October 2010 Issue

Modified Functional Foods — Do They Have a Place in a Healthful Diet?
By Christin L. Seher, MS, RD, LD
Today’s Dietitian
Vol. 12 No. 10 P. 44

While some experts believe they’re all about marketing, others say that products fortified with nutrients such as omega-3s are beneficial to certain populations. Regardless, a look at the trends reveals these foods’ popularity.

Picture this scene: You are standing in the kitchen after a long day at work, contemplating what to make for dinner. After a brief pause, you decide to make an Italian meal complete with salad and garlic cheese bread. You select a box of whole grain pasta with added omega-3 fatty acids, a jar of tomato sauce with extra fiber, your “heart-smart” spread, and probiotic low-fat cheese and get to work.

In today’s marketplace, consumers face a wide selection of functional food products to incorporate into their diet. Some choose these foods to rack up “bonus” health benefits from the products they buy while others select them to help with disease prevention and management.

As these new “superfoods” become increasingly more common in the American marketplace, Today’s Dietitian asked food and nutrition experts about their use, efficacy, and role in a healthful diet.

First, a Little Background
The term “functional food” most commonly refers to any food with benefits beyond its nutritive value. A formal legal definition has not been adopted in the United States, so many organizations have proposed their own. The Institute of Food Technologists defines functional foods as those “foods and food components that provide a health benefit beyond basic nutrition (for the intended population). These substances provide essential nutrients often beyond quantities necessary for normal maintenance, growth, and development, and/or other biologically active components that impart health benefits or desirable physiological effects.”1

The American Dietetic Association (ADA) sees all foods as functional, at least on some level, given that every food contributes energy or nutrients to the diet in some capacity. In its 2009 position statement on functional foods, the association defines unmodified or “conventional” foods (eg, fruits, vegetables) as the most basic functional foods. These foods contain bioactive substances beneficial to health (eg, antioxidants, fibers, phytochemicals), and their consumption has benefits for disease prevention.

Modified foods are those that have been enhanced or fortified with a specific nutrient to market that food as having an additional health-related benefit. Over the past five years, modified foods have increased in popularity, gaining a larger percentage of the market. Calcium-, antioxidant-, vitamin-, and herb-fortified beverages; products containing prebiotics and probiotics; and products containing added plant stanols/sterols, fibers, and omega-3 fatty acids are examples of how foods are commonly modified to increase their nutritive value.

Scientific consensus exists for the vast number of health benefits that result when conventional functional foods are regularly included in the diet. Dietary guidance for the public is based on the incorporation of fruits, vegetables, and whole grains, and their disease-preventive effects are advocated by the American Heart Association and the American Cancer Society in their advice to consumers. Less explored, and certainly more controversial, is the role that modified food products can play in the diet.

History of Fortified/Enhanced Foods
The addition of vitamins and minerals to foods for public health purposes began more than 100 years ago in the United States. In the last century, iodine was added to salt to prevent goiter, B vitamins were added to flour to replace those lost during processing, vitamin D was added to milk to prevent rickets, and, most recently, folate was added to the grain supply to prevent neural tube birth defects. The fortification (addition of nutrients) and enrichment (replacement of nutrients lost during processing) of these foods has arguably provided important public health benefits for the correction of nutritional deficiencies.

More recently, however, the trend has shifted in which the fortification of food products is occurring not for the prevention of specific nutrient deficiencies but for optimizing health and disease management efforts. Examples include adding omega-3s for brain and heart health, prebiotics and probiotics for gastrointestinal benefits, plant sterols and stanols for heart health, and fibers for a variety of health-related benefits.

This recent trend has created a situation in which there is concern that modified functional food products “blur the line between food and medicine,” according to David Kaplan, PhD, an assistant professor of philosophy and religion and director of the Philosophy of Food Project at the University of North Texas, in a paper titled “What’s Wrong With Functional Foods?”

How They Are Regulated
Since no legal definition for functional food exists in the United States, the FDA does not specifically regulate these foods before they go to market. Rather, the FDA treats (and thus regulates) these products according to how they are categorically defined: as a conventional food, food additive, dietary supplement, medical food, or food for special dietary use.

