On April 11, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
On April 11, 2011, the Food and Drug Administration updated its question and answer document on what it is doing to ensure the safety of products imported from Japan to add a link to a webpage on FDA standards for radionuclides in food and to reorder other cited documents. The Q&A continues to state that all milk and milk products and vegetables and fruits produced or manufactured from the four Japanese prefectures of Fukushima, Ibaraki, Tochigi and Gunma will be detained upon entry into the U.S. They will not be allowed to enter the U.S. food supply, unless shown to be free from radionuclide contamination, with the exception of the specific products restricted by the Government of Japan. Those products will be refused admission into the US. (See ITT's Online Archives or 04/05/11, 03/30/11, 03/28/11, 03/22/11 and 03/24/11 news, 11040529, 11032813, 11032813, 11032225, and 11032438, for previous BP summaries of the Q&A and FDA's import alert on the topic.)
The Consumer Product Safety Commission has issued a proposed rule to establish a mandatory consumer product safety standard for children’s portable bed rails. The proposed standard is substantially the same as the voluntary standard ASTM F 2085-10a, “Standard Consumer Safety Specification for Portable Bed Rails,” with certain modifications to strengthen the standard.
The Food and Drug Administration has issued a question and answer document regarding reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth.
On April 8, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
In an April 6, 2011 speech, Michael Taylor, Deputy Commissioner for Foods, provided an update on the Food and Drug Administration’s implementation of the Food Safety Modernization Act (FSMA). Among other things, FDA has prioritized some of the requirements it must implement, established six implementation teams, and created a new webpage dedicated to the FSMA.
The Food and Drug Administration has made available its Enforcement Report for April 6, 2011.
The Consumer Product Safety Commission published notice of the following voluntary recalls on April 7, 2011:
The Consumer Product Safety Commission has voted unanimously to approve publication in the Federal Register of a draft notice, with changes, that will announce a proposed rule to establish a mandatory safety standard for portable bed rails. It will simultaneously withdraw an October 2000 advance notice of proposed rulemaking on the topic. CPSC canceled its April 6, 2011 meeting on portable bed rails as it made its decision by ballot vote.
The House Energy and Commerce Committee’s Subcommittee on Commerce, Manufacturing, and Trade held a hearing on April 7, 2011 on a draft bill that would revise the Consumer Product Safety Improvement Act of 2008 (CPSIA) to make it less stringent. While the draft received strong support from the trade and many Representatives, some Congressional members likened the bill to a CPSIA wrecking ball, and the CPSC official who testified indicated it went farther than necessary.