VICUS.COM (20 July 2000) -- A number of food and drink
manufacturing companies are beginning to test the waters of the
potentially lucrative functional foods industry, many by fortification
of existing food and drink brands with proven ingredients. However, to
earn the public's trust, clinical science needs to back up the claims
made on labels (currently, these products are not regulated by the
Food and Drug Administration; Ross, 2000).
During the Nutracon 2000 conference in Las Vegas, Nev., held July
17-19, Nancy Green, vice president of Nutritional Products for
Tropicana, outlined that company's strategy to establish the value of
Tropicana orange juice as a functional
food, which is defined as food that may provide health benefits in
addition to its accepted nutritional value.
are some factors driving the demand for
Advances in nutritional science, agricultural technologies and
processing techniques (e.g., biotechnology, genetic
* Ready access to nutrition and medical information
through widespread media coverage, the Internet and other
* Emphasis on disease prevention, in response to
escalating health-care costs.
* Recent legislative events such as government
regulations, which have changed how foods are marketed and
* The aging of the population, which is increasing the
demand for healthier foods or food ingredients to improve
health. By 2030, an estimated one-third of the U.S. population
will be older than 65 years of age.
* The growing self-care movement. Consumers are becoming
more interested in being responsible for their own health and
are taking an active role in improving their health through
National Dairy Council
Tropicana, which is owned
by food-and-beverage giant PepsiCo, has been successful in its
approach, which bears a striking resemblance to the marketing plans
followed by major pharmaceutical companies. Importantly, from the
perspective of health-care professionals and consumers, it provides
guidelines for what we should be looking for in the development of
scientific support for functional food marketing claims.
Its strategy incorporates
four elements that are essential to establishing functional food
credibility, according to Green:
The presence of third-party credibility
distinguishes this strategy from a simple advertising campaign. A
company needs to partner with independent experts at a university
level who are contracted by the sponsoring company (Tropicana in this
case) to conduct a study that will determine the impact of the product
in a health condition.
- Identify a component of a product that
provides a health benefit.
- Affiliate with a university to design
and conduct a clinically relevant study to document that
- Present the results at a scientific
meeting and/or in a reputable journal.
- Institute a program to ensure that
consumers and health-care professionals learn of the results.
Once the study is completed, the results are submitted for review
to another group of independent experts, who examine the results and
judge their worthiness for presentation during a scientific meeting or
publication in a peer-reviewed scientific journal. Furthermore, the
study is carried out in a population that is similar to those who will
consume functional food.
Tropicana's approach has been successful. A recently completed
survey of consumers by the International Food Information Council
found that oranges and orange juice were among the most often
identified foods having health benefits (IFIC, 2000).
with health claims for functional foods, ask the following
questions before you accept the claims:
between the "active" substance in the research
referred to in the advertisement and the product being sold.
* Does the advertised product contain the actual
substance(s) being promoted as having health benefits?
* Have the benefits of this substance been proven to occur in
the product being advertised?
*Were the benefits actually found to occur in people like you?
for confirmation of claims by an independent third party.
* Was the proof obtained as part of an independent effort by a
*Have the results been presented and reviewed by experts in
the field through a scientific meeting or publication?
Green, vice president of Nutritional Products for Tropicana
Two case histories
presented by Green provide a standard for judging other functional
Homocysteine as a risk factor for heart disease
associated with an increased risk of coronary
heart disease, stroke and peripheral vascular disease. However,
folic acid has been shown to lower homocysteine levels in the blood
and may reduce the risks posed by this amino acid (American Heart
Association, 2000). Tropicana wanted to promote the value of its
orange juice, which contains folic acid, in preventing heart disease.
To do this, they contracted with the Medical College of Wisconsin
(Milwaukee) to conduct a clinical study. The researchers found that
daily consumption of orange juice was associated with an increase in
folate blood levels and a decrease in homocysteine. The results were
presented at the American College of Nutrition meeting in 1998 and
then used to provide scientific support for the Tropicana advertising
Case 2: Blood lipid
levels and the consumption of orange juice
In 1999, Tropicana wanted
to promote the value of its orange juice to raise high-density
lipoproteins (HDL; good cholesterol).
It contracted with the University of Western Ontario (Canada) to do a
study that would address this issue. The researchers found that
consumption of this brand of orange juice raised HDL cholesterol by
21%. The findings were then presented during the annual American Heart
Association meeting. Tropicana subsequently used these data as
scientific support for its orange juice advertising campaign.
The process followed by
Tropicana was complex, costly and time-consuming. It required
submitting its product to clinical research to prove that an
ingredient in its product actually accomplished in humans what was
suggested by earlier research.
It also required it to
work with several independent organizations that were not motivated by
the need to sell orange juice.
The results offer
consumers and health-care professionals information that is more
reliable and applicable to their health needs.
Russo Jr., Pharm.D., is senior vice president of medical
communications at Vicus.com. He is a pharmacist and medical writer
with more than 20 years of experience in medical education.