Logical Fortification

By Donna Berry, Contributing Editor

Since the early 1930s, most dairy processors have been voluntarily adding vitamin D to fluid milk to prevent rickets, a bone-debilitating disease that was prevalent at the time and linked to a deficiency in this fat-soluble vitamin. Since then, many food and beverage manufacturers have been adding vitamins, minerals and other nutrients to everyday foods because of research showing they are lacking in the diet. These efforts also add marketing value by creating a point of differentiation in the crowded marketplace.

And though the supplement market remains strong and continues to grow, many consumers prefer to get their nutrients from everyday foods,"  says Alice Wilkinson, vice president,  nutritional product development and quality, Watson Foods Co., West Haven, CT.  "Fortification is a great way to help consumers fill the gaps for nutrients that they need more of."

 Dennis Gordon, professor emeritus, North Dakota State University, Fargo, and an industry consultant residing in Cathlamet, WA, concurs: Foods nourish, not supplements; thus, foods and beverages should be the primary way we receive all our energy and nutrient needs. But deficiencies exist for certain nutrients among specific population segments. And thats when fortification is logical."

The right to fortify

Without a doubt, fortified foods can play a significant supporting role in the well-being of todays consumers," says Ram Chaudhari, Ph.D., FACN, CNS, senior executive vice president and chief scientific officer, Fortitech Inc., Schenectady, NY.

Interestingly, FDA made a decision in the 1940s that it would not require mandatory fortification for any food product. This policy remains; however, mandatory enrichment does exist when a product is formulated to conform to the standard of identity for the enriched version of the food.

Formulators dont have to enrich, but if they do, and a standard exists for the enriched product, the product must conform to the levels of nutrients specified. For every standard of identity for an enriched version of a food, there is a corresponding standard of identify for an unenriched version. The most recent standard of identity change became effective in January 1998, specifying that any grain products labeled as enriched have to include specified levels of folic acid.

The agency has a policy that encourages fortification and identifies fortification practices with labeling requirements, but these are not rigid standards," says Jonathan Hopkinson, senior applications scientist, Danisco USA, New Century, KS. Logically, there is very little reason to fortify foods provided that everyone has a balanced diet with proper exercise and exposure to sunlight (to make vitamin D). Unfortunately, very few people in this country have this kind of idealized lifestyle, especially within the lower socio-economic scales. People often cannot afford this kind of lifestyle, or they are not properly educated and so they make poor food choices. Fortification can help in these cases."

Fortification can definitely help fill nutrition gaps, but some authorities believe that food companies view the right to fortify" as a way to make processed foods more attractive, to the point where a consumer would choose vitamin-C fortified applesauce over a real apple.

Marion Nestle, professor, Department of Nutrition, Food Studies and Public Health, New York University, New York, and author of numerous nutrition books, believes  the only two consumables that should be fortified are salt (with iodine) and drinking water (with fluoride).

These are deficiencies due to geography, and fortification has made a huge public health difference," Nestle says. Evidence for the benefits of the others is more complicated, with often times the only benefit coming to marketers who use fortification as a means of selling products."

To prevent this, FDA established the jelly bean rule" in 1994 (Title 21 of the Code of Federal Regulations, Part 104, Section 20). This rule says foods low in fat, cholesterol and sodium cannot claim to be healthy unless they contain  at least 10% of the RDA of vitamin A, vitamin C, calcium, protein, iron or fiber. Further, companies cannot fortify foods with the sole intent of making that claim.

This basically prevents a food manufacturer from making a healthy claim for inherently low-nutrient foods," says Hopkinson. The rule has been somewhat effective, but there are ways to go around this."

Nestle concurs: The jelly bean rule forbids fortification for the express purpose of marketing junk foods as healthy. Companies can easily get around it, and do."

The other problem with fortification of foods is that most evidence suggests that consumers think the products are healthier and have fewer calories," Nestle says.

