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CCH NetNews™ |
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(October 20, 2009)
Food and Drug Law |
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The Drug Enforcement Administration (DEA) placed the substance fospropofol, including its salts, isomers and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into Schedule IV of the Controlled Substances Act. Fospropofol was approved by the FDA under the trade name Lusedra® for use as a drug product indicated for monitored anesthesia care sedation in adult patients undergoing diagnostic or therapeutic procedures. Fospropofol acts as a central nervous system depressant and elicits behavioral effects similar to Schedule IV sedative-hypnotics. The effective date of the final rule is November 5, 2009. DEA Order.
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Dried sweeteners derived from sugar cane syrup for use in food products should not be declared on labels as “evaporated cane juice,” in a draft guidance published by the FDA. Titled Guidance for Industry: Ingredients Declared as Evaporated Cane Juice,the draft document recommends to manufacturers that the phrase evaporated cane juice” not be used because it is not the common or usual name of the cane syrup sweeteners. The sweetener, instead, should be labeled as “dried cane syrup,”The inappropriate usage of “juice” on labels for dried syrup would result in misbranded or adulterated products. FDA Notice.
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On October 5, 2009, the FDA announced that the U.S. Department of Agriculture's (USDA) fresh produce chief Leanne Skelton will join the FDA to help develop new food safety rules, as part of a cooperative initiative between FDA and the USDA. Skelton has extensive experience working with the fruit and vegetable industry and will be on detail with the FDA for six months to help the agency develop new safety regulations for produce. Through the initiative, the FDA is gathering information and seeking feedback from the fresh produce industry, including small and organic farmers, on the impact such rules may have on their businesses and lives. FDA News Release.
On October 9, 2009, the FDA announced that it awarded 83 grants in fiscal year (FY) 2009 totaling $17.5 million to state and local regulatory agencies to boost food and feed safety initiatives. The grants fund major cooperative agreements in the four major areas of response, intervention, innovation, and prevention. The FDA's Food Protection Rapid Response Team (RRT) and Program Infrastructure Improvement Prototype Project cooperative agreements will develop, implement, exercise, and integrate an all-hazards food and foodborne illness response capability to more rapidly react to potential threats to the U.S. food supply. The Food Protection Task Force Conference program supports meetings that foster communication, cooperation, and collaboration among state, local, and tribal food protection, public health, agriculture, and regulatory agencies. FDA News Release.
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