A Special Message for Congressman Frank Pallone
DSHEA Versus NREA (The Nutraceutical Research and Education Act) and the Three Nutraceutical Objectives
by Stephen L. DeFelice, M.D.
It's time to revisit the Dietary Supplement Health Education Act
(DSHEA). Any new legislation and subsequent regulations, however, must
be based on a solid, rational foundation to accomplish well-defined
objectives. Unfortunately, this was not sufficiently done when the
current law and regulations were written over a decade ago.
Both healthy individuals and those who are ill take their dietary
supplements primarily for the prevention and treatment of diseases
particularly the major ones such as cardiovascular, cancer and
Alzheimer's. This self- evident fact has been confirmed by a number of
surveys. Of course, dietary supplements are also used for other health
conditions that are not recognized as diseases such as fatigue and aging
skin. These uses, however, are clearly of secondary importance. To put
it simply, people take supplements to get rid of their diseases, if they
have them, or to prevent them if they don't. When Americans are asked
what they want to know about the products they consume, the results of
surveys are wisely in harmony with what physicians and other health care
professionals agree upon.
They want to know the following:
1. Are the dietary supplements effective for the reasons consumed?
2. Are they acceptably safe?
3. And is the information available to them truthful?
The critical question then is, "How can we deliver these THREE
NUTRACEUTICAL OBJECTIVES?" The unequivocal answer is by conducting
clinical studies on the particular products sold. We can only know that
penicillin works against bacterial lobar pneumonia; that insulin
reverses diabetic coma; that niacin lowers blood lipids and that
cranberry juice reduces the severity of urinary tract infections in
women — and that all are acceptably safe - from data generated by
What does DSHEA do? Just the opposite! It effectively discourages
clinical research which results in the following: People do not know
whether the supplements they take are effective. They do not know if
they are acceptably safe. They are denied access to truthful information
regarding the effectiveness and safety of products.
The construct of DSHEA was an attempt to accommodate many players
in the very complicated dietary supplement sector. In a real sense, it
was a breakthrough milestone in our health sector because, for the first
time, the government permitted companies to legally make claims about
dietary supplements concerning bodily function. One well-intended
objective was to reduce the rampant practice of making unsubstantiated
and false claims regarding the beneficial impact of supplements on many
diseases. The Congress handed the FDA a very difficult assignment and,
for reasons too complicated to discuss here, an impossible task to carry
The major FDA attempt was to establish two types of claims
categories — "health" and "disease" related. Companies are prevented
from making the latter ignoring the fact that good ìhealthî largely
depends on the prevention and treatment of disease. As an example of
this epistemological chaos, if a company sponsors a well-controlled
clinical study on a mixture of dietary supplements that shows that the
product lowers cholesterol, the company cannot state the truth, namely,
that it ìlowers cholesterolî because FDA considers this to be a
ìdiseaseî claim. The company can, however, claim, "That it benefits the
body's cholesterol" or "Can contribute to a healthy heart" which not
only confuses the consumer but deprives him or her of the truth.
If, in a follow-up clinical study, the product is administered
along with a cholesterol-lowering pharmaceutical which work together to
significantly reduce the size of coronary artery plaques more than the
pharmaceutical alone, and the company wants to make this claim, it
cannot for two reasons. First, it is considered a disease claim. Second,
simply by the fact that it is given along with a pharmaceutical, it
also falls in the disease category.
Given the restrictive ground rules regarding claiming, what company
would make a substantial investment to sponsor clinical studies on its
products when it is not allowed to educate the public, let alone
physicians and other health care professionals, about the truth but,
instead, it is pushed into making misleading and/or confusing claims?
The company will, instead, like water, take the path of least resistance
to the marketplace.
Over 15 years ago, FIM proposed the NREA, or Nutraceutical Research
and Education Act, as way to accomplish the aforementioned critical
THREE NUTRACEUTICAL OBJECTIVES. <(1)
A nutraceutical is a food or part of a food that has a health benefit
including the prevention and treatment of disease. It includes dietary
supplements, foods, and functional foods which are really dietary
supplements in food dosage forms. The core principle of the proposed
NREA is to offer attractive economic incentives for companies to sponsor
clinical research or studies on their specific nutraceuticals that are
I came up with the concept of the NREA as a result of my long and
extensive experience with carnitine, which is legally both a
pharmaceutical and nutraceutical. My work with carnitine has taken me
deep into virtually all aspects of innovation in our medical system. For
example, there was evidence that this natural substance was effective
in the treatment of the rare condition, carnitine deficiency, which is a
debilitating and oftentimes fatal disease in children. But the high
cost of obtaining an NDA or FDA approval of the drug, coupled with the
very, very small market size, discouraged any company from pursing its
development. After the Orphan Drug Act was approved, however, my
colleague and proprietor of Sigma Tau, S.pA., Dr. Claudio Cavazza,
invested the time and money to successfully obtain FDA approval for
carnitine though no profit would come of it.
The Orphan Drug Act basically does two fundamentally positive
things; 1) it grants a company the exclusive right for seven years to
make a disease claim ñ sort of a methods patent — based on the results
of the clinical studies; and <(2)
it substantially reduces the amount of clinical data and total cost
required to obtain FDA approval. These two provisions effectively
spurred companies to invest in clinical research, and the Orphan Drug
Act has been a gratifying success.
