1. Statement of Identity

The product must be clearly identified by its common or usual name. Unlike "drugs," these products must explicitly feature the term "dietary supplement" on the Principal Display Panel (PDP). You may replace "dietary" with the type of ingredient, such as "Herbal Supplement" or "Calcium Supplement."

2. Net Quantity of Contents

This statement informs the consumer of the total amount of product available in the package. It must be placed in the bottom 30% of the PDP and expressed in:

• Weight, measure, or numerical count (e.g., 60 Veggie Capsules or Net Wt. 500mg).

3. The Supplement Facts Panel (Nutrition Labeling)

This is the technical core of the label. It must be enclosed in a box and include:

• Serving Size & Servings Per Container: Standardized based on the recommended consumption.

• Mandatory Nutrients: Total calories, fat, sodium, carbohydrates, etc., if present in significant amounts.

• Dietary Ingredients: Quantitative amounts of vitamins, minerals, or botanicals.

• Percent Daily Value (% DV): Based on the 2,000 calorie reference diet where applicable.

4. Ingredient List (Excipients and Allergens)

Ingredients not listed in the "Supplement Facts" panel must be listed below it as "Other Ingredients."

• Order of Predominance: Ingredients must be listed in descending order of weight.

• Allergen Disclosure: Under the FALCPA, major allergens (e.g., soy, milk, wheat) must be clearly identified.

5. Name and Place of Business

The label must provide the physical address of the manufacturer, packer, or distributor. For independent brands, this often includes a domestic US address or a phone number to facilitate Adverse Event Reporting (AER).

The Mandatory FDA Disclaimer

If your label features a Structure/Function claim (e.g., "Supports Immune Health"), the FDA strictly requires the following disclaimer to be displayed in a bold box:

"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."

Technical Formatting Checklist

• Font Size: Generally, the "o" in the smallest text must be at least 1/16th of an inch.

• Prominence: Information must be "likely to be read and understood by the ordinary individual under customary conditions of purchase."

• Language: All mandatory information must be in English.