Vitamin Fortification and Public Health Impact

Introduction

The manufacturers of food products usually employ fortification strategy to address problems of micronutrients deficiency among the consumers. Although the regulatory mechanisms controlling such fortification differ across countries, the guidelines mentioned by the Codex Alimentarius Commission serves as an international standard for the inclusion of essential vitamins in food products. Deliberate fortification points a significant departure from these guiding principles. Sometimes termed voluntary or liberal fortification, it is the addition of extra minerals and vitamins at the discretion of food producing companies for marketing and selling activities, but planned public health measure is not considered.

Whereas discretionary fortification differs from deliberate fortification programs of health agencies to address population health problems (e.g. in the early 1990s), New Zealand and Australia introduced folate fortification to minimize the risk of neural tube defects. In the United States, where most fortification is discretionary, an intentional fortification indicates micronutrient additions which do not fulfill standards of nutrition guidelines and other related regulations. In such countries as Canada where additions of micronutrients adhered to Codex principles are strictly governed, a discretionary fortification denotes fortification activity outside healthcare programs. The inclusion of nutrients through discretionary fortification may match with nutrient requirements among the population, but the prime aspect of practicing fortification is that it is not included in public health strategy.

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Food manufacturers argue that discretionary fortification can offer consumers with a variety of nutrients, hence helping them to satisfy their needs. However, the concerns have been raised that additional fortification may oppose the promotion of healthy eating, and it may expose consumers to risks of nutrient dependability. Fortification refers to consumption of some micronutrients above tolerable upper intake levels (ULs). Thus, whereas such consumption levels pose serious threats to the health of consumers is a subject of debate, some studies highlight the risks of excessive intake due to unrestricted levels of nutrients in food supply.

 Therefore, regulatory bodies face challenges in deciding safe levels of micronutrient addition and determine procedures to control the impacts of discretionary fortification on the consumers. As discretionary fortification continues to increase, it is necessary to consider its impact on public health and the consequences. The current paper examines some distinguishing features of the discretionary fortification by collecting data from a study of Novel Beverages sold in Canadian supermarkets. Further, the literature from the United States is reviewed to examine the population health consequences of discretionary fortification. Finally, the paper discusses major risks and challenges, which discretionarily fortified foods pose to the population and regulators as well as the implications of this practice on public health.

Discretionary Fortification: A Case Study of Novel Beverages Sold in Canadian Supermarkets

In 2010–2011, a small research of nutrition-related marketing of foods and beverages sold in four supermarkets in Canada was conducted. The survey focused on 18,525 unique products. Discretionarily fortified beverages were recognized containing “natural health product” and also displaying product approval through regulatory framework of healthcare agencies, which allowed manufacturer-initiated nutrient additions to food and beverages. Eighty-five of such beverages were identified and sixty-five were purchased for analysis. The nutrient parameters of beverages were compared to Dietary Reference consumption, and a content analysis of products was conducted (Dachner et al., 2014).

The sample of Novel Beverages included eighteen enhanced water drinks, thirty-two caffeinated energy drinks, and fifteen juices. Eighty percent of beverages were manufactured and marketed by PepsiCo or Coca-Cola highlighting the global presence of the products.    The discretionary fortification practices demonstrated in these products are different from controlled fortification formulated to address health problems of the population in several ways:

1. Only some of the micronutrients included are those for which there is a clear evidence of insufficiency among adults and youth, yet they appear to target all population. While some adults and youngsters may benefit from additional vitamin A, vitamin D, potassium, magnesium, and calcium found in some beverages, the most commonly used nutrients were B-vitamins that have little or no confirmation of insufficient consumption among this consumer subgroup. The approximate prevalence of insufficiency for vitamins B12 and B6 is higher among older people, but the analysis of the products is not recommended if they target this age group.
2. Several products strengthened with micronutrients did not contain dietary assessment of especially vitamin E, chromium, or pantothenic acid. Hence, it becomes impossible for consumers, regulators, and food manufacturers to gauge how the beverages relate to the needs or consumption levels among the population.
3. In opposition to carefully controlled additional micronutrients that relate to health interventions of the public, the degree of addition in these products differed widely. In many products, a single serving showed a level of addition being much higher than the human need in terms of a particular nutrient. Comparing the estimated needs for adults and young population, nineteen products contained five times more of the estimated average consumption (EAC) for vitamin B12, eleven beverages included triple EAC for vitamin B6, fourteen showed four times more of the EAC for niacin, fifteen included five times more of the EAC for riboflavin, and six contained three times more of the adequate consumption of pantothenic acid.
4. Whereas the standardization of adding extra nutrient to the energy content of particular food is critical to controlling exposure when strengthening is carried as a public health intervention, the energy content of beverages ranges from 0 to 220 kcal per serving, and zero- and low-calorie beverages include energy nutrients in excess than permissible levels. The strengthening of calorie-free products that might be considered as alternatives to water suggests that the intake of multiple servings may heighten nutrient loads (Sacco, Sumanac and Tarasuk, 2013).

