Dietary Supplements: Background Information
 
Table of Contents

What is a dietary supplement?

As defined by Congress in the Dietary Supplement Health and Education Act (http://www.fda.gov/opacom/laws/dshea.html#sec3), which became law in 1994, a dietary supplement is a product (other than tobacco) that

What is a new dietary ingredient?

A new dietary ingredient is a dietary ingredient that was not sold in the United States in a dietary supplement before October 15, 1994.

Are dietary supplements different from foods and drugs?

Although dietary supplements are regulated by the U.S. Food and Drug Administration (FDA) as foods, they are regulated differently from other foods and from drugs. Whether a product is classified as a dietary supplement, conventional food, or drug is based on its intended use. Most often, classification as a dietary supplement is determined by the information that the manufacturer provides on the product label or in accompanying literature, although many food and dietary supplement product labels do not include this information.

What claims can manufacturers make for dietary supplements and drugs?

The types of claims that can be made on the labels of dietary supplements and drugs differ. Drug manufacturers may claim that their product will diagnose, cure, mitigate, treat, or prevent a disease. Such claims may not legally be made for dietary supplements.

The label of a dietary supplement or food product may contain one of three types of claims: a health claim, nutrient content claim, or structure/function claim (http://www.cfsan.fda.gov/~dms/hclaims.html). Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition. Nutrient content claims describe the relative amount of a nutrient or dietary substance in a product. A structure/function claim is a statement describing how a product may affect the organs or systems of the body and it can not mention any specific disease. Structure/function claims do not require FDA approval but the manufacturer must provide FDA with the text of the claim within 30 days of putting the product on the market (http://www.cfsan.fda.gov/~dms/ds-labl.html#structure). Product labels containing such claims must also include a disclaimer that reads, "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."

How does FDA regulate dietary supplements?

In addition to regulating label claims, FDA regulates dietary supplements in other ways. Supplement ingredients sold in the United States before October 15, 1994, are not required to be reviewed by FDA for their safety before they are marketed because they are presumed to be safe based on their history of use by humans. For a new dietary ingredient (one not sold as a dietary supplement before 1994) the manufacturer must notify FDA of its intent to market a dietary supplement containing the new dietary ingredient and provide information on how it determined that reasonable evidence exists for safe human use of the product. FDA can either refuse to allow new ingredients into or remove existing ingredients from the marketplace for safety reasons.

Manufacturers do not have to provide FDA with evidence that dietary supplements are effective or safe; however, they are not permitted to market unsafe or ineffective products. Once a dietary supplement is marketed, FDA has to prove that the product is not safe in order to restrict its use or remove it from the market. In contrast, before being allowed to market a drug product, manufacturers must obtain FDA approval by providing convincing evidence that it is both safe and effective.

The label of a dietary supplement product is required to be truthful and not misleading. If the label does not meet this requirement, FDA may remove the product from the marketplace or take other appropriate actions.

What information is required on a dietary supplement label?

FDA requires that certain information appear on the dietary supplement label:

General information

  • Name of product (including the word "supplement" or a statement that the product is a supplement)
  • Net quantity of contents
  • Name and place of business of manufacturer, packer, or distributor
  • Directions for use

Supplement Facts panel

  • Serving size, list of dietary ingredients, amount per serving size (by weight), percent of Daily Value (%DV), if established
  • If the dietary ingredient is a botanical, the scientific name of the plant or the common or usual name standardized in the reference Herbs of Commerce, 2nd Edition (2000 edition) and the name of the plant part used
  • If the dietary ingredient is a proprietary blend (i.e., a blend exclusive to the manufacturer), the total weight of the blend and the components of the blend in order of predominance by weight

Other ingredients

  • Nondietary ingredients such as fillers, artificial colors, sweeteners, flavors, or binders; listed by weight in descending order of predominance and by common name or proprietary blend

The label of the supplement may contain a cautionary statement but the lack of a cautionary statement does not mean that no adverse effects are associated with the product. A label for a fictitious botanical product is available at http://vm.cfsan.fda.gov/~acrobat/fdsuppla.pdf.

Does a label indicate the quality of a dietary supplement product?

It is difficult to determine the quality of a dietary supplement product from its label. The degree of quality control depends on the manufacturer, the supplier, and others in the production process.

