How does FDA regulate dietary supplements?
In addition to regulating label claims, FDA regulates in other
ways. 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?
The FDA requires that certain information appear on the dietary
supplement label:
General information
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.
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.
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. (Click the interactions
link above to learn more about the possible dangers of combining
supplements with drugs.)
If you have any unexpected reactions to an herbal or a botanical
preparation, inform your doctor or other health care provider.
