人間栄養と評価科学

健康長寿科学研究におけるレギュラトリーサイエンスの意義
講演３
セッションⅠ
人間栄養と評価科学
科学的根拠を与える「行政科学」の側面と、既存の
基礎科学や応用科学とは異なる「評価科学」の側面
を持っていて、科学の所産を人間との調和の上で最
も望ましい姿に調整regulateして、方向づけていく
ための科学』としている。その上で、評価科学は、
健康や環境に対する有害性を予測し、防止する科学
としている。この評価科学の観点から、栄養問題の
取組みを検討、評価することにした。
東京大学名誉教授
細谷憲政
栄養の領域においては、国民、生活者の健康・栄
略　歴
養状態に不利益をもたらすものの検証を、評価科学
1949　東京大学医学部卒業
1955　東京女子医科大学助教授
1960　東京大学医学部衛生看護学科助教授
1965　東京大学医学部保健学科助教授
1971　東京大学医学部教授　保健栄養学講座担任
1986　東京大学名誉教授
1988　国際学院埼玉短期大学副学長
1991　茨城県健康科学センター長
1993　女子栄養大学大学院教授
1996　財団法人日本健康・栄養食品協会理事長
2006　帝京平成大学教授
保健学、栄養学、生化学における著書100冊以上
の対象とする。その取り組みの方法は、従来の評価
科学において先人達が開発した評価方法を活用し、
その目的は、有効性、安全性の評価・予測とする。
現在の日本に対して、国際的に問題視されている
ものに、機能性食品と特定保健用食品との問題があ
る。機能性食品Functional Food, FFは食物・栄養
学から誘導されている。これに対し、特定保健用食
栄養の課題は、口から摂り入れる食事は、生きる
品 Food for Specified Health Uses, FoSHU は、人
ために十分かどうかの検討から始められ（食物・栄
間栄養学の観点から、ヒト試験 clinical trial を実施
養）食品に含まれる栄養素の化学と代謝（分子レベ
し、保健の用途に適すると認可した（健康強調表示
ル、細胞レベル）が研究されてきた。
health claimできる）ものである。
栄養素欠乏症が解消してくると、人体の健康影響
また、これらに関連して、食薬区分（医薬品と栄
が、個体レベル、組織・器官レベルで追及される
養素、食品との区分）や成品 supplements, Sp の法
ようになった（人間栄養）
。現在では、根拠に基づ
制化の問題もある。Sp は、栄養領域のものであり、
いた（臨床）栄養の実際 evidence-based nutrition
欧米先進国においては、これらを活用して、生活習
practice, EBNP が必要とされている。科学の研究者
慣病誘発の危険要因の低減・除去 risk reductionも
は研究成果だけを得ることが目的であったりする
行っている。
が、人類の夢や希望のために進歩発展してきた科学
技術を正しく調整 regulateすることも必要になる。
将来にわたる影響を予測し、開発の道筋を的確に評
価する必要がある。このためには、あらゆる科学的
接近を学際的に総合して判断することになる。この
ような接近と価値観は既存の科学には見られなかっ
たが、これをRegulatory Science と呼ぶことが提唱
された。
内山充は、
“Regulatory Science”は『規制政策に
25
SessionⅠ
The Significance of Regulatory Science in Scientific Research on Health and Longevity
Lecture 3
Human nutrition and regulatory science
−Functional foods and supplements in Japan−
Norimasa Hosoya
the problem of malnutrition was resolved and
Professor Emeritus (Nutrition), University of Tokyo
lifestyle-related diseases/disorders became more
Past Records
1949 Graduated from Faculty of Medicine, University of Tokyo
1955 Assistant Professor, Tokyo Women’s Medical College
1960 Associate Professor, School of Health Care and Nursing,
Faculty of Medicine, University of Tokyo
1965 Associate Professor, School of Health Sciences, Faculty of
Medicine, University of Tokyo
1971 Professor and Head of Department, Department of Nutrition,
School of Health Sciences, Faculty of Medicine, University of
Tokyo
1986 Professor Emeritus (Nutrition), University of Tokyo
1988 Vice President, Kokusai Gakuin Saitama Junior College
1991 Director, Health Science Center, Ibaraki
1993 Professor, Graduate School of Kagawa Nutrition University
1996 Director General, Japan Health Food and Nutrition Food
Association
2006 Professor, Teikyo Heisei University
of an issue, however, the term“food and nutrition”
Publications : Over 100 original scientific publications on health,
nutrition and biochemistry
Kaori Nakajima
Assistant Manager, Overseas Business Department
The Nisshin OilliO Group, Ltd.
was replaced by the term“human nutrition.”
