dosage recommendation that may be used on a product label
where RDA information is lacking and that is labeled as
event report (AER)
report of an incident where it is believed that a substance
may have caused a health problem or detrimental event.
analysis of a substance or mixture to determine its constituents
and the relative proportion of each.
rate and extent to which a drug or dietary supplement is
absorbed into general circulation, thereby permitting access
to the site of action. Measured by the concentration in
body fluids, usually blood, or by the magnitude of the pharmacological
response. Expressed as a fraction of an administered dose.
of strength of a drug or substance by comparing its effects
in test animals to a reference standard.
compound for which a product is tested to determine if a
particular plant material is present. Used for quality control.
made from plants, including herbs.
that accompanies raw materials used to manufacture dietary
supplements that attests to their authenticity.
studies that use human beings (rather than animals). Clinical
trials are conducted in health care settings with voluntary
group of patients in a clinical trial who receive either
the current standard care or a placebo. Results of the control
group are compared to results of the treatment group. No
patient is placed in a control group without treatment if
any beneficial treatment is known. (See also randomized,
Dietary reference intakes (DRIs)
umbrella term for groups of values (including RDAs, AIs,
EARs, and UIs) that specify recommended dosages. Proposed
by the Food and Nutrition Board of the Institute of Medicine
of the National Academy of Sciences in partnership with
term "dietary supplement" has a specific legal meaning in
the U.S. established by DSHEA. It refers to a product that
supplements the diet and whose label clearly states that
it is a dietary supplement. It is distinct from a drug which
is represented as a substance that is intended to diagnose,
cure, mitigate, treat, or prevent diseases and which must
undergo extensive testing and be preapproved by the FDA
before being sold. There are specific cases where dietary
supplements may also be labeled as impacting disease.
Dietary supplements may contain the following kinds of ingredients:
vitamins, minerals, herbs, botanicals, other plant-derived
substances, amino acids (the individual building blocks
of protein) and concentrates, metabolites, constituents,
and extracts of these substances. They are intended for
ingestion in pill, capsule, tablet, or liquid form and are
not represented for use as a conventional food or as the
sole item of a meal or diet.
The term disease commonly refers to any deviation
from the normal structure or function of the human body
that is manifested by a characteristic set of one or more
signs or symptoms. The FDA is no longer proposing to broaden
the definition of disease to include such conditions as
pregnancy, menopause, and aging.
drop in potency of a dietary supplement while in storage
as a function of time and storage conditions (light, heat,
moisture, and air). Stable supplements have a low rate of
disintegration allowing for a later expiration date, while
others lose potency comparatively quickly.
portion of an ingredient, usually expressed as a percentage,
that dissolves in the human digestive tract -- thereby making
it available for absorption in the body. The combined effect
of dissolution and absorption determines how much of a consumed
ingredient ends up in the bloodstream.
clinical trial in which neither the researchers nor the
patients know who is receiving the treatment being tested
and who is in the control group. Blinding a study prevents
personal reactions and bias from influencing the study results.
If necessary, treatment received by any specific individual
can be quickly identified by a special code. (See also single
the United States, medicinal products used for the treatment
Dietary Supplement Health and Education Act passed in the
United States in 1994. DSHEA served to deregulate the labeling
of dietary supplements by giving manufacturers freedom to
market more products as dietary supplements and to provide
specified kinds of information about their products' benefits.
value" -- New dietary supplement regulations went into
effect in March of 1999 that require labeling of dietary
reference intakes (DRI) and which appear as "DV"
on product labels.
