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Volumen 68, Broj 3
UDC: 659.3:615.851.4]:613.2
DOI:10.2298/VSP1103266J
CURRENT TOPICS
Health claims made on food
Zdravstvene izjave i prehrambeni proizvodi
Jelena Jovičić, Budimka Novaković, Ljilja Torović
University of Novi Sad, School of Medicine, Department of Pharmacy, Novi Sad, Serbia
Key words:
food; food labeling; consumer health information;
health promotion; legislation
Introduction
According to the World Health Organization (WHO),
75% of all deaths in the year 2030 will be caused by mass
noncommunicable diseases (NCDs) 1. Causes of NCDs are
known and can be non-preventable (age and genetic heritage)
and preventable or modifiable (unhealthy eating habits, insufficient physical activity, tobacco use) 2.
Social and economic burden of population caused by
NCDs is enormous and growing, so WHO set a specific goal
in 2005 – an additional 2% reduction in chronic disease
death rates worldwide per year over the next 10 years 2. The
WHO's Action Plan 3 from 2008 promotes healthy eating
habits enabling consumers to make informed choices.
Declarations of foodstuffs, promotional materials and
advertising campaigns are considered as means of direct producer-consumer communication, making it vital for the information written on declarations (as well as on promotional
materials and in advertising campaigns) to be scientificallybased and well-understood by the consumers. Advances in
knowledge and understanding of the link between nutrition
and health resulted in shift from nutrition claims to health
claims written on food declarations. Health claims present
health benefits for consuming certain foods by consumers.
Public interest in health promotion is a driving force behind
the use of health claims and an incentive for innovation in
food industry and pharmaceutical industry. Therefore, a
well-designed legal system for approval of the use of health
claims should exist.
Codex Alimentarius, a joint body of the Food and Agriculture Organization of the United Nations (FAO UN) and
WHO defined health claims in 1997 as “any representation
that states, suggests, or implies that a relationship exists between a food or a constituent of that food and health” 4. Codex Alimentarius implies that national regulations concerning health claims should be harmonized in order not to disrupt free trade system 4.
Ključne reči:
hrana; hrana, obeležavanje; potrošači, zdravstvene
informacije; zdravstvo, unapređenje; zakonodavstvo.
Current legislation concerning health claims in different countries
Japan
Country that has introduced to the world the concept of
“functional food” and, parallel, the idea of health claims is
Japan. The use of health claims in Japan is controlled by the
Ministry of Health, Labour and Welfare (MHLW) 5.
In 2001, MHLW divided foods bearing health claims
into 2 groups: foods with nutrient function claims (FNFC)
and food for specified health uses (FOSHU). FNFC standards and specifications so far have included nutrient function claims for 17 ingredients (12 vitamins and 5 minerals).
FOSHU refers to foods containing ingredient with functions for health and is officially approved to claim its
physiological effects on the human body. FOSHU is intended to be consumed for the maintenance or promotion of
health or special use by people who wish to control health
conditions. In order to sell food as FOSHU, health claims
written on it must be approved by the MHLW. Specific requirements for FOSHU declarations limit their sales out of
Japan 6–8.
United States of America (USA)
The American Food and Drug Administration (FDA)
defined health claim as “any claim made on the label or in
labeling food, including dietary supplements, that expressly
or by implication, including “third party” references, written
statements (e.g., a brand name including a term such as
“heart”), symbols (e.g. a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or
health-related condition” 9, 10. There are three ways by which
FDA exercises its oversight in determining which health
claims may be used on a label or in labeling food or dietary
supplements:
1. The 1990 Nutrition Labeling and Education Act
(NLEA) provides for FDA to issue regulations author-
Correspondence to: Jelena Jovičić, University of Novi Sad, School of Medicine, Department of Pharmacy, Hajduk Veljkova 3, 21 000
Novi Sad, Serbia. Phon.: +381 21 422 760. E-mail: jovicic.j@gmail.com
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izing health claims for foods and dietary supplements
after FDA's careful review of the scientific evidence
submitted by food producer in health claim petitions
concerning link beetwen certain food component and
health. Health claims authorized as described, have to
comply with the NLEA (1990), Dietary Supplement Act
(1992) and Dietary Supplement Health and Education
Act (DSHEA, 1994). The most common NLEA authorized health claims are ones describing the link beetwen
fruit, vegetables and cereals and coronary artery disease,
as well as the ones linking saturated fatty acid content
and cholesterol content with the risk of cardiovascular
disease.
2. The 1997 Food and Drug Administration Modernization
Act (FDAMA) provides for health claims based on an
authoritative statement of a scientific body of the US
government or the National Academy of Sciences. Such
claims may be used after submission health claim notification to FDA.
