Canada introduces new organic regulations

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					                                                                                              292            inform May 2009, Vol. 20 (5)

            Previous reports on FDA’s regula-                                                               Researchers from the Eastern Regional
       tion of dietary supplements and foods with                                                      Research Center (ERRC: Wyndmoor, Penn-
       added dietary ingredients have raised con-                                                      sylvania, USA)—a unit of the US Depart-
       cerns about product safety and availabil-                                                       ment of Agriculture’s Agricultural Research
       ity of reliable information. Since then, the     label identifying the percentage of each       Service—irradiated ground beef and frank-
       FDA published draft guidance on require-         organic ingredient. Those products that        furter samples at doses of 0, 1, and 5 kGy
       ments for reporting adverse events (harmful      contain less than 70% organic ingredients      at 4°C and then stored them at 4°C for
       effects or illnesses) and current good man-      will be restricted to making organic claims    seven days (ground beef) or three months
       ufacturing practice regulations for dietary      on the ingredient list.                        (frankfurters).
       supplements.                                                                                         After irradiation and storage of the

                                                        USSEC gets new
            The GAO was asked specifically to                                                          samples, the scientists analyzed them for
       examine the FDA’s: (i) actions to respond                                                       trans and other fatty acids. The results
       to the new serious adverse event reporting
       requirements; (ii) ability to identify and       head                                           showed that 1 kGy irradiation did not induce
                                                                                                       any change in trans fatty acid content.
       act on concerns about the safety of dietary      In March, the board of directors of the        However, 5 kGy irradiation caused a small
       supplements; (iii) ability to identify and act   United States Soybean Export Council           but statistically significant increase in the
       on concerns about the safety of foods with       (USSEC: St. Louis, Missouri, USA) named        dominant trans fatty acid, C18:1 trans,
       added dietary ingredients; and (iv) actions      Miguel Escobar the USSEC interim chief         which increased from 3.99% (of total fatty
       to ensure that consumers have useful infor-      executive officer. The move came days after    acid content) for the nonirradiated ground
       mation about the safety and efficacy of          the board placed its CEO, Dan Duran, on        beef to 4.05% for the 5 kGy sample, and
       supplements. In the report, the GAO rec-         administrative leave with full pay and ben-    from 1.21% for the nonirradiated frank-
       ommends that the Secretary of Health and         efits while the board “considers its current   furter to 1.28% for the 5 kGy sample.
       Human Services (HHS) direct the com-             direction and the long-term goals of the            Irradiation had no apparent effect on
       missioner of the FDA to request additional       organization.”                                 C16:1 and C18:2 trans fatty acids. In addi-
       authority to oversee dietary supplements,              The action followed the request issued   tion, irradiation slightly decreased the rela-
       issue guidance on new dietary ingredients,       in December 2008 by the board of direc-        tive amount of polyunsaturated fatty acids
       and to clarify the boundary between dietary      tors of the American Soybean Association       of ground beef and frankfurters, particu-
       supplements and foods with added dietary         (ASA), which asked the US Secretary of         larly after storage. The researchers con-
       ingredients. In addition, the GAO recom-         Agriculture to look into the activities of     cluded that compared with variations in
       mends the HHS and FDA take steps to              the United Soybean Boa
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