Labeling Requirements Flashcards
1
Q
May I place intervening material on the information panel?
A
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.
2
Q
What type size, prominence and conspicuousness am I required to use on the principal display panel and the information panel?
A
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.
3
Q
Do I need to specify the country of origin if my product, or the ingredients in my product, is not from the United States?
A
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.
4
Q
Who regulates the statement “Made in the U. S. A.”?
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.
5
Q
How do I obtain a UPC bar code?
A
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.”
6
Q
Must expiration dating be included on the label of dietary supplements?
A
No. However, a firm may include this information if it is supported by valid data demonstrating that it is not false or misleading.
7
Q
- What is the statement of identity for a dietary supplement and where must I place it?
A
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.
8
Q
How am I required to identify a dietary supplement?
A
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”).
9
Q
Can the term “dietary supplement” by itself be considered the statement of identity?
A
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.”
10
Q
Should I make the statement of identity stand out?
A
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.
11
Q
How should I place the statement of identity on the principal display panel?
A
You must place the statement of identity of your dietary supplement product in lines generally parallel to the base of the package.
12
Q
What is the net quantity of contents statement for a dietary supplement?
A
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.
13
Q
Where must I locate the net quantity of contents statement on my label?
A
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
14
Q
How must I express the net quantity of contents statement on my label?
A
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.
15
Q
Why must I calculate the area of the principal display panel?
A
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.
16
Q
How do I calculate the area of the principal display panel?
A
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.
17
Q
Am I required to place the net quantity of contents statement conspicuously and prominently on my product labels?
A
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.
18
Q
What is the minimum type size that I can use for the net quantity of contents statements?
A
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.)
19
Q
What must I include in a weight-based net quantity of contents statement?
A
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.
20
Q
May I use qualifying phrases in the net quantity of contents statement?
A
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
Q
What must I include in a numerical count-based net quantity statement?
A
You must include the number of units in a container, e.g. “100 tablets.”
22
Q
What is the nutrition label for a dietary supplement called?
A
The nutrition label for a dietary supplement is called a “Supplement Facts” panel (see sample labels at the end of this chapter).
23
Q
How does “Supplement Facts” differ from “nutrition facts?”
A
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.
24
Q
What information must I list in the “Supplement Facts” panel?
A
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.
25
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.
26
May I use flexibility in the wording for "Serving Size?"
No. You must use the term "Serving Size."
27
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.
28
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.
29
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.
30
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."
31
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.
32
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.
33
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.
34
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.
35
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.
36
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.
37
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
38
When I use a separate column for amounts, can the heading "Amount per Serving" be placed over the column of amounts?
Yes.
39
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.
40
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.
41
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."
42
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).
43
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.
44
Do I need to list the % DV on my label?
The % DV must be declared for all dietary ingredients for which FDA has established Daily Values, except that 1) the percent for protein may be omitted, and 2) on the labels of dietary supplements to be used by infants, children less than 4 years of age, or pregnant or lactating women, you must not list any percent for total fat, saturated fat, cholesterol, total carbohydrate, dietary fiber, vitamin K, selenium, manganese, chromium, molybdenum, chloride, sodium, or potassium. See Appendix B for the daily values to be used for adults and children 4 or more years of age and Appendix C for the daily values to be used for infants, children less than 4 years of age, or pregnant or lactating women.
45
How do I calculate the % DV?
You calculate the % DV by dividing the quantitative amount by weight by the established Daily Value for the specified dietary ingredient and multiplying by 100 (except that the % DV for protein must be calculated in accordance with 21 CFR 101.9(c)(7)(iii)). In this calculation, you must use as the quantitative amount the unrounded amount, except that for total fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate, and dietary fiber, you may use the quantitative amount by weight declared on the label (i.e., the rounded amount). For example, the % DV for 60 mg of vitamin C is 100 (60 mg divided by the Daily Value for vitamin C, multiplied by 100).
46
What rounding rules must I use for expressing the % DV?
You must express the percentages to the nearest whole percent, except that "Less than 1 %" or "< 1 %" must be used when the amount present is big enough to be listed, but so small that the % DV when rounded to the nearest percent is zero. For example, a product containing 1 gram of total carbohydrate would list the % DV as "Less than 1 %" or "< 1 %."
