The Food and Drug Administration warned eight companies on October 14, 2010 that their over-the-counter (OTC) chelation products, some of which are marketed as dietary supplements, are unapproved drugs and devices, and that it is a violation of federal law to make unproven claims about these products.
The Food and Drug Administration has posted revised versions of the following Import Alerts on the detention without physical examination of:
The Consumer Product Safety Commission will be holding an open Commission meeting on October 20, 2010 to discuss a final rule to establish a publicly available and searchable database on the safety of consumer products and other products or substances regulated by CPSC. (See ITT's Online Archives or 05/25/10 and 10/08/10 news, 10052524 and 10100818, for BP summaries of the proposed rule and comments received on it.)
The Food and Drug Administration is extending to November 1, 2010, the comment period for the notice that appeared in the August 13, 2010 Federal Register, in which FDA requested input and comments from interested stakeholders on FDA’s medical user fee program and requested suggestions regarding the commitments FDA should propose for the next reauthorized program.
The Consumer Product Safety Commission has posted a draft final rule to establish publicly available, searchable database on the safety of consumer products and other products or substances regulated by CPSC. CPSC will discuss the draft at its October 20, 2010 Commission meeting, and a vote is scheduled for November 17, 2010. (See ITT's Online Archives or 05/25/10 and 10/08/10 news, 10052524 and 10100818, for BP summaries of the proposed rule and comments received on it.)
The Food and Drug Administration has posted revised versions of the following Import Alerts on the detention without physical examination of:
The Consumer Product Safety Commission has published notice of the following voluntary recall:
The Consumer Product Safety Commission has updated its list of meetings between CPSC and industry stakeholders that are open to the public, unless otherwise stated:
The Consumer Product Safety Commission has published notice of the following voluntary recalls:
The Food and Drug Administration is announcing its intention to accept and consider a single source application for award of a cooperative agreement to the World Health Organization (WHO) in support of building a global surveillance and monitoring system for combating counterfeit/falsified medicines and risks and breaches in the supply. The support will be one year with the possibility of an additional three years.