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Appraising the Public Health Impact of This Practice

The advantages of micronutrient inclusion into specific products can be assessed by considering nutritional requirements of target groups. However, the evaluation of public health impact of unrestricted fortification as a policy measure demands thorough analysis of the impacts of this practice on nutrient consumption among consumers. Much of studies in this area are speculative and have examined the effect of nutrient policy proposals or suggested the maximum level of nutrients for daily consumption to the population. While identifying the genuineness for using unrestricted fortification results into consumption levels over upper limits, this research is restricted by the need for imposing restrictions on food manufacturers that exploit the opportunities due to changing regulatory practices and public responses to new products’ usage (Dachner et al., 2014).

Table 1

The Nutrient Content of Products per Serving

Source:  Sacco, Sumanac and Tarasuk (2013)

Note: The above table shows nutrient content of Novel Beverages compared to nutrient requirements and prevalence of insufficiency for Canadian population aged19–30

Improved Nutrient Consumption

The United States presents an appropriate environment for studying the impact of discretionary and deliberate fortification because of the consistent practice by food manufacturer in terms of nutrient fortification and extensive controlling of dietary consumption. More than half of the population consume every day some fortified food products such as breakfast cereals, beverages, and fast food. Examining data collected by National Health and Nutrition Survey from 2006 to 2010, Dwyer et al. concluded that fortification and enrichment rendered a substantial impact on the prevalence of insufficiency for vitamin A, iron, folate, and thiamin among both adults and children. Enrichment and fortification also increased intakes of riboflavin, niacin and vitamins C, D B12, and B6 but with less estimated impacts on nutrient sufficiency. Among adults and older people, the deficiency of such vitamins as A, C, and D were low even with additional micronutrients. For nutrients such as magnesium, vitamins C and E and calcium, fortification appeared inadequate to balance suboptimal dietary consumption. The analyses of intakes of fortified foods compared to usual nutrient consumption in other countries also reflect that their intake weakens the occurrence of deficiencies for some but do not include all nutrients, and some additional nutrients may appear unnecessary. These results demonstrate the haphazard nature of the impact of manufacturer-driven food fortification. Next, the benefits only increase when added micronutrients are not already acquired in adequate amounts from natural sources when the level of fortification is adequate to shift, otherwise the intakes come to sufficient levels (Dwyer et al., 2014).

These conditions are not assured when voluntary or mandatory strengthening of nutrients occurs at the discretion of food manufacturers. Throughout the discussion, the study defines benefit as usual nutrient consumption adequate to meet current requirements of the population. Thus, we can argue that some advantages may occur from higher levels of consumption, but the requirement estimates summarized represent consumption levels related to optimum health and reduced risk of chronic degenerative diseases. Contradicting to the benchmark used for the establishment of the requirement of nutrients in the past, the requirement estimates make the Institute of Medicine’s dietary consumption process exceed the nutrient consumption levels needed to avoid nutrient inadequacies. Reviews of emerging research might uncover health benefits with higher consumption levels for some nutrients, but the existing requirement estimates build the most scientific predictions of nutrient needs for optimal health currently (Pfeiffer et al., 2013).

Influence of Fortification on Dietary Patterns

The analyses of the impacts of food fortification on the upper levels of estimated daily consumption reflect that this practice can lead to exposure of nutrients in some cases, which is higher than the defined upper limits. Among 2–19 year-olds in 2006–2010, small proportions of the estimated level of consumption for vitamin A, folate, and niacin surpassed the upper limits when nutrient consumption from enrichment and fortification were considered. Even without considering additional fortification, 11 percent of children’s zinc consumption exceeded the upper limit, but this was increased to 19 percent when fortified nutrients were added. When age groups were separated further, 45 percent of 2–8 year-olds consumed zinc from added and natural sources above the upper limits. This analysis disclosed no indication of consumption level above the upper limits for adults. The results indicate that there is little or no risk of excessive nutrient addition from fortification, but it is significant to examine the possibility of distinctive nutrient addition with different consumer choices. An interindividual difference in nutrient exposure is usually considered with mandatory fortification because of individual differences in consumption patterns and food selection. However, the possibility of such difference is enlarged with unrestricted fortification because this practice expands the range of food choices by presenting options with higher nutrient density (Bailey et al., 2013).

In an effort to distinguish consumption habits within the United States’ population, Sacco et al. evaluated sex- and age-specific consumption of nutrients from deliberately fortified foods by collecting data from the 2007–2008 NHANES. Manufacturer-driven strengthening was identified from added nutrients, food code descriptions, and ingredient lists excluding food items having identity standards for fortification or enrichment. Among adults, an increased intake of iron and calcium from deliberate fortified foods was observed with a greater risk of consumption above the upper limit for some sex/age groups. Among children aged from 2 to 18 years, higher consumption of retinol, folic acid, zinc, copper, and selenium from deliberate fortified foods showed a greater possibility of consumption above the upper level with marked impacts for some groups. For instance, among 4–10 year-olds, zinc consumption above the upper limits ranged from 5.2 percent within the lowest quintile to 36.8 percent in the highest one (Evans et al., 2013; Sacco et al., 2013).