What the FDA does regulate are the claims made on a modified food product’s packaging. The FDA allows manufacturers to use three types of claims: health claims, nutrient content claims, and structure/function claims. Health claims describe the relationship between a food (or food component) and a disease or health-related condition. The FDA approves these claims for use based on a detailed review of the supporting scientific literature and expert consensus.

According to Marion Nestle, PhD, the Paulette Goddard professor of nutrition, food studies, and public health at New York University and author of Food Politics, “The only reason for functional ingredients [in food products] is to make health claims for them.” In fact, Nestle notes that the food industry is aggressively lobbying for health claims to be approved in the European Union, which has been reluctant to approve these claims for most functional ingredients “because the science just isn’t there,” she says.

Trends in the U.S. Functional Foods Market
According to the Wall Street Journal, modified functional foods were a $30 billion-plus industry in 2008, with consumer demand for these products continuing to rise. Business consulting group PricewaterhouseCoopers notes that this puts the functional food industry at 5% of the U.S. market, with projected growth outpacing the general market by as much as 500%.

According to a market analysis by PricewaterhouseCoopers released in August 2009, conditions optimizing this growth include demand from more health-conscious consumers, a focus on disease prevention and a trend toward wellness initiatives, recent labeling laws allowing health claims to be made on food products, emerging industry technologies making the fortification of different foods possible, and the food industry’s ability to capitalize on premium pricing and fill market niches.2 However, the Institute of Food Technologists maintains that the products currently on the market represent only a small fraction of what is possible in relation to functional foods’ potential.1

And these yet-to-be developed products will likely find an eager group of consumers upon their arrival. The 2009 Functional Foods/Foods for Health Consumer Trending Survey conducted by the International Food Information Council Foundation (IFIC) indicated that 89% of Americans thought certain foods contained health benefits beyond basic nutrition, a significant increase from when the survey was conducted in 2007. In addition, 92% of those surveyed could name a specific food and its associated health benefit.

Consumers could most readily identify health benefits associated with calcium, vitamin D, and bone health; consumption of whole grains, B vitamins, folate, plant sterols, and a reduced risk of heart disease; the role of antioxidants in preventing free radical damage; omega-3 fatty acids and cognitive development in children; and probiotics and digestive health. They believed the top health conditions that could be improved through nutrition included heart, bone, and digestive health and reported weight control, proper growth and development, and improvement in physical energy levels as other benefits to the consumption of functional foods.

While this survey assessed consumers’ knowledge of all types of functional foods, the results mimic the top-selling modified functional food products in the United States. According to PricewaterhouseCoopers, products claiming to boost energy were the top seller, with 29% of the market segment—almost $8 billion in 2007.2 Products identified as having benefits for gastrointestinal, bone, and heart health were popular with older consumers, while products claiming to manage weight, provide mental clarity, or improve infant health were tops for younger consumers.

What’s Hot?
According to the Nutrition Business Journal, functional beverages are again this year’s hot topic, with many companies expected to debut new products and continue aggressively marketing old ones. In fact, functional beverages are such a hot topic that the ADA released a Hot Topic brief on the subject for RDs in February 2008, noting that these beverages were starting to outpace soft drink sales.

Sharon Palmer, RD, author of the ADA Hot Topic brief, cautions that when evaluating the healthfulness of a functional beverage, “It depends on what ingredients are added to the beverages. For example, a sugar-free green tea beverage might be a better alternative to drinking sweetened beverages, especially if it contains a healthy dose of real green tea. There are many health advantages linked to drinking green tea. But other functional beverages may be fortified with herbal supplements that are poorly evaluated for safety, efficacy, and dosage. And still other functional beverages may contain added vitamins or minerals that serve as a small portion of a vitamin pill.”

In addition, Palmer notes that there may be additional adverse health effects associated with consuming these beverages. “Another consideration is that many functional beverages can contain high amounts of sugar and calories, and research has linked drinking sugar-containing beverages with obesity,” she says. “Science indicates that people don’t compensate for the calories they drink.”

