Labeling Requirements Flashcards
May I place intervening material on the information panel?
No. You may not place intervening material, which is defined as label information that is not required (e.g., UPC bar code), between label information that is required on the information panel.
What type size, prominence and conspicuousness am I required to use on the principal display panel and the information panel?
You are required to use a print or type size that is prominent, conspicuous and easy to read. The letters must be at least one-sixteenth (1/16) inch in height based on the lower case letter “o,” and not be more than three times as high as they are wide, unless you petition for an exemption in accordance with 21 CFR 101.2(f). The lettering must contrast sufficiently (it does not need to be black and white) with the background so as to be easy to read. See Chapter IV for the type size requirements for the nutrition label.
Do I need to specify the country of origin if my product, or the ingredients in my product, is not from the United States?
Yes. Unless excepted by law, the Tariff Act requires that every article of foreign origin (or its container) imported into the United States conspicuously indicate the English name of the country of origin of the article.
Who regulates the statement “Made in the U. S. A.”?
FDA does not have regulatory authority over such statements. The U.S. Customs Service regulates country of origin marking (i.e., “Made in the U.S.A.”) as authorized by the Tariff Act of 1930. Their website is www.customs.ustreas.gov.
How do I obtain a UPC bar code?
The UPC bar code may be obtained from the Uniform Code Council. Their website is www.uc-council.org. Click on the button that says “I Need a UPC Bar Code.”
Must expiration dating be included on the label of dietary supplements?
No. However, a firm may include this information if it is supported by valid data demonstrating that it is not false or misleading.
- What is the statement of identity for a dietary supplement and where must I place it?
The statement of identity for a dietary supplement is the name that appears on the label of the dietary supplement. As a general matter, the statement of identity of a food (including dietary supplements) is the name specified by federal law or regulation, or, if no such name is specified, the common or usual name of the food. If the food has no common or usual name and the nature of the food is not obvious, the statement of identity must be an appropriately descriptive term. In the case of dietary supplements, both the Federal Food, Drug, and Cosmetic Act and FDA’s regulations specify that the statement of identity must include the term “dietary supplement,” except that the word “dietary” may be replaced with a description of the type of dietary ingredient(s) in the product (e.g., “herbal supplement”) or the names of one or more dietary ingredients in the product (e.g., “bee pollen supplement”). You must place the statement of identity on the principal display panel of the dietary supplement and on any alternate principal display panels. Brand names are not considered to be statements of identity and should not be unduly prominent compared to the statement of identity.
How am I required to identify a dietary supplement?
You must identify a dietary supplement by using the term “dietary supplement” in the statement of identity, except that you may delete the word “dietary” and replace it with the name of the dietary ingredient(s) in the product (e.g., “calcium supplement”) or an appropriately descriptive term indicating the type of dietary ingredient(s) in your dietary supplement product (e.g., “herbal supplement with vitamins”).
Can the term “dietary supplement” by itself be considered the statement of identity?
Yes. This term describes the basic nature of a dietary supplement and therefore is an “appropriately descriptive term” that can be used as the product’s statement of identity. The statement of identity for a dietary supplement may therefore consist simply of the term “dietary supplement,” or “dietary supplement” may be part of a longer statement of identity (e.g., “cod liver oil liquid dietary supplement”). In either case, the word ‘‘dietary’’ may be deleted and replaced by another appropriately descriptive term identifying the contents of the product, such as “calcium supplement,” “herbal supplement”, or “herbal supplement with vitamins.”
Should I make the statement of identity stand out?
Yes. You must make the statement of identity one of the most important features on the principal display panel. To do this, you must use bold type and a type size reasonably related to the most prominent printed matter on the front panel of your label.
How should I place the statement of identity on the principal display panel?
You must place the statement of identity of your dietary supplement product in lines generally parallel to the base of the package.
What is the net quantity of contents statement for a dietary supplement?
The net quantity of contents statement for a dietary supplement is the statement that informs consumers of the amount of dietary supplement that is in the container or package.
Where must I locate the net quantity of contents statement on my label?
You must locate the net quantity of contents statement on your product label as a distinct item in the bottom 30 percent of the principal display panel, in lines generally parallel with the base of the container. If the principal display panel of your product is 5 square inches or less, the requirement for placement within the bottom 30 percent does not apply when the declaration of net quantity of contents meets the other requirements of 21 CFR 101
How must I express the net quantity of contents statement on my label?
You must express the net quantity of contents statement in either weight, measure, numerical count or a combination of numerical count and weight or measure. When you express this quantity as a weight or measure, you must specify both metric (grams, kilograms, milliliters, or liters) and U.S. Customary System (ounces, pounds, or fluid ounces) terms.
