DSHEA and previous food labeling laws, the FDA permits three types
of claims that manufacturers may use under specified conditions:
health claims (that a substance has impact on a disease)
nutrition support claims, which include "structure-function claims."
claims describe the level of a nutrient in a food or dietary supplement.
For example, a supplement containing at least 200 milligrams of
calcium per serving could carry the claim "high in calcium." A supplement
with at least 12 mg per serving of vitamin C could state on its
label, "Excellent source of vitamin C."
health claim is a statement that a food or substance can diagnose,
treat, mitigate, cure, or prevent a disease or health-related condition.
Nutrition Labeling and Education Act (NLEA) passed in 1990 established
the FDA's authority to require preapproval of these claims based
on "significant scientific evidence".
recent court ruling
remanded the FDA to clarify its definition of this phrase.
to pre-approval requirement for health claims
provision in the Food and Drug Administration Modernization Act
of 1997 allows companies to notify FDA of their intent to use a
new health claim based on an authoritative statement of one or more
federal scientific bodies. It gives FDA 120 days to respond. If
the agency does not act to prohibit or modify the claim within that
time, the claim can be used without the usual preapproval requirement.
of diet-to-health links on which a manufacturer may base a health
vitamin folic acid and a decreased risk of neural tube defect-affected
pregnancy, if the supplement contains sufficient amounts of folic
and a lower risk of osteoporosis, if the supplement contains sufficient
amounts of calcium
psyllium seed husk (as part of a diet low in cholesterol and saturated
fat) and coronary heart disease, if the supplement contains sufficient
amounts of psyllium seed husk.
a guidance document for industry, FDA established interim criteria
for determining the adequacy of health claims submitted under the
new procedure. Under these criteria, which will remain in place
until FDA publishes final regulations, the authoritative statement,
which is the basis for the health claim, must:
from a federal scientific body (for example, the National Institutes
of Health, national Centers for Disease Control and Prevention,
U.S. Department of Agriculture, or National Academy of Sciences)
published by the scientific body and be currently in effect
state a relationship between a nutrient and a disease or health-related
be a statement made individually by an employee of a federal scientific
body but rather reflect a consensus within the scientific body
be based on the scientific body's deliberative review of the scientific
said it would consult with the scientific body when appropriate
to determine whether a statement is an authoritative one.
and other nutrition support claims
types of nutrition support claims are permitted by the FDA. One
describes a link between a nutrient and the deficiency disease that
can result if the nutrient is lacking in the diet. For example,
the label of a vitamin C supplement could state that vitamin C prevents
scurvy. When these types of claims are used, the FDA requires that
the label must mention the prevalence of the nutrient-deficiency
disease in the United States.
may also be labeled with nutrition support claims that refer to
the supplement's effect on the human body's structure or function,
including the overall effect on a person's well-being. These are
known as structure-function claims. Examples of structure-function
Calcium builds strong bones.
Antioxidants maintain cell integrity.
maintains bowel regularity.
can use structure-function claims without FDA authorization. They
base their claims on their review and interpretation of the scientific
literature. Like all label claims, structure-function claims must
be true and not misleading.
claims can be easy to spot because, on the label, they must be accompanied
with the disclaimer "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."
who plan to use a structure-function claim on a particular product
must inform FDA of the use of the claim no later than 30 days after
the product is first marketed. While the manufacturer must be able
to substantiate its claim, it does not have to share the substantiation
with FDA or make it publicly available.
the submitted claims promote the products as drugs instead of supplements,
FDA can advise the manufacturer to change or delete the claim.
specific labeling regulations required by the FDA can be seen in
Reading the Label.