Safety and regulatory issues of fat replacers

Manufacturers of fat replacers must be aware of existing legislative require­ments to obtain approval for the use of fat replacers as well as the labeling of foods. Safety of fat replacers are regulated under two FDA approval categories, GRAS and food additives. GRAS substances are defined as ingredients that are produced from common food components and generally recognized by experts qualified by scientific training or by scientific procedures to be safe under conditions of its intended use (Middlekauff 1974; Warshaw and Franz 1996). GRAS category was established in 1958 and many new substances including fat replacers have been approved (Middlekauff 1974, 1989; Vanderveen 1994).

There are two approaches to submit GRAS affirmation petition to the FDA. The first is a manufacturer’s self-determination of the substance claiming as GRAS. The other is petitioning FDA to grant the ingredient as GRAS. The majority of fat replacers have received GRAS status by FDA (Warshaw and Franz 1996; Clydesdale 1997). The determination of the ingredients as GRAS is based on long history of safe use or scientific data that support the safety of the ingredients for specific applications (Warshaw and Franz 1996; Mattes 1998). Examples of fat replacers approved as GRAS are starches, gums, and microparticulated proteins.

Obtaining a new ingredient approval as a food additive is more complex than a GRAS affirmation petition. A food additive is defined as a substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (Middlekauff 1974). Food additives, unlike a GRAS substance, cannot be added in the foods or marketed before the FDA approves their use. Therefore, a food additive petition requires submission of extensive research data on the new ingredient’s safety and intended use. Only olestra has received food additive approval for a lipid-based fat replacer.

Fat replacers could substitute a significant proportion of fat in the diet and be consumed in gram quantities each day by some individuals, so their safety must be examined more carefully. Traditional safety evaluation methods are not adequate to evaluate the fat replacers because most other food additives are consumed in only 1±2 per cent of food products, whereas fat replacers are consumed in large amounts. Because of this, a specially designed safety evaluation program must be developed with the consideration of exact chemical structure, stability during production, and identification of degradative byproducts of fat replacers. Consideration also should be made in the toxicological, physiological, and nutritional testing (Artz and Hansen 1994; Borzelleca 1996). Safety testing of fat replacers should be conducted on animals and the results from animal testing could be confirmed in human studies. If the fat replacers are not absorbed, effects on gastrointestinal tract, colonic microflora ecology, toxicity of degraded metabolites, and laxative effects should be considered (Gershoff 1995; Mahungu et al. 2002). If the fat replacers are absorbed, their absorption and elimination pathway must be assessed.

Since dietary fats are a source of essential fatty acids and a carrier for fat-soluble vitamins, reduced consumption of traditional fats by consuming fat replacers could lead to a depletion of these nutrients. So the studies to investigate the long-term effects of fat replacers on the absorption or utilization of essential fatty acids and fat-soluble and water-soluble nutrients should be conducted. It has been shown that olestra-containing products lowered the serum concentration of carotenoids and fat-soluble vitamins (Westrate and van het Hof 1995; Schlagheck et al. 1997; Broekmans et al. 2003). With the exception of olestra, few studies have been undertaken that relate consuming fat replacers to the nutritional status of dietary components. In addition, the effects of the interaction of the fat replacer or its metablite with orally dosed drugs also should be considered (Vanderveen 1993, 1994; Mahungu et al. 2002). The effect of fat replacers on selected population groups with health problems such as obesity, cardiovascular disease, and diabetes as well as with healthy people should be considered.

The majority of fat replacers approved by the FDA are GRAS substances because they are created from common food components of carbohydrate or protein, so the minimal requirement for safety testing was required. However, olestra has received food additive approval and more extensive research data including toxicological, clinical, nutritional, and gastrointestinal testing was required for the food additive petition.

Considering both the scientific literature and the FDA review process, the fat replacers that are currently available in the market are safe. As new fat replacers are developed, their safety and availability will be regulated by the GRAS or food additive petition process.