U.S. Food and Drug Administration perspective of the inclusion of effects of low-level exposures in safety and risk assessment

Environmental Health Perspectives
D GaylorB Schwetz

Abstract

A brief overview is provided of some of the general safety and risk assessment procedures used by the different centers of the U.S. Food and Drug Administration (U.S. FDA) to evaluate low-level exposures. The U.S. FDA protects public health by regulating a wide variety of consumer products including foods, human and animal drugs, biologics, and medical devices under the federal Food, Drug, and Cosmetic Act. The diverse legal and regulatory standards in the act allow for the consideration of benefits for some products (e.g., drugs) but preclude them from others (e.g., food additives). When not precluded by statutory mandates (e.g., Delaney prohibition), the U.S. FDA considers both physiologic adaptive responses and beneficial effects. For the basic safety assessment paradigm as presently used, for example in the premarket approval of food additives, the emphasis is on the identification of adverse effects and no observed adverse effect level(s) (NOAEL). Generally, the NOAEL is divided by safety factors to establish an acceptable exposure level. This safety assessment paradigm does not preclude the consideration of effects whether they are biologically adaptive or beneficial at lower dose levels. The flexibility to consider issue...Continue Reading

References

Oct 1, 1984·Fundamental and Applied Toxicology : Official Journal of the Society of Toxicology·K S Crump
Oct 1, 1994·Risk Analysis : an Official Publication of the Society for Risk Analysis·D W GaylorR J Scheuplein

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Citations

Jan 20, 2006·Journal of Veterinary Pharmacology and Therapeutics·R GehringJ E Riviere
Oct 5, 2010·International Journal of Toxicology·Peter J BugelskiJacques Descotes
Mar 10, 2016·Food Additives & Contaminants. Part B, Surveillance·J P RheederG S Shephard

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