3. The 2003 FDA Consumer Health Information for Better
Nutrition Initiative provides for qualified health claims
where the quality and strength of scientific evidence
falls below that required for FDA to issue an authorizing
regulation. Such health claims have to be qualified to
assure accuracy and non-misleading presentation to consumers 10, 11.
According to the strenght of supporting evidence, FDA
recognizes 4 categories of health claims: A (supported by
strong scientific evidence), B (moderate scientific evidence
level), C (low scientific evidence level) and D (the lowest
scientific evidence level) 10, 12.
Use of health claims in advertising campaigns is controlled by the Federal Trade Commission (FTC) leading to
conflicting situations when health claims not approved by the
FDA are used in advertising 11, 13.
European Union
Health claims in the European Union (EU) are covered
by the European Commission Regulation No 1924/2006 on
nutrition and health claims made on foods 14 in which a
health claim is defined as “any claim that states, suggests or
implies that a relationship exists between a food category, a
food or one of its constituents and health”. According to the
authorisation protocol, health claims in EU are divided into
“article 13 claims” and “article 14 claims” accordant with the
Regulation 1924/2006. Health claims other than those referring to the reduction of disease risk and to children's development and health, describing or referring to the role of nutrient or other substance in growth, development and functions of the body or psychological and behavioural functions
or slimming or weight control are considered “article 13
claims”, as well as health claims based on newly developed
scientific evidence which include a request for the protection
of proprietary data. Reduction of disease risk claims and
claims referring to children's development and health are
“article 14 claims”.
Health claims in use in the EU must be authorized by
the European Food Safety Authority (EFSA). EFSA is supJovičić J, et al. Vojnosanit Pregl 2011; 68(3): 266–269.
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posed to publish a list of approved, well-defined health
claims in January, 2010. Criteria for authorisation of health
claims in Europe are defined in the Process for the Assessment of Scientific Support for Claims on Foods
(PASSCLAIM) project 15. The basic clause of PASSCLAIM
is that the link beetwen food constituent and disease risk reduction is confirmed by studies on humans 15.
Health claims are allowed only on food with certain
nutrient profiles. Nutrient profile includes saturated fatty acids, sodium, dietary fiber and unsaturated fatty acid content
of food. Definition of nutrient profiles is supposed to prevent
“masking” of undesired nutrient profile of certain food by
health claims 16.
Republic of Serbia
National regulation concerning health claims is currently underway.
Note: In July 2010, after this manuscript had been
accepted, national regulation of health claim use was
adopted. Now, in December 2010, the implementation of
the regulation provisions concerning health claims is still
pending.
Despite the regulation differences, requirements and
limitations for the use of health claims are similar. A health
claim must not attribute to food the property of preventing,
treating or curing a human disesase. Health claims should not
be false, ambiguous or misleading, nor should it give rise to
doubt about the safety and (or) the nutritional adequacy of
other foods or a balanced and varied diet. It is not allowed
for health claims to encourage or condone excess consumption of food, refer to changes in bodily functions which could
give rise to or exploit fear in the consumer 14.
Health claims have to refer to food ready for consumption in accordance with the manufacturer's instructions and
must relate to the quantity of a product that can reasonably
be expected to be consumed provided that a significant
quantity of the nutrient or other substance to which the claim
relates will produce the nutritional or physiological effect
claimed as established by generally accepted scientific evidence. Health benefit can be the result of the presence, absence or a reduced content in food or category of food of a
nutrient or other substance in respect to which the claim is
made 14.
Health claims that are not allowed are these suggesting
that health could be affected by not consuming food bearing
a health claim, making reference to the rate or amount of
weight loss and referencing to recommendations of individual doctors or health professionals. Beverages containing
more than 1.2% alcohol by volume shall not bear health
claims 14.
The use of health claims in labeling, presentation and
advertising is allowed if followed by statements indicating
the importance of a varied and balanced diet and healthy
lifestyle, the quantity of food and pattern of consumption required to obtain the claimed beneficial effect, a statement
addressed to persons who should avoid using food (where
appropriate) and an appropriate warning for products that are
likely to present health risk if consumed to excess 14.
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Limitations of free trade
Different health claim regulation frameworks present a
limitation in free trade systems. The most common conflicting situation is importing foodstuffs bearing a health claim
into a country with different (or non-existant) health claim
regulation. As a result, international community strives to
harmonize regulatory systems 13.
Examples of health claims compliant and noncompliant with the mentioned regulations (US, EU, Serbia)
are given in Table 1.
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and nutritive characteristics of food are not among consumers' priorities 18–20. Consumers' attitudes are tightly related to
their age, social status and education level. Various EU nations are concerened by different health issues, making it
necessary for the development and marketing of new food
products to be market-oriented 12, 13, 21.
