The Importance of CFR 101

Code of Federal Regulations:

Code of Federal Regulations (CFR), Title 21 Part 101 is the part of the Food and Drug Administration’s Department of Health and Human Services. This subchapter is a part of “Food for Human Consumption” and focuses specifically on Food Labeling Regulations.

Food and Drug Administration (FDA) is responsible for assuring that foods sold in the United States are safe, wholesome and properly labeled. This applies to foods produced domestically, as well as foods from foreign countries. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act are the Federal laws governing food products under FDA jurisdiction.  21 CFR 101 is responsible for all aspects of food labeling.

 

Why is CFR Title 21 Important?

Code of Federal Regulations Title 21, 101, is important as a manufacturer because the FDA has specific regulations on food packaging and labels that need to follow when creating your product. This is also important because the factors on the label influence the consumer’s decision to purchase the product.

CFR is also important because the label needs to state what is in the product, as not to be misleading to the consumer. The product name and label need to be truthful, as the consumer should not be misled, and the consumer needs to understand what they are purchasing.

 

Snapshot of CFR Title 21:

21 CFR 101 consists of seven total subparts, each one specifically dealing with a topic of food labeling. They are as follows:

 

Subpart A- General Provisions

This section is deals with the general provisions of the labels.

  • 1- Principal display panel of package form food.
  • 2- Informational panel of package form food.
  • 3- Identity labeling of food in packaged form.
  • 4- Food; designation of ingredients.
  • 5- Food; name and place of business of manufacturer, packer, or distributor.
  • 7- Declaration of net quantity of contents.
  • 8- vending machines.
  • 9- Nutrition labeling of food.
  • 10- Nutrition labeling of restaurant foods whose labels or labeling bear nutrient content claims or health claims.
  • 11- Nutrition labeling of standard menu items in covered establishments.
  • 12- Reference amounts customarily consumed per eating occasion.
  • 13- Nutrient content claims—general principles.
  • 14-Health claims: general requirements.
  • 15- Food; prominence of required statements.
  • 17- Food labeling warning, notice, and safe handling statements.
  • 18- Misbranding of food.

Subpart B- Specific Food Labeling Requirements

  • 22- Foods; labeling of spices, flavorings, colorings and chemical preservatives.
  • 30- Percentage juice declaration for foods purporting to be beverages that contain fruit or vegetable juice.

Subpart C- Specific Nutrition Labeling Requirements and Guidelines.

  • 36- Nutrition labeling of dietary supplements
  • 42- Nutrition labeling of raw fruit, vegetables, and fish
  • 43- substantial compliance of food retailers with the guidelines for the voluntary nutrition labeling of raw fruit, vegetables, and fish.
  • 44- What are the 20 most frequently consumed raw fruits, vegetables, and fish in the United States?
  • 45– Guidelines for the voluntary nutrition labeling of raw fruits, vegetables, and fish.

Subpart D- Specific Requirements for Nutrient Content Claims

  • 54- Nutrient content claims for “good source,” “high,” “more,” and “high potency.”
  • 56- Nutrient content claims for “light” or “lite”
  • 60- Nutrient content claims for the calorie content of foods.
  • 61- Nutrient content claims for the sodium content of foods.
  • 62- Nutrient content claims for fat, fatty acid, and cholesterol content of foods.
  • 65- Implied nutrient content claims and related label statements.
  • 67- Use of nutrient content claims for butter.
  • 69- Petitions for nutrient content claims.

Subpart E- Specific Requirements for Health Claims

  • 70 Petitions for health claims.
  • 71- Health claims: claims not authorized.
  • 72- Health claims: calcium, vitamin d, and osteoporosis.
  • 73- Health claims: dietary lipids and cancer.
  • 74- Health claims: sodium and hypertension.
  • 75- Health claims: dietary saturated fat and cholesterol and risk of coronary heart disease.
  • 76- Health claims: fiber-containing grain products, fruits, and vegetables and cancer.
  • 77- Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease.
  • 78- Health claims: fruits and vegetables and cancer.
  • 79- Health claims: folate and neural tube defects.
  • 80- Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries.
  • 81- Health claims: soluble fiber from certain foods and risk of coronary heart disease (CDH).
  • 82- Health claims: soy protein and risk of coronary heart disease (CHD).
  • 83- Health claims: plant sterol/stanol esters and risk of coronary heart disease (CDH).

