations.
The Food and Drug Administration posted to its website information requesting exceptions from provisions of its new rules on unique device identifiers (UDIs) for medical devices (see 13092020). The webpage includes information on requests for exceptions or alternatives to UDI requirements; time extensions for applicability of UDI rules to Class III devices; and continued use of National Health Related Items Code (NHRIC) and National Drug Code (NDC) codes. FDA is phasing in UDI requirements over a six-year period, with the first requirements for Class III devices taking effect in September 2014.
US Trading Company is recalling batch of chili powder imported from Thailand because of the presence of Salmonella, said the Food and Drug Administration March 13. The chili powder comes in a 6.3 ounce clear plastic tub. The bar code 7 21557 53317 8 is printed on the front of the tub. The code 359XP is affixed to the bottom of the container. FDA said it found the problem in a lot of chili powder during routine sampling. Production and distribution of the product have been suspended while FDA, the California Department of Public Health, and US Trading continue the investigation, it said.