Experts Weigh In
The ADA holds the position that “functional foods that include whole foods and fortified, enriched, or enhanced foods have a potentially beneficial effect on health when consumed as part of a varied diet on a regular basis, at effective levels.”3

One potential benefit, according to the IFIC, is that incorporating functional foods allows a consumer to take greater control over the health benefits provided by the food products they choose in their diet.4 Felicia Stoler, DCN, MS, RD, FACSM, author of Looking Skinny in Fat Genes, sees a role for modified foods in a healthful diet. “People have to eat food anyway … [and] if the food they eat is providing them with some other value, if it’s going to help them, why wouldn’t they eat these items?” she says, adding that modified functional foods provide “added health benefits to the foods they are already eating.”

Scientific evidence of such benefits is stronger for some functional ingredients than for others. Fiber, probiotics, omega-3s, and plant stanols and sterols are among the most highly supported ingredients. Incorporating plant stanols and sterols into the diet is even advocated in the Therapeutic Lifestyle Changes (TLC) diet issued by the National Heart, Lung, and Blood Institute for lowering LDL cholesterol. According to TLC guidelines, adding 2 g per day of phytosterols and stanols can lead to a 5% to 15% reduction in LDL cholesterol.

Stoler notes that these products “are not a cure” for any disease and should not be treated as such; she does, however, acknowledge there may be a therapeutic role for functional ingredients added to foods, noting that for those who do not eat a well-balanced diet, added nutrients from these types of products may be an option. “In reality, most people use convenience products,” she says. “If we can provide them with ideas, suggestions, and recommendations for foods they can consume with added nutritive value, why wouldn’t we?”

However, not all experts agree that modified food products are beneficial. A primary caution for consumers looking to incorporate modified functional foods into their diet is the perception that a food is healthful despite actually having limited health benefits. According to Nestle, the purpose of modified functional foods “is to convince the public that processed food products are healthier than real foods, which they are not. But they are a huge growth mechanism for the otherwise stagnant food industry, which considers them essential for future growth. Hence, functional foods are about marketing, not health. The public wants healthful foods and functional foods are marketed as healthful, regardless of what else they do or do not contain besides the functional ingredients.”

Kaplan agrees, noting in the paper that the food industry could be misleading the public into thinking that “dietary magic bullets in their food will ensure a healthy diet regardless of what they eat.”

Another problematic issue is that the amount of a functional ingredient included in a serving of a modified food product is often too small to produce any noticeable health effect. In addition, because manufacturers are not required to list how much of a functional ingredient is added to their product, consumers may not know how much they need to consume to gain the health benefits associated with the functional ingredient.

Finally, the efficacy of many functional ingredients has been called into question. “People need to learn to take a whole-foods approach to better health and nutrition rather than a reductionist view that focuses on individual nutrients. In fact, many benefits associated with micronutrients and phytochemicals are related to the foods they come from, not the individual nutrients. We do not fully appreciate the synergy or the bioavailability of these nutrients when they are consumed in a food in their natural state vs. in a ‘pill,’” says Palmer.

Kaplan raises a similar argument in his paper: “The fundamental practical problem with functional foods is that they do not work very well, and when they do work their health and nutritive effects are far less significant than their advocates would have us believe. That is because the very reductivist premise of functional foods—that food is the kind of thing that can be understood in terms of its component parts—is mistaken.”

What to Watch For
This past summer, the controversy surrounding modified functional foods, their efficacy, and their price sparked debate in regard to the fortification of infant formula with bioactive ingredients such as DHA, arachidonic acid, prebiotics/probiotics, and antioxidants such as lutein, lycopene, and beta-carotene, despite limited research.

Nestle, the author of a recent piece on the subject for The Atlantic, says she’s still waiting for the evidence that these products make formula-fed infants healthier. “Infant formula manufacturers, faced with the problem that all infant formulas are alike except for the brand name, have been looking for ways to charge more for their products,” she explains.

What makes this such a hot topic is that, according to a report released in June by the Center on Budget and Policy Priorities, the Women, Infants, and Children (WIC) program, which spent more than $850 million on infant formula last year, could directly attribute $91 million of its spending to higher-priced fortified formulas, with little supporting evidence of their efficacy in improving the health of full-term, healthy newborns. In fact, neither the USDA nor the FDA has evaluated the efficacy of adding commonly supplemented components to infant formula, let alone some of the newer ingredients now being sold to the WIC program and to wider consumers.

