Federal law requires dietary supplement manufacturers and distributors to ensure the products they issue are safe. Because the Food and Drug Administration (FDA) receive numerous inquiries from consumers seeking health-related information regarding nutritional supplements, certain labeling guidelines were implemented to guide nutraceutical distributors in making responsible product claims.
Supplement labeling is required to be truthful and not misleading. Any products not meeting this requirement may be removed from the consumer marketplace, as well as any other actions deemed appropriate by the FDA.
The Dietary Supplement Labeling Guide, the criteria by which companies are to make claims on their product labels, was created to assure that the labels on supplements sold in the U.S. are properly labeled. As a distributor, it is important to know the products you sell are complaint to government standards and include viable information that can assist consumers make informed purchasing decisions. Done correctly, supplement distributors can find a balance between compliant labeling that provides effective product marketing. Below is a summary of the FDA guidelines that apply when labeling your products.
General Dietary Supplement Information
Prior to including any claims on your supplement labels and/or packaging, it is important to know the five label statements that are required on every container and packaging of dietary supplements.
- The Statement of Product Identity – Identifies the supplement by using the common or usual name or an appropriately descriptive term. This must be place on the principal display panel and an alternative panel if present on the packaging.
- Net Quantity of Contents Statement – This informs consumers of the amount of dietary supplement that is in the container they are purchasing.
- Nutritional Fact Labeling – This refers to the “Supplement Facts” panel and should list the names and quantities of dietary ingredients that are present in the product.
- Ingredient/Allergen Statement – When listing the ingredients, they must be preceded by the word “Ingredients” which not only includes compounds and the actual supplement but also any binders, colors, excipients, fillers, flavors and sweeteners. In this case you may use the term “Other Ingredients.”
- The Name and Place of Business of the Manufacturer, Packer or Distributor
Claims for Dietary Supplements
Health claims describe the relationship between the nutritional supplement and the risk-reducing effect it has upon a disease or health-related condition. This may be a written statement, third party reference, a symbol, or vignette. A qualified health claim is supported by less scientific evidence however it should be accompanied by a disclaimer that explains the level of scientific evidence supporting the specific claim.
Nutrition content claims state or imply the relative level of a nutrient in a dietary supplement. They are limited to claims authorized by FDA standards; however, they may be used on labels without review by the agency. They must also comply with all FDA definitions and regulations to ensure accuracy of statements.
Structure/function claims describe the role of the substance intended to maintain the structure or function of the body. Structure/function claims may be statements regarding how the product will affect organs or bodily systems, but cannot refer to a specific disease. Another way of stating a structure/function claim is by describing the general well-being from consumption of the supplement(s). These types of claims do not require approval from the FDA, but all structure/function claim texts should be provided to the FDA within 30 days of market introduction. These claims will require the FDA disclaimer that states, “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Maintaining FDA compliancy is essential in growing both your brand recognition and a credible reputation. Your supplement label is the introduction to your brand and benefits, and should be a valuable marketing tool, as well as ensure consumer safety with appropriate, correct, and compliant labeling. To guarantee that your product labels meet government regulations, it is crucial to choose an experienced and knowledgeable supplement manufacturer that can assist you with label and packaging questions.