The Dietary Supplement Health and Education Act

The DSHEA was signed by President Clinton on October 15, 1994. For the first time dietary supplements were given their own set of rules by which to abide. The DSHEA included definitions of dietary supplement and new dietary ingredient and provided for the creation of a commission to advise on the regulation of these substances.

Important Definitions

According to the DSHEA, a dietary supplement is a product that

• is intended to supplement the diet;
• contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other substances) or their constituents;
• is intended to be taken by mouth as a pill, capsule, tablet, or liquid;
• is not represented as a conventional food or as a food replacement;
• is labeled on the container’s front panel as being a dietary supplement;
• includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless waived by the secretary of the Department of Health and Human Services).

The DSHEA presumes that ingredients introduced prior to October 15, 1994, are safe. A new dietary ingredient, on the other hand, is an ingredient not sold in the United States in a dietary supplement prior to that date or one that is part of a dietary supplement introduced on or after October 15, 1994. At least 75 days before marketing a dietary supplement containing a new dietary ingredient, manufacturers must provide the FDA with their basis for deeming the ingredient “reasonably expected to be safe.”

If they meet the criteria above, botanicals may be considered dietary supplements. A botanical is a plant, or part of a plant, that is used for one or more of its specific characteristics, including medicinal properties, flavor, and scent; herbs are a subset of this group, usually the green, leafy portion of the plant. Botanicals are identified by Latin names designating the genus and species of the plant. Many botanicals, however, have numerous common names or are identified only by their genus. For example, the commonly known dietary supplement black cohosh (Cimicifuga racemosa) is also known as baneberry, black snakeroot, bugwort, cohosh bugbane, rich weed, rattle root, solvlys, and squaw root, to name a few. Botanicals can be sold in many forms, including fresh or dried, as liquid or solid extracts, in tablets and capsules, as loose powders, and in tea bags.

The intended use of a consumable product is essentially what determines its classification—and therefore its regulation—as a food, drug, or dietary supplement. Drugs are created to treat, cure, or somehow mitigate a disease or condition. A dietary supplement cannot claim to have these
effects; if such a claim is made by the manufacturer of a dietary supplement, the substance must then be regulated as a drug. However, a manufacturer can claim a supplement is “used for” anything at all, even though it may have no effect.

The list below describes common preparations of botanicals.

Tea
Process – Also known as an infusion, a tea a liquid that can be drunk is made by adding boiling water hot or cold to fresh or dried botanicals and steeping them.
Product – a liquid that can be drunk hot or cold

Decoction
Process – Sometimes botanicals are  more aggressively processed. A decoction is made by simmering botanicals in boiling water for longer periods of time.
Product – a liquid that can be drunk

Tincture
Process – A botanical is soaked in a  solution of alcohol and water to  both concentrate and preserve
botanical substances, and they can be identified by the concentration of botanical substance in the final product.
Product – a liquid that can be drunk (diluted or as a make a tincture. Tinctures concentrate

Extract
A botanical is soaked in a liquid can be consumed as a to extract certain chemicals and the extract is concentrated.
Product – can be consumed as a liquid, in capsules, or as tablets containing the evaporated substance

Labeling

Labels must include the word supplement and identify the product as a dietary supplement. The required information on dietary supplement labels includes the name and quantity of each nutrient and dietary ingredient or, for proprietary blends, the total quantity of all dietary ingredients (except
inert ingredients) in the blend. Since 1997 all supplements must bear a label entitled “Supplement Facts,” which is very similar in format and content to the “Nutrition Facts” label that appears on all food and beverages marketed in the United States. Labels on herbal and botanical products must state which part of the plant the contents come from. Below is  a sample label from a bottle of Ginkgo biloba.

Some dietary supplements are included in official compendia, such as the U.S. Pharmacopoeia, the Homeopathic Pharmacopoeia of the United States, or the National Formulary. If a supplement is included in a compendium, it must correspond with the specifications of that compendium. For dietary supplements not included in official compendia, the label must correctly identify each substance and the amount in the supplement.

Dietary supplement labels must also contain nutritional information, including ingredients present in significant amounts, and first listing those for which the FDA has established %DVs. Labels must also include the quantity per serving for each dietary ingredient and may include the source of the ingredients.

The FDA published the Dietary Supplement Labeling Guide in 2005. This guide was created in response to numerous questions from the dietary supplement industry regarding all legislation relevant to dietary supplement labels.

Health Claims on Dietary Supplement Labels

The use of health claims on food products is regulated by the Nutrition Labeling Education Act of 1990.  Health claims describe the relationship between a specific nutrient and a disease or condition. In order to appear on the food or dietary supplement label, health claims must be evaluated
and preapproved by the FDA based on “significant scientific agreement.” Few such health claims have been authorized by the FDA.

