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CCH NetNews™ |
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(November 17, 2009)
Food and Drug Law |
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A draft guidance to assist persons making tobacco product ingredient submissions to the FDA as required by the Family Smoking Prevention and Tobacco Control Act (Public Law No. 111-31, ¶2006) was published by the FDA. Titled "Listing of Ingredients in Tobacco Products", the draft guidance explains: (1) the statutory requirement to submit a list of all ingredients in tobacco products; (2) definitions; (3) who submits ingredient information; (4) what information is included in the submissions; (5) how to submit the information; (6) when to submit the information; and (7) the FDA's compliance policies. Information must be submitted to the FDA by December 22, 2009, and include the ingredients added as of the date of submission. FDA Notice.
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The usage of clear and consistent markings on dosage delivery devices packaged with over-the-counter (OTC) liquid drug products was recommended by the FDA for firms that manufacture, market, or distribute these drug products. In a draft guidance titled "Dosage Delivery Devices for OTC Liquid Drug Products," the agency clarified that dosage delivery devices should: (1) be included for all drug products that are liquid formulations; (2) bear markings that are consistent with the labeled directions; and (3) be labeled in a manner to ensure that the dosage device is only used with the products with which they are included. FDA Notice.
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The comment periods for three draft guidances addressing microbial food safety hazards of leafy greens, tomatoes, and melons were extended by the FDA to January 4, 2010. Titled “Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens(¶41,944), "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes" (¶41,945), and "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons", (¶41,946) all three draft guidances originally appeared in the August 3, 2009, Federal Register and had comment deadlines of November 2, 2009. FDA Notices, Leafy Greens, Tomatoes, Melons.
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On November 5, 2009, the FDA warned consumers that "Stiff Nights," a product marketed as a dietary supplement for sexual enhancement, contains an illegal ingredient that can dangerously lower blood pressure. The FDA determined that the product contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra®. Sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. The product is distributed on Internet sites and at retail stores by Impulsaria LLC of Grand Rapids, Mich. It is sold in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules. FDA News Release.
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