R. FLORA & ASSOCIATES

DIETARY SUPPLEMENT LABELING GUIDELINES - Mandatory Information

What follows is a summary of the basic requirements for mandatory information on dietary supplement labels.  This is a great starting point for setting up and checking your labels, but the actual regulations contain far more detail and should be consulted whenever you are preparing or reviewing labels for your dietary supplement products.

Whenever you have questions about labels and labeling, R. FLORA & ASSOCIATES, INC. is here to help you.  With our vast experience in label preparation and review, there are few questions that we cannot answer.

PRINCIPAL DISPLAY PANEL

The following information must appear on the principal display panel.  The minimum allowable type size is 1/16" (unless exempted).

Product Name

Statement of Identity

The statement of identity should either be included in the name of the product or should follow the product name and must include the term “dietary supplement” or the term “supplement” modified by the name or type of dietary ingredients in the product.  The statement of identity must appear in a type size that is reasonably related to the most prominent printed matter on the panel and must be in lines that are generally parallel to the base of the package.  The FDA has taken the position that "reasonably related to the most prominent printed matter on the panel" means the letters are not less than half the height of the letters of the largest print on the PDP.

[21 CFR §101.3]

Net Quantity of Contents Declaration

The net quantity of contents declaration must appear on the lower 30% of the principal display panel, except on packages with a PDP of 5 square inches or less, in lines generally parallel to the base of the package.

There must be adequate space between the net quantity of contents declaration and other printed label information.  The space between the net contents declaration and any other information printed above or below shall be at least the height of the lettering used in the net contents declaration.  The space to the right or the left shall be at least twice the width of the letter "N" of the style of type used in the net contents declaration.

There are type size requirements for net quantity of contents declaration that vary with the area of the principal display panel.  They are as follows:

        Area of Principal Display Panel                  Minimum Type Size
    5 square inches or less                                                1/16"
    More than 5, but not more than 25 sq. in.                   1/8"
    More than 25, but not more than 100 sq. in.              3/16"
    More than 100, but not more than 400 sq. in.            1/4"
    More than 400 square inches                                       1/2"

If lower case, or both upper and lower case letters are used, the lower case letter "o" shall meet the minimum type size requirement.

The net quantity of contents declaration must appear in both the English (inch-pound) system and the metric (SI) system.  Either the English or metric units may be listed first, however, whichever units are second must be in parentheses.

[21 CFR §101.105 and proposals at 58 FR 29716, 5/21/93, and 58 FR 67444, 12/21/93] 

INFORMATION PANEL

The following information must either appear on the information panel with no intervening information, or on the principal display panel.  There are special type size requirements for the information in the “Supplement Facts” box (below).  The minimum allowable type size for all other mandatory information is 1/16" (unless otherwise exempted).

Nutrition Information

The following are examples of the typical “Supplement Facts” box, formatted in compliance with the current regulations:

Note: This example corrects an error in the example published by FDA at 62 FR 49853, 9/23/97 by identifying the propylparaben and sodium benzoate as preservatives.

If the sources of each dietary ingredient are included in the “Supplement Facts” box (as shown above), then only the ingredients that have not been identified need appear in the ingredients list which, in this case will be identified as “Other ingredients:”.

The ingredients list must be located immediately below the “Supplement Facts” box.  If there is insufficient space below, then immediately to the right of the “Supplement Facts” box.

As an alternative to listing the quantitative amounts of each dietary ingredient in a column under the heading “Amount Per Serving” in the “Supplement Facts” box (as shown above), the heading “Amount Per Serving” may be placed over the column of names of the dietary ingredients with the quantitative amounts of each dietary ingredient following one space to the right of each name.II.  Multiple vitamins for children and adults:

Note: This example corrects two errors in the example published by FDA at 62 FR 49853, 9/23/97, by changing “Other ingredients” to “Ingredients” and by adding “riboflavin” to the list of ingredients.  We have also moved the “Amount Per Serving” heading over the column of quantitative amounts as permitted by the regulations (the regulations allow this heading to appear over either the column of dietary ingredients or the column of quantitative amounts).

If the sources of each dietary ingredient are not included in the “Supplement Facts” box (as shown above), then all of the ingredients must appear in the ingredients list which, in this case will be identified as “Ingredients:”.

There are special labeling requirements for any dietary ingredient that is a liquid extract.  If the solvent has not been removed, the quantity listed must be the total volume (or weight) of the extract, including the solvent, and the information must include the concentration of the dietary ingredient and the condition of the starting material (e.g., fresh or dried).  For example, for the dietary ingredient “Fresh Dandelion Root Extract, x mL (y:z) in 70% Ethanol,” “x” is the number of milliliters of the entire extract, “y” is the weight of the starting material, and “z” is the volume of solvent.  When part of the solvent has been removed, the final concentration shall be stated.  For example, if the original extract was 1:5 and 50% of the solvent was removed, then the final concentration will be 1:2.5.

For a dietary ingredient that is an extract from which the solvent has been removed, the weight of the ingredient is the weight of the dried extract.