FDA is authorized to issue Good Manufacturing Practice (GMP) regulations describing conditions under which dietary supplements must be prepared, packed, and stored. FDA published a proposed rule in March 2003 that is intended to ensure that manufacturing practices will result in an unadulterated dietary supplement and that dietary supplements are accurately labeled. Until this proposed rule is finalized, dietary supplements must comply with food GMPs, which are primarily concerned with safety and sanitation rather than dietary supplement quality. Some manufacturers voluntarily follow drug GMPs, which are more rigorous, and some organizations that represent the dietary supplement industry have developed unofficial GMPs.

Are dietary supplements standardized?

Standardization is a process that manufacturers may use to ensure batch-to-batch consistency of their products. In some cases, standardization involves identifying specific chemicals (known as markers) that can be used to manufacture a consistent product. The standardization process can also provide a measure of quality control.

Dietary supplements are not required to be standardized in the United States. In fact, no legal or regulatory definition exists in the United States for standardization as it applies to dietary supplements. Because of this, the term "standardization" may mean many different things. Some manufacturers use the term standardization incorrectly to refer to uniform manufacturing practices; following a recipe is not sufficient for a product to be called standardized. Therefore, the presence of the word "standardized" on a supplement label does not necessarily indicate product quality.

What methods are used to evaluate the health benefits and safety of a dietary supplement?

Scientists use several approaches to evaluate dietary supplements for their potential health benefits and safety risks, including their history of use and laboratory studies using cell or animal studies. Studies involving people (individual case reports, observational studies, and clinical trials) can provide information that is relevant to how dietary supplements are used. Researchers may conduct a systematic review to summarize and evaluate a group of clinical trials that meet certain criteria. A meta-analysis is a review that includes a statistical analysis of data combined from many studies.

What are some additional sources of information on dietary supplements?

Medical libraries are one source of information about dietary supplements. Others include Web-based resources such as PubMed (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?holding=nih) and FDA (http://www.cfsan.fda.gov/~dms/ds-info.html). For general information on botanicals and their use as dietary supplements please see Background Information About Botanical Dietary Supplements (http://ods.od.nih.gov/factsheets/botanicalbackground.asp).

