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.
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. 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.
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 models. 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)
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