This is when responsible research and development comes into play, explains Wilkinson. Consumers have come to expect that a fortified food is incredibly healthy regardless of the matrix," she says.

As science evolves

During the past two decades, the nutrition and scientific communities have focused on a relatively short list of nutrients that are deficient in most Americans diets. This list includes calcium, dietary fiber, folic acid, iron, omega-3 fatty acids, potassium, zinc and vitamins B6 and D," says Gordon. As long as researchers continue to publish papers about the need for any of these nutrients and this information is communicated to the press and then to the consumer, food companies will make these nutrients a priority in their fortification efforts, in particular with popular products such as beverages, breads and snack bars.

The heyday of discovering essential nutrients is over," Gordon adds. There might be some new discoveries about essentiality, but now the industry should focus on how to best get essential nutrients into the needy populations."

Right form, adequate level

One segment that could benefit from fortification, for example, is teenage girls, who tend to be significantly lacking in calcium and iron. Formulators need to understand that not all iron ingredients are the same," says Wilkinson. "The ones that tend to be easiest to work with are typically less bioavailable to the consumer. It is imperative that a formulator work closely with their nutrient supplier to identify the right nutrient form for an application so that the consumer gets the most benefit."

Hopkinson adds: Ethically, if you suggest a product is healthier because it has been fortified with an important nutrient, then this fortification should benefit the consumer. Consider fortifying a product with a calcium salt that is not bioavailable. The product may contain a large amount of calcium in its ash, but the consumer expects he or she is benefitting from those calcium ions. The fact is, virtually all the calcium ends up in the sewer."

Cristina Munteanu, technical service scientist, Corn Products International, Westchester, IL, says, Important factors to consider when developing enhanced foods are the active ingredient; target fortification level based on frequency of consumption; taste; texture throughout shelf-life; and whether the finished product will highlight a claim or statement."

According to a joint statement of the Food and Nutrition Board of the Institute of Medicine and the Council on Foods and Nutrition of the American Medical Association issued in 1968, and still valid today, there are six underlying principles that serve as the foundation for logical fortification of foods and beverages. First, the intake of the nutrient, in the absence of fortification, is below the desirable level in the diets of a significant number of people. Second, the food from which the nutrient is to be derived is likely to be consumed in quantities that will make a significant contribution to the diet of the population in need. Further, the addition of the nutrient is unlikely to create an imbalance of essential nutrients; the nutrient added is stable under proper conditions of storage and use; the nutrient is physiologically available from the food to which it will be added; and last, there is a reasonable assurance against intake sufficiently in excess to be toxic.

Formulating factors to consider

As the nutrients added to a product become more numerous, the application challenges increase. In order to successfully introduce fortified products that are on-trend and will resonate with consumers, it is necessary to have a multi-pronged approach to product development," says Chaudhari. Start by prioritizing the benefit of a particular ingredient in a given application. For example, to be credible, a meal-replacement beverage should offer a minimum concentration of active components to ensure a measurable benefit. It is also easy to focus on active ingredients and overlook the importance of the underlying foundation properties of the drink. Many of the active ingredients contribute metallic or bitter flavors. Hence, acidity, saltiness and sweetness should be carefully balanced to optimize a products taste and flavor profile.

When identifying ingredients, it is important to consider usage of multi-functional ingredients," Chaudhari continues. For example, sugar functions as a sweetener, osmotic-balancing agent and energy source. Similarly, glycerol is a sweetener, energy source, osmotic balancing agent and muscle dehydration preservative. Phosphate salts contribute free phosphate molecules, provide isotonic balance and buffer acidity, with the latter important for microbial safety, color stability and flavor release."

Chaudhari says it is also important to consider how temperature, pH, oxygen, light and moisture might affect the stability of added nutrients. For example, moisture transfer between a foods matrix and added nutrients can impact the stability of the nutrients. Selection of the right kind of coating can protect the nutrient from breaking down in the product, which could impact taste and limit shelf life. 