Similarly, the examination of folic acid consumption among children and adults showed higher possibility of consumption above the upper level in association with the intake of higher levels of supplements. Among adults and older people, the highest occurrence of folic acid consumption above the upper limits (13.5 percent) was among people aged 60 and older, who consumed fortified ready-to-eat cereals, grain products with folate supplements and folic acid. Such consumption patterns constitute the foundation of nutrient supplements upon which discretionary fortification is being exposed. The upper limits are the only available standards against it, which estimates the safety of added nutrients. However, it is necessary to recognize their fortification in food products. Defined as the average consumption that renders no adverse health impacts to almost all population groups, the upper limits provide the ‘best estimate’ of a safe intake of extra nutrients (Bailey et al., 2012).

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Risks vs. Benefits and Impacts of Fortification

Although insufficient consumption of nutrients can cause malnutrition and deficiency of vitamins, there is also anxiety whether people consume nutrients more than upper limits. For some nutrients (for example, copper and zinc), the safety level between the EAR (estimated average requirement) and UL, which represents adequate consumption versus excessive consumption, is relatively low. Currently, the debates around daily values have focused on how they should be determined and whether modifying these values could bring changes in the nutrients fortification of foods. However, discretionary fortification appears to differ from the conventional approach to the daily values mentioned on nutrient contents of food products and regulated language regarding nutrient-related claims, exposing that discretionary fortification may not be sensitive to changes in daily values. There is no evidence which demonstrates that excessive intake of micronutrients offers any benefit to health. Without such proof of benefit, the question arises whether discretionary fortification can render harmful effects or wasteful inefficiency in food consumption (Evans et al., 2013)

There is a necessity to identify the nutritional needs of individuals by evaluating their marginal deficiencies (e.g. vitamin D) in order to fully know the potential impacts of discretionary fortification. Despite upper limits having been established for many nutrients, the impact of chronically high consumption of them from supplements and fortified foods are not known. Moreover, the intake of supplements and fortified products is interrelated, and individuals with a high consumption level of fortified food also use supplements. The intake of fortified foods causes higher likelihood of nutrient consumption near or above the upper limits as the consumption of supplements does. Further, enlarged fortification can seriously impact the upper tails of consumption exposures. Whether discretionary fortification offer benefits, it depends on manufacturer-driven fortification of food, which micronutrients are selected as fortificants, what quantity of the fortificants is used, and what part of the population consume fortified foods. Individual differences can impact the results of fortification. Several gene polymorphisms can change the absorption, digestion, and metabolic responses of consumers to certain nutrients. Fortification with folic acid was suggested because of a high frequency of polymorphisms in numerous folate-dependent genes that are involved in single-carbon metabolism. It is now understood that these polymorphisms can change folate requirements for pregnant women (Lill et al., 2012).

Another emerging research of interest, which could impact the result of strengthening, is the constitution of the gut microbiota. The diversity and size of the gut microbiota within some population groups can be impacted by individual diet, which may affect absorption of certain nutrients. Moreover, it is less known and not fully understood regarding the potential impact on health by strengthening with non-nutrient bioactive food ingredients. Flavanols can demonstrate an example of non-nutrient bioactive nutrients because research has proposed health benefits. Many investigators have reported inverse relationships between the intake of flavonoid-rich food and the risk of cardiovascular diseases. Some evidence demonstrates that family of flavans, for example, flavan-3-ols, particularly relates to vascular health.  

The vascular health improvement could be attributed to a number of factors such as the flavanol-caused reductions in reactivity of platelets, the changes induced by flavanol in the immune system, and the improvements in vascular reactivity by flavanol that helps in vascular tissue repair. Significantly, the majority of intervention researches on flavanols were performed among individuals with different levels of health complications such as diabetes, hypertension, smoking issues, and cardiovascular problems. Further research on the impacts of additional flavanol among “healthy” persons is required before suggesting a diet that includes flavanol fortification. Undoubtedly, the flavanol supplementation has produced positive results; it should be observed that the amounts of flavanols used in trials exceed the amount that the majority of consumers currently utilize (Sacco et al., 2013).

Conclusion

Fortification is a market-driven strategy, which has been used successfully by food manufacturers in order to replenish nutrient supplies and other associated deficiencies with additional micronutrients. The staple foods are classic example of mandatory fortification. The researchers are more interested in improving health of individuals rather than focusing on prevention of deficiencies. However, recent findings do not suggest whether discretionary fortification and enrichment improves health of the population, and its long-term impacts remain unknown.

Discretionary fortification has raised significant concerns among proponents of public health systems, and several rules and regulations have been implemented by various governments to address public health needs. The health benefits and advantages from manufacturer-initiated fortification seem to be remote because it has become a common practice for manufacturers to add micronutrients without direct evidence of need. Unfortunately, healthcare agencies are ill-equipped to assess the risks of allowing expanded fortification of food products for marketing activities. While nutritional science can expose the benefits of mandatory fortification of nutrients, the long-term health consequences of chronic exposure due to the excessive nutrient load are yet unknown. Hence, the potential risk of mandatory and voluntary fortification and its effect on the population continue to be a subject of debate and remain to be discovered.