The Food and Drug Administration (FDA) frequently addresses inquiries regarding the labeling of dietary supplements. These queries arise from the dynamic landscape of dietary supplement regulation over recent years. Landmark events shaping dietary supplement labeling include:
- The Nutrition Labeling and Education Act of 1990 (NLEA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by mandating nutrition labeling for most foods, including dietary supplements.
- The Dietary Supplement Health and Education Act of 1994 (DSHEA), which further amended the FD&C Act by defining “dietary supplements,” establishing specific labeling requirements, and allowing for optional labeling statements.
- Regulations published on September 23, 1997 (62 FR 49826), implementing the DSHEA. These regulations cover the statement of identity, nutrition labeling, ingredient labeling, and nutrient content and health claims for dietary supplements. Amendments regarding the nutrition labeling of extracts followed on June 5, 1998 (63 FR 30615).
- Regulations published on January 15, 1997 (62 FR 2218), mandating a label warning statement on dietary supplements containing added iron and requiring unit-dose packaging for supplements containing 30 milligrams or more of iron. The unit-dose packaging requirement was later eliminated due to a court challenge in January 2003.
- A final regulation published on July 11, 2003 (68 FR 41434), amending labeling requirements for both dietary supplements and conventional foods to mandate the declaration of trans fat in nutrition labeling, requiring trans fat, when present at 0.5 g or more, to be listed in the Supplement Facts panel of dietary supplements on a separate line under saturated fat by January 1, 2006.
This guide aims to facilitate the proper labeling of dietary supplements sold in the United States, encompassing both domestically produced and imported products. It’s important to note that FDA regulations do not require label approval for the import or distribution of dietary supplements.
This guide addresses frequently asked questions about dietary supplement labeling in a question-and-answer format. For questions not covered in this guide, contact an FDA District Office or the:
Division of Dietary Supplement Programs (HFS-810)
Office of Nutritional Products, Labeling, and Dietary Supplements
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740-3835
240-402-2375
It is crucial to remain compliant with any new requirements for dietary supplements that may be published after the release of this guide. New regulations are published in the Federal Register before their effective date and are compiled annually in Title 21, Part 101 of the Code of Federal Regulations (21 CFR 101). Summaries of new regulations (proposed and final) are available on the FDA website (http://www.fda.gov).
FDA guidance documents, including this one, do not establish legally enforceable responsibilities. They represent the agency’s current thinking and should be considered as recommendations, unless specific regulatory or statutory requirements are cited. The term “should” signifies a suggestion or recommendation, not a requirement.
Key Labeling Components for Dietary Supplements
Proper dietary supplement labeling is essential for informing consumers and ensuring compliance with FDA regulations. Several key components must be accurately and prominently displayed on the product label.
1. Principal Display Panel (PDP)
The PDP is the portion of the package label most likely to be seen by consumers at the point of sale. It must include:
- Statement of Identity: Clearly identifies the product as a dietary supplement. For example, “Vitamin C Dietary Supplement.”
- Net Quantity of Contents: States the amount of product in the package (e.g., “60 Capsules,” “2 fl oz”).
2. Information Panel
This panel, typically located to the right of the PDP, contains essential information about the product, including:
- Supplement Facts Panel: Provides detailed information about the nutrients or dietary ingredients in the product. This includes serving size, list of dietary ingredients, amount per serving, and % Daily Value (DV) when established.
- Ingredient List: Lists all other ingredients in descending order of predominance by weight.
- Name and Address of Manufacturer, Packer, or Distributor: Allows consumers to contact the responsible party with questions or concerns.
3. Supplement Facts Panel: The Core of Nutritional Information
The Supplement Facts panel is a crucial component of the dietary supplement label. It provides consumers with detailed information about the product’s nutritional content, allowing them to make informed decisions. This panel follows a standardized format specified by the FDA.
- Serving Size: Clearly states the recommended serving size. This is a critical factor for understanding the amount of each nutrient consumed.
- Dietary Ingredients: Lists all dietary ingredients present in the supplement, including vitamins, minerals, herbs, and other botanicals.
- Amount Per Serving: Specifies the quantity of each dietary ingredient per serving.
- % Daily Value (DV): Indicates the percentage of the recommended daily intake for each nutrient that the serving provides, based on a 2,000-calorie diet.
4. Other Important Labeling Elements
In addition to the core labeling components, several other elements contribute to a compliant and informative dietary supplement label:
- Statement of Identity (Detailed): A more detailed description of the dietary supplement, if necessary, to clarify its specific nature (e.g., “Vitamin D3 Cholecalciferol Dietary Supplement”).
- Directions for Use: Provides clear instructions on how to take the supplement.
- Cautions and Warnings: Highlights any potential risks associated with the product, such as warnings for pregnant women or individuals with specific medical conditions.
- Allergen Information: Discloses any common allergens present in the product, such as milk, eggs, or nuts.
- Lot Number and Expiration Date: Allows for product traceability and ensures that consumers are using the supplement within its shelf life.
5. Claims on Dietary Supplement Labels
Dietary supplement labels may include certain claims, but these claims are strictly regulated by the FDA. There are three main types of claims allowed on dietary supplement labels:
- Health Claims: Describe the relationship between a dietary supplement ingredient and reducing the risk of a disease or health-related condition. These claims require pre-approval by the FDA.
- Nutrient Content Claims: Describe the level of a nutrient in the product (e.g., “High in Vitamin C,” “Good Source of Fiber”). These claims are also regulated by the FDA and must meet specific requirements.
- Structure/Function Claims: Describe the role of a nutrient or dietary ingredient in affecting the structure or function of the body (e.g., “Calcium helps build strong bones,” “Fiber promotes digestive health”). These claims do not require FDA pre-approval, but the label must include a disclaimer stating that the statement has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease.
Staying Compliant and Informed
The dietary supplement industry is subject to ongoing regulatory changes. To ensure compliance, manufacturers, packers, and distributors should:
- Regularly consult the FDA website for updates and new guidance documents.
- Attend industry conferences and workshops to stay informed about the latest regulations.
- Seek expert advice from regulatory consultants or legal professionals specializing in dietary supplement labeling.
By adhering to these guidelines and staying informed about regulatory changes, dietary supplement companies can ensure that their products are properly labeled, providing consumers with the information they need to make safe and informed choices.
