The Food and Drug Administration is proposing to reclassify ultraviolet tanning lamps from class I to class II. The reclassification would make the tanning lamps 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 from “ultraviolet lamps for tanning” to “sunlamp products.” Comments on the reclassification, which is being proposed on FDA’s own initiative, are due by Aug. 7.
The Food and Drug Administration posted transcripts and archived webcasts of its meeting on the Food Safety Modernization Act proposed rules on product safety and preventative controls in human food, held in Washington, D.C., Feb. 28-March 1. FDA already posted presentations from the session (see 13031417).At the meeting, FDA officials discussed the proposals, asked for comments, and responded to questions on the rules. FDA also held meetings in Chicago and Portland on the food safety rules (see 13020627).
On May 6 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 an order debarring David Freeman for five years from providing services to any person that has an approved or pending drug product application, in connection with his 2010 conviction for introducing and delivering into commerce a misbranded drug. Along with his accomplice Ashley Brandon Foyle, Freeman imported omeprazole from Muhi Trading Corporation, and his company Omega Biotech had repackaged and sold the drug. Neither Freeman, Omega, or Muhi Trading were registered to manufacture, prepare, propagate, compound, or process drugs, FDA said. The agency already published an order debarring Foyle on May 1 (see 13043018).
On May 3-5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 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 issued its weekly Enforcement Report for April 24 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 said it will refuse imports of MEDICAMAT S.A.’s “Punch-Hair-Matic-Suction Assisted Follicular Extraction and Re-implantation” device, after discovering that the device is intended for unregistered uses and is not covered by a premarket approval or investigational device exemption for those uses.
A revised guide is now available on controls for safe and sanitary growing, harvesting, processing, and shipping of oysters, clams, mussels, and scallops for human consumption, the Food and Drug Administration said. The changes were adopted at the 2011 biennial meeting of the Interstate Shellfish Sanitation Conference, and then went through an FDA concurrence process. As such, the guide “represents the agency’s current thinking on appropriate controls,” FDA said.