TIME TO CORRECT THE EPISTEMOLOGIC CHAOS THAT PREVENTS NUTRACEUTICAL
October 12, 1999
What is Health?
What is Disease?
What is a Health Claim?
What is a Medical Claim?
Stephen L. DeFelice, M.D.
The current nutraceutical (foods, medical foods and dietary
supplements) industry is market-driven, but needs to become research-driven.
Nutraceutical companies sponsor very little clinical research
to evaluate the efficacy and safety of their commercialized products,
and few realize that their present and future success requires
that they start proving what they are claiming.
Why is this happening? Mainly because current federal laws
and regulations have created epistemologic chaos regarding certain
nutraceutical definitions. These faulty definitions are applied
by the FDA and then serve to limit the freedom of companies to
make legitimate medical or health claims. It is, therefore, crucial
that we resolve this epistemologic dilemma in order to form a
rational foundation for new Congressional laws that will encourage
nutraceutical clinical research.
For example, current laws such as DSHEA mistakenly attempt
to distinguish the difference between a health and medical claim.
If, for example, a nutraceutical dietary supplement lowers cholesterol
and a company makes such a claim, it is considered a medical and
not a health claim and, therefore, not permitted to be made by
the company. The company may be permitted to claim, "it benefits
the body's cholesterol" in order to be considered a health
The ultimate result is that the truth - that the product does
lower cholesterol - cannot be claimed by a company. A misleading
cholesterol claim, however, can be made. This common type of epistemologic
chaos borders on sophistry and is clearly unacceptable. It both
robs the patient of important truthful information concerning
his or her health and also profoundly discourages nutraceutical
clinical research, the essential element in medical discovery,
be it for the management of a disease or abnormal condition.
There is an urgent need for Congress to pass new laws which
contain new, precise language defining such critical terms as
health, disease, health claim and medical claim. This will allow
and encourage companies to conduct nutraceutical clinical research
on products that will help to reduce or eliminate disease, the
manifestations of disease or other abnormal conditions, premature
death, and yes, health care costs.
The four core questions to be answered are as follows:
1. What is health?
2. What is disease?
3. What is a health claim?
4. What is a medical claim?
In addition to having queried various experts on these questions,
I turned to both lay and medical dictionaries for enlightenment.
The following are representative definitions which are in harmony
with those of the experts:
American Heritage Dictionary:
1. The state of an organism with respect to functioning, disease
and abnormality at any given time.
2. The state of an organism functioning normally without disease
3. Optimal functioning with freedom from disease and abnormality.
Stedman's Medical Dictionary:
The state of the organism when it functions optimally without
evidence of disease or abnormality.
American Heritage Dictionary:
An abnormal condition of an organism or part, especially as a
consequence of infection, inherent weakness, or environmental
stress, that impairs normal physiologic function.
Stedman's Medical Dictionary:
Morbus; illness; sickness; an interruption, cessation, or disorder
of body functions, systems, or organs.
In FDA's recent attempt to define "disease", it states
that the latter is "any deviation from, impairment of, or
interruption of the normal structure or function of any part,
organ, or system (or combination thereof) of the body that is
manifested by a characteristic set of one or more signs or symptoms,
including laboratory or clinical measurements that are characteristic
of a disease."
This definition is an exercise in classic tautology. Basically,
it states that a disease is a disease which is not very helpful
in clarifying epistemologic chaos. If FDA had added "or abnormality"
at the end of the definition after" disease" then it
would be in harmony with the experts, lay and medical dictionaries.
(To further complicate the issue, it is possible that FDA may
be applying this definition of disease to dietary supplements
only and not to other categories such as foods.)
What is very encouraging and surprising is the basic commonality
and consistency of the perception of the meaning of "health"
and "disease". Both make good sense because they reflect
the truth of reality.
Regarding the term "health", both dictionary definitions
describe two conditions - "disease" and "abnormalities".
Neither tries to distinguish the difference between the two. For
example, few would call a sore knee after playing tennis or periodic
fatigue or PMS diseases. But they are indeed abnormal conditions
which often, like disease, require medical management. After all,
a problem is a problem no matter what you call it.
Regarding the term "disease", the words "disorder
of body functions" and "abnormal condition of an organism
or part..... that impairs normal physiologic function" certainly
includes a sore knee, periodic fatigue and PMS, none of which
is commonly perceived as a disease. Cutting through all the complexities
of both medical and lay dictionaries, be it a specific disease
or a specific abnormal condition, both types of entities are commonly
referred to in general definitions of health and disease. In order
to be healthy, we must be free of disease and any other abnormal
condition. For complex historical reasons, the simplicity of this
self-evident truth has eluded us.
In the final analysis, we must ask ourselves what is important
to the patient. This fundamental principle is too often forgotten.
If a patient has either PMS or pancreatic cancer, the patient
needs medical management. Giving a condition a name and categorizing
it with a legal-regulatory label is academic and does not meet
the real needs of real people. What is important is whether therapy
will benefit the patient and not fruitless epistemologic debates,
particularly when such debates powerfully discourage clinical
research on nutraceutical discovery.
Considering the aforementioned and using common sense, I would
propose the following four definitions:
1. Health is the absence of disease or any other abnormal
condition which may generally, but not always, require medical
2. Disease is a condition that impairs health and could
benefit from medical management.
3. A health claim deals with a substance that has a
beneficial clinical effect on a disease or abnormal condition.
4. Similarly, a medical claim deals with a substance
that has a beneficial clinical effect on a disease or abnormal
In conclusion, it follows that there is no difference between
a health and medical claim.
Congress must act now on FIM's proposal, the NREA (Nutraceutical
Research & Education Act), which was introduced in Congress
by Representative Frank Pallone (D-NJ) on October 1, 1999. The
NREA permits companies to make claims based primarily on the results
of the clinical research conducted on the specific product commercialized.
If a nutraceutical lowers cholesterol, then the claim should reflect
the truth, i.e., it lowers cholesterol. If a nutraceutical decreases
insomnia, then the claim should reflect it. No distinction is
made between a health or medical claim.
If we are compelled to continue to categorize claims, we should
replace the terms "health" and "medical" claims.
Instead we should use a new term, "medical-health" claims
as the legal and regulatory language of choice.