It is both puzzling and disturbing to note that the general message
of the critical importance of encouraging clinical research, clearly
demonstrated by the Orphan Drug Act, has escaped notice by Congress and
the pharmaceutical and nutraceutical sectors where the difficulties of
conducting clinical studies continue to inexorably rise retarding
medical discovery. But, unfortunately, it is not surprising.
In 1976, I formed and funded FIM with the sole objective of
educating the public and the key players in the health sector,
concerning the importance of encouraging clinical research. I relied
heavily on the mass media to carry this message forward. FIM held
numerous high-level conferences, made proposals, spent large sums on
public relations firms and other parties to spread the message. The
result? Virtually a zero response except for modest coverage from the
industry media. The mass media was nowhere to be seen. We have a
definite, almost unbudgeable cultural blind spot when it comes to
clinical research. In fact, our society views it with suspicion.
The FIM NREA proposal is based on the same principles of the
successful Orphan Drug Act. If a company sponsors clinical studies on
its product and FDA approves it, that company will have a seven-year
claims exclusivity period. I was mistakenly convinced that, because of
our nation's "exuberant enthusiasm" about nutrition, the key players in
the health sector arena, particularly the mass media, would want to
learn about and accept the general clinical research message necessary
to deliver the promise of nutraceuticals to the people. FIM's
educational effort, once more, did not resonate in any quarter.
It has always puzzled me why the business health sector that can
market nutraceuticals has powerfully resisted changes when the changes
involve delivering to the customers what they want as confirmed by
multiple surveys. In addition, they are blind to the fact that the
potential nutraceutical OTC market is far larger and more profitable
than the current health food one coupled with much lower costs to market
nutraceuticals. The marketing approach is unique and substantially
different than the classic OTC industry. <(2)
Over ten years ago I was fortunate enough to meet Representative Frank
Pallone (D-NJ) who is quite knowledgeable about the promise and problems
of the nutraceutical sector. We discussed the importance of clinical
research in achieving the THREE NUTRACEUTICAL OBJECTIVES. He became
highly interested and we had a few more meetings. At one of our FIM
conferences he, as a speaker, announced he would introduce the
Nutraceutical Research and Education Act in Congress. And so he did on
October 1, 1999. <(3) The result? Very little interest or support, and, because of this, the Act was temporarily laid to rest.
The following are a few points that should be considered in any new legislation.
The issue of safety: Justifiable concerns with safety played a
major role in DSHEA and will also if it is revisited. Dietary
supplements, when compared to pharmaceuticals, are vastly safer. For
example, if all FDA approved pharmaceuticals were made freely available
as dietary supplements, a large percentage of Americans would be deathly
ill or no longer with us within a very short period of time! This is
not to say that dietary supplements are without risks, but they do not
compare to pharmaceuticals.
National placebo: To the skeptics who do not believe that dietary
supplements, themselves, offer much promise, there is another important
and little appreciated side of the coin. Nutraceuticals are our nation's
freely available placebos. Up to 50% of millions of Americans who
suffer from a broad variety of conditions experience significant placebo
improvement when taking them. We now know that something definitely
happens to the brain's machinery during a placebo response which
somehow, through a natural mechanism in the body, leads to a beneficial
response in these millions.
Cost reduction: And here's another little appreciated but definite
benefit: Those millions whose conditions improve find no need to visit a
doctor's office to receive a prescription for expensive pharmaceutical
drugs and/or undergo costly medical tests. Though not yet sufficiently
quantitated, there is little doubt that this results in an enormous
reduction in health care costs.
In the final analysis, whether DSHEA is revisited or not, the
enactment of the NREA not only compensates for some of the major
deficiencies of DHSEA, but also presents a wonderful opportunity for
Congress and the nutraceutical industry to deliver the promise of
nutraceuticals to Americans—soon. To repeat, the NREA will lead to
clinical trials that clinically demonstrate the effectiveness and safety
of nutraceuticals related to disease and other conditions. Physicians
and other healthcare professionals respect clinical data as the gold
standard of acceptability and will recommend products that meet these
standards to their patients. As a result, the NREA generated proven
nutraceuticals largely will replace DSHEA's unsubstantiated clinically
Regarding the NREA's impact on the future nutraceutical industry,
it will divide it into two general sectors similar to the ethical and
generic pharmaceutical industries, but with important differences. The
former, similar to the NREA industry, because of the exclusivity given
to the claim, develops proprietary, high profit margin products which
generate sufficient funds to sponsor clinical research while the latter,
similar to the DSHEA industry, is a commodity, nonproprietary industry
with low profit margins with little incentives to invest in clinical
Recently, Congressman Pallone has been appointed as Chairman of the
Energy and Commerce Subcommittee on Health. For this reason and the
reasons supporting the NREA, FIM urges Congressman Pallone to
reintroduce his NREA. After all, Congress should be comfortable with the
concept behind this proposal because it is the same as with the
successful Orphan Drug Act that it enacted.
1. <http://fimdefelice.org/archives/arc.researchact.html FIM Rationale and Proposed Guidelines for the Nutraceutical Research & Education Act - NREA. <http://www.fimdefelice.org/nrea.html
2. Clinical Research and Nutraceutical Brand names and Trademarks.
<Clinical Research & Nutraceutical Trademarks
December 20, 1999 commentary by Stephen L. DeFelice, M.D.
3. "Bill H.R.3001 - The Nutraceutical Research and Education Act. <http://www.fimdefelice.org/nrea.html