Why must I calculate the area of the principal display panel?
You must calculate the area of the principal display panel (calculated in square inches or square centimeters) to determine the minimum type size that is permitted for the net quantity of contents statement.
How do I calculate the area of the principal display panel?
You may calculate the area of the principal display panel for rectangular or square shaped packages by multiplying the height by the width (both in inches or both in centimeters), and for cylindrical shaped packages by multiplying 40% of the circumference by the height. For example, a rectangular package that is 8 inches high and 6 inches wide would have a principal display panel of 48 square inches. A cylindrical package having a circumference of 10 inches and a height of 2 inches would have a principal display panel of 8 square inches.
Am I required to place the net quantity of contents statement conspicuously and prominently on my product labels?
Yes. You are required to use a print style that is prominent, conspicuous, and easy to read, with letters not more than three times as high as wide. Use letters that contrast sufficiently with the background.
What is the minimum type size that I can use for the net quantity of contents statements?
The smallest type size permitted for the net quantity of contents statement is based on the size of the principal display panel. You may determine the height of the type by measuring the height of upper case letters, when only upper case letters are used, or the height of a lower case letter “o,” or its equivalent, when mixed upper and lower case letters are used. The table below sets out the minimum type size in inches (in.), with metric equivalents (millimeters (mm) and centimeters (cm)) in parentheses.
Minimum Type Size Area of Principal Display Panel
1/16 in. (1.6 mm) 5 sq. in. (32 sq. cm.) or less
1/8 in. (3.2 mm) More than 5 sq. in. (32 sq. cm.) but
not more than 25 sq. in. (161 sq. cm.)
3/16 in. (4.8 mm) More than 25 sq. in. (161 sq. cm.) but not more than 100 sq. in. (645 sq. cm.)
1/4 in. (6.4 mm) More than 100 sq. in. (645 sq. cm.) but not more than 400 sq. in. (2580 sq. cm.)
1/2 in. (12.7 mm) Over 400 sq. in. (2580 sq. cm.)
What must I include in a weight-based net quantity of contents statement?
You must include only the quantity of the dietary supplement in a container, and not the weight of the container, wrappers and packing materials, except that in the case of dietary supplements packed in containers designed to deliver the dietary supplement under pressure, the propellant is included in the net quantity declaration.
May I use qualifying phrases in the net quantity of contents statement?
No. You may not use qualifying phrases that qualify a unit or weight, measure, or count (such as “jumbo quart” and “full gallon”) in the net quantity of contents statement because they tend to exaggerate the amount of the dietary supplement in the container.
What must I include in a numerical count-based net quantity statement?
You must include the number of units in a container, e.g. “100 tablets.”
What is the nutrition label for a dietary supplement called?
The nutrition label for a dietary supplement is called a “Supplement Facts” panel (see sample labels at the end of this chapter).
How does “Supplement Facts” differ from “nutrition facts?”
The major differences between “Supplement Facts” panel and “Nutrition Facts” panel are as follows:
You must list dietary ingredients without RDIs or DRVs in the “Supplement Facts” panel for dietary supplements. You are not permitted to list these ingredients in the “Nutrition Facts” panel for foods.
You may list the source of a dietary ingredient in the “Supplement Facts” panel for dietary supplements. You cannot list the source of a dietary ingredient in the “Nutrition Facts” panel for foods.
You are not required to list the source of a dietary ingredient in the ingredient statement for dietary supplements if it is listed in the “Supplement Facts” panel.
You must include the part of the plant from which a dietary ingredient is derived in the “Supplement Facts” panel for dietary supplements. You are not permitted to list the part of a plant in the “Nutrition Facts” panel for foods.
You are not permitted to list “zero” amounts of nutrients in the “Supplement Facts” panel for dietary supplements. You are required to list “zero” amounts of nutrients in the “Nutrition Facts” panel for food.
What information must I list in the “Supplement Facts” panel?
You must list the names and quantities of dietary ingredients present in your product, the “Serving Size” and the “Servings Per Container.” However, the listing of “Servings Per Container” is not required when it is the same information as in the net quantity of contents statement. For example, when the net quantity of contents statement is 100 tablets and the “Serving Size” is one tablet, the “Serving Per Container” also would be 100 tablets and would not need to be listed.
What is the serving size for a dietary supplement?
One serving of a dietary supplement equals the maximum amount recommended, as appropriate, on the label for consumption per eating occasion, or in the absence of recommendations, 1 unit (e.g., tablet, capsule, packet, teaspoonful, etc). For example, if the directions on your label say to take 1-3 tablets with breakfast, the serving size would be 3 tablets.
May I use flexibility in the wording for “Serving Size?”
No. You must use the term “Serving Size.”
