Exploring Issues

Nutrients may be added to a food to correct a dietary insufficiency recognized by the scientific community to exist and known to result in nutritional deficiency disease if sufficient information is available to identify the nutritional problem and the affected population groups, and if the food is suitable to act as a vehicle for the added nutrients. The food also must not the subject of any other federal regulation that prohibits nutrient addition. Before implementing such a fortification plan, manufacturers are urged to contact the FDA.

Nutrients may be added to a food to restore nutrients to a level representative of the food prior to storage, handling and processing. Scientific documentation must support that the nutrients in question have been lost in storage, handling or processing in a measurable amount equal to at least 2% of the Daily Reference Value of protein and of potassium, and 2% of the Reference Daily Intake in a normal serving of the food. It also must show that good manufacturing practices and normal storage and handling cannot prevent the loss of the nutrients.  All nutrients - including protein, iodine and vitamin D - that are lost in a measurable amount must restored, and all ingredients in the product that contribute nutrients must be considered when determining restoration levels. Again, the food must not be prohibited from fortification by any other federal regulation.

Nutrients may be added to a food in proportion to the total caloric content of the food in order to balance the vitamin, mineral and protein content if a normal serving of the food contains at least 40 Cal. (2% of a daily intake of 2,000 Cal.). Other federal regulations must not prohibit nutrient addition, and the food must contain certain levels of 21 specified nutrients per 100 Cal.

Nutrients may be added to food products that replace traditional foods (for example, an orange drink that is typically consumed at breakfast instead of orange juice). Under this provision, the nutrients added can only be stated as part of the product's ingredient statement.

Nutrients may be added if required by other regulations. This would include the mandatory fortification of flour, including the recently added requirements for folic acid fortification when it becomes final in 1998.

It is only appropriate to add a nutrient if the nutrient is stable in the food under customary conditions of storage, distribution and use; is physiologically available from the food; is present at a level that will give reasonable assurance that the fortification will not result in an excessive intake of the nutrient, considering cumulative amounts from other sources in the diet; is suitable for its intended purpose; and is in compliance with applicable provisions of the acts and regulations that govern the safety of substances in food.

Any claims or statements in the labeling of food about the addition of a nutrient must be made only if the claim is not false or misleading and if it otherwise complies with U.S. Food Regulations.

  Jeanne Rader, Ph.D., director of the division of science and applied technology for the office of food labeling, U.S. Food and Drug Administration, Washington, D.C., says that although the FDA guidelines for nutrient fortification aren't presently under formal revision there are specific policy areas being addressed as the need arises. But this is pretty much the way it has been since the guidelines were implemented.

  Some issues that have been or are being looked at for adjustment include whether widespread fortification with calcium would be appropriate for reducing the risk of osteoporosis. Questions that stem from this issue include whether it would be appropriate to fortify the entire food supply, how extensive the fortification should be, and what alternatives there are to widespread fortification.

Addressing the guidelines

  How do these guidelines affect the way we develop a product? The easiest way to approach the FDA guidelines is to break them into three fundamental requirements.

Determine need. "In general, the most important single consideration is whether there is a need for the fortification," says Rader. "Can you demonstrate that the population is lacking certain nutrients?"

  Many companies rely simply on what is written in the popular press to determine what fortification should be performed. This is one reason so many companies have been scrambling to add antioxidant vitamins. But appropriate fortification according to FDA guidelines begins with need, not consumer popularity.

  "Because of the impact it can have, anytime you fortify a food you have to consider who eats the product, how much of the product they may consume, as well as when and how they may consume it," says Vala Jean Stults, Ph.D., R.D., who works in consumer affairs for Hunt-Wesson, Fullerton, CA, and is a full-time lecturer at California State University, Long Beach.

  Earlier this year, Hunt-Wesson introduced Peter Pan Plus, a vitamin-fortified peanut butter. Prior to creating the product, the development team at Hunt-Wesson used data from USDA's continuous survey of intakes of individuals to determine a specific need. At the time of the project, the most recent data available was from around 1992 and 1993.