47
What if the amount of a dietary ingredient present in my product is high enough to declare, but so low that the % DV rounds to zero?
You must declare "Less than 1%" or "< 1%" because your label might confuse consumers if you declare 5 mg and list 0% DV. For example, if a product contains 5 mg of potassium, the % DV calculates to 0.14 percent (5 mg divided by 3,500 mg), which you would round to zero. In this case, you would declare "Less than 1%" or "< 1%" for the % DV.
Note: This does not pertain to dietary ingredients having RDIs because they may not be listed when present at less than 2 percent of the RDI.
48
Can I show more than one column for % DVs?
Yes. You may show more than one column. FDA has established four sets of Daily Values for many nutrients. Appendix B shows the Daily Values to be used for adults and children 4 or more years of age and Appendix C has the Daily Values to be used for children under 4 years of age, for infants, and for pregnant and lactating women. When you show more than one column, you must clearly identify each column (e.g., % Daily Value for Children Under 4 Years of Age).
49
What are "other dietary ingredients?"
"Other dietary ingredients" are those dietary ingredients that do not have Daily Values (i.e. RDIs or DRVs) such as phosphatidylserine.
50
Where must I list "other dietary ingredients?"
You must list "other dietary ingredients" in the "Supplement Facts" panel following the listing of dietary ingredients having Daily Values.
51
How must I list "other dietary ingredients?"
You must list "other dietary ingredients" by common or usual name in a column or linear display. FDA has not specified an order that you must follow. You must list the quantitative amount by weight per serving immediately following the name of the dietary ingredient or in a separate column. You must place a symbol in the column for "% Daily Value" that refers to the footnote "Daily Value Not Established," except that the symbol must follow the weight when you do not use the column format.
52
How must I list liquid extracts?
You must list liquid extracts using the volume or weight of the total extract and the condition of the starting material prior to extraction when it was fresh. You may include information on the concentration of the dietary ingredient and the solvent used, e.g., "fresh dandelion root extract, x (y:z) in 70% ethanol," where "x" is the number of mL or mg of the entire extract, "y" is the weight of the starting material, and "z" is the volume (mL) of solvent. You must identify the solvent in either the nutrition label or ingredient list.
53
How must I list dried extracts?
For dietary ingredients that are extracts from which the solvent has been removed, you must list the weights of the dried extracts.
54
May I list constituents of a dietary ingredient?
Yes. You may list constituents of a dietary ingredient indented under the dietary ingredient and followed by their quantitative amounts by weight per serving. You may declare the constituents in a column or in a linear display.
55
How must I list proprietary blends?
You must identify proprietary blends by use of the term "Proprietary Blend" or an appropriately descriptive term or fanciful name. On the same line, you must list the total weight of all "other dietary ingredients" contained in the blend. Indented underneath the name of the blend, you must list the "other dietary ingredients" in the blend, either in a column or linear fashion, in descending order of predominance by weight. These ingredients should be followed by a symbol referring to the footnote "Daily Value Not Established." Dietary ingredients having RDIs or DRVs must be listed separately and the individual weights declared.
56
How must I display the "Supplement Facts" panel?
The "Supplement Facts" nutrition information (referred to as a panel) must be enclosed in a box by using hairlines. The title, "Supplement Facts," must be larger than all other print in the panel and, unless impractical, must be set full width of the panel. The title and all headings must be bolded to distinguish them from other information.
57
How must I present the information in the "Supplement Facts" panel?
You must present all information using the following:
A single easy-to-read type style;
All black or one color type, printed on a white or neutral contrasting background, whenever practical;
Upper- and lowercase letters, except that you may use all uppercase lettering on small packages (i.e., packages having a total surface area available to bear labeling of less than 12 square inches);
At least one point leading (i.e., space between lines of text); and
Letters that do not touch.
58
What are the type size requirements for the "Supplement Facts" panel?
Except as provided for small and intermediate-sized packages, you must set information other than the title, headings, and footnotes in uniform type size no smaller than 8 point. You also must use a type size larger than all other print size in the nutrition label for the title "Supplement Facts." You may set the column headings and footnotes in type no smaller than 6 point type. See the section on "Special Labeling Provisions" for the exceptions for small and intermediate-sized packages.