Glossary

adverse effect - An unwanted side effect.
amino acid - A chemical building block of protein.
animal study - A laboratory test using animals to study the development and course of human diseases, and to test the safety and effectiveness of new treatments before they are given to humans.
binder - An inactive ingredient (one that has no medicinal effect on the body, such as starch, salt, or sugar) used to hold together the contents of a pill or tablet.
botanical - Having to do with plants or plant parts, or dietary supplement products made from plants.
capsule - A gelatin shell containing a dose of medicine, a vitamin, or other dietary supplement.
case report - A detailed record of the diagnosis, treatment, and follow-up of an individual patient. Case reports also contain some information about the patient (such as age, gender, and ethnic origin).
cell - The individual unit that makes up the tissues of the body. All living things are made up of one or more cells, which are the smallest units of living structure capable of independent existence.
clinical trial - A type of research study that uses volunteers to test the safety and efficacy (the ability to produce a beneficial effect) of new methods of screening (checking for disease when there are no symptoms), prevention, diagnosis, or treatment of a disease. Also called a clinical study.
constituent - A component, part, or ingredient of a larger whole. For example, valerenic acid and valepotriate are constituents of the dietary supplement valerian.
conventional food - Edible substances, excluding organic food, genetically modified food, functional food, and dietary supplements.
cure - To heal or restore health; a treatment to restore health.
Daily Value - DV. A term used on a food or dietary supplement product label to describe the recommended levels of intake of a nutrient. The percent Daily Value (% DV) represents how much of a nutrient is provided in one serving of the food or dietary supplement. For example, the DV for calcium is 1,000 mg (milligrams); a food that has 200 mg of calcium per serving would state on the label that the % DV for calcium is 20%.
data - Facts and information.
diagnose - The process of using signs and symptoms to identify a disease.
dietary supplement - A product that is intended to supplement the diet. A dietary supplement contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other substances) or their components; is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and is identified on the front label of the product as being a dietary supplement.
drug - Any substance (other than food) that is used to prevent, diagnose, treat, or relieve symptoms of a disease or abnormal condition. Also, a substance that alters mood or body function or that can be habit-forming or addictive, especially a narcotic.
evidence - Information used to support the use of a particular screening procedure, treatment, or preventive measure. In medicine, evidence needed to determine effectiveness is provided by laboratory research, clinical trials, and other studies.
filler - An inactive ingredient (one that has no medicinal effect on the body, such as lactose or starch) that is used to provide consistency and uniformity in the size and weight of a pill or tablet.
Food and Drug Administration - FDA. The FDA is an organization in the federal government responsible for protecting public health by assuring the safety and efficacy of drugs and medical devices, and the safety of cosmetics, dietary supplements, and the food supply. FDA regulates dietary supplements under a different set of regulations than those covering conventional foods and drug products (prescription and over-the-counter). The dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to get FDA approval before producing or selling dietary supplements.
health claim - A statement on a food or dietary supplement product label that describes a relationship between a food, food component, or dietary supplement ingredient and the reduction in risk of developing a disease or health-related condition. For example: “Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect.”
herb - A plant used in cooking, in tea, and for medicinal purposes.
label - When referring to dietary supplements, information that appears on the product container, including a descriptive name of the product stating that it is a "supplement"; the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and each dietary ingredient contained in the product. Supplements must also include directions for use, nutrition labeling in the form of a Supplement Facts panel that identifies each dietary ingredient contained in the product and the serving size, amount, and active ingredients.
laboratory study - Research done in a laboratory. A laboratory study may use cells in test tubes or animals to find out if a drug, procedure, or other treatment is likely to be safe and useful. Laboratory studies usually take place before any testing is done in humans.
meta-analysis - A methodical review of the results of multiple research studies. In a meta-analysis, statistical methods are used to measure the combined results of these studies and estimate an overall effect.
mineral - In nutrition, an inorganic substance found in the earth that is required to maintain health.
mitigate - To make milder or less painful.
nutrient - A chemical compound (such as protein, fat, carbohydrate, a vitamin, or mineral) that is found in food. Nutrients are used by the body to function and maintain health.
nutrient content claim - A statement on a food or dietary supplement product label that describes the amount of a nutrient or dietary substance in a product. Examples of nutrient claims for dietary supplement products include fortified, high, rich in, excellent source of, good source of, and high potency.
prevent - To stop from happening.
proprietary - A product or technique that is developed and owned by a company or individual, cannot be used by others without approval, and may be protected by patent or copyright.
quality control - A system to ensure that consistency and uniformity are maintained in the manufacturing of a product.
regulate - To govern, make uniform, and bring under the control of a rule, principle, or legal system. In the United States, the FDA has the authority to regulate dietary supplements.
rigorous - Accurate, precise, and without deviation from standards.
risk - The chance or probability that a harmful event will occur.
standardization - A process manufacturers may use to ensure batch-to-batch consistency of their products and to provide a measure of quality control. Dietary supplements are not required to be standardized in the United States. Some manufacturers use the term incorrectly or to mean different things and the presence of the word "standardized" on a supplement label does not necessarily indicate a level of product quality.
structure/function claim - A statement on a food or dietary supplement label that describes how a product may affect the organs or systems of the body; a specific disease cannot be mentioned. Structure/function claims do not require FDA approval, but the manufacturer must provide the FDA with the text of the claim within 30 days of putting the product on the market. Labels must also include a disclaimer that reads, "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." For example: "Calcium builds strong bones."
supplement - A nutrient that may be added to the diet to increase the intake of that nutrient. Sometimes used as a synonym of dietary supplement.
systematic review - A structured method of identifying, selecting, and analyzing appropriate research to answer a specific question.
treat - To care for a patient with a disease by using medicine, surgery, or other approaches.
uniformity - The quality of being consistently the same and not varying or fluctuating in color, size, weight, composition, or any other physical feature.
vitamin - A nutrient that the body needs in small amounts to function and maintain health. Examples are vitamins A, C, and E.

Disclaimer

Reasonable care has been taken in preparing this document and the information provided herein is believed to be accurate. However, this information is not intended to constitute an "authoritative statement" under Food and Drug Administration rules and regulations.

About ODS

The mission of the Office of Dietary Supplements (ODS) is to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population.

General Safety Advisory

  • The information in this document does not replace medical advice.
  • Before taking an herb or a botanical, consult a doctor or other health care provider-especially if you have a disease or medical condition,
    take any medications, are pregnant or nursing, or are planning to have an operation.
  • Before treating a child with an herb or a botanical, consult with a doctor or other health care provider.
  • Like drugs, herbal or botanical preparations have chemical and biological activity. They may have side effects. They may interact with certain medications. These interactions can cause problems and can even be dangerous.
  • If you have any unexpected reactions to an herbal or a botanical preparation, inform your doctor or other health care provider.
Document Last Updated: 4/12/2006 10:52 AM
Office of Dietary Supplements
National Institutes of Health
Bethesda, Maryland 20892 USA
Web: http://ods.od.nih.gov
E-mail: ods@nih.gov		 National Institutes of Health Department of Health and Human Services FirstGov, Your First Click to the US Government