Food and Drug Administration regulations require that the labeling of dietary supplements include a descriptive name of the product that indicates that it is a dietary supplement; the name and place of work of the manufacturer, packer, or distributor; a list of ingredients; and the net content of the product. Dietary ingredients for which daily values have not been established should be listed by their common or usual names when present in a dietary supplement. They must be identified as having no daily values by using a symbol in the column corresponding to the% of the daily value that refers to the footnote “Daily Value Not Established”. Yes.
You can place the amount of your diet ingredient in a separate column or immediately after the name of your diet ingredient. Language consistent with the serving size statement, such as “Each tablet contains” or “Quantity per 2 tablets” can be used instead of the heading “Amount per serving”. You can also use terms such as capsule, package, or teaspoon. You can declare information per unit in addition to that required per portion.
You can use additional columns when taking a product with different servings, such as one tablet in the morning and two in the evening. You must label the columns appropriately, for example,. For example, the amount of fat would be indicated in terms of grams in the Nutrition Facts and Supplement Information panels. However, the units of measurement for the amounts of vitamins and minerals are not specified for use in the nutrition information panel because they must be indicated in% of the daily value, not by weight.
You must use the units of measurement indicated in 21 CFR 101.9 (c) (iv) for daily values of vitamins and minerals when including these nutrients in the supplement information (for example,. You can show more than one column. The FDA has established four sets of daily values for many nutrients. Appendix B shows the daily values to be used for adults and children aged 4 years and over and Appendix C contains the daily values to be used for children under 4 years of age, for infants and for pregnant and lactating women.
If you show more than one column, you must clearly identify each column (p. e.g. You can list the components of a dietary ingredient marked under the dietary ingredient and followed by their quantitative amounts by weight per serving. You can declare components in a column or in a linear screen.
You can use a tabular format in small packages. It can also present supplemental data information in a linear way (that is,. See 21 CFR 101.9 (j) (1 (ii) (A) (for an illustration of a tabular display) and 21 CFR 101.9 (j) (1 (ii) (A) (for an illustration of a linear display). If there is not enough space for the supplementary data panel in the information panel or main display panel, you can place it in other panels that consumers can easily view in accordance with 21 CFR 101.9 (j) (1).
Supplements are considered a subset of foods, so many of the requirements are transferred to the main display panel. Ii) The number of calories, if declared, and the quantitative amount by weight per serving of each dietary ingredient to be included in paragraph (b) (i) of this section shall be presented in a separate column aligned to the right of the name column or immediately after the list of names within the same column. You should only declare them when they are added to the product for supplementation purposes or if you make a statement about it. You must include the name and contact information of the manufacturer, packager, or distributor of the supplement.
The nutrition label for a dietary supplement is called the supplement information panel (see sample labels at the end of this chapter). For dietary supplement companies, navigating industry rules and regulations can be daunting. Ii) All nutrition label information on intermediate-sized containers, which have 12 to 40 square inches of surface area available for labeling, shall be in a letter size not less than 6 dots, except that the size not less than 4.5 dots can be used on packages that have less than 20 square inches available for labeling and more than 8 dietary ingredients to list and on packages that have 20 to 40 square inches available for labeling and more than 16 dietary ingredients To be listed listed. You must list liquid extracts using the volume or weight of the total extract and the state of the starting material before extraction when it was fresh.
More than half of the herbal and dietary supplements analyzed by the researchers contained ingredients that differed from the list on their labels. The FDA doesn't regulate the supplement industry the way it does with pharmaceutical products and medical devices, Navarro and Angelone noted. When the source ingredients are listed on the nutrition label and two or more are used to provide a single dietary ingredient, all sources will be listed in parenthesis in descending order by weight. In addition, the 4.5-dot type can be used on packages smaller than 20 square inches that include more than 8 dietary ingredients.
You should list dietary ingredients that have daily values in the same order as on conventional food labels, except that vitamins, minerals, and electrolytes are grouped together. In the United States, the FDA is the main regulatory body that monitors supplements and claims made by supplement companies. Iii) When nutrition information is presented in any panel according to § 101.9 (j) (1 (ii) (D), the list of ingredients will continue to be located immediately below the nutrition label or, if there is not enough space below the nutrition label, immediately adjacent and to the right of the nutrition label, as specified in § 101.4 (g). When you need a fast and accurate labeling solution for dietary supplement products that works with your production environment, talk to the experts at CTM Labeling Systems.