Dietary Supplement Facts and Label Review
There’s a lot of detail required for dietary supplement labels. Between supplement facts, structure-function health claims, content claims, and required formatting, it’s easy to overlook some of the FDA requirements for labeling.
Dietary Supplement Facts and Label Review
As part of our Label Review services, NaturPro helps clients develop, review and suggest improvements to dietary supplement labels, to ensure compliance with FDA regulatory requirements
Our clients enjoy the following benefits:
- Reliability: 100% accuracy and FDA compliance
- Experience: 15+ years of experience reviewing supplement labels
- Science-driven: Our reviews are based on the most current, reliable information, techniques and evidence
- Perspective: We have experience on the business side of the industry, so we know what the law is, whether it’s followed, and what is likely to happen if you don’t.
Label Review (Basic): $350-550 — review only label — for “red flags” and suggested improvements
Label Review (Complete): $550-850 – review of label for red flags and suggested improvements, and matching finished product specifications
Label and Marketing Review: $800-1500 per label – web page / sales sheet
(Volume discounts may apply for similarly labeled products — Contact for Pricing
FDA Dietary Supplement Labeling Guidelines
The following outlines some of the most frequently asked questions (FAQ) for dietary supplement labels:
- How are dietary supplements defined?Dietary supplements are defined, in part, as products (other than tobacco) intended to supplement the diet that bear or contain one or more of the following dietary ingredients:
- A vitamin;
- A mineral;
- An herb or other botanical;
- An amino acid;
- A dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
- A concentrate, metabolite, constituent, extract, or a combination of any ingredient mentioned above.Further, dietary supplements are products intended for ingestion, are not represented for use as a conventional food or as a sole item of a meal or the diet, and are labeled as dietary supplements.
- What label statements are required on the containers and packages of dietary supplements?Five statements are required: 1) the statement of identity (name of the dietary supplement), 2) the net quantity of contents statement (amount of the dietary supplement), 3) the nutrition labeling, 4) the ingredient list, and 5) the name and place of business of the manufacturer, packer, or distributor.
- Where do I place the required label statements?You must place all required label statements either on the front label panel (the principal display panel) or on the information panel (usually the label panel immediately to the right of the principal display panel, as seen by the consumer when facing the product), unless otherwise specified by regulation (i.e., exemptions).
- What label statements must I place on the principal display panel?You must place the statement of identity and the net quantity of contents statement on the principal display panel. Where packages bear alternate principal display panels, you must place this information on each alternate principal display panel.
- How do I locate the principal display panel?The principal display panel of the label is the portion of the package that is most likely to be seen by the consumer at the time of display for retail purchase. Many containers are designed with two or more different surfaces that are suitable for use as the principal display panel. These are alternate principal display panels.
- What label statements must I place on the information panel?You must place the “Supplement Facts” panel, the ingredient list, and the name and place of business of the manufacturer, packer, or distributor on the information panel if such information does not appear on the principal display panel, except that if space is insufficient, you may use the special provisions on the “Supplement Facts” panel in 21 CFR 101.36(i)(2)(iii) and (i)(5). See questions 46 and 56 in Chapter IV for more details.
- Where is the information panel?The information panel is located immediately to the right of the principal display panel as the product is displayed to the consumer. If this panel is not usable, due to package design and construction (e.g. folded flaps), the panel immediately contiguous and to the right of this part may be used for the information panel. The information panel may be any adjacent panel when the top of a container is the principal display panel.
- What name and address must I list on the label of my product?You must list the street address if it is not listed in a current city directory or telephone book, the city or town, the state, and zip code. You may list the address of the principal place of business in lieu of the actual address.
- 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.
- What is the nutrition label for a dietary supplement called?The nutrition label for a dietary supplement is called a “Supplement Facts” panel.
- 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.How does “Supplement Facts” differ from “nutrition facts?”The major differences between “Supplement Facts” panel and “Nutrition Facts” panel are as follows:
- 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.
- 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.
- 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.
- 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.
For more information, visit FDA Dietary Supplement Labeling Guide