  "We took the data tape and analyzed it for the two ages we were interested in - children age 6 to 12 and adults over 55 - to see who ate peanut butter and when," says Stults. "Then we looked at the nutrient intake because we wanted to know who was getting less than the recommended daily values."

  In reviewing the data for the age groups in question, Stults and the rest of the group set a standard that nutrients consumed at below 70% to 75% of the DV would be appropriate candidates for fortification. In the end, they determined that 50% of the targeted groups were most likely to be deficient in vitamins A, B6 and E; folic acid; and the minerals iron, copper, zinc and magnesium. Consequently, these nutrients were chosen to be added.

  Although this involved setting up a complex study matrix, "as a nutritionist, that's how I approached it, and the company was willing to go along with it rather than just throwing some vitamins in," says Stults.

Find appropriate vehicle. According to Rader, the next requirement is to determine if the food in question is really an appropriate vehicle. Of course, stability, flavor and ingredient interaction issues are part of this process, but determining if a food is an appropriate vehicle also includes determining if that vehicle will be used by the target consumer. For example, if a company fortifies orange juice with a certain nutrient, the vehicle may be appropriate and the nutrient may be bioavailable, but the target market may not drink orange juice.

  "You really have to target some group and make sure the nutrient is available and that they'll consume the product," says Rader. "This requires a knowledge of food intake patterns that show who's eating what product, and things of that sort."

  That saves a lot of missteps, and the USDA can again be helpful because it maintains intake data across a wide range of population groups. Independent market research also is helpful. Both of these tools were used in the creation of Peter Pan Plus.

  "We had market research data that showed the perception of peanut butter as an appropriate product for fortification," says Stults. "Our target consumers perceive peanut butter as being a nutritious food that is high in protein, so they saw it as an appropriate source for vitamins and minerals."

  Some may argue that peanut butter - because of its fat content -shouldn't be considered appropriate under a provision of the labeling regulations often referred to as the "Jelly Bean" rule, which indicates that a product can't be fortified if it is nutritionally inadequate in other areas. According to the research used by Stults, however, peanut butter's fat content wasn't considered an issue because the targeted consumers - children and the elderly - are not as concerned about fat and calorie restriction.

  It is highly recommended that product designers follow the guidelines' recommendation to contact FDA before embarking on a non-mandated fortification project. Maintaining a dialog with the agency will help demonstrate that your company is making the best effort to support the fortification with currently available science and regulations. In fact, FDA may have information that can help the project.

  "You would want FDA to be comfortable with whatever you put on the market," says Stults. "In the case of peanut butter, there's a standard of identity that typically has not included fortification. We wanted to be sure that we weren't going to get surprised."

  Not every food company is so concerned with determining need and appropriateness. For these, the sole criteria usually is a potential marketing benefit. Some industry sources indicate that the labeling provisions of the Nutrition Labeling and Education Act may have even encouraged this practice. How? Labeling regulations require that nutrients - such as vitamin C, calcium, iron, etc. - appear on the Nutrition Facts panel. If a product has too many zeros, some companies believe it reflects negatively on the product.

  Examples of this practice may include some of the juices, cereals and snacks fortified with high calcium levels that have been introduced since 1993. In February of 1995, the National Dairy Council (NDC) wrote a letter to FDA stating that "some food manufacturers are fortifying foods with calcium to gain a market advantage, perhaps without assessing its full impact on the population as a whole."

  "We became concerned because there really seemed to be a plethora of food products being fortified with calcium," says Gregory Miller, Ph.D., F.A.C.N., vice president of nutrition research and technology transfer at the National Dairy Council, Rosemont, IL. "This has happened in the past and it faded out, but it's come back."

  Miller emphasizes that the Council's position is not against fortification - milk itself is fortified - but it is against fortification without consideration for the consequences.

Determine nutrient levels that are safe and appropriate. After identifying appropriate nutrients for the target market and determining that peanut butter was an appropriate vehicle, the Hunt-Wesson researchers looked at what levels of nutrients to use.

  "Historically in the United States, the foods that have been fortified have typically been milk, ready-to-eat cereals, etc.," says Stults. "And 25% of the RDA is a level that will make a positive nutritional impact, but won't be a level that will create a risk of over-fortification to any great degree."

