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CCH NetNews™ |
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(July 27, 2010)
Food and Drug Law |
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A draft guidance for tobacco retailers who wish to implement effective training programs for employees was issued by the FDA. Titled “Tobacco Retailer Training Programs, ”the draft guidance outlines training programs and standards to provide for reduced civil money penalties. Currently a two schedule penalty program exists, and under each schedule, retailers who violate the new provisions are subject to increasing penalties for multiple violations within prescribed time periods. For the first three violations in a 24-month period, retailers with an approved training program are subject to lower penalties than retailers with no training program. The provisions are designed to limit youth access to cigarettes and smokeless tobacco products, as well as restricting advertising and promotion of such products, to curb the appeal of these products to minors. The draft guidance is to be used until the FDA establishes standards for approved retailer training programs.
FDA Notice.Read IRN» (ip access user) » (Read Intelliconnect) »
A draft guidance prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was published by the FDA providing the results of the ICH Q4B evaluation of the Bulk Density and Tapped Density of Powders General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft document recommends that the analytical procedures described in the official pharmacopoeial texts, Ph.Eur. 2.9.34. Bulk Density and Tapped Density of Powders, JP 111 3.01 Determination of Bulk and Tapped Densities, and USP General Chapter <616> 112 Bulk Density and Tapped Density of Powders, can be used as interchangeable in the ICH regions subject to conditions.
FDA Notice.Read IRN» (ip access user) » (Read Intelliconnect) »
On July 14, 2010, a major marketer of dietary supplements, Iovate Health Sciences U.S.A. and its two affiliated Canadian companies, agreed to pay $5.5 million to settle Federal Trade Commission charges that it falsely advertised that their supplements could help consumers lose weight and treat or prevent colds and other illnesses. The money will be used to refund customers who purchased products whose advertisements included individuals dressed like physicians and claims that they were clinically proven to treat a variety of ailments. The settlement also bars the marketers from claiming that any drug or dietary supplement they advertise or sell is effective for diagnosing, curing, mitigating, treating, or preventing any disease unless the claim is approved by the FDA.
FTC News Release.On July 13, 2010, a bill to amend and reauthorize the controlled substance monitoring program under Section 2 of the National All Schedules Prescription Electronic Reporting Act of 2005 was proposed. Titled “National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010,” the proposed legislation would also amend the Public Health Service Act to authorize the Secretary of Veterans Affairs to share information about the use of controlled substances by veterans with state prescription monitoring programs to prevent misuse and diversion of prescription medicines.
S. 3575, 111th Cong., 2nd Sess. (2010).© 2010 CCH. All Rights Reserved.
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