While a dietary supplement can never be claimed to “diagnose, prevent, mitigate, treat, or cure” a specific disease, the DSHEA allows use of specified statements on the labels of dietary supplements. In addition to the approved health claims listed below, dietary supplement labels can contain statements about nutritional support. These statements, known as structure-function claims, may describe how the product affects the structure or function of the body or the overall well-being of the consumer. Before making such statements on a label, however, manufacturers of dietary supplements must prove that the nutritional support statement is truthful and not misleading, and they  must notify the FDA within 30 days of making the statement. When a nutritional support statement appears, the label must also state, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Diet/Disease Claim	Approved Claim	Dietary Supplements Permitted to Display Claim
Calcium and osteoporosis	Regular exercise and a healthy diet with enough calcium help teen and young adult white and Asian women maintain good bone health and may reduce their risk of osteoporosis.	some calcium supplements
Folate and neural tube defects	Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect.	some dietary supplements containing folate
Dietary soluble fiber and coronary heart disease	Diets low in saturated fat and cholesterol that include 3 grams of soluble fiber from whole oats per day may reduce the risk of heart disease.	dietary supplements containing psyllium seed husk
Plant stanol and plant sterol esters and coronary heart disease	Diets low in saturated fat and cholesterol that include two servings of foods that provide a daily total of at least 3.4 grams of plant stanol esters in two meals may reduce the risk of heart disease.	dietary supplements in soft gel form

Additional Information Given to Consumers

Manufacturers of dietary supplements often seek to promote their product by providing supporting material such as a scientific study or the statement of a medical or nutrition professional. Under certain conditions, this additional material is not considered to be “labeling,” per se, and is therefore not regulated in the same fashion.

If the manufacturer uses a reprinted scientific article, it must be printed in its entirety and must not be accompanied by any added information. Additional publications used in connection with the sale of dietary supplements cannot be misleading, cannot promote a particular manufacturer or brand, must present a balanced view of the available scientific evidence, and must be physically separate from the dietary supplements in the store.

Good Manufacturing Practices

The DSHEA gave the FDA the authority to establish special good manufacturing practices for dietary supplements. In March 2003 the FDA released its “Proposed Rule for Dietary Supplement Current Good Manufacturing Practices,” which addresses important components of dietary supplement manufacture, including design and construction of manufacturing facilities, quality-control procedures, testing of the final product(s) or incoming and in-process materials, management of consumer complaints, and record keeping and filing of compliance with these standards. The basic tenets of the current good manufacturing practices require that dietary supplement manufacturers
use current industry standards in the processing of dietary supplements to avoid contamination (by pesticides, heavy metals, or other impurities) and improper labeling and to ensure that product labels accurately reflect the identity, purity, quality, strength, and composition of dietary supplements. The following are some examples of product quality problems that these rules are meant to address:

• contains more of the active or inactive ingredients than listed on the label;
• contains less active ingredients than listed on the label;
• contains the wrong ingredient(s);
• contains a drug contaminant;
• contains other contaminant(s), such as bacteria, mold, pesticide, or lead;
• package contains foreign material, such as glass;
• improper packaging and/or mislabeled product.

The “Proposed Rule for Dietary Supplement Current Good Manufacturing Practices” was open to public comment for a year before it was to be considered final. After approval, dietary supplement companies would have 36 months to implement the changes necessary to comply with the rule. Until then, dietary supplement manufacturers were to follow good manufacturing practices for foods. During the comment period, however, the FDA received more than 1600 pages from consumers and members of the dietary supplement industry. A final rule therefore has been delayed and is expected in late 2006 (for current information, see http://www.cfsan.fda.gov/~dms/ds-ind.html#GMPS).

Creation of New Government Entities

Appointed in 1995, the Commission on Dietary Supplements directs the labeling of dietary supplements, essentially to determine how to provide scientifically valid information about them. The first commission comprised scientists from various U.S. universities with expertise in dietary supplements, a member of the Council for Responsible Nutrition, a Seton Hall University School of Law professor, a public relations specialist, and a representative from the Herb Research Foundation.

Responsibilities carried out by the Commission on Dietary Supplements are now being performed by the Office of Nutritional Products, Labeling, and Dietary Supplements’ Division of Dietary Supplement Programs, which comprises a regulations and review team, a compliance and enforcement team, and a clinical review team. Led by Dr. Susan Walker, the division creates policies, regulations, and guidance documents to ensure the safe manufacture and labeling of dietary supplements and reviews safety information submitted by dietary supplement manufacturers 75 days before the marketing of a product to ensure that it is reasonably expected to be safe.

The DSHEA also called for the creation of the Office of Dietary Supplements (ODS), which is housed within the National Institutes of Health and is responsible for facilitating research into the role of dietary supplements in disease prevention and health promotion. The mission of ODS is to strengthen knowledge about dietary supplements by evaluating available research and stimulating and supporting more scientific trials, as well as by educating people about the current state of knowledge. As part of their mission, ODS hosted the 2000 National Nutrition Summit and created numerous resources, including Computer Access to Research on Dietary Supplements, International Bibliographic Information on Dietary Supplements, Annual Bibliographies of Significant Advances in Dietary Supplement Research, and Dietary Supplement Ingredient and Labeling databases. The ODS’s 2004–2009 strategic plan comprises five major goals:

1. expanding the evaluation of dietary supplements in reducing the risk for chronic disease;
2. fostering research on dietary supplements for optimal health and performance;
3. enhancing understanding of the basic effects of dietary supplements on biological systems;
4. improving methodologies;
5. expanding outreach and education.

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