In Japan, since the first efforts involved“food
and nutrition,”they were divided into the food
aspect (agricultural issues) and the human body
aspect (medical issues). This vertical structure
penetrated science and research, academics,
government administration, politics and the
economy, society, and culture and remains to this
day. These two fields do not compromise with
or complement each another. Internationally,
though, they were integrated together as“human
nutrition.”Researchers (PhD holders) in nonmedical
Issues Concerning Nutrition
fields are known to have achieved more results
These days it is thought necessary for
than those in the medical field.
science/technology to take into consideration the
impact on human beings and social problems.
Meanwhile, nutrition is being reconsidered
The impact on human beings involves health;
i n t e r n a t i o n a l l y. I n t h e U n i t e d S t a t e s , t h e
the meaning of being healthy is“to have good
terminology and concepts of orally-ingested foods
nutritional status.”Social problems involve lifestyle
or food substances have been reorganized and
and environmental issues.
standardized. The nutrition care process (NCP)
was built on these terms and concepts (in 1996),
In Japan there is some confusion between
and thus evidence-based nutrition practice has
“health care”and“prevention.”
“Health care”looks
been standardized. Furthermore, the international
at human health from the point of view of health
standardization of this practice has also been
itself ; it maintains and promotes health and also
proposed (2004).
decreases the incidence of ailments by reducing
and eliminating the risk of disease.“Prevention,”
Regulatory Science
on the other hand, anticipates illness and, from
Generally speaking, scientific research can be
the point of view of disease, endeavors to prevent
divided into two types: basic research and applied
people from becoming ill. Traditionally it has been
research. Basic research pursues original findings;
considered one aspect of medicine.
applied research aims at creating new technologies
or new materials. In contrast, science that requires
The issue of nutrition and eating began
regulation aims, internationally and domestically, to
with the question of whether our food intake is
“regulate”the social systems and the products of
sufficient, and over nearly a century they came to
scientific technology in a manner that is desirable
be bundled together as“food and nutrition.”When
for the general public.
26
The Significance of Regulatory Science in Scientific Research on Health and Longevity
SessionⅠ
Lecture 3
Health care is a science that questions what
in Japan as a scientific term in 1984. Actually,
is necessary to maintain and promote the health
however, there is no nutrient, nutritional substance,
of the people and improve the living environment
or food taken orally that does not function in
and aims to acquire evidence and conclusions
the human body. In the United States, therefore,
regarding the desirable directions. This kind of
“functional food”is treated as a marketing term,
approach and consideration were not evident in
and the existence of “functional food” per se
existing science, so in Japan Dr. Mitsuru Uchiyama
is denied. In the European Union, the concept,
(1987) proposed the term“regulatory science.”
definition, regulation, and usage are changing.
Therefore, internationally the scientific rationality
According to Dr. Uchiyama, “regulatory
of“functional food”is doubted.
science”has two aspects “administrative
:
science,”
in which scientific substantiation is given to
In Japan, however, regarding so-called
regulatory policies, and“regulatory science,”which
functional food, clinical trials are carried out from
differs from existing basic science and applied
a human nutrition point of view and those that
science. In harmonizing the products of science
are judged to be suitable for specified health uses
with human beings, he explained (1994),“regulatory
are approved as Foods for Specified Health Uses
science”adjusts “regulates”
(
) them to the most
(FoSHUs). These FoSHUs are allowed to carry
desirable form and sets guidelines to maintain
approved health claims on their labels and are
that form. And on top of that,“regulatory science”
accepted by society as legitimate.
