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G. H. PAULI, Director Division of Product Policy, Office of Premarket Approval, Center for Food Safety and Applied Nutrition - US Food and Drug Administration, Washington, DC 20036

Historically, except for a relatively small number of nutrients, food ingredients have not been expected to have an effect on the human body. The use of traditional safety factors to set a safe level for humans, based on no adverse effect level in animals, may limit consumption to levels that would have no effect on human health. Thus, appropriate safety testing will likely need to address issues that cannot be addressed by classical toxicity testing with animals. Additionally, it is necessary to pay extra attention to communicating reasons for using such ingredients, so that consumers are not misled. The presentation will discuss issues that manufacturers need to consider before bringing such a product to market.