Food, Drugs & Device Update – March 2011

Topic of the Month: With the widespread devastation in northern Japan caused by a magnitude 9.0 earthquake on March 11, 2011, and the resulting damage at the Fukushima Daiichi nuclear power plant, the FDA noted that its current screening at U.S. borders will be augmented with radiation screening of shipments.

On March 22, 2011, to complement the measures taken by the government of Japan and to strengthen the global food safety net regarding certain products, the FDA issued Import Alert 99-33 regarding the importation of all milk and milk products and fresh vegetables and fruits produced or manufactured from the four Japanese prefectures of Fukushima, Ibaraki, Tochigi and Gunma. 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 United States and 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.

Other food products from this area, including seafood, although not subject to the Import Alert, will be diverted for testing by the FDA before they can enter the food supply. The FDA will also monitor and test food products, including seafood, from other areas of Japan as appropriate.
I. Agency Developments
GAO: food safety coordination efforts fragmented

The Food Safety Working Group (FSWG), co-chaired by the Secretaries of Health and Human Services and Agriculture along with officials from the FDA, Food Safety Inspection Service, the Centers for Disease Control and Prevention, and various other agencies, has not developed a government-wide performance plan that provides a comprehensive picture of the federal government’s food safety efforts, according to a Government Accountability Office (GAO) report. The report noted that the continuity of food safety coordination efforts was potentially hampered by changes in executive branch leadership, and as a presidentially appointed working group, the FSWG’s future was uncertain. As a result, the collaboration that had begun under the FSWG may be short lived, putting some of the longer-term efforts, such as developing results-oriented food safety goals and measures, at risk of not being completed.

The GAO identified options to reduce fragmentation and overlap in food safety oversight in the form of alternative organizational structures, but a detailed analysis of the advantages, disadvantages, and potential implementation challenges was not conducted. Some of the alternative organizational structures include a single food safety agency, a food safety inspection agency, a data collection and risk analysis center, and a coordination mechanism led by a central chair. Additionally, the GAO suggested that Congress consider commissioning the National Academy of Sciences or a blue ribbon panel to conduct a detailed analysis of alternative organizational structures for food safety. Finally, the agency noted that passage of the Food Safety Modernization Act (111-353) (FSMA) strengthened a major part of the food safety system; however, the FSMA did not apply to the federal food safety system as a whole or create a new risk-based food safety structure. GAO Report, No. 11-289
II. Drug and Biologics Developments
Weight control drug product proposed reclassification
Benzocaine would be reclassified from its previously proposed monograph status (category I) for over-the-counter (OTC) weight control use to nonmonograph status in a proposed rule by the FDA. An approved new drug application (NDA) or abbreviated new drug application (ANDA) for the marketing of OTC weight control products containing benzocaine would be required, because agency data could not sufficiently support benzocaine’s safety and effectiveness in OTC weight control use. Although, an advanced notice of proposed rulemaking in 1982 included the recommendation of an advisory panel, consisting of health care providers from outside FDA, and recommended that benzocaine should be generally recognized as safe and effective (GRASE) for weight control, the FDA reviewed the information and data available to the panel as well as information and data that had been developed since 1982 to make its determination that  benzocaine was not GRASE when used in OTC weight control products.  FDA Proposal, ¶46,164

Medication guides in outpatient settings draft guidance issued
Medication Guides should be dispensed in outpatient settings, even when the drug is dispensed to a healthcare professional for administration to the patient, the first time the drug is dispensed, and if the Medication Guide is materially changed, according to a draft guidance published by the FDA. Titled “Medication Guides—Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS),” the draft guidance addresses two topics pertaining to Medication Guides for drug and biological products: (1) when the FDA intends to  exercise enforcement discretion regarding dispensing requirements for Medication Guides that must be distributed with a drug or biological product dispensed to a healthcare professional for administration to a patient instead of being dispensed directly to the patient for self- administration or to the patient’s caregiver for administration to the patient; and (2) when a Medication Guide will be required as part of a REMS. The draft guidance also addresses questions that have arisen concerning these topics. FDA Notice, ¶42,091
II. Food Developments

Food temperature device regulations amended
Processors of thermally processed low-acid foods packaged in hermetically sealed containers will be allowed to use alternative “temperature-indicating devices,” in addition to the currently approved “mercury-in-glass thermometers,” during processing in a final rule promulgated by the FDA. Use of temperature-indicating devices that do not contain mercury will eliminate concerns about potential contamination of the food or the processing environment from broken mercury-in-glass thermometers. In the original proposed rule, the agency sought to establish new documentation and records requirements relating to temperature-indicating devices and clarify requirements for other equipment and procedures, including: temperature-recording devices, sensors, vents, screens, air supply and controls and water circulation, drain valve and water level indicators, temperature recording device sensors, and flow control. The final rule establishes the recordkeeping requirements relating to temperature-indicating devices and reference devices maintained by the processor and permit the use of advanced technology for measuring and recording temperatures during processing. The final rule also includes metric equivalents of avoirdupois (U.S.) measurements where appropriate. The final rule will permit low-acid canned food processors to transition from mercury-in-glass thermometers to alternative temperature-indicating devices and consistent with the agency’s determination that oral sodium phosphate salt products indicated for bowel cleansing should be limited to prescription only.  FDA Order, ¶46,416
Salmonella testing procedure draft guidance issued
Testing procedures for Salmonella species (spp.) in human foods and direct human-contact animal foods, and the interpretation of test results, when the presence of Salmonella spp. in the food may render the food injurious to human health were published in a draft guidance by the FDA. Titled “Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods,” the draft guidance will be applicable to firms that manufacture, process, pack, or hold human foods or direct human-contact animal foods intended for distribution to consumers, institutions, or food processors. The draft guidance does not apply to egg producers and other persons who are covered by FDA’s final rule “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.”  FDA Notice, ¶42,098