With U.S. consumers seeking products to boost a healthy lifestyle, the dietary supplement market is thriving. Because many consumers struggle to incorporate recommended amounts of vitamins and minerals into their diets, they often rely on dietary supplements to fill the nutritional gaps. The accessibility of dietary supplements contributes to their popularity, as they are sold directly to consumers in retail stores, without the need for a prescription.

The U.S. Food and Drug Administration (FDA) categorizes dietary supplements as a type of food, so they are subject to some of the same regulations as food products, including certain labeling requirements. However, some elements of dietary supplement labels are unique, and understanding the basic labeling requirements is important for companies intending to market their dietary supplement in the U.S. Additionally, FDA prohibits or strictly regulates certain claims made on dietary supplement labels.

Labeling regulations can be confusing and difficult to implement onto a product label. Keep reading for an overview of the basics of FDA’s requirements for dietary supplement labels.

FDA’s Classification of “Dietary Supplement”

When considering whether your product is a dietary supplement, it is important to remember that FDA often classifies products primarily based on intended use. The intended use may be determined from claims made in reference to the product and the types of ingredients found in the product. Intended use can be inferred from the product’s labeling, promotional material, advertising, websites, and any other relevant factor. Even if a claim that suggests a certain intended use does not appear on the physical label, FDA may take enforcement action if a claim is found on a company’s website that violates FDA’s regulations.

Dietary supplements are a subset of “food” intended to supplement the diet with specific dietary substances. Importantly, these products do not purport to be conventional food. For example, a dietary supplement could be blueberry extract in the form of a capsule, as opposed to the actual blueberry. The supplement’s purpose is to increase the consumption of the dietary substance, often by offering it in a different form. Some dietary supplements even contain dietary ingredients not found in conventional food but are marketed as a beneficial inclusion into consumers’ diets.

Dietary Supplement Label Requirements

The minimum requirements that should be incorporated into the label of a dietary supplement that is to be marketed in the U.S. are:

• Statement of identity (product name) – The label must say “dietary supplement” or “supplement” preceded by the type of ingredient(s) in the product, such as “fiber supplement”
• Net quantity of contents
• Ingredients list, stating all ingredients in the product, including additives
• Manufacturer, packer, distributor name and address – Must include the corporate name and street address of entity (unless the address is listed locally)
• Domestic U.S. phone number or mailing address to which a consumer can report a serious adverse event.
• Supplement Facts Chart

A Supplement Facts Panel must adhere to mandatory formatting and content elements. The panel must list the names and quantities of dietary ingredients present in the product, the “Serving Size” and the “Servings Per Container,” if not listed in the net quantity of contents statement.

Serving size is based on the maximum amount recommended “per eating occasion.” If the directions state to consume 1-3 capsules with breakfast, the serving size should be listed as 3 capsules. If the supplement directs consumers to consume multiple times a day, the label can list serving sizes per serving and per day in two separate columns. Information can also be presented for more than one age or demographic group, such as infants, ages 1-3, or pregnant women.

Dietary Supplement Claims

Companies often violate FDA regulations with claims made on their dietary supplements’ labels. When creating a label for a dietary supplement, companies should be aware of how FDA regulates the following claims:

Nutrient Content Claims – Characterized by the level of a nutrient, such as “high in fiber” and “low sodium,” as defined by FDA’s regulation. Any product that makes a nutrient content claim must comply with the conditions and nutrient levels described in FDA’s regulations for that claim.

Health Claims – Describe the risk reduction of a disease related to consumption of a certain nutrient. FDA must authorize these claims. In some cases, FDA may state certain conditions where a food may reduce the risk of a certain health condition. For example, FDA authorized a claim that eating oats may lower the risk of heart disease. When a company includes one of these authorized claims on their label, the claims must meet the conditions FDA has set forth for that specific claim and must comply with labeling requirements for that claim.

Structure/Function Claims – Describe the role or mechanism of a nutrient to affect the structure or function of the body. Structure/function claims describe the general well-being from consumption of the supplement or effects on conditions that are common but not serious and associated with natural states. The claims may not reference a disease state or condition commonly associated with the disease. Companies must notify FDA when they make a structure/function claim on a dietary supplement label and the label must bear a disclaimer about the claims.

Drug Claims – Suggest that a dietary supplement can diagnose, mitigate, treat, cure, or prevent specific diseases or a class of diseases. FDA prohibits dietary supplement labels to include drug claims. A dietary supplement label also cannot claim effects that imply disease treatments, such as “relieves crushing chest pain”, which is a claim that references a heart attack. If a dietary supplement bears a label with drug claims, FDA can regulate the product as a drug even though it does not have the active pharmaceutical ingredient necessary to treat the disease.

Enforcement Actions

FDA may issue a Warning Letter or place a company on an Import Alert for an unapproved drug if drug claims are made on a dietary supplement’s label. If a company is on this Import Alert, their products are subject to Detention Without Physical Examination (DWPE) and their shipments will be stopped at the U.S. port of entry. These shipments are not permitted to enter the U.S. unless the importer petitions FDA and can prove that their products are not out of compliance. This process is lengthy and burdensome for companies, so it is important for companies to create labels that are in compliance before shipping to the U.S.