Considerations in Making GRAS Determinations

On Dec. 18, 2002, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) held a joint press conference announcing FDA's new policy officially allowing qualified health claims for conventional foods. This event, coupled with the previous Pearson v. Shalala decision, is sure to increase the development and use of functional ingredients to supply the increasing consumer demand for "functional foods," already a multibillion-dollar market and growing. Inclusion of a value-added substance (i.e., functional ingredient) into food provides some apparent marketing advantages, but to be added to food, a substance must first be approved for use in food, either via a food additive petition or obtaining GRAS (generally recognized as safe) status.

One obvious source of functional food ingredients is dietary supplement ingredients. The Dietary Supplement Health and Education Act (DSHEA) not only provided appropriate definitions for these materials, but also changed the framework for safety determinations, labeling and claims, as well as nutritional support statements. DSHEA dramatically increased the interest, availability and use of dietary supplements ... and drove innovative dietary supplement companies to explore new ingredients and new uses.

Dietary supplement ingredients used in conventional foods can be positioned to provide beneficial nutrients that promote good health and help protect against disease. But more importantly, adding an ingredient that carries a health claim to a conventional food can create a "value-added" functional food with that same health claim. For such a nutraceutical to migrate into conventional food use, it must meet the obligatory regulatory requirements for a food additive, such as via a food additive petition (21CFR170.3(e)(1)), or a determination that the potential food additive is GRAS (21CFR170.30). The most commonly sought method for ingredient approval is a GRAS determination using unbiased, "qualified experts." FDA deems suitable qualified experts as "experts qualified by scientific training and experience to evaluate the safety of food and food ingredients" (21CFR170.3(i)(3)). If the GRAS route is selected, the decision to notify FDA of the GRAS determination prior to marketing these products is voluntary (21CFR170.36).

Laboratory Work & Scientific Experts

There are two routes to take for a GRAS determination by experts: 1) through proof that the ingredient enjoyed common use in food by a significant number of consumers prior to Jan. 1, 1958; or 2) through scientific procedures. Most ingredients are new, and GRAS determinations will involve a qualified panel of experts and rigorous scientific procedures.

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