21 CFR 101.36(e)
59
Must I use hairlines in the Supplement Facts panel?
Except for small and intermediate-sized packages, you must use a hairline rule that is centered between the lines of text to separate each dietary ingredient from the dietary ingredient above and beneath it. FDA has provided an exception for certain packages with space constraints. See the section on "Special Labeling Provisions" for the exceptions for small and intermediate-sized packages.
60
How closely must I follow the "Examples of graphic enhancements used by the FDA" in appendix B to Part 101?
You are not required to follow Appendix B to Part 101. Appendix B and its specifications are a model, which FDA has suggested in the interest of uniformity of presentation. For example, 21 CFR 101.36(e)(3)(i) requires the use of an "easy-to-read" type style, not specifically Helvetica type, as suggested in Appendix B.
21 CFR 101.36(e)(9)
61
How do I provide nutrition labeling when my product contains two or more packets of supplements (e.g., a packet of capsules for the morning and a different packet for the evening)?
You may present the information for each packet (e.g., a packet of capsules for the morning and a different packet for the evening) in an individual nutrition label or you may use an aggregate nutrition label. For two packets, this would consist of five columns. List all of the dietary ingredients in the first column. List the amounts and percents of the morning packet in the second and third columns and similar information for the evening packet in the fourth and fifth columns (see the illustration of aggregate nutrition labeling in 21 CFR 101.36(e)(10)(iii)).
62
What kind of samples will FDA collect to determine compliance with 21 CFR 101.36?
FDA will collect a composite of 12 subsamples (consumer packages) or 10 percent of the number of packages in the same inspection lot, whichever is smaller. FDA will randomly select these packages.
63
What if it is not technically feasible for me to comply with the nutrition labeling requirements?
FDA may permit you to use an alternative means of compliance or additional exemptions in accordance with 21 CFR 101.9(g)(9). If your firm needs such special allowances, you must make your request in writing to the Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-800), Food and Drug Administration, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835.
64
Must dietary ingredients that I have added to my products be present at 100% of the amount that I declare?
For dietary ingredients that are specifically added, your product must contain 100% of the volume or weight that you have declared on the label, with the exception of a deviation that is attributable to the analytical method. Products that contain less than this amount of such a dietary ingredient would be misbranded and in violation of the law. Dietary ingredients that are naturally-occurring must be present at 80% of the declared value. For example, if you add vitamin C that was isolated from a natural source or made synthetically to your dietary supplement product, it would be subject to the 100% rule. However, if you added rose hips to your product, the vitamin C in the rose hips is naturally-occurring and must be present at least 80% of the declared value.
65
What are the circumstances in which my dietary supplement products would be exempt from the nutrition labeling requirements?
Your dietary supplement product is not required to have a "Supplement Facts" panel if:
Your firm is a small business that has not more than $50,000 gross sales made or business done in sales of food to consumers or not more than $500,000 per year from total sales in accordance with 21 CFR 101.36(h)(1);
You sell less than 100,000 units of the product annually, your firm has fewer than 100 full-time equivalent employees in accordance with 21 CFR 101.36(h)(2) and you file an annual notification with FDA as specified in 21 CFR 101.9(j)(18)(iv); or
You ship the product in bulk form, do not distribute it to consumers in such form, and you supply it for use in the manufacture of other dietary supplements in accordance with 21 CFR 101.36(h)(3).
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.
66
What are small packages?
Small packages are those packages having less than 12 square inches of total surface area available to bear labeling.
67
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.
68
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.
69
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.)
70
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.
71
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.
72
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).
73
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."
74
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.
75
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.
76
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.
77
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).
78
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).
79
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.
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What is an "ingredient"?
The Dietary Supplement Health and Education Act uses the term "ingredient" to refer to the compounds used in the manufacture of a dietary supplement. For instance, when calcium carbonate is used to provide calcium, calcium carbonate is an "ingredient" and calcium is a "dietary ingredient." The term "ingredient" also refers to substances such as binders, colors, excipients, fillers, flavors, and sweeteners.
