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Federal Register Notice - the GRAS Proposal |
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How to Submit a GRAS Notice |
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Federal Register Notice - Substances Generally Recognized as Safe; Reopening of the Comment Period |
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GRAS Regulatory Submissions |
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Guidance for Industry: Frequently Asked Questions About GRAS |
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Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related IssuesJuly 2011 |
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New Dietary Ingredients in Dietary Supplements (Explanation including: definition, notification process, and table of notifications received) February 2001 |
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Liquid Dietary Supplements: Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages January 2014 |
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Substances added to Foods and Beverages: Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements January 2014 |
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New Dietary Ingredients (NDI): New Dietary Ingredient Notifications and Related Issues July 2011 |
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Liquid Dietary Supplements: FDA Letter to Industry Concerning Liquid Vitamin D Dietary Supplements June 2010 |
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Liquid Dietary Supplements: FDA Letter to Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages |
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Liquid Dietary Supplements: Draft Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods (December 2009) |
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Frequently Asked Questions about FDA's Regulation of Infant Formula |
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Guidance for Industry: Enzyme Preparations: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices |
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Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements |
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21 CFR Part 182 |
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21 CFR Part 184 |
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21 CFR Part 186 |
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21 CFR Standardized Food Parts 131 |
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21 CFR Standardized Food Parts 133 |
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21 CFR Standardized Food Parts 136 |
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21 CFR Standardized FoodParts 137 |
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Nutrient Content Claims: Food Labeling; Nutrient Content Claims; Definition for "High Potency" and Definition for "Antioxidant" for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods Small Entity Compliance Guide July 2008 |
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Structure/Function Claims: Small Entity Compliance Guide January 9, 2002 |
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Substantiation for Claims: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act November 2004 |
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Regulations & Laws about Dietary Supplements |
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Concerns About Novel Ingredients in Conventional Foods |
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Evidence-Based Review System for the Scientific Evaluation of Health Claims January 2009 |
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Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements December 1999 |
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Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body June 1998 |
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Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements July 10, 2003 |
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Adverse Event Reporting and Recordkeeping: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act September 2013 |
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New Dietary Ingredients Notification Process |
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