The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation." The document provides guidance to egg producers on how to comply with certain provisions contained in FDA's final rule "Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation," including how to implement Salmonella Enteritidis (SE) prevention measures, how to sample for SE, and how to maintain records documenting compliance with the final rule.

The Food and Drug Administration (FDA) is announcing the establishment of a docket to assist with its evaluation of FDA policies on communications and activities related to (i) off-label uses of marketed products, and (ii) use of products that are not yet legally marketed for any use. The FDA states that it would like to obtain comments and information regarding scientific exchange about both unapproved new uses of products already legally marketed (“off-label” use) and use of products not yet legally marketed for any use.

On December 22, 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 CSMS message #11-000318 notifying Food and Drug Administration filers located within the San Diego area to send all routine FDA-related mail correspondence to: 2320 Paseo de las Americas, Suite 200, San Diego, CA 92154. Filers should not use the address: 9777 via de la Amistad, RM131, San Diego, CA 92154.

On December 21, 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 21, 2011, the Food and Drug Administration issued a warning to consumers not to use the ShoulderFlex Massager, imported by King International and sold by various companies, due to serious potential health risks. King International recalled the ShoulderFlex Massager on Aug. 31, 2011. However, during a recent compliance audit, FDA found that the company had gone out of business and not followed through with recall procedures.

The Food and Drug Administration announced on December 21, 2011 the creation of the Food Safety Preventive Controls Alliance (FSPCA) to develop training and guidelines for industry on the upcoming hazard analysis and preventive controls requirements for food and feed facilities, which are mandated by the Food Safety Modernization Act.

On December 20, 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 is seeking comments and information that will assist it in its deliberations about ways to help individuals with celiac disease avoid the presence of gluten in drug products. In particular, FDA is interested in information on ingredients present in human drug products marketed in the U.S. that are currently derived from wheat, barley, or rye. Comments are due by February 21, 2012.

The Environmental Protection Agency has issued a final rule, effective February 21, 2012, to list isobutane (R-600a) and R-441A as acceptable substitutes, subject to use conditions, for the ozone-depleting substances chlorofluorocarbon (CFC)-12 and hydrochlorofluorocarbon (HCFC)-22 in household refrigerators, freezers, and combination refrigerators and freezers. This final rule also lists propane (R-290) as an acceptable substitute, subject to use conditions, as a substitute for CFC-12, HCFC-22, and R-502 in retail food refrigerators and freezers (stand-alone units only).