  Why is avoiding over-fortification so important?

  "The possibility of pushing nutrification is there and some risk is involved," says Paul Lachance, Ph.D., D.Sc., F.A.C.N., head of the department of food science, Rutgers, The State University of New Jersey, New Brunswick. "The mineral risk is what you would meet first."

  With minerals such as iron and selenium, intakes approaching 10 times the recommended intake have been shown potentially to cause health problems. Two vitamins - vitamin A and vitamin D - present a comparable risk. Admittedly, few companies would be able to fortify a food to such levels because the product would be unpalatable. But the levels of the product under consideration are not the sole issue.

  "When you're looking to fortify a product, you have to look at the diet and how many of these products the target consumer will eat in a day," says Audra Davies, principal scientist, food ingredients/nutraceuticals, Watson Foods Co. Inc., West Haven, CT. "Eating a fortified cereal for breakfast, drinking two bottles of a fortified beverage and eating a fortified snack bar is already pretty hypernutritious."

  This is the issue that raised the red flag for NDC's Miller with respect to calcium-fortified foods.

  "One manufacturer has a product in which one slice of bread has as much calcium as a glass of milk," says Miller. "We did some calculations that showed there could be overconsumption in segments of the population that already have pretty good calcium intake, such as teenage boys."

  Teenage boys tend to be faithful consumers of milk. When Miller considered the calcium from other sources - including that from fortified products such as bread - he found that members of this group had the potential to consume 6,000 mg of calcium per day. That's 4,000 mg more than the 2,000 recommended by expert panels.

  On the other side of this issue, of course, is the fact that attitudes are changing with regard to what constitutes an appropriate dietary level. For many nutrients, the recommended daily values have been determined based on preventing deficiency disorders. Now, interest is shifting more toward viewing nutrients as a way to prevent other illnesses.

  "We're in this whole nutraceutical revolution where we are fortifying with specific nutrients that have been associated with very specific medical conditions," says Davies. "It's a very different approach than what it was 50 years ago."

  Classical nutrient deficiencies were identified by observing symptoms of a specific disease. Now, researchers are examining other nutrient effects by learning to associate biological markers with disease. Excess homocystein in the blood, for example, has been found to be a biological marker for heart disease. If certain nutrients are found to affect homocystein levels, they may eventually be found to be useful in reducing heart disease incidence. As research of this nature advances, it may well turn out that other fortification vehicles, or higher levels of certain nutrients, may be found appropriate.

  "There's a lot of research looking at these markers as indicators for disease because there's no other way to follow the disease," says Fergus Clydesdale, Ph.D., professor and department head of the food science department at the University of Massachusetts, Amherst. "If we're ever going to see health claims become more mainstream, we'll need to rely on biological markers."

Available for action

  With respect to future health claims, an issue of increasing importance in nutrient fortification is bioavailability. After all, if you're going to make a nutrient claim, that nutrient better be in a form that is effectively used by the body. In addition to being important for the future, nutrient availability is specified in the FDA fortification guidelines.

  The first step in assuring bioavailability is to select a form of the nutrient that is bioavailable. Most of the various chemical forms of vitamins and minerals have been subjected to animal testing to determine how well they are absorbed and used. This information is usually readily available from a vitamin and mineral supplier.

  Keep in mind, though, that the more bioavailable a nutrient is, the more unstable it is likely to be. This not only may cause the nutrient to break down during storage, but it could interact with other ingredients and generate off-flavors. In many cases, the more stable, less bioavailable form of a nutrient is the choice to make.

  "Nutrients don't have to be in the most bioavailable form," says Lachance. "Ferrous sulfate is highly reactive, so you're better off going with something more stable. Ferric ortho phosphate is only 10% bioavailable, but it works well."

  Today, most companies are satisfied to select the nutrient form that balances bioavailability with stability. This is, however, only part of the story. The food product matrix itself can affect how well, or if, a nutrient is absorbed. One example is found in foods high in phytate or fiber because they can bind minerals.