(in the context of dietary supplements)
likelihood of benefit from use of a product when taken according
to published or labeled guidelines.
average requirement (EAR)
intake value that is estimated to be optimal for about half
of the individuals in a specified group. In other words,
the EAR meets a specified requirement in 50 percent of an
age- and gender-specific group. At this level of intake,
the remaining 50 percent of the specified group would not
have its needs met. EAR is one of the guidelines encompassed
in DRI (dietary reference intakes) established by the National
Academy of Sciences.
inert substance used as a medium in pills and capsules that
forms a vehicle for delivery of a drug or dietary supplement.
solution obtained by soaking a plant in solvent, then allowing
it to evaporate.
added to food to increase its flavor, storage characteristics,
color, aroma, nutritional content, or other qualities.
refers to a broad category of food that is formulated for
(and promoted as having) special health benefits.
modified organisms (GMOs)
that have been created or modified by the use of genetic
engineering techniques in which DNA has been introduced,
deleted, or inhibited.
Manufacturing Practices (GMPs)
for manufacturing dietary supplements that are used to ensure
a consistent level of quality. GMPs embody procedures that
ensure purity, cleanliness, freshness, and proper labeling.
Recognized As Safe" -- a category of food additives
designated by the U.S. Food and Drug Administration.
analysis critical control points (HACCP)
adopted by Codex for controlling outbreaks of contaminated
foods. The USDA and FDA are working to integrate Codex guidelines
into U.S. regulations. This could affect dietary supplements
for specific cases where food bacteria or other extreme
conditions infiltrate a supply.
claim that a dietary supplement or drug can be used to prevent
or treat abnormalities or disease.
supplement derived from a seed-producing plant that does
not develop persistent woody tissue but dies down at the
end of a growing season.
term homeopathy comes from the Greek homoios (meaning "similar")
and pathos (meaning "suffering"). Homeopathic
remedies are usually dilutions of natural substances from
plants, minerals, and animals. These remedies act to stimulate
the body's natural healing responses to specific symptoms.
Homeopathy was founded by Dr. Samuel Hahnemann in the late
effect resulting from concurrent use of multiple drugs or
dietary supplements. The result may be antagonism (counteracting)
or synergism (amplifying) and consequently may be adverse
in some cases.
international unit (I.U.) is a standard unit of measurement
of biological activity that is used for fat soluble vitamins
A,D, &,E (as well as for some hormones, enzymes, and
vaccines). It is an internationally-recognized standard
established by the International Conference for Unification
of Formulae. One I.U. represents a different amount for
different substances. The weight equivalents for fat soluble
vitamins are as follows:
Carotene (Vitamin A)
= 833 IU
2.5 mcg = 100 IU
= 1 IU
(lowest observed adverse effect levels)
lowest intake at which some adverse effects have occurred
under certain circumstances; the lowest dosage of a particular
dietary supplement at which an adverse effect was ever reported.
(Developed by CRN.)
and chemical changes that take place within an organism;
all energy and material transformations that occur within
living cells. Includes growth as well as energy changes:
all transformations of chemical energy of foodstuffs to
mechanical energy or heat. Includes anabolism (the conversion
of ingested substances into the constituents of protoplasm),
and catabolism (the breakdown of substances into simpler
substances, the end products usually being excreted).
published research report about a dietary supplement or
class of dietary supplement that includes information regarding
category, pharmacology, precautions, side effects, patient
consultation, and general dosing information.
identified as foods that are either unprocessed or organically
grown, or that contain products that are unprocessed or
have been organically grown.
naturopath, naturopathic physician
medicine focuses on the body's innate ability to heal. Naturopathic
physicians provide complete diagnostic and therapeutic services
and are licensed or accredited, depending on where they
received their degree and what state they practice in. They
consider a patient's diet, lifestyle, work, and personal
history when designing treatment -- which may include nutrition,
herbs, homeopathy, acupuncture, hydrotherapy, massage, and
counseling as well as more conventional therapies.
