On December 5, 2011, the Food and Drug Administration updated its question and answer document on lipstick and lead. Though the document does not describe what has been updated, it has ten FAQs on issues such as whether FDA has limits on lead in cosmetics and possible next steps for regulation. FDA states that although it does not believe that the lead content found in its recent lipstick analyses poses a safety concern, it is evaluating whether there may be a need to recommend an upper limit for lead in lipstick in order to further protect the health and welfare of consumers. The FAQ also lists numerous lipstick brands, shades, lots, and corresponding lead levels according to 2007 EPA testing.
The Food and Drug Administration has issued its Biennial report to Congress on the Food Emergency Response Network, which is an integrated, secure laboratory system for Federal, State, and local government agencies engaged in food safety and defense activities. The report, which is required by the Food Safety Modernization Act (FSMA), states that FERN plays a critical role in food safety and defense by integrating these food-testing laboratories into a network that is able to detect, identify, respond to, and aid in the recovery from emergencies involving biological, chemical, or radiological contamination of food.
On December 5, 2011, 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 reports that the Device Registration and Listing Module (DRLM) of the electronic registration and listing system (FURLS) was unavailable from 4:00 PM EST on Friday, December 2, 2011 until 8:00 AM EST on Sunday, December 4, 2011 due to required maintenance.
The Food and Drug Administration reports that on December 1, 2011, U.S. Marshals seized at its request all dietary supplements by a Wisconsin maker for false claims made about their safety and effectiveness in treating diseases such as asthma, cardiovascular disease, cataracts, glaucoma and infections. The products are not FDA-approved as safe and effective for treating any diseases. According to the complaint, the company also failed to follow the current good manufacturing practice (cGMP) requirements for dietary supplements, as required by federal law.
On December 2, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On December 1, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On November 30, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
U.S. Customs and Border Protection has issued a CSMS message announcing that the Food and Drug Administration's MARCS/OASIS import system will be down for maintenance on Saturday December 3, 2011, starting at approximately 2:30 a.m., and is not anticipated to be back up until 11:30 a.m. EST. As a result, FDA will be operating under the Prior Notice scenario 2 contingency. During the periods when OASIS/MARCS is down ACS, PNSI and the link between ACS and OASIS will be operational. However, the OASIS downtime will prevent submitters who filed via ABI from receiving prior notice confirmation and would prevent CBP from auto-checking the prior notice confirmation for ABI filers.
The Food and Drug Administration has updated its question and answer document on low levels of lead found in food products commonly consumed by children in order to add information on whether any recalls of juice or baby food were conducted due to excessive levels of lead. FDA states that it knows of one regarding pomegranate juice concentrate manufactured in 2009 because the product contained elevated levels of lead.