  "Suppose you were using zinc to fortify and you put it in a high-phytate food. You may lose a great deal of the zinc's punch because of the phytate," says Rader. "Fiber components can sequester many minerals. They may be in the product, but won't be absorbed by the body."

  Particularly with minerals such as iron, product designers must be very careful to avoid product interactions that can affect availability. Some minerals may even bind to vitamins and affect their absorption.

  "There's no question that there are some possible effects," says Rader. "They may not happen all the time or affect all nutrients, but to deny them is not appropriate either."

  One way to examine how well nutrients are released from the food product matrix is to borrow testing procedures used in the pharmaceutical and nutritional supplement industries.

  "It's possible to manufacture a pharmaceutical that's like a marble and can't be digested," says Rader. "The components may be of the highest quality, but you'll get no more benefits than if you actually ate a marble. The body has to have access to the material before it can then act on it. In vitro tests that mimic the stomach are a very powerful first step. If you can't digest the material, it doesn't matter what's in it. That's the very most bottom line."

  Says Philip Katz, president, Shuster Laboratories Inc., Quincy, MA: "The United States Pharmacopeia has a whole protocol for tablets, capsules, caplets, etc. The procedure uses temperature-controlled acidic solutions that simulate gastric juices. The product is put into the solution and agitated. Then you assay the solutions periodically to test for the nutrients."

  This sort of testing attempts to mimic what the stomach is like and determine what will or won't be digested. Although this is an important step, it only determines if the nutrient can be freed from a certain matrix. The next critical step is to determine whether the material will move from the intestines to the bloodstream.

  "You have to make it available in the product matrix, and the body has to handle it into the blood," says Rader. "However, such bioavailability studies are still in their infancy."

  To determine how well a nutrient is released from a product matrix and how well it is subsequently used by the body would require animal and human studies similar to those used to determine nutrient bioavailability in the first place. Such testing could provide much needed insight as to how nutrients are used - a critical factor if the "brave new world" of disease-fighting fortification is ever going to become a reality in the food industry.

  "Bioavailability is the one area where we know the least, but need to know a lot more," says Rader. "We don't have a good handle on variation from person to person, or on variations that might show if certain ethnic groups may have more or less difficulty in absorbing certain components. Once the material is in a soluble form, is everyone going to be able to use it?"

  Further complicating this is the fact that the human body changes its absorption patterns depending on its current status. "People who have good stores of a nutrient will absorb less," says Rader. "Studying this phenomenon, however, will require a great deal more physiological knowledge... Again, it's a matter of targeting and bringing the nutrition to the people that need it. In the future, there will be a lot more specificity and directness in some of these areas."

Wrapping up the project

  With all the background research required before even starting to formulate bench samples, just how long does it take to formulate a product following the FDA guidelines? Not as long as you may think. Government information resources can take a project fairly far. This proved to be the case when Hunt-Wesson created Peter Pan Plus.

  "All we really had to do was analyze the data tapes. USDA had done all the work," says Stults. "This took about two months. Then we had to work with the FDA to get their perspective. So, all-in-all, it was about a 6- to 8-month process."

  If bioavailability becomes a more critical issue, this timeline may require significant stretching. Granted, modified USP digestion tests would be fairly rapid and simple to execute. The potential schedule-buster would be if human and animal testing for nutrient availability were performed. If the efficacy of a fortified food needs to be demonstrated for a health claim, don't rule this out as a future requirement.

  Another evaluation that is not routinely done at present also may become more important in the future. "When a new product is introduced, post-market surveillance should be performed to see if the product is hitting the target group as it should and if it is working the way it was anticipated," says Miller. "What looks like a good idea on paper may not be a good idea when it's put into practice."

  All of this may sound like creating fortified foods now and especially in the future is going to be more trouble than it's worth. Still, fortification fundamentally deals with consumer perception of a food's health benefits. It is best for consumers and the food industry alike to make sure that fortification is appropriate and effective.

  "If you're going to be successful, you have to be responsible or you'll end up hurting yourself," says Miller. "The ethical manufacturers will do it right and, in the long run, will still be here."

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