Worldwide , osteoporosis and anaemia are two major health concerns that could be alleviated, or even eliminated, by modifications in dietary intake — notably by mineral fortification/enrichment to increase consumption of relevant metal ions.
However, a number of issues regarding fortification are still being actively debated. These include such complex factors as bioavailability, dosage, choice of anion and interaction with other food components. The metal ions most often referenced are calcium, magnesium, iron and zinc, plus various salts of these (including elemental iron).
The enrichment of foods with minerals has a long history. Indeed, the UK legislated for the compulsory addition of iron and calcium to flour in 1943. However, the consumer in the West and in Japan has recently become more aware of the need for minerals and the general deficiency in minerals in many diets. The issue of osteoporosis, for example, has had a particularly high profile because of the significant increase in life expectancies, notably those of females.
Consequently, many food and drink producers have brought out ranges of highly innovative and interesting products to respond to the latent demand. Indeed, the supplement industry, previously the major source of mineral enrichment of the diet, is suffering because of the growing importance of mineral fortification in the soft drink sector in all the developed markets.
There is also increased understanding of differing needs within a population, linked to both dietary preferences and genetic factors. For example, according to the US National Medical Association (NMA), a huge 89% of African Americans are not consuming the recommended daily amount of calcium. The four most popular metal ions are calcium, magnesium, iron (also elemental) and zinc. Of these, calcium is of particular interest because of its association with osteoporosis, and it has received substantial support from worldwide medical circles.
A cereal grain fortified with vitamins and minerals is acceptable but a fortified jellybean is not
Magnesium requirements are generally much lower and medical insufficiency is rare. The ion is implicated in the electroneurological system and is heavily promoted as an 'anti-fatigue/recuperation' supplement in Europe, the US and Japan. Calcium:magnesium balance issues have implications for fortification when blends are used, as well as providing the opportunity for a ‘natural’ claim to be made in Japan where dolomite is promoted (the original rock having the desirable Ca:Mg ratio).
Iron fortification is especially associated with women’s health (anaemia) and here the problem is significantly associated with populations in less developed parts of the world. Yet, the developed world has also identified a need to monitor/fortify. The problems involve achieving a satisfactory load without unacceptable taint and with adequate bioavailability. There have, though, been recent technological advances — claims have been linked to bioavailability, chelation, phytate restriction of absorption, etc. Zinc deficiencies are typically related to inadequate diets and traumas associated with severe burns.
Definitions
The terminology is often confusing. In principle, enrichment means restoring the level of vitamins and minerals in a food to those approximating the levels found in the unprocessed material. Fortification, by contrast, means increasing the amount of micronutrients to a level greater than that found in the unprocessed food.
However, the two terms are often used interchangeably, even within the food industry. Adding thiamin, niacin, riboflavin and iron to flour is enrichment, whereas adding folic acid and calcium constitutes fortification. The distinction might be considered academic were it not for some legal implications, notably in the USA. There are some other factors, such as Reference Daily Intake (RDI) and bioavailability, around which the industry, along with the relevant regional and global authorities, continues to search for legal and technical consensus.
Legislation
In the USA, the US Food and Drug Administration (FDA) is the key body. It sets much stricter regulations for foods than for supplements. According to FDA, a fortified food is one that would normally be expected to naturally have a particular level of a given metal ion, and fortification involves increasing that level.
A product that would not normally contain such a component may not be fortified. For example, a cereal grain fortified with vitamins and minerals is acceptable but a fortified jellybean is not. This argument is sometimes referred to as the jellybean rule. FDA's policy neither encourages the indiscriminate addition of nutrients to foods nor considers it appropriate to fortify fresh products, meat, poultry or fish products, sugars or snack foods such as candies or carbonated beverages.
The NLEA Act (1990) requires labels to carry nutrient content descriptors and permits modified labels of standardized foods as well as certain health claims. The only direct acceptable health focused claim concerning minerals is that “calcium reduces the risk of osteoporosis.” Some softening of the FDA position has occurred since the FDAMA (1997) — the Modernization Act. This permits companies to try to launch products with the FDA having only 120 days to comment before the launch date.
In the case of supplements, the DSHEA (1994) has given companies much more freedom to make less clearly supported health (but not cure/prevention) claims; they must only inform the FDA within 30 days of launch.
In the European Union (EU), there is an ongoing development in food legislation covering permitted additives ingredients and claims. The same applies in the supplement sector, considered in the EU as falling awkwardly between food and medicine — but treated within the food ambit. Medicines, however, have a separate and very strict delineation, controlled by the EMEA and are beyond consideration in this article.
All the signs are that the EU will tighten legislation, especially regarding claims, and 'promoting healthy bones' is as close as the EU will allow to the stronger US 'reducing osteoporosis risk.' Existing legislation already covers the following:
- Nutritional Products, 90/496/EEC and 96/8/EC (setting minimum quantities for the minerals to be found in the respective food)
- Infant Formulae and Infant Food 96/5/EC, limiting the anions that may be used.
