This practice point does not address all requirements for dietary supplement labeling and should not be construed as comprehensive in its treatment of the subject. Moreover, readers should not consider this practice pointer as legal advice or opinion. The purpose is to provide readers general information concerning the topic addressed.
In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which defined the term “dietary supplement” to include substances, such as vitamins, minerals, botanicals, and amino acids. 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. Under DSHEA, dietary supplements are deemed to be food, except for purposes of the drug definition. The complete statutory definition is found in section 201(ff) of Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 321.) In DSHEA, Congress recognized the importance of labels, calling for them to include information such that “consumers may make informed and appropriate health care choices for themselves and their families.” The Food and Drug Administration (FDA) has primary oversight responsibilities for dietary supplements and their labels. As necessary, the FDA may take actions through courtesy letters, warning letters, recalls, seizures, and injunctions.
In accordance with the regulatory framework, the following label statements are required on packages and containers of dietary supplements:
- the statement of identity (name of the dietary supplement)
- the net-quantity-of-contents statement (amount of the dietary supplement)
- the nutrition labeling
- the ingredient list
- the name and place of business of the manufacturer, packer, or distributor
All required label statements should be placed either on the principal display panel (PDP) 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.
The statement of identity is used to recognize a common name that describes a single item and must be placed on the PDP. Within the statement of identity there are multiple requirements for identifying dietary supplements. These requirements include use of the term “dietary supplement,” or manufacturers can replace the word “dietary” and use an ingredient name in its place.
The net quantity of contents is the amount of supplement in the container or package and can be expressed either in weight, measure, numerical, or a combination. If a net quantity is being characterized in weight, it should be expressed in the metric or the U.S. customary system. The weight is defined as the weight of the supplement itself. Also, the net quantity of contents shall be placed on the PDP within the bottom 30 percent of the area of the label panel in line generally parallel to the base on which the package rests as it is designed to be displayed. The bottom location requirement is waived for PDPs of five square inches or less.
Nutrition information is provided in the form of a “Supplement Facts” panel, including the product serving size, the amount, and percent daily value, if established, of each dietary ingredient. It also includes total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron when they are present in measurable amounts. 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 and the information must include the amount per serving. If the dietary ingredient is a proprietary blend, the information must include the total weight of the blend and the components of the blend in order of predominance by weight. The requirements for formatting of the Supplement Facts panel are dictated by the regulations.
The label must also include a complete list of ingredients by their common or usual names, either in descending order of predominance or with the source of the dietary ingredient in the “Supplement Facts” panel following the name of the dietary ingredient (e.g., calcium (from calcium carbonate).)
Lastly, the label shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. Additionally, the label should also contain directions for use.
Practice Pointers
- The label of a dietary supplement product is required to be truthful and not misleading. If the label does not meet this requirement, the FDA may remove the product from the marketplace or take other appropriate actions.
- The label of the supplement may contain a cautionary statement but the lack of a cautionary statement does not mean no adverse effects are associated with the product.
- If the supplement bears a claim to affect the structure or function of the body (structure/function claim), a claim of general well-being, or a claim of a benefit related to a classical nutrient deficiency disease, include on the label the disclaimer, “[T]his statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Daniel S. Wittenberg is a partner at Snell & Wilmer L.L.P. in Denver, Colorado.