Understanding FDA Label Requirements for Dietary Supplements
As a dietary supplement manufacturer, it is imperative to understand and comply with the FDA labeling requirements to ensure the safety and quality of your products. In this article, we walk you through the required basic information that your company must include on your labels in order to follow the regulations set forth by the FDA.
The Food and Drug Administration (FDA) is responsible for regulating dietary supplements to ensure that they are safe for consumption and accurately labeled. The FDA requires that all dietary supplement labels include the following information:
• The Statement of Identity
• The Net Quantity of Contents
• Nutrition Labeling (Supplement Facts Panel)
• Ingredient Declaration
• The Name and Place of Business of the Manufacturer, Packer, or Distributor
Per the FDA, “The statement of identity for a dietary supplement is the name that appears on the label of the dietary supplement.” In most cases the identity statement will read as “dietary supplement,” however, the word “dietary” may be removed and replaced with a description or name of dietary ingredients in the product (e.g., herbal supplement or amino acid supplement). The identity statement must be high contrast, boldface type, and be generally half the size of the most prominent printed matter of the same panel. It is important to note that this statement must also be parallel to the bottom edge of the label.
The Net Quantity of Contents is the amount of product in a container and must be declared in terms of avoirdupois measurements which is the standard US measurement (e.g., fl. oz., lbs.). This statement must be presented in the lower 30% of the label and be in boldface.
The Supplement Facts Panel is the nutrition label for dietary supplements. Nutrients such as total calories, cholesterol, sugars, etc. must be listed when present in measurable amounts (amount that exceeds the amount that can be declared as zero). It is to be noted that if you make a structure/function claim, the ingredient that is used to substantiate the claim must be included in the Supplement Facts Panel. Right below the Supplement Facts Panel is the Ingredient Declaration or “Other Ingredients” listing which should include any ingredient not marketed as a dietary ingredient. If your product needs an allergen statement, then that statement may go in between the Ingredient Declaration and the Name and Place of Business.
The Name and Place of Business of the Manufacturer, Packer, or Distributor are important so that consumers can report a serious adverse event. This information must include a domestic address or phone number. If the address can be found in a current city or telephone directory, it may be omitted. The name of the business must be preceded by the phrases “Manufactured for…”, “Distributed by…” or other appropriate wording.
There are typically three types of panels you can utilize when it comes to labels. They are the Principal Display Panel (PDP), Information Panel, and Alternate or Other Information Panel. Both the Statement of Identity and the Net Quantity of Contents must reside on the PDP. This panel is the primary panel of the label that would most likely be viewed by consumers at the time of purchase. The Nutrition Label, Ingredient Declaration, and the Name and Place of Business are usually located on the Information Panel, but may be placed on the PDP if there is enough room. The Alternate or Other Information Panel is an optional panel that may include marketing information about the product or include other graphics, given that they do not break any rules and regulations.
Of course, there are many other items that may need to be placed on your product’s label, but it all depends on your formulation, claims you make on your product, as well as what states the product is being sold in. Failing to comply with FDA labeling requirements can result in serious consequences for dietary supplement manufacturers. The FDA may perform inspections, issue a warning letter, seize products, or take legal action including criminal prosecution and fines against non-compliant companies. Additionally, consumers may take legal action against companies for false or misleading labeling, resulting in damage to the company’s reputation and financial losses.
To ensure that your dietary supplement labels are in compliance with FDA requirements, it is essential to stay up to date with the latest regulations and guidelines. This can be achieved by regularly reviewing the FDA’s website and consulting with a knowledgeable attorney or regulatory specialist. Furthermore, it is important to thoroughly review and verify all information included on your label to ensure accuracy and compliance. Before finalizing your label, consider having it reviewed by a third-party specialist such as REJIMUS, INC. to identify any potential issues and make necessary revisions.