Foundation of Supplement Labeling: The DSHEA
Passed in 1994, the Dietary Supplement Health and Education Act (DSHEA) provides the regulatory framework that governs how dietary supplements are labeled and marketed in the United States. Unlike drugs, which require pre-market approval from the FDA for safety and effectiveness, dietary supplement manufacturers are responsible for ensuring their products are safe and that their labeling is truthful and not misleading before they enter the market. The FDA primarily acts with post-market authority, inspecting manufacturing facilities and reviewing product labels for compliance.
Mandatory Label Statements
To avoid being considered misbranded, every dietary supplement label must include five key statements. These must be prominent, conspicuous, and easy to read for consumers. The specific placement for these statements is detailed in FDA guidance.
1. Statement of Identity
This is the product's name and a descriptive term indicating that it is a "dietary supplement". The word "dietary" can be replaced with a description of the ingredients, such as "Herbal Supplement" or "Vitamin C Supplement". This statement must appear on the Principal Display Panel (PDP), which is the part of the label most likely to be shown to the consumer.
2. Net Quantity of Contents
This statement declares the total amount of the supplement in the package and must be placed on the bottom 30% of the PDP. It must be expressed in either weight, measure, or numerical count.
3. Supplement Facts Panel
This is the core of the labeling regulations, presenting the nutritional information in a structured, boxed format. Key details include:
- Serving Size: The maximum amount recommended per serving.
- Servings Per Container: The total number of servings in the package.
- Dietary Ingredients: A list of every dietary ingredient, with ingredients that have a Daily Value (% DV) listed first, followed by others.
- Quantitative Amount: The weight or amount per serving for each ingredient.
- % Daily Value (% DV): The percentage of the Daily Value for ingredients where one has been established. Ingredients without a Daily Value must have a symbol directing to a footnote stating, "Daily Value Not Established".
4. Ingredients List
All ingredients not listed in the "Supplement Facts" panel must be listed below it under the heading "Other Ingredients". This includes fillers, binders, flavors, and other non-dietary components.
5. Manufacturer/Distributor Information
The name and place of business of the manufacturer, packer, or distributor must be included, along with a domestic phone number or mailing address for serious adverse event reporting. This information is crucial for consumer safety and product accountability.
Claim Regulations
Manufacturers can make certain claims on supplement labels, but they must be truthful and not misleading. The FDA categorizes claims into three main types:
- Nutrient Content Claims: Characterize the level of a nutrient in the supplement, such as "high in calcium" or "excellent source of vitamin C". These must adhere to specific FDA definitions.
- Health Claims: Describe the relationship between a substance and a disease or health-related condition. These are subject to FDA pre-market review and require significant scientific agreement.
- Structure/Function Claims: Describe the role of a nutrient or ingredient intended to affect the structure or function of the body. A mandatory disclaimer must accompany these claims: "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".
Supplement Facts vs. Nutrition Facts: A Comparison
It is critical to distinguish between the labeling requirements for dietary supplements and conventional foods. The table below highlights key differences.
| Feature | Supplement Facts Panel (Dietary Supplements) | Nutrition Facts Panel (Conventional Foods) |
|---|---|---|
| Panel Title | "Supplement Facts" | "Nutrition Facts" |
| Dietary Ingredients without DV | Must be listed with the footnote "Daily Value Not Established" | Not permitted to be listed |
| Ingredient Source | May be listed (e.g., source of botanical) | Cannot be listed |
| "Zero" Amount Declaration | Not permitted to list "zero" amounts of nutrients | Required to list "zero" amounts of some nutrients |
| Botanical Identification | Must include the part of the plant used (e.g., leaf, root) | Not permitted to list the plant part |
Compliance and Ongoing Responsibilities
Beyond accurate labeling, manufacturers must also comply with Current Good Manufacturing Practices (cGMPs) to ensure quality control, proper handling, and recordkeeping. For any product containing a "new dietary ingredient"—one not marketed in the U.S. before October 15, 1994—a manufacturer must submit a New Dietary Ingredient (NDI) notification to the FDA at least 75 days before introducing the product to market, unless an exemption applies. For further reading, consult the Dietary Supplement Labeling Guide from the FDA.
Conclusion
Navigating the FDA labeling requirements on food supplements is a critical responsibility for manufacturers. The framework established by DSHEA, centered on the five mandatory label statements and a clear Supplement Facts panel, aims to ensure transparency and consumer safety. Adherence to strict formatting rules and proper handling of claims, including the required disclaimer for structure/function claims, is non-negotiable. Ultimately, manufacturers bear the weight of substantiating their claims and producing a truthful, compliant product, as the FDA monitors the market and can take action against non-compliant goods post-distribution.
