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 applicable regulations within the U.S. and Internationally. For support regarding 21 CFR Part 101, REJIMUS can provide the necessary help your company needs whether you specialize in the food and beverage industry or dietary supplement industry. 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. To further ensure your products are compliant with the FDA, REJIMUS also offers training programs for the food and beverage and dietary supplement industries specifically for labeling requirements in the United States, Canada, or Mexico.

Part 101 Food Labeling

TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B – FOOD FOR HUMAN CONSUMPTION

Subpart A – General Provisions
§ 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.

Subpart B – Specific Food Labeling Requirements
§ 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.

Subpart C – Specific Nutrition Labeling Requirements and Guidelines
§ 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.

Subpart D – Specific Requirements for Nutrient Content Claims
§ 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.

Subpart E – Specific Requirements for Health 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).

Subpart F – Specific Requirements for Descriptive Claims That Are Neither Nutrient Content Claims nor Health Claims
§ 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.”

Subpart G – Exemptions From Food Labeling Requirements
§ 101.100 – Food; exemptions from labeling.
§ 101.108 – Temporary exemptions for purposes of conducting authorized food labeling experiments.

Appendix A to Part 101 [Reserved]
Appendix B to Part 101 – Graphic Enhancements Used by the FDA
Appendix C to Part 101 – Nutrition Facts for Raw Fruits and Vegetables
Appendix D to Part 101 – Nutrition Facts for Cooked Fish

All information on this page is current as of September 12, 2022.