(no observed adverse effect levels)
level of a dietary supplement at which there are no credibly-substantiated
adverse reactions observed in humans. From CRN.
legal definition that, according to the Dietary Supplement
Health and Education Act (DSHEA), is any non-toxic food
extract supplement that has scientifically proven health
benefits for disease treatment or prevention. DSHEA requires
that this food component be standardized in the nutraceutical
product and manufactured under good manufacturing practices
(GMPs). Nutraceuticals are not whole foods, yet are partially
or completely derived from them. There are four types of
vitamins, minerals, and other dietary supplements in the
form of pills or capsules
products based on extracts from foods or beverages in
normal use (such as garlic, broccoli, red wine)
food extracts claiming a medical benefit (such as oat
bran lowering cholesterol, aloe vera juice healing ulcers)
natural substances that people might not usually eat but
that may prevent or treat illness (such as colloidal silver,
the processes involved in the taking in and utilization
of food substances by which growth, repair, and maintenance
of activities in the body as a whole or in any of its parts
are accomplished. Includes ingestion, digestion, absorption,
labeling term for products produced under the authority
of the Organic Foods Production Act, which regulates allowable
soil conditions and restricts the use of irradiation, genetically-engineered
organisms, pesticides, fertilizers, and additives in the
production of foods. From OTA.
the United States, drugs that do not require a prescription.
potency that is manufactured into a dietary supplement to
allow for disintegration so that the product maintains the
potency level of its labeled unit amounts through the expiration
of research by a group of professionals of comparable knowledge
and expertise in a specific scientific or medical field.
study of drugs and dietary supplements and their origin,
nature, properties, and effects upon living organisms.
treatise on drugs or dietary supplement and their preparation,
especially a book containing formulas and information that
provides a standard for preparation and dispensation.
to the chemistry of plants, plant products, and plant processes.
treatment plan or outline. In clinical trials, a protocol
is the plan for using an experimental procedure or treatment.
of one or more products performed by an independent laboratory
to measure quality. Products are picked randomly from a
retail store shelf in accordance with a procedure that ensures
random and unbiased selection.
research study that uses two or more groups of research
subjects. The treatment group receives the experimental
treatment while the control group receives either a placebo
or current standard treatment. (If the research is also
a clinical trial, these research subjects are people.)
Dietary Allowance (RDA)
intake goals for healthy people in 16 different age and
gender groups based on a consensus of the Food and Nutrition
Board of the Institute of Medicine of the National Academy
of Sciences. RDAs serve as the basis for the U.S. Recommended
Daily Allowances, the Food and Drug Administration's standards
for required nutrition labeling of foods.
Daily Allowance (US RDA)
intake goals established by the U.S. Food and Drug Administration
and based on the highest RDA values in a gender/age group.
US RDAs are more widely used than RDAs.
Many varieties and categories of research are relevant to
dietary supplements. See clinical trial, control group,
double-blind study, in-vitro research, peer review, placebo,
randomized controlled trial, single-blind study, treatment
safe dietary supplement is one that does no harm when used
under defined conditions and as intended. An unsafe substance
may result from toxicity, drug interactions, contraindications,
allergies, or contamination.
period of time during which a dietary supplement remains
sufficiently potent to be effective. The expiration date
on a product label should indicate the end of this time
trials in which the patients do not know which treatment
they are receiving -- but the researcher does. (See also
double blind research.)
/ function claims
that a dietary supplement benefits by maintaining healthy
or normal structures or functions of the human body -- as
opposed to preventing or treating abnormalities (health
upper intake level (UI)
maximum level of daily nutrient intake that is unlikely
to pose risks of adverse health effects to almost all of
the individuals in the group for whom it is designed. UI
is one of the guidelines encompassed in DRI (dietary reference
intakes) established by the National Academy of Sciences.
extent, quality, or degree to which a substance is poisonous;
in other words, the degree to which it interferes with normal
physiological functions. Because almost any substance can
be poisonous if consumed in sufficient quantity, toxicity
generally refers to intake of excessive dosages.
group of patients who receive the new treatment in a clinical
trial. Results of the treatment group are compared to results
of the control group. Researchers can then judge whether
the new treatment is as good as or better than current standard
intake level (UI)
See tolerable upper intake level.