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What is unique about the ingredient labeling of dietary supplements?
Ingredients that are sources of dietary ingredients may be listed within the "Supplement Facts" panel, e.g., "Calcium (as calcium carbonate)." When ingredients are listed in this way, they do not have to be listed again in the ingredient statement (also called an ingredient list).
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Do I need an ingredient statement when all of my ingredients are listed in the "Supplement Facts" panel?
No. If you place all source ingredients in the "Supplement Facts" panel and you have no other ingredients, such as excipients or fillers, you do not need an ingredient statement.
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How must I identify the ingredient list?
You must precede the ingredient list by the word "Ingredients," except that you must use the words "Other Ingredients" when you have identified some ingredients (i.e., as sources) within the nutrition label.
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Where must I place the ingredient list on the label?
When present, you must place the ingredient list on dietary supplements immediately below the nutrition label, or if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label.
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What type size must I use for the ingredient list?
You must display this information prominently and conspicuously, but in no case may the types size be less that 1/16 inch in height as measured by the lower case "o", or its equivalent,
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Must I list the ingredients in a specified order?
Yes. You must list the ingredients in descending order of predominance by weight. This means that the ingredient that weighs the most is first and the ingredient that weighs the least is last.
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How must I declare spices, natural flavors, or artificial flavors?
You must declare these ingredients in ingredient lists by using either specific common or usual names or by using the declarations "spice," "natural flavor" or "artificial flavor," or any combination thereof.
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Can I indicate that a spice is also a coloring?
Yes. Paprika, turmeric, saffron and other spices that are also colorings, may be declared either by name or the term "spice and coloring." For example, paprika may be listed as "paprika" or as "spice and coloring."
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How must I declare artificial colors?
It depends on whether or not the artificial color is certified. List a certified color by its specific or abbreviated name, e.g., "FD&C Red No. 40" or "Red 40."
A color that is not certified may be listed as an "Artificial Color," "Artificial Color Added," "Color Added,"or by its specific common or usual name.
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May I use "and/or" labeling for fats and oils?
Yes. When a blend of fats and/or oils is not the predominant ingredient of your product and you vary the makeup of the blend you may use "and/or" labeling or language such as:
INGREDIENTS:...vegetable oil shortening (contains one or more of the following: cottonseed oil, palm oil, soybean oil)."
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How do I list a chemical preservative?
You must list the common or usual name of the preservative followed by a description that explains its function e.g., "preservative," "to retard spoilage," "a mold inhibitor," "to help protect flavor," or "to promote color retention."
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What is the standard for the common names of herbs used on labels?
The common name of ingredients of herbal dietary supplements must be in accordance with the standardized common names in the American Herbal Products Association’s Herbs of Commerce book. The part of the plant (e.g., root, leaf, flowers) as well as English name of the part of the plant is required (e.g., Calendula flowers rather than Calendulae flos). The Latin binomial name of the herb is only required when the standardized common name is not listed in the Herbs of Commerce (McGuffin, 2000). The Latin name for a plant must be consistent with internationally accepted rules on nomenclature.
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When must safety information be provided?
Safety information that is considered “material” with regards to potential consequences that may result from taking the dietary supplement must be provided (Office of the Inspector General, 2003). Some herbal dietary ingredients may require specific statements regarding contraindications, cautions, drug interactions, or use in pregnancy. Some examples include:
“Keep out of reach of children”
“Do not use if you are pregnant or nursing a baby”
“Discuss use of herbal product with a health care professional” (Office of the Inspector General, 2003).
Precautionary information on a Gingko biloba supplement: “If you are taking a prescription medicine such as an anticoagulant agent, please contact your doctor before taking this product” or “If you are taking medication, facing surgery or have bleeding problems, consult your physician before taking this product.”
Precautionary information on a hawthorn tincture: “Consult your healthcare provider before use if you have a heart condition.”
All products that contain laxative herbs and are labeled with an express or implied structure/function claim must include the following information on the label: “NOTICE: Do not use this product if you have abdominal pain or diarrhea. Consult a healthcare provider prior to use if you are pregnant or nursing a baby. Discontinue use in the event of diarrhea or watery stools. Do not exceed recommended dose. Not for long-term use” (American Herbal Products Association, 2015b).