Type size and graphic enhancements for the Supplement Facts box:

1.    All information in the Supplement Facts box must utilize:

    a.    A single, easy-to-read type style;

    b.    All black or one color type, printed on a white or other neutral contrasting color background;

    c.    Upper- and lowercase letters, except all uppercase lettering may be used for packages that have a total surface area available to bear labeling of less than 12 square inches;

    d.    At least 1-point leading (i.e., space between lines of text); and

    e.    Letters that do not touch.

2.    Must be larger than all other type in the Supplement Facts box – The title “Supplement Facts.”  “Supplement Facts” should extend all the way across the top of the box unless impractical.  Otherwise, it should be justified left.

3.    Must be 6-point type minimum – The headers “Amount Per Serving” and “% Daily Value” and the footnotes.

4.    Must be 8-point type minimum – All of the other information in the Supplement Facts box.

5.    Must be bold type – The title “Supplement Facts” and the headers “Amount Per Serving” and “% Daily Value.”

6.    May be bold type – The term “Proprietary Blend” or other descriptive term or fanciful name for the proprietary blend.

7.    May not be bold type – Any other information in the Supplement Facts box.

8.    Heavy bars, recommended 7-point rule – Separate 1) the "Serving Size" and "Servings Per Container" information from the headers “Amount Per Serving” and “% Daily Value”; 2) the §101.36(b)(2) dietary ingredient information from the §101.36(b)(3) dietary ingredient information; and 3) the §101.36(b)(3) dietary ingredient information from the footnotes (if either the §101.36(b)(2) dietary ingredient information or the §101.36(b)(3) dietary ingredient information is absent there will be one 7-point heavy bar after the 3-point bar instead of two).

9.    Medium bar, recommended 3-point rule – Separates the headers “Amount Per Serving” and “% Daily Value” from the §101.36(b)(2) dietary ingredient information (or the §101.36(b)(3) dietary ingredient information if there is no §101.36(b)(2) dietary ingredient information).

10.    Hairlines, recommended 1/4-point rule – Separates each line of dietary ingredient information.

11.    When sub-dietary ingredients are indented, the hairlines above the sub-dietary ingredient must be indented the same amount.

12.    Top, bottom, and sides of box, recommended 1/2-point rule – Used for the 4 sides of the Supplement Facts box.  There should be a space of 3-points text measure from the inside of the hairlines to the information within the box.

[21 CFR §101.36]

Ingredients Declaration

List ingredients by common or usual name in descending order of predominance by weight after the heading “Ingredients.”  However, as indicated above, if the sources of the dietary ingredients are included in the “Supplement Facts” box (as shown above in the first example), then the ingredients list will be labeled “Other ingredients:” instead of “Ingredients:”, and must only include those ingredients that are not already identified in the “Supplement Facts” box.

Ingredients present in amounts of 2% or less are not required to be in order provided they are listed under the heading "Contains 2% or less of..." and the heading follows the last ingredient that is over 2%.  A threshold of 1.5%, 1.0%, or 0.5% may be used in place of 2%, as long as none of the ingredients following the heading exceed the threshold.

The ingredients list must include all ingredients in the product including excipients, binders, fillers, disintegrants, colors, flavors, preservatives (which must be further identified as preservatives), coating ingredients, capsule shell ingredients, etc.

As indicated above, the ingredients list must be located immediately below the “Supplement Facts” box.  If there is insufficient space below, then immediately to the right of the “Supplement Facts” box.

The common or usual names of ingredients that are botanicals (including algae and fungi) shall be consistent with the names standardized in Herbs of Commerce, 1992 edition.  Except for algae, the names must include the part of the plant used.  If the botanical is not included in Herbs of Commerce, 1992 edition, then the name of the botanical must be followed by a parenthetical statement of the Latin binomial name.

[21 CFR §101.4]

Food Allergen Labeling

If the supplement contains a major food allergen from one of the following eight foods or food groups; 1) milk, 2) eggs, 3) fish, 4) Crustacean shellfish, 5) tree nuts, 6) peanuts, 7) wheat, or 8) soybeans; either –

    a.  the word “Contains” followed by the name of the food source from which the allergen[s] is[are] derived, must be printed immediate after or adjacent to the list of ingredients, in a type size no smaller than the type size used in the list of ingredients; or

    b.  the common or usual name of the major food allergen in the list of ingredients is followed in parenthesis by the name of the food source from which the major food allergen is derived.  The name of the food source in not required when

        i.  the common or usual name of the ingredient uses the name of the food source from which the major food allergen is derived, or

        ii.  the name of the food source from which the major food allergen is derived appears elsewhere in the ingredient list, unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of a food ingredient that is not a major food allergen.

In the case of tree nuts, fish, and Crustacean shellfish, the name of the food source from which the major food allergen is derived must include the name of the specific type of tree nut or species of fish or Crustacean shellfish.

[Food Allergen Consumer Protection Act of 2004]

Name and Place of Business Declaration

The label must include the name and place of business of either the manufacturer, packer, distributor, etc. or some combination of these.  If the name and place of business statement is for any entity other than the manufacturer, the statement must be qualified by a phrase that reveals the connection that the entity has with the supplement; such as “Manufactured for...”, “Distributed by...”, or any other wording that expresses the facts.