Understanding the concept of overage is imperative for proper fortification. Formulators must incorporate the concept of overage, which is the use of kinetic data on nutrient stability to calculate the amount of added nutrient so that the anticipated level of the nutrient at the end of the products shelf-life is in accordance with the level indicated on the label," Chaudhari says. Understanding proper ingredient selection and determining overages for each ingredient are specific to each finished products composition."

Other important considerations are processing and storage conditions. Customization is key," says Wilkinson. And not just product formulation, but every manufacturing plant is different. One pasteurizer might impact a nutrient differently than the next, and this must be considered when determining usage levels."

Chaudhari adds: Multiple ingredients can be incorporated into a fortified food or beverage product, but the formulation of these products goes beyond just adding a few vitamins here, a cup full of antioxidants there and tossing in some botanicals. To minimize interactions between nutrients in a premix, certain nutrients can be separated into individual premixes, or some might be encapsulated for stability."

In the end, it is the responsibility of the formulator to design a product that delivers the specified amounts of the nutrients promised at the end of shelf life. The product should make sense to the consumer and, of course, taste great.

Donna Berry, president of Chicago-based Dairy & Food Communications, Inc., a network of professionals in business-to-business technical and trade communications, has been writing about product development and marketing for 13 years. She has a B.S. in Food Science from the University of Illinois in Urbana-Champaign. She can be reached at [email protected].

Health Seekers

According to the 2011 U.S. Trend Study by Health Focus International, St. Petersburg, FL, 67% of shoppers believe that all food categories can be improved for nutritional functionality. Further, more than half believe that foods can be fortified with vitamins, minerals and other ingredients and still be natural, with 88% of consumers saying they want foods that enhance health.

Legally Healthful and Indulgent?

Although FDA has established guidelines that forbid the fortification of "junk" foods in order to make them appear more healthy (i.e., the "jelly bean rule," 21 CFR 104.20), manufacturers continue to challenge the parameters of this edict. "Healthful indulgence" has emerged as a catchphrase in recent yearsand for good reason. In a country burdened by escalating obesity rates in children and adults alike, and a population that disproportionately ignores federally proffered nutritional guidelines, fortification of nearly any productregardless of relative inherent nutrient value and/or caloric levelemerges as fair play. Consider the following examples from the beverage space:

  Regular and Diet 7Up Antioxidant (containing 10% DV for vitamin E, with 25 grams of sugar per 8-oz. serving in regular);

  Diet Coke Plus (15% DV for niacin and vitamins B6 and B12, 10% for zinc and magnesium)survived FDA's Dec. 2008 challenge that the product violated guidelines without relabeling or reformulation;

  Vitaminwater Multi-V (100% DV for vitamin C, 40% for vitamins B3, B5, B6 and B12, also contains vitamins A, C and E, and zinc, and 13 grams of sugar per 8-oz. serving)lawsuit instigated by Center for Science in the Public Interest (CSPI) in Jan. 2009 still pending after a federal judge rejected The Coca-Cola Company's motion for dismissal in July 2010.

Fortified juices, like apple and orange, are also growing more common (often to deliver 100% DV for calcium and vitamin C). Although the concept of juice fortification apparently moves the discussion into a more nutritionally sound arena, 100% fruit juices still naturally contain a high degree of sugar per serving (generally around 20-plus grams per 8-oz. serving)and further fortification of juices could lead to increased regulatory and special-interest scrutiny.

Although the playing field has clearly shifted when it comes to adding a healthful spin to foods formerly consumed just for fun, like sodas and similar beverages, product designers who ignore the reality of the jelly bean rule will likely need to prepare a potential defense of their formulation logic when FDA (or CSPI) comes a-knockin'at least until the rules change.

Douglas J. Peckenpaugh, culinary editor & community director of content

For more on how health and indulgence continue to intersect, visit the SupplySide® Community at SupplySideCommunity.com.