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What information is not mandatory, but can help clients assess the product in order to make the best use of it?
Intended Use. Provides consumers with sufficient information about the range of uses for a supplement and about how its ingredients support health. All intended use claims (nutritional, structure/function, health) would be based on publicly available scientific evidence.
Disclaimer: According to the law, claims must be accompanied by the following disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease” (Office of Inspector General, 2003; U.S. Food and Drug Administration, 2005).
Directions for Use. This would provide consumers with adequate directions for intended use. The directions would include guidance on the appropriate dosage regimen (how many and how often to take), how best to take (with or without meal, with specific liquid, etc.) and when to take (morning or bedtime, etc.).
Formula information: Gives a quick read on what is unique in this herbal formula. For example, “Padma Basic—potent multi-compound Traditional Tibetan herbal formula.” This information can also be located on the PDP part of label.
Storage conditions: This section informs how to store the supplement correctly in order to protect its freshness and effectiveness.
Good Manufacturing Practice (GMP) logo: Ensures that supplements are consistently produced and controlled according to the highest quality standards and GMP-certified.
Nutrition, structure/function, or health claims: If applicable and desired.
Actual size diagram: Shows the approximate actual size of capsules, softgels, or tablets and help consumer decides if this size will work well for him/her.
Tamper evident: Section states: “Do not use if outer seal is broken or missing.”
Caffeine or gluten status: For example, “Naturally Caffeine Free” or “Gluten Free.” Be aware of the FDA’s new Gluten-Free rule, found here.
Third Party Certification: This section gives information about additional levels of oversight by a reputable third party certifier. For example, National Sanitation Foundation (NSF) certification mark, U.S. Pharmacopeial Convention (USP) verification, USDA organic seal; National Nutritional Foods Association certification, ConsumerLab.com seal, Ecological Certification (Demeter Biodynamic® seal), Religious Certification (Kosher and IFANCA Halal seal), Social Certification (Fair for Live, Fair Trade and FairWild seal), etc. (Whybark, 2004).
Expiration date: It means the time period during which a herbal dietary supplement should remain within the established shelf-life specifications. FDA does not require manufacturers to place “expired by”, “use by” or “best before” dates on dietary supplements labels. This information is entirely at the discretion of the company. However, including a shelf-life date is always preferred (U.S. Food and Drug Administration, 2010). You must be able to back up your expiration date with validating data documentation.
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What information is not mandatory, but can help clients assess the product in order to make the best use of it?
Intended Use. Provides consumers with sufficient information about the range of uses for a supplement and about how its ingredients support health. All intended use claims (nutritional, structure/function, health) would be based on publicly available scientific evidence.
Disclaimer: According to the law, claims must be accompanied by the following disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease” (Office of Inspector General, 2003; U.S. Food and Drug Administration, 2005).
Directions for Use. This would provide consumers with adequate directions for intended use. The directions would include guidance on the appropriate dosage regimen (how many and how often to take), how best to take (with or without meal, with specific liquid, etc.) and when to take (morning or bedtime, etc.).
Formula information: Gives a quick read on what is unique in this herbal formula. For example, “Padma Basic—potent multi-compound Traditional Tibetan herbal formula.” This information can also be located on the PDP part of label.
Storage conditions: This section informs how to store the supplement correctly in order to protect its freshness and effectiveness.
Good Manufacturing Practice (GMP) logo: Ensures that supplements are consistently produced and controlled according to the highest quality standards and GMP-certified.
Nutrition, structure/function, or health claims: If applicable and desired.
Actual size diagram: Shows the approximate actual size of capsules, softgels, or tablets and help consumer decides if this size will work well for him/her.
Tamper evident: Section states: “Do not use if outer seal is broken or missing.”