Domestic Address - The place of business statement must include the street address, city, state, and Zip Code.  The street address is not required if the business name, city, state, and Zip Code are present and the street address is listed in current city directory or telephone directory.

Foreign Address - The place of business statement must include the street address, city, state, country, and postal code.  The street address is not required if the business name, city, state, country, and postal code are present and the street address is listed in current city directory or telephone directory.

[21 CFR §101.5]

Country of Origin Statement

If the supplement is manufactured in a country other than the United States and the name and address of the manufacturer do not appear on the retail package label, then a country of origin statement must appear legibly and permanently in close proximity to the name and place of business statement in at least a comparable type size.  The statement must name the country where the supplement was manufactured, preceded by “Made in,” “Product of,” or other words of similar meaning.

In addition, in any case in which the words, “United States,” or “American,” the letters “USA,” any variation of such words or letters, or the name of any city or location in the United States, or the name of any foreign country or locality other than the country of origin appears on the container, and those words may mislead or deceive the purchaser as to the actual country of origin, then a country of origin statement must appear legibly and permanently in close proximity to such words, letters, or name, in at least a comparable type size.  The statement must name the country where the supplement was manufactured, preceded by “Made in,” “Product of,” or other words of similar meaning.

[19 CFR §134.46]

Labeling Requirements for Serious Adverse Event Reporting

The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 (DS&NDCPA) requires the label of a dietary supplement being marketed in the United States to include a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event associated with the use of the dietary supplement.  If the label does not include the required domestic address or phone number, the supplement is misbranded.

This requirement is different than the requirement by the Fair Packaging and Labeling Act (FPLA) to include a name and place of business statement.  The FPLA requires the name and place of business statement to include the street address of the establishment, except that if the street address of the establishment appears in a local city or telephone directory it may be excluded from the label statement.  A P.O. box number is not an acceptable replacement for the street address.  Other information may be included, such as the P.O. box number, a phone number, fax number, e-mail address, web address, etc., but is not required.

Under the DS&NDCPA, the domestic address or domestic phone number of the location where the responsible person may be contacted to report a serious adverse event associated with the use of the supplement must include the full US mailing address that includes either the street number or the P.O. box and the city, state, and zip code of the responsible person if the domestic address is used, or the 10-digit phone number that includes the area code if the domestic phone number is used.  Unlike the requirements of the FPLA name and place of business statement, either the street address or the P.O. box must appear on the label if the domestic address is used, regardless of whether or not they appear in a local city or telephone directory.

The FPLA name and place of business statement and the DS&NDCPA domestic address or domestic phone number statement may be combined as long as all of the requirements are met for each.

While the DS&NDCPA does not require a label to include any information other than a domestic address or a domestic phone number where the responsible person may be reached, FDA recommends (but does not require) that the label also bear a clear, prominent statement informing consumers that they may report serious adverse events to the domestic address or domestic phone number on the label.  The responsible person could also recommend that a doctor should be called for medical advice.  An example of an acceptable multipurpose statement is “You should call your doctor for medical advice about serious adverse events.  To report a serious adverse event or to obtain product information, contact...”  Other similar language would be acceptable.

Responsible persons may also provide on the label an email address or website to which reports may be made, provided that such email address or website is in addition to the domestic address or domestic phone number required by law.

[Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 and Guidance for Industry: Q and A for same dated September 2009]

Warnings Statements

Most dietary supplements do not require warning statements.  However, there are a few warnings required by regulation:

    1.    Dietary supplements in self-pressurized containers. [21 CFR §101.17(a)]

    2.    Dietary supplements in self-pressurized containers containing halocarbon or hydrocarbon components. [21 CFR §101.17(b)]

    3.    Dietary supplements containing or manufactured with a chlorofluorocarbon or other ozone-depleting substance. [21 CFR §101.17(c)]

    4.    Protein products. [21 CFR §101.17(d)]

    5.    Dietary supplements containing iron or iron salts. [21 CFR §101.17(e)]

    6.    Dietary supplements containing psyllium husk. [21 CFR §101.17(f)]

    7.    Juices that have not been specifically processed to prevent, reduce, or eliminate the presence of pathogens. [21 CFR §101.17(g)]

    8.    Dietary supplements containing aspartame. [21 CFR §172.804(d)(2)]

    9.    In California, dietary supplements containing certain laxative substances listed by the State of California. [California Code of Regulations; Title 17; Division 1; Chapter 5; Subchapter 2; Group 1; Article 3; Section 10750 (17 CCR § 10750)]

    10.    In California, dietary supplements containing dehydroepiandrosterone (DHEA).  Further, it is a misdemeanor in California for any manufacturer, wholesaler, retailer, or other person to sell, transfer, or otherwise furnish DHEA to a person under 18 years of age. [California Sherman Food, Drug, and Cosmetic Law; Article 4; Sections 110423(b) and 110423.2]

Other warnings, though not mandated by regulation or law, may be included to insure safe use of the product.