美国FDA药品标签法规要求 U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.
2.FDA食品标签要求(Food Labeling Requirements) FDA要求所有食品产品必须符合标签合规标准。标签必须清晰标明产品的成分、营养成分、过敏原信息、生产日期等。标签内容必须遵循FDA的格式要求,并且反映真实的产品信息。 3.食品成分与配方合规(Ingredient and FormulaCompliance) ...
Draft-Not for Implementation Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry Draft Guidance This guidance is being distributed for comment purposes only.Although you can ...
regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient. To date, no CBD-containing drug has met applicable FDA requirements to be legally marketed for nonprescription use. As explained below, nonpres...
Ingredients – Every ingredient included in your hard cider in descending order of predominance. Nutritional facts – A detailed breakdown about your hard cider’s nutrient content that follows the formatting requirements (21 CFR 101.9(d)). Allergens – Call outs if your hard cider includes any ...
Furthermore, even if CBD could be considered an inactive ingredient in a nonpreion drug product, that product would still need an approved new drug application to be legally marketed, because the product would not meet the general requirements for nonpreion drug products under section 505G of th...
demonstrate that these are each an “active ingredient” as defined in 21 CFR 201.66(b)(2) because each ingredient is intended to furnish pharmacological activity.5 Thus, (b)(4) product does not meet requirements under section 505G of the FD&C Act, under which it would be deemed to be ...
6.4 Medications6.4.1 FDA Unique Ingredient Identifier FDA唯一成分标识符6.4.1.1 General Considerations 一般注意事项The Unique Ingredient Identifier (UNII) should be used to identify active ingredients (specifically, active moieties) that are administered to investigational subjects in a study (either ...
“permit the use of additional units of measure for dietary ingredients to allow for use of more appropriate units of measure when metric weight is not the most accurate way to express the quantity of the dietary ingredient.”4 The comment gave as examples the use of CFUs in the labels of...
.fda.gov/FoodLabelingGuide TABLEOFCONTENTS 1.INTRODUCTION4 2.BACKGROUND4 3.GENERALFOODLABELINGREQUIREMENTS5 4.NAMEOFFOOD7 Juices 5.NETQUANTITYOFCONTENTSSTATEMENTS14 6.INGREDIENTLISTS17 Colors FoodAllergenLabeling 7.NUTRITIONLABELING25 General NutrientDeclaration ...