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CCH NetNews™ |
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(July 20, 2010)
Food and Drug Law |
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A public docket to solicit comments, data, and other information helpful to the implementation of §4205 of the Patient Protection and Affordable Care Act of 2010, was established by the FDA. The new PPACA section requires chain restaurants and similar retail food establishments with 20 or more locations doing business under the same name and offering for sale substantially the same menu items to disclose nutrient content information for standard menu items appearing on restaurant menus and menu boards. PPACA also requires vending machine operators that own or operate 20 or more vending machines to disclose nutrient content information for certain articles of food sold from vending machines. The FDA is required to consider standardization of: (1) recipes and methods of preparation, reasonable variation in serving size and formulation of menu items, space on menus and menu boards, inadvertent human error, training of food service workers, variations in ingredients, and other factors as the Secretary determines; and then must (2) specify the format and manner of the nutrient content disclosure requirements. The FDA is tasked to promulgate regulations carrying out the provisions no later than March 23, 2011.
FDA Notice.Read IRN» (ip access user) » (Read Intelliconnect) »
The thresholds for importation, exportation, and domestic distributions of the List I chemicals pseudoephedrine and phenylpropanolamine were removed by the Drug Enforcement Administration (DEA) as part of DEA’s implementation of the Combat Methamphetamine Epidemic Act of 2005. Under the existing regulations the threshold for nonretail distribution, import, export, and international transactions of pseudoephedrine is 1 kilogram and for phenylpropanolamine, 2.5 kilograms. The final rule will require any registrant manufacturing, distributing, importing, or exporting pseudoephedrine or phenylpropanolamine, in any quantity, either as bulk chemicals or in over-the-counter drug products, will be subject to the reporting and recordkeeping requirements.
FDA Order.
Actonel® (risendronate sodium) Tablets, 75 milligrams (mg), and Actonel® with Calcium (risendronate sodium and calcium carbonate (copackaged)) Tablets, 35 mg/500 mg, were not withdrawn from sale for reasons of safety or effectiveness in a determination by the FDA. Actonel® is indicated for the treatment of postmenopausal osteoporosis, and Paget’s disease in men and women.
FDA Notice.Read IRN» (ip access user) » (Read Intelliconnect) »
On July 9, 2010, food safety requirements will become effective for large-scale egg producers having 50,000 or more laying hens – about 80 percent of production — to address the contamination of eggs with the bacterium Salmonella Enteritidis. According to the FDA, as many as 79,000 illnesses and 30 deaths due to consumption of contaminated eggs may be avoided annually with the food safety requirements. The new regulations require egg producers to adopt preventive measures and to use refrigeration during egg storage and transportation. Large-scale egg producers that produce shell eggs for human consumption and do not sell all of their eggs directly to consumers must comply with the refrigeration requirements under the rule; this includes producers whose eggs receive treatments such as pasteurization.
FDA News Release.© 2010 CCH. All Rights Reserved.
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