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Food coloring is any substance that imparts color when added to food or beverages. Colorants can be natural (carotenoids, anthocyanins) or synthetic (e.g. tartrazine). Used in both commercial products and domestic cooking. Colorants can be supplied as liquids, powders, gels, or pastes

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ENDS use e-liquids containing nicotine and other ingredients to create aerosols. Products can resemble cigarettes, pens, or USB devices. FDA has authorized 34 tobacco-flavored e-cigarette products

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CGMP is FDA's regulations for pharmaceutical manufacturing processes. It ensures proper design, monitoring, and control of manufacturing facilities. Regulations are flexible to allow manufacturers to implement modern controls. "C" stands for "current," requiring up-to-date technologies

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Orange Book data files are in ASCII text format with tilde (~) delimiters. Three files are available: Products.txt, Patent.txt, and Exclusivity.txt. Appendices are available in PDF format: A, B, and C

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Final rule published in Federal Register May 27, 2016. Rule became effective July 26, 2016. Applies to food manufacturers subject to nutrition labeling requirements

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DMF is a confidential submission for drug manufacturing information. DMF submission is voluntary and not required by law. DMF is not a substitute for IND, NDA, ANDA, or Export Application

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