Caffeine or gluten status: For example, “Naturally Caffeine Free” or “Gluten Free.” Be aware of the FDA’s new Gluten-Free rule,
Third Party Certification: This section gives information about additional levels of oversight by a reputable third party certifier. For example, National Sanitation Foundation (NSF) certification mark, U.S. Pharmacopeial Convention (USP) verification, USDA organic seal; National Nutritional Foods Association certification, ConsumerLab.com seal, Ecological Certification (Demeter Biodynamic® seal), Religious Certification (Kosher and IFANCA Halal seal), Social Certification (Fair for Live, Fair Trade and FairWild seal), etc. (Whybark, 2004).
Expiration date: It means the time period during which a herbal dietary supplement should remain within the established shelf-life specifications. FDA does not require manufacturers to place “expired by”, “use by” or “best before” dates on dietary supplements labels. This information is entirely at the discretion of the company. However, including a shelf-life date is always preferred (U.S. Food and Drug Administration, 2010). You must be able to back up your expiration date with validating data documentation.
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What does the law say about providing information about proprietary blends on labels?
Labels of proprietary blends (privately-held formulas) are not required to provide information about the quantity of individual ingredients. DSHEA only requires that proprietary blends specify on the label the net weight of the blend and list the ingredients in descending order of weight (Office of Inspector General, 2003). All herbal ingredients of the blend should be followed by a symbol “†” referring to the footnote “†Daily Value Not Established” (U.S. Food and Drug Administration, 2005c). The proprietary blend provision was initially written into FDA label regulations to protect proprietary recipes in an environment in which there is no patent protection.
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What does the law say about organic labeling?
The United States Department of Agriculture (USDA) National Organics Program (NOP) sets forth guidelines for labeling your product as organic. You need to be certified organic to use the terms “organic,” “100% organic,” and “made with organic ingredients” on your label and in your marketing materials. There is an exemption for businesses that gross less than $5,000 in sales (retail or wholesale) on their organic products, but you are still expected to abide by the organic regulations and be able to prove that you make less than $5,000.
You do not need to be certified to list organic ingredients in your ingredients list on the Information Panel, though the ingredients do need to be certified organic to be listed as such. For example, in your ingredients list, you might write out “organic rose hips, organic nettle leaf” or put a * next to these items and then put “* organic” at the end of your ingredients list.
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What information should appear on a cosmetic label?
Principal Display Panel (front label):
Name of product
Identity
Warning statement per 21 CFR 740.10, if needed.
Net quantity of contents (See FDA’s Guidance for how this should appear since it varies.)
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Information Panel (side/back label):
Directions for safe use
Warnings
Name and place of business
Ingredient declaration (in descending order of prominence, various exceptions apply)
Any other required information
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According to the law, what kinds of claims are manufacturers allowed to make about their dietry supplements?
By law, manufacturers may make only three types of claims for dietary supplement products (U.S. Congress/Senate, 1994; U.S Food and Drug Administration, 2003): nutrient content claims, structure/function claims, and health claims. You may want to put a claim on your product in order to better explain its use to your potential customers, which may also improve sales. However, all claims must adhere to strict laws regarding proper language. Although you do not need FDA approval to list a structure/function claim, you do need to send your claims to the FDA and have information (that meets FDA standards) on file to prove your claim is true. It is legally much easier to avoid claims all together.
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When making structural/funciont claims on a herbal product label, what four requirements must be met to ensure that claims are not misleading?
Under Federal law, the FDA has three main requirements to ensure that structure/function claims are truthful and not misleading:
Substantiation of claim with appropriate scientific evidence (discussed in more detail below)
Notification to the FDA of claims within 30 days of first marketing the supplement
Disclaimer statement: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease”(U.S Food and Drug Administration, 2005).
The addition of a facts box in the informtion panel.
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What are the two parts of a health claim?
Health claims characterize a relationship between a substance and disease or a health-related condition. This type of claim can be used for conventional foods and dietary supplements. In contrast to structure/function claims, health claims include both a substance and a disease. An example of a health claim is: “Three grams of soluble fiber from oatmeal daily in a diet low in saturated fat and cholesterol may reduce the risk of heart disease.” This implied claim shows a relationship between two elements: a substance - soluble fiber, and a disease - heart disease. An example of structure/function claim is: “Eating three grams of soluble fiber from oatmeal daily as part of a diet low in saturated fat and cholesterol is good for you.” This claim does not present both elements, but may contain one element (soluble fiber) or another (U.S. Food and Drug Administration, 2013).