This has prompted many experts, along with the Center on Budget and Policy Priorities, to call for more stringent oversight in the legislation reauthorizing the WIC program, due to be revisited by Congress later this year.

Take-Home Messages
What is the bottom line?

Consumers are using modified food products in record numbers. The trends survey conducted by the IFIC demonstrates that many Americans are already adding functional foods to their diet for their reported health benefits, with many more considering incorporating them in the future. Stoler points out that people are asking about them, and it is a disservice not to “put our own personal beliefs aside and listen to the needs of the client.”

Many times consumers select products that may not be the most healthful choices or that may provide minimal health benefits. This appears to be strongly influenced by the misconception that modified foods are healthful based on their associated health claims. Consumers need to be educated on how to delineate between products that can provide demonstrated health benefits and those that are not as effective or provide minimal nutritional value.

Some of these foods can, however, be incorporated healthfully into the diet and may provide some benefit for certain populations. For example, Palmer notes that fortified electrolyte beverages may be appropriate for certain athletes, and Stoler acknowledges that populations without access to fresh fruits and vegetables may benefit from products that replace these nutrients.

A Golden Opportunity   
Eighty-five percent of those who responded to the IFIC survey indicated they were interested in learning more about functional foods and their associated health benefits. While media sources (Internet, television, and magazine articles) were listed as the most utilized source of information by these consumers, medical and health professionals were noted as the most trusted sources.

This puts dietitians in a unique position to work with clients to help them sort through the plethora of food products now available. “People need to learn to sort through advertising to find the truth in all types of foods. Dietitians are perfectly poised to help people understand the truth,” says Palmer.

Stoler agrees, noting it is up to dietitians to work with clients to “see what behaviors we can modify, work within the constraints of their budget, their lifestyle, and their willingness to change.”

— Christin L. Seher, MS, RD, LD, is founder of Strategic Health Solutions, LLC, serving northeastern Ohio.


Approved Health Claims
Currently, several health claims are approved for legal use in the United States as long as they meet FDA-established criteria. They include the following:

• diets with enough calcium and reduced risk of osteoporosis in certain populations;

• diets low in sodium and reduced risk of hypertension;

• diets low in total fat and reduced risk of cancer;

• diets low in saturated fat, total fat, and cholesterol and reduced risk of coronary heart disease;

• low-fat, fiber-containing grain products, fruits, and vegetables and reduced risk of cancer;

• diets rich in fruits and vegetables and reduced risk of cancer;

• diets rich in fruits, vegetables, and grain products that contain fiber, specifically soluble fiber, and reduced risk of coronary heart disease;

• diets adequate in folate and reduced risk of neural tube defects;

• consumption of dietary noncariogenic carbohydrate sweeteners and reduced risk of dental caries;

• consumption of soluble fiber from certain foods and reduced risk of coronary heart disease;

• consumption of soy protein and reduced risk of coronary heart disease;

• consumption of plant sterol/stanol esters and reduced risk of coronary heart disease;

• diets rich in whole grain foods and reduced risk of heart disease and certain cancers;

• diets rich in potassium and reduced risk of high blood pressure and stroke;

• consumption of fluoridated water and reduced risk of dental caries; and

• diets low in saturated fat, cholesterol, and trans fat and reduced risk of heart disease.

For more information, visit www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/



1. Institute of Food Technologists Expert Report. Functional Foods: Opportunities and Challenges. Available at:
Expert-Reports/Functional-Foods/~/media/Knowledge Center/Science Reports/Expert Reports/Functional Foods/Functionalfoods_expertreport_full.pdf
. Accessed July 20, 2010.

2. PricewaterhouseCoopers. Leveraging growth in the emerging functional food industry: Trends and market opportunities. Available at: http://download.pwc.com/ie/pubs/pwc_leveraging_growth_in_the_emerging.pdf. Accessed July 29,
3. American Dietetic Association. Position of the American Dietetic Association: Functional foods. J Amer Diet Assoc. 2009;109(4):735-746.

4. International Food Information Council Foundation. Background on functional foods. Available at: http://www.foodinsight.org/Resources/Detail.aspx?topic=Background_on_Functional_Foods. Accessed July 20, 2010.