21 CFR PART 101
While many companies offer label design and production services, few can efficiently and cost effectively review such labeling for compliance with the application regulations within the U.S. and Internationally. Additionally, we can help identify issues that could potentially lead to costly regulatory or legal challenges with respect to language that is either not allowed or does not have suitable claim substantiation.
TITLE 21–FOOD AND DRUGS Subpart A–General Provisions Subpart B–Specific Food Labeling Requirements Subpart C–Specific Nutrition Labeling Requirements and Guidelines Subpart D–Specific Requirements for Nutrient Content Claims Subpart E–Specific Requirements for Health Claims Subpart F–Specific Requirements for Descriptive Claims That Are Neither Nutrient Content Claims nor Health Claims Appendix A to Part 101–Monier-Williams Procedure (With Modifications) for Sulfites in Food, Center for Food Safety and Applied Nutrition, Food and Drug Administration (November 1985)
Part 101 Food Labeling
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B–FOOD FOR HUMAN CONSUMPTION
§ 101.1 – Principal display panel of package form food.
§ 101.2 – Information panel of package form food.
§ 101.3 – Identity labeling of food in packaged form.
§ 101.4 – Food; designation of ingredients.
§ 101.5 – Food; name and place of business of manufacturer, packer, or distributor.
§ 101.7 – Declaration of net quantity of contents.
§ 101.8 – Vending machines.
§ 101.9 – Nutrition labeling of food.
§ 101.10 – Nutrition labeling of restaurant foods whose labels or labeling bear nutrient content claims or health claims.
§ 101.11 – Nutrition labeling of standard menu items in covered establishments.
§ 101.12 – Reference amounts customarily consumed per eating occasion.
§ 101.13 – Nutrient content claims–general principles.
§ 101.14 – Health claims: general requirements.
§ 101.15 – Food; prominence of required statements.
§ 101.17 – Food labeling warning, notice, and safe handling statements.
§ 101.18 – Misbranding of food.
§ 101.22 – Foods; labeling of spices, flavorings, colorings and chemical preservatives.
§ 101.30 – Percentage juice declaration for foods purporting to be beverages that contain fruit or vegetable juice.
§ 101.36 – Nutrition labeling of dietary supplements.
§ 101.42 – Nutrition labeling of raw fruit, vegetables, and fish.
§ 101.43 – Substantial compliance of food retailers with the guidelines for the voluntary nutrition labeling of raw fruit, vegetables, and fish.
§ 101.44 – What are the 20 most frequently consumed raw fruits, vegetables, and fish in the United States?
§ 101.45 – Guidelines for the voluntary nutrition labeling of raw fruits, vegetables, and fish.
§ 101.54 – Nutrient content claims for “good source,” “high,” “more,” and “high potency.”
§ 101.56 – Nutrient content claims for “light” or “lite.”
§ 101.60 – Nutrient content claims for the calorie content of foods.
§ 101.61 – Nutrient content claims for the sodium content of foods.
§ 101.62 – Nutrient content claims for fat, fatty acid, and cholesterol content of foods.
§ 101.65 – Implied nutrient content claims and related label statements.
§ 101.67 – Use of nutrient content claims for butter.
§ 101.69 – Petitions for nutrient content claims.
§ 101.70 – Petitions for health claims.
§ 101.71 – Health claims: claims not authorized.
§ 101.72 – Health claims: calcium, vitamin D, and osteoporosis.
§ 101.73 – Health claims: dietary lipids and cancer.
§ 101.74 – Health claims: sodium and hypertension.
§ 101.75 – Health claims: dietary saturated fat and cholesterol and risk of coronary heart disease.
§ 101.76 – Health claims: fiber-containing grain products, fruits, and vegetables and cancer.
§ 101.77 – Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease.
§ 101.78 – Health claims: fruits and vegetables and cancer.
§ 101.79 – Health claims: Folate and neural tube defects.
§ 101.80 – Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries.
§ 101.81 – Health claims: Soluble fiber from certain foods and risk of coronary heart disease (CHD).
§ 101.82 – Health claims: Soy protein and risk of coronary heart disease (CHD).
§ 101.83 – Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD).
§ 101.91 – Gluten-free labeling of food.
§ 101.93 – Certain types of statements for dietary supplements.
§ 101.95 – “Fresh,” “freshly frozen,” “fresh frozen,” “frozen fresh.”
Appendix B to Part 101–Graphic Enhancements Used by the FDA
TITLE 21–FOOD AND DRUGS
Subpart A–General Provisions
Subpart B–Specific Food Labeling Requirements
Subpart C–Specific Nutrition Labeling Requirements and Guidelines
Subpart D–Specific Requirements for Nutrient Content Claims
Subpart E–Specific Requirements for Health Claims
Subpart F–Specific Requirements for Descriptive Claims That Are Neither Nutrient Content Claims nor Health Claims
Appendix A to Part 101–Monier-Williams Procedure (With Modifications) for Sulfites in Food, Center for Food Safety and Applied Nutrition, Food and Drug Administration (November 1985)
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