foresees the risks to health and the environment
and prevents (assesses) damage. Nowadays the
Another issue is confusion in the differentiation
“administrative science”that Dr. Uchiyama
of categories. Japan coined the term“functional
proposed is called “public policy”(Shinichi
food,”but the difference between“functional food”
Kobayashi, 2008).
and“supplement”is vague. There is also FoSHU;
food that has pursued scientific evidence of its
Looking from this perspective, we can
effect and safety through clinical trials of the
understand that the science related to nutrition
functional food component and the food product
practice is the same as the“regulatory science”
itself.
proposed by Dr. Uchiyama. Guidance on nutrition
and ways to supplement one’
s diet, dietary
If the term“functional food”is to be adopted,
reference intakes, DRIs, (recommended dietary
it must follow such rules as the Codex Alimentarius,
allowances, RDAs), food composition tables,
and its scope, definition, and criteria must be
guidelines, and so on are regulated at the national
clarified. If the term“functional food component”
level or by public institutions.
is to be adopted, it should follow international
trends and obtain the status of“supplement,”and
For that reason, the professional people
the difference from nutrients and drugs should
who deal with such topics achieve good results
be clarified. In Europe and the United States,
in those fields. If one cannot obtain results, one
nowadays supplements are being tested with
might reassess one’
s own potential and reconsider
clinical trials to prove their efficacy.
the solution to the problem at hand. This is an
important issue from the point of view of ethics.
Supplements
At present, due to such factors as overeating
Functional Food
or malnutrition, there is an increase in the number
The term“functional food”was first used
of people whose health is in transition from being
27
SessionⅠ
The Significance of Regulatory Science in Scientific Research on Health and Longevity
Lecture 3
healthy to not-so-healthy. In order to respond
Regulation
to this situation, substances that come between
Science has fields of research that produce
nutrients and drugs have appeared. In the United
evidence (in the case of nutrition, nutrition science)
States, such substances have been given legal
and fields that, based on the evidence, aim for
status (1994) and are called dietary supplements.
a specific objective and achieve that objective
In Europe, with the exception of some herbs and
(nutrition practice). In order to regulate both fields,
traditional medicine, they go by the name of food
one must gather as much reference material as
supplements. Nevertheless, despite the fact that
possible, investigate, foresee, and evaluate. For
“health food” and “natural food” do not exist
that purpose, much scientific debate --- that is to
internationally, in Japan the legalization of so-called
say, academic debate and evaluative debate --- is
health foods is being discussed. It is very strange
necessary.
indeed.
Meanwhile, system analysis by specialists
Internationally speaking, supplements known
will also be necessary, and decision makers must
in the field of clinical nutrition are considered
regulate matters on the basis of the results of this
as “oral nutritional supplements”(ONS). They
analysis and according to policy.
are the same as those nutrients used in enteral
nu t ri t i o n , su c h a s v ita m in s , m in e r a ls , a n d
In this case, not only so-called specialists
amino acids. In Europe and the United States,
but also the general public, the consumers, must
for the last quarter of a century, scientifically
participate in the debate, too.
substantiated ONSs have been utilized by nutrition
specialists in the field of health and medicine.
Conclusion
In Japan, those who talk about supplements are
Whatever the case may be, in Japan,
agricultural chemists and pharmacologists. They
academia, private sector, industry, and government
are considered as“nutritional researchers,”and
must work together toward legalizing supplements
what they discuss is the functionality of such non-
as soon as possible, establishing their status, and
nutrients as phytochemicals, bioactive compounds,
giving them a role in the fields of health care,
and herbs and how they might be included in
medicine, and social welfare. At the same time,
pharmaceuticals.
it is urgent for Japan to contribute in this area in
terms of international trade as well.
Science analyzes and demonstrates the
evidence. In pure science, chemicals are extracted,
purified, identified, and their physiological
function is observed. Therefore, first of all the
purified substances must be sorted into different
categories: drugs or supplements or nutrients.
Then the substances must be classified according
to how they are combined, processed, mixed, or
polymerized.
Of all the major developed countries, Japan
is the only one that does not have a law for
supplements.
28

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