The underlying principle of all regulatory frames is for
health claims to be truthful, clear and understandable. In
practice, this seems to be the most controversial and scientificaly challenging principle. Inadequate wording of health
claims may mislead consumers. Word “may” causes conTable 1
Health claims in EU, USA and Serbia
Relevant data on foodstuffs
Food constituent
Health effect
Health claim
EU*
(example of an authorized
health claim 26)
Mixture of long chain
omega-3 polyunsaturated
fatty acides
Blood pressure reduction
(3 g/day) and serum
triglyceride level reduction (2–4 g/day)
On the label of a dietary
supplement contraining
mixture of long omega-3
polyunsaturated fatty acides: “helping the reduction of serum triglyceride
levels and maintaing of
normal blood pressure”
USA†
(example of health claim
in use in USA – not in
compliance with the regulation 27)
Water-soluble dietary fiber
Serbia‡
(example of health claim
in use in Serbia – sample
product taken from the
market)
Not defined
Coronary artery disease
risk reduction
Treatment of type 2 diabetes (according to the
producer)
On breakfast cereal's label: “reduces cholesterol
by 4% in 6 weeks”
On the label of herbal tea:
“proven efficacy in the
treatment of type 2 diabetes: “one package of
this tea is enough to reduce blood sugar levels by
10–15%”
Note:
*On the basis of the data presented, the European Food Safety Authority (EFSA) concluded that a cause and effect relationship exists between the
consumption of eicosapentaenoic and docosahexaenoic acid and blood pressure and serum triglyceride level reduction. Opinion based on relevant
scientific data, including:
1.
Ayalew-Pervanchon A, Rousseau D, Moreau D, Assayag P, Weill P, Grynberg A. Long-term effect of dietary {alpha}-linolenic acid or decosahexaenoic acid on incorporation of decosahexaenoic acid in membranes and its influence on rat heart in vivo. Am J Physiol Heart Circ Physiol
2007;293:H2296-304.
2.
Connor WE. Importance of n-3 fatty acids in health and disease. Am J Clin Nutr 2000;71:171S-5S.
3.
Calder PC. n-3 fatty acids and cardiovascular disease: evidence explained and mechanisms explored. Clinical Science 2004;107:1-11.
4.
Geleijnse JM, Giltay EJ, Grobbee DE, Donders AR, Kok FJ. Blood pressure response to fish oil supplementation: metaregression analysis of
randomized trials. J Hypertens 2002;20:1493-9.
5.
Balk EM, Lichtenstein AH, Chung M, Kupelnick B, Chew P, Lau J. Effects of omega-3 fatty acids on serum markers of cardiovascular disease
risk: a systematic review. Atherosclerosis 2006;189:19-30.
†
Health claim linking water-soluble dietary fiber and coronary artery disease risk reduction is Nutrition Labeling and Education Act (NLEA) authorized. Food and Drug Administrations (FDA's) position was that the health claim in question attributed the property of drug to food and in May 2009,
asked the producer to provide scentific proof for the alleged cholesterol level reduction of 4% in 6 weeks. In June 2009, producer submitted 4 articles
about the claim in question. In an public letter, FDA announced that the results of 3 out of 4 submitted articles were inconclusive and called for the
revision of all available scientific data on the subject and the revision of possible health claim wording in order to prevent the misleading of consumers. The case is still pending.
‡
Health claim in question does not comply with either USA, EU or Japan regulations
Consumers and health claims
The basic purpose of health claims is consumers' benefit by providing information about heatlhy eating habits, but
food industry often uses health claims for advertising purposes 13, 17. A well educated and motivated consumer is able
to make informed choices about his diet 12, 13.
Studies done both in the USA and the EU showed that
taste and price dictate food choices and that health benefits
sumers to doubt a health claim, while words such as
“proven” or “proof” are percieved as assuring. An average
consumer prefers desriptive adjectives and visual representations over numbers. According to the consumers' associations, nutrition claims are often percieved as health claims 22,
23
. The absence of health claims can decrease the use of
foods with proven health benefits (fruits and vegetables) 13.
The European Consumers' Organisation – Bureau Européen des Unions de Consommateurs (BEUC) pointed out
Jovičić J, et al. Vojnosanit Pregl 2011; 68(3): 266–269.
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that food labels already contain too much information, making it hard for consumers to prioritize and demotivates them
5, 13, 23–25
. In the USA, the majority of consumers are unable to
make a distinction between different health claims categories
(A, B, C, D), regardless health claims' wording, despite FDA
efforts 27.
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Conclusion
Food labeling is equally important for food producers and
consumers. Health claims should be used cautiously, in order
not to undermine the fact that diet as a whole, and not a specific
food constituent, is the key to maintaining good health.
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Received on June 1, 2009.
Revised on December 31, 2009.
Accepted on October 20, 2010.