FAQs| American Dietary Supplement (1) – How Do You Label A Dietary Supplement?

We have collected frequently asked questions on the dietary supplement in the United States for your reference.

Q1. What is a Dietary Supplement?

A: A dietary supplement is an edible product that contains one or more dietary supplement ingredients such as: vitamins, minerals, herbs (plants), amino acids, and other substances that supplement the diet by increasing total intake, or their concentrates, metabolites, components, extracts, or combinations of such substances.

These edible ingredients in the dietary supplement can be divided into two categories: "Dietary ingredients" (as described above) and "other ingredients." Other ingredients include fillers, binders, excipients, preservatives, sweeteners, and flavorings.

Dietary supplements come in various dosage forms, such as tablets, capsules, gummies, soft gels, liquids, and powders. They can also be presented in forms identical to those of regular foods.

Q2. What contents should the manufacturers label on their supplement facts?

A: Dietary supplement facts are required to include the following information:

• Product name, with the term "dietary supplement" clearly stated, or using the name or type of dietary ingredient in place of "dietary" (e.g., "Iron Supplement" or "Herbal Supplement");
• Name and business address of the manufacturer, packer, or distributor;
• List of dietary ingredients;
• A list of "other ingredients" not included in the dietary ingredient list; and
• Net quantity of contents.

In addition, the dietary supplement label must include a US domestic address or phone number to enable reporting of serious adverse events to the manufacturer, packer, or distributor listed on the label.

Q3: Is it necessary to label all ingredients on the supplement facts?

A: Yes, all ingredients should be listed on the supplement facts. Ingredients that are not included in the “dietary ingredient” list should be presented in the list of "other ingredients" below.

Q4. Are the serving sizes for dietary supplements standardized? Or is there a limit on the amount of a specific dietary ingredient in a serving of a dietary supplement?

A: No, there are no laws or regulations that set limits on the serving size or the amount of a specific dietary ingredient in a dietary supplement. Manufacturers can determine the serving size at their discretion, and FDA approval is not required.

Q5. What types of claims can be made on the label of a dietary supplement?

A: According to regulations, a dietary supplement label can include three types of claims:

• Health claims;
• Structure/Function claims; and
• Nutrient content claims.

Each type of claim has specific requirements, and more detailed information can be found in "What Claims are Permitted on US Food Labels?"

Additionally, similar to regular foods, dietary supplements can also make claims on their labels that are not specifically regulated by law (e.g., flavor claims), but these claims must be truthful and not misleading.

Q6. Why do some dietary supplements have the statement that "This claim has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?

A: Under 21 CFR 101.93, if a structure/function claim or certain other claims are made on a dietary supplement label, the label must include this disclaimer. The purpose is to inform consumers that the FDA has not evaluated the claim. The disclaimer must also state that the product is not intended for "diagnosis, treatment, cure, or prevention of any disease," because only drugs are legally allowed to make such claims.

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