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What four things should be considered when substantiating a structural/functional claim?
To meet this regulatory requirement, the following should be considered when assembling the evidence to substantiate a claim:
The meaning of the claim being made: When making claims based on clinical research, be sure that the research directly supports the claim. This requires the manufacturer to “understand the meaning of the claim and to clearly identify each implied and expressed claim” (U.S. Food and Drug Administration, 2008). For example, a study that shows that a botanical supplement increases metabolism does not necessarily support a claim that the botanical supplement will promote weight loss (U.S. Food and Drug Administration, 2008).
The relationship of the evidence to the claim: It is important to determine “whether studies or evidence have a relationship to the specific claim being made or to the dietary supplement product itself” (U.S. Food and Drug Administration, 2008). For example, the claim that a botanical product improves memory and cognitive ability in school-aged children should not be supported with a study that shows those benefits in an elderly population (U.S. Food and Drug Administration, 2008).
The quality of the evidence. This means the scientific quality of studies. Any claim must be supported by publicly available scientific evidence including evidence from well-designed and adequate clinical studies. The gold standard is randomized, double blind, parallel group, placebo-controlled study (U.S. Food and Drug Administration, 2008).
The totality of the evidence: This means the “strength of the entire body of evidence”, including quality and quantity of studies, consistency and reproducibility of the findings, etc. It is important to consider both favorable and unfavorable studies, and not rely just on the research that supports the claim (U.S. Food and Drug Administration, 2008).
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What are structure/function claims?
The Dietary Supplement Health and Education Act of 1994 (DSHEA) added section 403(r)(6) to the Federal Food, Drug, and Cosmetic Act (FD&C Act)(2). This section of the law states that a dietary supplement may bear certain statements on its label or in its labeling if the claim meets certain requirements. Section 101.93(f) simply restates part of the definition of the types of claims that may be made under section 403(r)(6) of the FD&C Act. Section 101.93(f) reads:
(f) Permitted structure/function statements. Dietary supplement labels or labeling may, subject to the requirements in paragraphs (a) through (e) of this section, bear statements that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, provided that such statements are not disease claims under paragraph (g) of this section. If the label or labeling of a product marketed as a dietary supplement bears a disease claim as defined in paragraph (g) of this section, the product will be subject to regulation as a drug unless the claim is an authorized health claim for which the product qualifies.
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Are there other claims that can be made for dietary supplements, besides structural/functional claims?
Yes. Section 403(r)(6) also states that dietary supplements can use claims about nutrient deficiency diseases (for example, vitamin C and scurvy) or that describe the effect of the dietary supplement on general well-being.
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What requirements must I meet to make any of these types of claims for my dietary supplement?
There are three requirements you must meet. First, the law says you can make these claims if you have substantiation that the claims are truthful and not misleading. You must have this substantiation before you make the claims. Second, you must notify FDA that you are using the claim within 30 days of first marketing your product. Third, the claim must include a mandatory disclaimer statement that is provided for in the law.
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Can my FDA disclaimer include any information that I want it to?
We have published regulations that describe exactly what the disclaimer must say and what you must include in your notification to us and where you must send it
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How Do I Determine if a Claim is a Structure/Function Claim or a Disease Claim?
Whehter a claim is a disease claim depends on the definition of disease as defined by the FDA.
A claim that doesn't explicitely name a disease can still be contrued as a disease claim based on the context.
10 criteria for disease claims:
Criterion 1: Claims an effect on a disease or class of diseases (see section E, starting on page 1012 of the preamble to the rule).
A statement is a disease claim if it mentions a specific disease or class of diseases. For example, a claim that a product is "protective against the development of cancer" or "reduces the pain and stiffness associated with arthritis" would be a disease claim.
A statement also is a disease claim if it implies that it has an effect on a specific disease or class of diseases by using descriptions of the disease state. Examples of implied disease claims are "relieves crushing chest pain (angina)," "improves joint mobility and reduces inflammation (rheumatoid arthritis)," or "relief of bronchospasm (asthma)."
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What is the definition of a disease according to the FDA?
Section 101.93(g) defines disease as:
...damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.
