Governed by The Food and Drug Administration (FDA), dietary supplement labeling requirements are complex. Manufacturers must comply with a set of regulations that make sure consumers know exactly what they are consuming. To help you navigate the complex landscape of FDA regulations, here is a guide to supplement label requirements.
What Qualifies as a Dietary Supplement?
First things first, which consumer products does the FDA consider as dietary supplements? According to the FDA, a dietary supplement is a vitamin, mineral, herb, or any other botanical amino acid or dietary substance meant to be consumed by people to increase their total nutritional intake. Therefore, if a product comprises at least one of the above mentioned, its labels must adhere to FDA requirements.
Supplement Label Regulations
While Paragon Laboratories can help to prepare the supplement facts panel for your product(s) upon request, we also recognize that brands want to stay informed on the labeling requirements. Our goal is to help you stay educated by providing the following details.
Supplement label information are split into two locations on a product’s packaging: the front-facing label panel and the informational panel. The front label panel is the main branded side that consumers see as when quickly browse through an aisle at their retail store or a search results page on an eCommerce platform, like Amazon. Next to the front label panel is the information panel, which lists out technical details such as supplement facts, ingredients, and the manufacturer’s name and address.
The FDA-compliant label requires five specific pieces of information be listed:
- Statement of identity: This is the name that appears on the front label panel or principal display panel. This is the federally regulated or specified name.
- Net quantity of contents statement: This informs consumers of the amount of dietary supplements contained in the package. This section would be found in the bottom 30% of the principal display panel. You need to state the net quantity in either weight, numerical count, measure, or a combination of the three.
- Nutrition labeling: Also referred to as the supplement facts panel, this section is where all the dietary ingredient names and corresponding quantities of each ingredient per serving are listed.
- Ingredient list: All the ingredients used are listed here. This list is placed on the nutrition label and must appear prominently. Some people refer to this as the list of the inactive ingredients, which commonly appears below the supplement facts panel.
- Manufacturer, packer, distributor details: Typically placed below the ingredient list, this section should clearly show the name, city, state, and zip code of the producer, packer, or distributor.
Supplement Facts Label Requirements
The Supplement Facts, or information panel, of a supplement label possesses must include the following:
- Serving size info: Every dietary ingredient present and the quantities present must be named and identified. By FDA standards, the serving of a dietary supplement is equivalent to the “maximum amount recommended” on the label for one serving. For example, if your product recommended amount is 1-3 teaspoons, then the serving size is 3 teaspoons. The section should also indicate the number of servings in the container.
- Total Calories: This should identify the number of calories per serving, when present in measurable amounts.
- Name and Quantity of every ingredient: You must list each ingredient’s name in the supplement and indicate the quantity measurements. These measurements can be listed as g, mg, mcg, mcg RAE, and IU.
- Calories from and types of fat: You must list the calories from fat, cholesterol, saturated fat, total fat, polyunsaturated fat, and monounsaturated fat, when present in measurable amounts.
- Critical Components: When present in measurable quantities, the FDA requires the manufacturer to list the following with matching daily value: total carbohydrate, sodium, dietary fiber, sugars, protein, vitamin A, Vitamin C, calcium, and iron.
- Percentage daily value (DV) of each dietary ingredient: This daily value will indicate the percentage within one supplement serving. To calculate the %DV value, divide the quantitative amount by the weight established in the DV for the specified dietary ingredient, and multiply it by 100.
- Common names only for ingredients with no daily value: For ingredients that do not have an established daily value threshold by the FDA, you must use its common name.
Labeling Formats for Supplement Facts
The FDA allows for a variety of supplement facts formatting depending on the supplement type, ingredients present, and intake frequency. They offer an extensive list of examples that contain the different format assortments you can use to design your own supplement facts. Keep in mind that no matter what type of dietary supplement you plan to manufacture, you will always need an FDA-compliant label. Failing to do so will lead to corrective action enforced by the FDA.
How Paragon Laboratories Can Help
Equipped with our 50 years of industry experience, Paragon’s team of experts offers a label proof process that ensures your supplement label is tailored to comply with all the requirements set forth by the FDA. We rigorously vet every claim to ensure your dietary supplements can be sold throughout the United States. Ready to start your supplement brand? Contact us today and get a free quote.