Dietary Supplement Labeling Guide: Chapter III. Net Quantity of Contents

April 2005

Contains Nonbinding Recommendations

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Questions

1. What is the net quantity of contents statement for a dietary supplement?
2. Where must I locate the net quantity of contents statement on my label?
3. How must I express the net quantity of contents statement on my label?
4. Why must I calculate the area of the principal display panel?
5. How do I calculate the area of the principal display panel?
6. Am I required to place the net quantity of contents statement conspicuously and prominently on my product labels?
7. What is the minimum type size that I can use for the net quantity of contents statement?
8. What must I include in a weight-based net quantity of contents statement?
9. What must I include in a numerical count-based net quantity statement?
10. May I use qualifying phrases in the net quantity of contents statement?

Answers

1. 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.

   21 CFR 101.105(a

2. 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.

   21 CFR 101.105(f)

3. 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.

   Public Law 102-329, August 3, 1992 and 21 CFR 101.105

4. 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.

   21 CFR 101.1

5. 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.

   21 CFR 101.1

6. 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.

   21 CFR 101.15 and 21 CFR 101.105(h)

7. 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.)

   21 CFR 101.105(h) and (i)

8. 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.

   21 CFR 101.105(g)

9. 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."

   21 CFR 101.105(a)

10. 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.

    21 CFR 101.105(f)