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FDA Confirms Direct Final Rule on Regulation of Tobacco Products
March 8, 2011 by Kelly Sly|FDA and EPA

The Food and Drug Administration has issued a notice confirming the April 14, 2011 effective date of its direct final rule which will amend certain of its general regulations to include tobacco products, where appropriate, in light of FDA’s authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act. With these amendments, tobacco products will be subject to the same general requirements that apply to other FDA-regulated products. (See ITT's Online Archives or 11/29/10 news, 10112945, for previous BP summary of the direct final rule.)

Revised FDA Import Alerts
March 8, 2011 by Elizabeth Parker|FDA and EPA

The Food and Drug Administration has posted revised versions of the following Import Alerts on the detention without physical examination of:

FDA Says Malfunction Reports Needed for All Medical Devices Until Further Notice
March 8, 2011 by Barbara Chaves|FDA and EPA

The Food and Drug Administration has issued a notice to clarify that device manufacturers and importers of all devices, including class I and those class II devices that are not permanently implantable, life supporting, or life sustaining, must continue to submit malfunction reports in full compliance with FDA's Medical Device Reporting (MDR) requirements, pending future notice by FDA.

FDA Commissioner Calls for APEC to Address Counterfeit Medicine, Etc.
March 8, 2011 by Barbara Chaves|FDA and EPA

During March 2, 2011 remarks at the APEC Dialogue on Corruption and Illicit Trade, Food and Drug Administration Commissioner Hamburg stated that the issue of counterfeiting, particularly of medicine and other medical products, must be elevated to the highest levels of international discourse, both within APEC and more broadly.

Revised FDA Import Alerts
March 7, 2011 by Elizabeth Parker|FDA and EPA

The Food and Drug Administration has posted revised versions of the following Import Alerts on the detention without physical examination of:

CPSC to Reopen Comment Period on Feasibility of Kid's 100 ppm Lead Content Limit
March 4, 2011 by Barbara Chaves|FDA and EPA

On March 3, 2011, the Consumer Product Safety Commission voted to publish a notice keeping the record open for an additional 15 days to allow Commission-requested comments to be submitted on the technological feasibility of meeting the 100 parts per million lead content limit for children's products. This limit is set to take effect August 14, 2011, unless CPSC determines it is not technologically feasible with regard to a product or product category. According to a blog by Commissioner Nord, the notice should be published in about a week, effectively providing three weeks to respond. She indicates that CPSC will consider all comments submitted, but the notice appears to be limited to specific information and studies requested by the Commissioners during their February 16, 2011 hearing.

CPSC to Vote on Holding 4th Meeting of Phthalate Panel in March
March 3, 2011 by Barbara Chaves|FDA and EPA

The Consumer Product Safety Commission is scheduled to vote by March 8, 2011 on a Federal Register notice announcing the fourth meeting of the Chronic Hazard Advisory Panel (CHAP) on Phthalates and Phthalate Substitutes, to be held on March 30-31, 2011. The panel, which was required by the Consumer Product Safety Improvement Act of 2008 (CPSIA), was appointed to study the effects on children’s health of all phthalates and phthalate alternatives as used in children’s toys and child care articles. Its work will help CPSC determine whether to continue the CPSIA's interim ban on certain phthalates or whether to regulate other phthalates or phthalate substitutes.