Japan has been the most successful in introducing a cogent and widely accepted regulation system in this sector; by Western standards, however, some anomalies still remain. It does specifically regulate a list of chemical additives whilst largely approving ‘natural’ ingredients. This approach has given opportunities for such products as oyster shell, dolomite, haem iron to be particularly valued. The FOSHU (Foods for Specified Health Use) classification has improved consumer confidence in these products in general and has thus given a significant boost to the demand for mineral salts.
Supply
Giract has considered the various mineral ingredients in three groups of salts: inorganic, (commodity) organic and exotic (organic). The choice of salt is driven by a number of factors, including cost-effectiveness of cation delivery, solubility, taste/smell, colour, ‘protection’ such as chelation and claims regarding bioavailability.
Identification of suppliers specifically for food fortification purposes is not always evident. Much of the distribution is done by fine chemical companies who offer a wide range of suitable salts.
A new generation of products such as CCP (calcium phosphopeptide), CCM (calcium citrate malate) and soluble fibres such as inulin are already seen in the market as calcium/magnesium absorption promoters. These claims are likely to increase the current debate on absorption and bioavailability of various mineral salts in the human system.
Prices
The relevant price when choosing a particular salt is the cost per unit of metal ion (cation) used in fortification. This is naturally dependent on the salt, and varies significantly per salt and across regions. Thus, the exotic mineral salts, particularly in Japan, are very expensive when used to deliver a particular level of cation enrichment.
Choice of a specific mineral salt is naturally related to application. For example, for calcium, the first choice is a low cost inorganic salt (carbonate, sulphates). If these low cost minerals cannot fulfil technical requirements, phosphates would be the next choice. Next, for example for taste/pH reasons, more expensive organic salts would be chosen (such as citrate or a lactate).
The 'exotic' products — frequently with claims of high bioavailability or 'ultra-natural' provenance — are high-priced and used when a particular claim is made or inferred — mostly in supplements in the US and W. Europe, whereas their use in foods is increasing in Japan. Thus, exotic products such as shell calcium and sesame minerals can be expensive. However, these prices have come under some pressure recently owing to the widening choice of products and the less buoyant Japanese economy. These command a premium based on their label-friendly marketing appeal.
Demand
Giract has estimated the market for the four metal ions sold as salts (or elemental iron) in the food fortification/supplement sector in the three regions to be around $350 million. In zinc and magnesium, the supplement sector is the major contributor, whereas the compulsory addition in flour in certain countries makes this sector very important for iron and significant for calcium.
Because of a complete lack of secondary data in this area, Giract devised a novel methodology to estimate demand for each sector. Initially, interviews with demand companies, supplemented by exhaustive shop checks, provided data on the products where fortification occurred, the target load of the cation and the choices of particular salts used to fortify. This work also provided evidence of the degree of 'penetration;' that is, the share of the total food category that is fortified.
Second, the base supply of the cation in the unfortified product was established from analytical data and further interviews. Thus the average rate of addition to achieve fortified status could be calculated.
Third, from Giract’s database, and the interviews, assessments were made of the total production of each food product group and supplement category (single mineral/multimineral). From these data and price levels, established from supply side interviews, the value of the market by sector was obtained.
Finally forecasts were generated, based on Giract’s assessment of the following factors: rate of growth of the whole end-product sector, in turn dependent on such factors as population growth, awareness of mineral needs, changes in legislation, changes in food fashions/habits, etc.; any change in penetration of fortified products in the sector; any change in choice of mineral used for fortification. These results were analysed and further discussed with the industry leaders to sharpen their focus.
The total demand for calcium is much higher than any other. This is reinforced by the relatively good understanding of the need for calcium fortification in the three regions. The important food end-use sectors include infant foods, soft drinks, dairy, cereals, flour/rice, etc. The soft drink sector has become highly important for calcium fortification, with the US and Spain being two major markets.
Conclusions and forecasts
The total food fortification/supplement market for the relevant mineral salts in the three regions is expected to grow. The major obstacle to growth will continue to be the severe restrictions in the health claims that can be made, particularly in Western Europe and the US. Although the Japanese authorities are less strict about the claims, Giract believes that the overall legislative situation is more cogent and clear in this market, thereby helping the market to grow faster.
There are significant opportunities for the suppliers of mineral salts in all three regions, but a serious scientific effort needs to be made in verifying such key issues as bioavailability and RDI, and obtaining a scientific consensus across markets. Awareness of the benefits of minerals is already reasonably high amongst consumers, but any attempt at cutting corners and rushing to the market place with ‘half’ claims and counter claims can only be at the peril of a growing, long-term market.