The United States Food and Drug Administration (FDA) has identified five pieces of information that must be present on all supplements sold in the United States. All supplements must include a statement of identify, net quantity of contents statement, ingredient list, name and place of business of the manufacturer, packer or distributor, and a Supplement Facts panel.
The Supplement Facts panel serves a crucial role in providing accurate and comprehensive information about the composition and nutritional value of dietary supplements. However, meeting the criteria for these labels can be challenging given the inherent complexity and intricate composition of ingredients in various supplements.
What is a Supplement Facts Panel?
The Supplement Facts panel is a standardized label located on the packaging of all dietary supplements including vitamins, minerals, herbs, and other botanical products. It details key information such as serving size, daily values of various nutrients, ingredients list, and specific health claims. This ensures that consumers have access to vital data necessary for making informed decisions regarding their supplement intake.
Required Information
The supplement panel information must be presented in an enclosed box clearly labeled as “Supplement Facts.” The Supplement Facts panel must include the following information:
Serving Size and Servings Per Container
Indicate the serving size, which should reflect the amount a consumer would typically consume. Adjacently, denote the servings per container. However, if the net quantity of contents is the same information as the servings per container, it is not required to be listed.
Nutrient Declaration
The FDA requires the quantity and % DV be provided for the following nine ingredients: sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron. In addition, all measurable amounts of total calories, calories from fat, total fat, saturated fat and cholesterol must be included. Calories from saturated fat and the amount of polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, sugar alcohol, and other carbohydrate may be declared, but they must be declared when a claim is made about them.
Name and Quantity of Ingredients
Each ingredient’s name and amount must be indicated. Quantity measurements should be listed in International Units (IU).
Percent Daily Value (% DV)
The % DV informs consumers about how much nutrient in a serving of the product contributes to their total daily diet. It’s based on the general daily intake levels for adults and children aged 4 years and above. If no DV exists for a particular ingredient, state its quantity in relevant metric units without the %DV.
Other Dietary Ingredients
Other dietary ingredients are those that do not have Daily Values. If you choose to list nutrients not required by the FDA, they should appear after the required nutrients, in the same format. List all other ingredients, such as fillers, colors, or binders, in descending order of predominance by weight. This should be distinct from the dietary ingredients list.
Formatting
The FDA provides specific recommendations for supplement label formatting based on the product packaging size. This includes requirements for the size and placement of the panel as well as font size. For complete guidelines, review the FDA’s Dietary Supplement Guide.
Additional tips for clarity and compliance:
Font and Size – A single, easy-to-read font, with a contrast between the print and background should be used to ensure that the text is legible.
Language – Use English unless sold in a locale where a different language is predominant. If a second language is used, all required information must appear in both languages.
Placement – The Supplement Facts panel often appears directly to the right of the front information panel and should be placed in a location that’s easily viewable by consumers.
Supplement Facts Panel Simplified
As a supplement manufacturer, it’s paramount to ensure that your Supplement Facts Panel is not just compliant but also clear and informative. The complexity of supplement ingredient compositions, estimation of proper serving sizes and daily values, as well as maintaining stringent quality control standards necessitates a focus on accuracy and regulatory knowledge. Partnering with a company experienced in FDA compliance can simplify the process of creating accurate and compliant supplement labels.
RL Food Testing Laboratory continuously reviews regulatory requirements and can ensure product labels are accurate and contain all necessary information. We offer comprehensive product assessments and detailed analytical reports to substantiate compliance with CGMPs. Our team understands the nuances of dietary supplement labeling and helps manufacturers navigate these complex guidelines to maintain compliance.
In an industry where reputation is vital, the precision and transparency of your Supplement Facts Panel can be a testament to your brand’s dedication to quality and consumer well-being.