Subpart F- Specific Requirements for Descriptive Claims That Are Neither Nutrient Content claims nor Health Claims

  • 91- Gluten-free labeling of food.
  • 93- Certain types of statements for dietary supplements.
  • 95- “Fresh,” “freshly frozen,” “fresh frozen,” frozen fresh.”

Subpart G- Exemptions from Food Labeling Requirements

  • 100- Food; exemptions from labeling.
  • 108- Temporary Exemptions for purposes of conducting authorized food labeling experiments.

 

Important Highlights of CFR Title 21:

In the supplement and nutraceutical industry, it is important that these specific subparts of the Code of Federal Regulations, Title 21, be noted. While it is important to note all aspects of CFR 101, taking note of the following is especially important in the supplement industry and as a supplement manufacturer:

 

101.1- Principal Display Panel (PDP).

The principal display panel, or the PDP, is the portion of the package label that is most likely to be seen by the consumer at the time of purchase. This shows the statement of identity (the product name) and the net quantity statement (the total weight).  Most food containers are designed with two or more different surfaces that are suitable for the PDP. The following image is an example of the alternative PDPs.  21 CFR 101.1

The statement of identity, name of the food, and the net quantity has a required type size and prominence as according to 21 CFR 101.3(a) and 21 CFR 101.105.(a)

 

101.2 – Information Panel of Package Form Food.

The information panel is the label panel immediately to the right of the PDP, as displayed to the consumer.  If this panel is not usable due to packaging design and construction, such as folded flaps, then the information panel is the next label panel immediately to the right. 21 CFR 101.2(a)  Things that are included in the informational panel of the package include the nutritional labeling, ingredients, and the name and address of the manufacturer of whom the product is manufactured and distributed by.

 

101.3-  Ingredient List

The ingredient list is part of the informational panel of the package. The ingredient list must include ingredients declared by its common or usual name, and in descending order of predominance by weight. The requirements state that the ingredients cannot be listed under a vague term such as “protein” or “meat”. Also, ingredients that contain sub-ingredients must include those as well. An example of sub-ingredients: Ketchup (tomatoes, vinegar, sugar, salt).

101.3 (g) states that dietary supplements must be identified by the term “dietary supplement” and must include the type of dietary ingredients that are in the product (i.e. “herbal supplements with vitamins.”) 21 CFR 101.3

 

101.5- Food; Name and Place of Business Manufacturer, Packer, or Distributor.

This is in correlation of where the informational panel should be, how large it should be, and what it should include. The packaging and label needs to include the name and address of the manufacturer, the distributor, or packer.

This includes the complete address and says: “manufactured or distributed by” 21 CFR 101.5

 

101.7-Net Quantity of Contents

The net quantity of content statements on the label provides the statement on the label which provides the amount of food in the container- 21 CFR 101.1015(a) This is placed as a distinct item in the bottom 30% percent of the principal display panel. In lines generally parallel with the base of the container- 21 CFR 101.101(e)(f)  Example: Net wt 1 lb 8 oz. (680g)

 

101.9- Nutrition Facts

The nutrition facts information is required to be based on serving size determined by the Reference Amount of Food Customarily consumed per eating occasion (RACC). This is in correlation with the serving size of the product and calories, plus serving size and servings per container.  This is a required item on the food packages label.

 

More detailed information on CFR-Code of Federal Regulations Title 21 can be found here:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=101

http://ucanr.edu/sites/Postharvest_Technology_Center_/files/231301.pdf

Note: Under FDA’s laws and regulations, FDA does not pre-approve labels for food products. Questions concerning the labeling of food products may be directed to the Food Labeling and Standards Staff (HFS-820), Office of Nutrition, Labeling, and Dietary Supplements, Center for Food and Safety and Applied Nutrition, Food and Drug Administration, 5100, Paint Branch Parkway, College Park MD 20740-3835, Telephone: (240)-402-2371

 

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