What nutrients am I required to list in the “Supplement Facts” panel?
Total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron must be listed when they are present in measurable amounts. A measurable amount is an amount that exceeds the amount that can be declared as “zero” in the nutrition label of conventional foods, as specified in 21 CFR 101.9(c). If present in a measurable amount, trans fat must be listed on a separate line underneath the listing of saturated fat by January 1, 2006.
Calories from saturated fat and the amount of polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, sugar alcohol, and other carbohydrate may be declared, but they must be declared when a claim is made about them.
Must I declare vitamins and minerals (other than vitamin A, vitamin C, calcium, and iron) listed in 21 CFR 101. 9(c)(8)(iv) and (c)(9)?
No. You are only required to declare them when they are added to the product for purposes of supplementation, or if you make a claim about them.
Am I required to list any other nutrients if I make a claim about them?
Yes. When you make a claim about calories from saturated fat, insoluble fiber, polyunsaturated fat, sugar alcohol, monounsaturated fat, other carbohydrate, and soluble fiber, you must list that nutrient.
May I declare dietary ingredients not having Daily Values (i.e., RDIs or DRVs)?
Yes. Dietary ingredients for which no daily values have been established must be listed by their common or usual names when they are present in a dietary supplement. They must be identified as having no Daily Values by use of a symbol in the column for “% Daily Value” that refers to the footnote “Daily Value Not Established.”
If I use a magnesium salt as a binder, where must I declare it?
You must list the specific magnesium salt in the ingredient statement below the “Supplement Facts” panel, not in the “Nutrition Facts” panel. Ingredients in dietary supplements that are not dietary ingredients, such as binders, excipients, fillers, must be included in the ingredient statement.
Must I declare vitamin E when it occurs naturally in my product and I make no claim for it?
No. Because Vitamin E is not one of the 14 mandatory dietary ingredients, it does not need to be declared when it occurs naturally.
May I declare protein on the label if my product contains only individual amino acids?
No. You may not declare protein on your products that contain only amino acids.
Must I list the dietary ingredients in my products in a specified order?
Yes. You must list the dietary ingredients that have Daily Values in the same order as for the labels of conventional foods, except that vitamins, minerals and electrolytes are grouped together. This results in the following order for vitamins and minerals: Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin, pantothenic acid, calcium, iron, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, sodium, and potassium.
May I use synonyms for my dietary ingredients?
Yes. You may use the following synonyms in parentheses after your dietary ingredients: Vitamin C (ascorbic acid), thiamin (vitamin B1), riboflavin (vitamin B2), folate (folacin or folic acid), and calories (energy). Alternatively, you may list “folic acid” or “folacin” without parentheses in place of “folate.” You may also express energy content parenthetically in kilojoules immediately following the caloric content.
If the calcium carbonate in my product supplies calcium , should I list the weight of the entire salt or just of the calcium?
You must list the weight of calcium, rather than the weight of the calcium carbonate, the source ingredient, in the “Supplement Facts” panel.
May I list the amount of my dietary ingredient in a separate column?
Yes. You may place the amount of your dietary ingredient in a separate column or immediately following the name of your dietary ingredient
When I use a separate column for amounts, can the heading “Amount per Serving” be placed over the column of amounts?
Yes.
May I use language other than the term “Amount Per Serving?”
Yes. Language consistent with the declaration of the serving size, such as “Each Tablet Contains” or “Amount Per 2 Tablets” may be used in place of the heading “Amount Per Serving.” You may also use terms, such as capsule, packet, or teaspoonful.
May I present information on the “Amount Per Unit” basis?
Yes. You may declare information on a “per unit” basis in addition to the required “per serving” basis.
May I present information on more than one serving?
Yes. You may use additional columns when you have a product with different servings, such as one tablet in the morning and two at night. You must label the columns appropriately, e.g., “Amount per 1 Tablet” and “Amount per 2 Tablets.”
Am I required to use the units of measurement specified for use in the “Nutrition Facts” panel?
Yes. For example, the amount of fat would be listed in terms of grams in both the “Nutrition Facts” and “Supplement Facts” panels. However, units of measurement for amounts of vitamins and minerals are not specified for use in the “Nutrition Facts” panel because they must be listed by % Daily Value, not by weight. You should use the units of measurement given in 21 CFR 101.9(c)(8)(iv) for the Daily Values of vitamins and minerals when listing these nutrients in “Supplement Facts” (e.g., the amount of vitamin C must be listed in terms of milligrams because its Daily Value is stated in milligrams).
What is the % DV?
The % DV is the percent of the Daily Value (i.e., Reference Daily Intakes or Daily Reference Value) of a dietary ingredient that is in a serving of the product.