On June 15, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Environmental Protection Agency has finalized its guidance for certification bodies (CBs) on the reported values that qualify products for the ENERGY STAR program. This guidance also assists manufacturers report consistent information on product performance to CBs.
The Food and Drug Administration has issued a final rule, effective June 18, 2012, to require over-the counter sunscreen products to comply with certain content and format requirements for OTC drug labeling. FDA also announces the availability of a draft guidance for industry, “Enforcement Policy-OTC Sunscreen Drug Products Marketed Without an Approved Application," available here, and a proposed information collection on SPF labeling and testing requirements for OTC sunscreen products containing specified ingredients and marketed without approved applications, and on compliance with Drug Facts labeling requirements, available here. Comments on the draft guidance and on the proposed information collection are due by August 16, 2011. FDA's Web page on sunscreen products is available here.
On June 14, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Environmental Protection Agency is soliciting applications for the critical use exemption from the phaseout of methyl bromide for 2014. Critical use exemptions last only one year. All entities interested in obtaining a critical use exemption for 2014 must provide EPA with technical and economic information to support a “critical use” claim and must do so even if they have applied for an exemption in previous years. EPA also invites new data on the technical and economic feasibility of methyl bromide alternatives. Applications for the 2014 critical use exemption must be postmarked on or before August 15, 2011.
The Food and Drug Administration reports that MGA Entertainment of Van Nuys, CA is recalling 6,200 units of the Bratz Makeup Design Sketch Book, which was distributed nationwide and sold through retail stores and e-commerce web sites. The eye shadow portion has the potential to be contaminated with Staphylococcus warneri and Staphylococcus intermedius. MGA is recalling products produced between November 5, 2010 and February 25, 2011. MGA has ceased production and distribution of this product. To date there have been no reports of illness or injury.
In April 2011, the Environmental Protection Agency issued an overview of the ten Action Plans it has issued so far, outlining the risks that ten chemical substances may present and identifying the steps EPA is taking or plans to take to address its concerns. Among other things, EPA plans regulatory action to label, restrict, or ban certain of the chemicals, or to require the submission of additional data needed to determine the risk. For some, EPA plans to initiate a “Concern List” rulemaking under Section 5(b)(4) of the Toxic Substances Control Act (TSCA), a previously unused authority that allows EPA to take certain action against chemicals of concern.
On June 13, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
On June 10, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Environmental Protection Agency has announced that it plans to obtain information on nanoscale materials in pesticide products to determine their potential effects on the environment and human health. A document announcing EPA’s plan will soon be published in the Federal Register for public comment.