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)
- Weight management event set for Jan. 29 January 17, 2020Weight management continues to be a category that drives the supplement industry. A webinar on Jan 29 that features a host of expert speakers will examine the latest trends in this category.
- FDA, USDA and EPA launch joint biotechnology website January 17, 2020Three federal agencies have teamed up to provide a one stop shop for information on the regulation of biotechnology products.
- NutraCast Podcast: Weight management analysis and trends with Joshua Schall January 17, 2020It is a new year, and for many that means a new diet. The ever-changing world of nutrition programs, dieting and wellness can be difficult to navigate.
- Views differ sharply on whether CBD legislation is best way to break logjam January 17, 2020Dietary supplement industry stakeholders are divided over whether proposed legislation to alter the regulatory definitions of dietary ingredients to specifically include CBD is the best way to break the logjam on the substance.
- 3 brain games boost memory, focus, and flexible thinking January 17, 2020Three free brain games for your phone can help with memory, attention, and flexible thinking. And unlike with other games, there's research to back up the benefits.Jordan Bennett-NYU
- Little kids learn gratitude, but revenge comes naturally January 17, 2020Children are eager to retaliate but need some help learning to repay a favor, research on reciprocity suggests.Pat Harriman-UC Irvine
- Sepsis accounts for 1 in 5 deaths worldwide January 17, 2020Twice as many people as previously believed die of sepsis worldwide—and a disproportionately high number of them are children.Allison Hydzik-Pittsburgh
- ‘Smart building skins’ change shape in the heat January 17, 2020See how smart skins for buildings that react to environmental cues like heat or light could make the structures far more energy efficient.National Science Foundation
- Real risks associated with cannabis exposure during pregnancy January 17, 2020A new study has definitively shown that regular exposure to THC, the main psychoactive ingredient in cannabis, during pregnancy has significant impact on placental and fetal development.
- Internet use reduces study skills in university students January 17, 2020Research has shown that students who use digital technology excessively are less motivated to engage with their studies, and are more anxious about tests. This effect was made worse by the increased feelings of loneliness that use of digital technology produced.
- New dog, old tricks? Stray dogs can understand human cues January 17, 2020Pet dogs are highly receptive to commands from their owners. But is this due to their training or do dogs have an innate ability to understand human signals? A new study finds that 80% of untrained stray dogs successfully followed pointing directions from people to a specific location. The results suggest that dogs can understand […]
- Walnuts may be good for the gut and help promote heart health January 16, 2020Researchers found that eating walnuts daily as part of a healthy diet was associated with increases in certain bacteria that can help promote health. Additionally, those changes in gut bacteria were associated with improvements in some risk factors for heart disease.