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Animal food label clarifications promulgated


Effective November 18, 2013, the FDA will require that animal food labels list the common or usual names of all color additives that are required to be certified by the agency. The FDA published the proposed rule in the November 23, 2009, Federal Register proposing a regulation that would require that the common or usual name of all color additives that are required to be certified by FDA be listed on the label of animal foods. Additionally, the proposed rule suggested how color additives not certified by the FDA should be declared on the ingredient list of animal foods. The final rule will amend FDA’s animal food regulations to include certain requirements of the 1990 Amendments, as was previously done with the human food regulations. According to the agency, the two year effective date will allow animal food manufacturers time to deplete their current label inventories as they make the transition to the new label. The FDA did not expect the final rule to require a major label redesign because it would likely only necessitate minor changes in wording on the ingredient list.

FDA Order, ¶40,440

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Proposal would amend brand name tobacco rules


The manufacturer of a cigarette or smokeless tobacco product with a trade or brand name that is also the trade or brand name of a nontobacco product would be able to continue to use the name if the tobacco product was sold in the United States on or before June 22, 2009 under a recent FDA Proposal. The proposed rule would amend the FDC Act to ensure manufacturers would not have to monitor whether a trade or brand name is registered for a nontobacco products after the initiate sale of the tobacco product. This proposal would still prevent tobacco product manufacturers from exploiting imagery and consumer identification associated with the trade or brand name of a nontobacco product by protecting nontobacco products that precede the sale of tobacco products with the same name. These rules will also prevent nontobacco companies from creating brand names used by tobacco brands to the detriment of the tobacco manufacturers.

FDA Proposal, ¶46,178

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Blood donor history questionnaire draft guidance published


The FDA published a draft guidance titled “Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components” that recognizes the abbreviated donor history questionnaire and accompanying materials (aDHQ documents), version 1.3 dated August 2011, as an acceptable mechanism for collecting blood donor history information from frequent donors of blood and blood components. The aDHQ documents will provide blood establishments that collect blood and blood components with a specific process for administering questions to frequent donors of blood and blood components to determine their eligibility to donate. The guidance also provides information to licensed manufacturers who choose to implement the acceptable aDHQ documents on how to report the manufacturing change consisting of the implementation of the aDHQ documents.

FDA Notice, ¶42,153

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Efficacy of anticoccidial drugs, draft guidance


The FDA published a draft guidance titled “Evaluating the Effectiveness of Anticoccidial Drugs In Food-Producing Animals” discussing general considerations for the evaluation of the efficacy of anticoccidial drugs in poultry, minor species and food-producing mammals. The draft guidance provides recommendations regarding protocol development, study conduct, animal welfare, substantial evidence of effectiveness, feed preparation, drug assays, and combination approvals. Additionally, the draft document discusses considerations for studies used to substantiate effectiveness of anticoccidial drugs in poultry, including battery studies and commercial field studies. The draft document supersedes a previous Center for Veterinary Medicine draft guidance titled “Draft Guideline for the Evaluation of The Efficacy of Anticoccidial Drugs and Anticoccidial Drug Combinations in Poultry.

FDA Notice, ¶42,157

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Medical product shortages review by FDA


In a report titled “A Review of FDA's Approach to Medical Product Shortages,” the agency noted that drug and other medical product shortages have the potential to adversely affect patient care by delaying treatment or forcing the use of second-choice products. The FDA highlighted that recent shortages involved drugs for life-threatening conditions and, in some cases, the product in shortage has been the only product for the patient’s condition. The agency conducted a review of medical product shortage activities in four medical product Centers in the FDA and talked to external parties in the drug arena to gain perspectives on the problem. The report identified a number of respects in which the FDA’s internal processes might be improved, so that the agency could maximize its contribution to the prevention and mitigation of shortages.

The FDA identified five areas to be addressed immediately, including: (1) letters to drug manufacturers reminding them of their current legal obligations to notify the FDA in advance of the discontinuation of certain drugs and urging voluntary notification of the FDA of other potential disruptions to the supply of drugs that are not currently required, as soon as they become aware of them; (2) development of guidance and regulations that clarify and enhance the information on potential drug shortages that is submitted by industry; (3) additional staffing resources for the FDA’s efforts to prevent and mitigate shortages; (4) support of legislation that requires early notification by manufacturers for drug shortages and provides new authority to the FDA to enforce these requirements; and (5) implement and maintain a database that can analyze the characteristics of drug shortages.

FDA Report, ¶400,040

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