Copenhagen-based Danisco has received a welcome boost from the US Food and Drug Administration (FDA) with the announcement that its Litesse polydextrose has been approved for use in almost all foods and beverages. It can now be used as a bulking agent, formulation aid, humectant and texturiser in all foods with the exception of meat, poultry, baby foods and infant formula.
The regulation under 21CFR172.841 has been amended to permit the use of polydextrose at GMP levels in these new categories. Danisco USA spearheaded the effort for this Food Additive Petition (FAP) approval from the FDA for polydextrose to be used beyond its existing categories.
According to the Danish company, that approval allows for numerous new possibilities for low calorie, fibre-enriched, reduced sugar, low glycemic foods and beverages made with its Litesse polydextrose – including yoghurt, cereal, cookies, crackers, bread, cake, chocolate, candy, ice cream, soft drinks, juice, smoothies, flavoured water, sauces, dressings, cheese and snack chips.
Litesse polydextrose has already been on the market for a quarter of a century and is marketed by Danisco as a single ingredient with multiple benefits. The company cites its versatility and cost effectiveness as the reason why Litesse can be incorporated into so many products.
For example, the company says that its clean, neutral taste masks the ‘off notes’ that can result from the addition of soy, vitamins, minerals and other supplements found in nutritional products. The product is also more water soluble than most carbohydrates and polyols, allowing up to 80percentw/w solutions at 20°C. This in turn makes it easy to use and to incorporate into many products.
Another major advantage is improved texture and mouthfeel. In its finished formulation, Litesse contributes solids and enhances eating quality. Danisco says that Litesse solutions have a higher viscosity than sucrose or sorbitol solutions at equivalent concentration and temperature, and behave as Newtonian fluids. This characteristic enables it to achieve the desirable mouthfeel and smooth textural qualities that can be lost when replacing sugars and fats in food products.
Finally, the humectant qualities of Litesse help maintain softness and freshness while also extending shelf life. This is especially important for baked goods.
With 9700 employees in 47 countries, Danisco is one of the world’s leading suppliers of food ingredients, sugar and industrial bioproducts. The company’s ingredients are used in almost every second ice cream and cheese, every third box of detergent and every fourth loaf of bread produced globally.
Overcoming caries challenge
Another company receiving good news from the FDA is Cargill. The watchdog has issued an interim final rule to amend the regulation authorising a health claim on noncariogenic carbohydrate sweeteners and dental caries – in other words tooth decay – to include isomaltulose, a noncariogenic sugar.
FDA is taking this action in response to a health claim petition submitted on behalf of Cargill.
In its ruling, the watchdog says: “Based on the totality of publicly available scientific evidence, FDA now has determined that the nutritive sweetener isomaltulose, like other noncariogenic carbohydrate sweeteners listed in the dental caries health claim regulation, is not fermented by oral bacteria to an extent sufficient to lower dental plaque pH to levels that would contribute to the erosion of dental enamel.
Therefore, FDA has concluded that isomaltulose does not promote dental caries, and it is amending the regulation authorising a health claim relating certain noncariogenic sweeteners and the nonpromotion of dental caries to include isomaltulose as a substance eligible for the claim.”
FDA had previously concluded that there was significant scientific agreement among qualified experts to support the relationship between certain noncariogenic carbohydrate sweeteners – for example some sugar alcohols, D-tagatose, and sucralose – and the nonpromotion of dental caries. The principal evidence that substantiates this relationship is in vivo data on the effects of noncariogenic carbohydrate sweeteners on human dental plaque pH.
However, the current petition based its assertion that isomaltulose is noncariogenic on evidence from an indwelling telemetric plaque pH assay of the cariogenic potential of isomaltulose. This assay demonstrated to the FDA’s satisfaction that isomaltulose did not result in decreases in plaque pH below the critical level of pH5.7 when introduced as either an aqueous solution or as a tablet, and therefore, would be considered to not promote demineralisation of dental enamel.
“The results of the isomaltulose plaque pH assay are consistent with the evidence relied upon by the agency when adding other noncariogenic sweeteners to the list of sweeteners eligible for this health claim. Therefore, based on the totality of publicly available evidence pertaining to the cariogenic potential of isomaltulose and to the relationship between dental plaque pH and dental caries, FDA concludes that there is significant scientific agreement that isomaltulose does not promote dental caries. Accordingly, FDA is amending rule 101.80 to authorise extending the dental caries health claim to include isomaltulose,” notes the organisation.
In welcoming the FDA’s decision, Cargill global product manager Anne Mollerus said: “Xtend isomaltulose, a slow release carbohydrate, offer consumers the highly desirable benefits of sustained energy release and lower glycemic response. We are pleased that the dental claim can be added to its attributes.”
According to Cargill, its Xtend Isomaltulose is a fully digestible, sustained energy sweetener that is ideal for use in foods where extended energy is desired. It is obtained from sucrose by enzymatic conversion and has the same energy value as sucrose, but much slower digested and completely absorbed resulting in sustained release of energy to the body. Some of the applications for Xtend isomaltulose include tooth friendly confectionary, beverages and chewing gum.
