Dietary Supplement Labeling Guide: Chapter IV. Nutrition Labeling

The two exemptions for small businesses and low-volume products (a. and b. above) are available to you only if your products' labels bear no claims or other nutrition information.

21 CFR 101.36(h)(1) - (3)

Special Labeling Provisions

  1. What are small packages? Small packages are those packages having less than 12 square inches of total surface area available to bear labeling. 21 CFR 101.36(i)(2) and 21 CFR 101.9(j)(13)
  2. What is the telephone provision for small packages? In lieu of a "Supplement Facts" panel, you may print labels for small packages with a telephone number or address that consumers can use to obtain nutrition information. You may use a telephone number or an address in place of the "Supplement Facts" panel only if you place no claims or other nutrition information on the product label. 21 CFR 101.36(i)(2) and 21 CFR 101.9(j)(13)(i)
  3. What is the minimum type size that I may use for small packages? You may use a type size no smaller than 4.5 point for the "Supplement Facts" panel on the labels of small packages. 21 CFR 101.36(i)(2)(i)
  4. May I use a tabular or linear format for the "Supplement Facts" panel on a small package? Yes. You may use a tabular format on small packages. You also may present "Supplement Facts" information in a linear (i.e., string) fashion if the label will not accommodate the "Supplement Facts" panel in a tabular format. (See 21 CFR 101.9(j)(13)(ii)(A)(1) for an illustration of a tabular display and 21 CFR 101.9(j)(13)(ii)(A)(2) for an illustration of a linear display.) 21 CFR 101.36(i)(2) and 21 CFR 101.9(j)(13)(ii)(A)
  5. What are intermediate-sized packages? Intermediate-sized packages are those packages having from 12 to 40 square inches of total surface area available to bear labeling. 21 CFR 101.36(i)(2)(ii)
  6. What is the minimum type size for intermediate-sized packages? The "Supplement Facts" panel on the labels of intermediate-sized packages must use type size no smaller than 6 point, except that type no smaller than 4.5 point may be used on packages that have 20 to 40 square inches that list more than 16 dietary ingredients. Also, 4.5 point type may be used on packages with less than 20 square inches that list more than 8 dietary ingredients. Furthermore, the type size used in the "Supplement Facts" panel on an inner container may be as small as needed to accommodate all required information if the "Supplement Facts" on the outer container meets these type size requirements. 21 CFR 101.36(i)(2)(ii) and (i)(2)(iv)
  7. May I use a tabular or linear format for the "Supplement Facts" panel on an intermediate-sized package? You may use a tabular format on an intermediate-sized package if the package shape or size cannot accommodate vertical columns. You may use a linear format if the label will not accommodate a tabular format. (See 21 CFR 101.9(j)(13)(ii)(A)(1) for an illustration of a tabular display and 21 CFR 101.9(j)(13)(ii)(A)(2) for an illustration of a linear display). 21 CFR 101.36(i)(2) and 21 CFR 101.9(j)(13)(ii)(A)
  8. May I abbreviate on the labels of intermediate- sized packages? You may use the abbreviations in 21 CFR 101.9(j)(13)(ii)(B) in the "Supplement Facts" panel for small and intermediate-sized packages, e.g, "Serv size" for "Serving Size" and "Servings" for "Servings Per Container." 21 CFR 101.9(j)(13)(ii)(B)
  9. Must I always use hairlines on the labels of intermediate-sized packages? No. You may use a row of dots connecting the columns containing the name of each dietary ingredient and the quantitative amount (by weight and as a percent of Daily Value) in the "Supplement Facts" panel on a small or an intermediate-sized package if you use the minimum type size and there is not sufficient space for you to use hairlines. 21 CFR 101.36(i)(2)(v)
  10. Are there special requirements that I must follow for the labeling of dietary supplements for children? Yes. On products for children less than 2 years of age, other than infant formula, you must not declare calories from fat, calories from saturated fat, saturated fat, polyunsaturated fat, monounsaturated fat, and cholesterol. Also, on products for children less than 4 years of age, you may not include % DVs for total fat, saturated fat, cholesterol, total carbohydrate, dietary fiber, vitamin K, selenium, manganese, chromium, molybdenum, chloride, sodium, or potassium. 21 CFR 101.36(b)(2)(iii) and (i)(1)
  11. Must I include a footnote comparing a 2,000 calorie diet to a 2,500 calorie diet in the "Supplement Facts" panel of my product? No. You are not required to place the footnote on dietary supplements that is required by 21 CFR 101.9(d)(9) on conventional foods. However, you are required to include the footnote "Percent Daily Values are based on a 2,000 calorie diet" when you declare total fat, saturated fat, total carbohydrate, dietary fiber, or protein. 21 CFR 101.36(b)(2)(iii)(D)
  12. May I locate the "Supplement Facts" panel on other than the information panel? Yes. If there is insufficient space for the "Supplement Facts" panel on the information panel or the principal display panel, you may locate it on other panels that can readily be seen by consumers in accordance with 21 CFR 101.9(j)(17). 21 CFR 101.36(i)(2)(iii) and (i)(5) and 21 CFR 101.9(j)(17)
  13. May I omit the "Supplement Facts" panel on individual unit containers in multi-unit retail packs? Yes. You may omit the "Supplement Facts" panel on individual units if nutrition information is fully provided on the outer package of the multi-unit pack and the unit containers are securely enclosed and are not intended to be separated for retail sale. You must label each individual unit with the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.9(j)(15). 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15)
  14. How do I provide the "Supplement Facts" panel if my dietary supplements are sold from bulk containers? The retailer must display a "Supplement Facts" panel clearly at the point of purchase (e.g. on a counter card, sign, tag affixed to the product, or some other appropriate device). Alternatively, the required information may be placed in a booklet, looseleaf binder, or some other appropriate format that is available at the point of purchase. 21 CFR 101.36(i)(4), 21 CFR 101.9(a)(2) and (j)(16)
  15. Does FDA have sample labels for dietary supplements? Yes. See sample labels below.
  16. Sample LabelsA) Dietary supplement containing multiple vitamins (see 21 CFR 101.36(e)(10)(i)):B) Dietary supplement containing multiple vitamins for children and adults (see 21 CFR 101.36(e)(10)(ii)):
  17. C) Multiple vitamins in packets (see 21 CFR 101.36(e)(10)(iii)):
  18. D) Dietary supplement containing dietary ingredients with and without RDIs and DRVs (see 21 CFR 101.36(e)(10)(iv):

Content current as of:

Regulated Product(s)