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:
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.
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.
On May 14 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 14 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 is formally reclassifying intravascular administration set air removal systems as Class II devices that do not require premarket approval, in an order that codifies a reclassification that took effect March 4. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. But FDA reclassified them in response to a request from Anesthesia Safety Products, LLC related to the AirPurge System. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to design characteristics, testing, biocompatibility, and labeling. Air removal systems will not be exempt from premarket notification requirements.
The Food and Drug Administration announced the reclassification of colon capsule imaging systems as Class II medical devices subject to special controls. Colon capsule imaging systems were previously classified in Class III and required premarket approval. The reclassification took effect Jan. 29; FDA’s final order merely codifies it into regulation. Although they will no longer need FDA approval, the devices will still be subject to premarket notification requirements, as well as certain extra "special controls" related to testing, biocompatibility, and labeling.