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support may be made in labeling for a dietary supplement,
because of a disease or medical condition; this type of claim
without the approval of a health claim regulation, if:
is distinguished from a claim to treat the disease. As an
" the manufacturer has substantiation that such statement
example, the following claim would be appropriate for a
is truthful and not misleading;
medical food: For use under medical supervision, this
" the labeling contains, prominently displayed, the
product can be helpful in the dietary management of X
following additional text, This statement has not been
disease or medical condition.
evaluated by the Food and Drug Administration. This
At first impression, the medical food provision may
product is not intended to diagnose, treat, cure, or prevent
appear to be outside the scope of interest for a company that
any disease; and
wants to sell conventional foods. However, it should be
" the manufacturer notifies FDA no later than 30 days
recognized that the number of consumers who are patients
after the first marketing of the dietary supplement with the
and for whom particular types of medical foods might be
statement (21 USC §343(r)(6)).
of interest is substantial and growing. Medical food status
After this legislation (part of DSHEA) was passed in
also can be an initial bridge mechanism for introducing a
1994, it appeared at first that there might be reluctance within
product that is subsequently promoted to a wider segment of
the dietary supplement industry to use the statement of
the population. Ensure® appears to have gained its foothold
nutritional support exemption from health claim clearance
in the marketplace in this manner.
requirements because of the mandated disclaimer labeling.
Statements of Nutritional Support for
However, thousands of statements of nutritional support have
Dietary Supplements
now been filed with FDA by companies that have told the
Agency that they are using the statements in labeling.
The Dietary Supplement Health and Education Act
FDA recently published a draft guidance describing
(DSHEA) defines dietary supplements as food products
the amount, type and quality of scientific evidence that
that (a) are intended to be ingested in the form of a tablet,
the Agency recommends a manufacturer possess to
capsule, powder, soft gel, gel cap, or liquid droplet (or, if not
substantiate a statement of nutritional support made
intended for ingestion in such a form, that are not represent-
for a dietary supplement (FDA/CFSAN/ONPLDS,
ed to be useful either as a conventional food or as a sole
2004c). While the guidance does not constitute legally
item of a meal or the diet) and (b) provide a vitamin,
enforceable criteria, it does provide useful insight into
6
On Nov. 29, 1996, FDA published an ANPR (FDA, 1996a) to initiate a reevaluation of &
FDA s current view of the competent and reliable
the regulation of & medical foods, but then withdrew the ANPR on Nov. 26, 2004 (FDA,
2004c ).
scientific evidence standard that FDA will apply in
Expert Report 19
evaluating support for such a claim. FDA s guidance
(1) Morning sickness associated with pregnancy;7
recommends that manufacturers consider four factors in
(2) leg edema associated with pregnancy; (3) mild
assessing substantiation for a claim: the meaning of the
mood changes, cramps, and edema associated with
claim, the relationship of the evidence to the claim, the
the menstrual cycle; (4) hot flashes; (5) wrinkles;
quality of the scientific evidence and the totality of the
(6) other signs of aging on the skin, e.g., liver spots,
scientific evidence.
spider veins; (7) presbyopia (inability to change
On Jan. 6, 2000 (FDA, 2000a), FDA published final
focus from near to far and vice versa) associated with
regulations that specify whether particular types of claims
aging; (8) mild memory problems associated with
will be deemed by the Agency to be unacceptable disease
aging; (9) hair loss associated with aging; and
claims (i.e., not to be acceptable structure/function
(10) noncystic acne.
claims) in the labeling of dietary supplements (21 CFR
FDA states, however, that claims to relieve conditions
§ 101.93(f), (g)). Key provisions of these regulations are
such as the following would be disease claims under the final
described below.
regulations: toxemia of pregnancy; osteoporosis; glaucoma;
Definition of Disease
arteriosclerotic diseases of coronary, cerebral or peripheral
blood vessels; cystic acne; severe depression associated with
The definition of disease or health-related condition
the menstrual cycle; and benign prostatic hypertrophy. FDA
mirrors that in the health claims rule in 21 CFR § 101.14(a)(5).
also states that the claim helps to maintain normal urine flow
Thus, a disease is damage to an organ, part, structure, or
in men over 50 is a disease claim.
system of the body such that it does not function properly
(e.g., cardiovascular disease), or a state of health leading
Structure/Function Claims Included in the OTC Drug Review
to such dysfunctioning (e.g., hypertension); except that
Under the final regulations, certain claims that are
diseases resulting from essential nutrient deficiencies
included in the FDA s OTC (Over-The-Counter) Drug
(e.g., scurvy, pellagra) are not included in this definition
Review may nevertheless be acceptable structure/function
(21 CFR §101.93(g)(1)).
claims for the labeling of a dietary supplement, although
Claims Relating to Signs or Symptoms of Disease
other claims from the OTC Drug Review would be deemed
by FDA to remain exclusively disease claims that are not
The regulations provide that a labeling statement will
acceptable for dietary supplements. For example, FDA states
be deemed to be a prohibited disease claim if the statement
that claims that are included in the antacid OTC drug
claims, explicitly or implicitly, that the product has an effect
monograph but that also may be acceptable structure/function
on a specific disease or class of diseases, or on the charac-
claims include relief of sour stomach and relief of upset
teristic signs or symptoms of a specific disease or class of
stomach, because the claims refer to a nonspecific group of
diseases, using scientific or lay terminology (21 CFR
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