Observations at the interface of mutation research and regulatory policy.

Between 1970 and 1975 developments in environmental mutagenesis proceeded with amazing speed. These developments were both structural and conceptual in nature. A new infrastructure was built and new concepts about how best to protect consumers from exposures to mutagens emerged. The internal dynamics within the Food and Drug Administration played an important role and is discussed with regard to modifications in testing protocols as well as changes in the overall approach used to protect consumers. It is clear that this exciting period in the early days of environmental mutagenesis has provided a base for growth and development of the field and continues to affect and guide future developments.

Soy isoflavones: a safety review.

Soy isoflavones have been a component of the diet of certain populations for centuries. The consumption of soy generally has been considered beneficial, with a potentially protective effect against a number of chronic diseases; because of their estrogenic activity, however, negative effects of isoflavones have been postulated. This review examines the literature associated with the safety of soy isoflavones, including dietary soy isoflavone exposure data of populations with high soy intakes, human studies in which soy protein or isoflavones were provided, and toxicologic studies investigating the potential genotoxicity, carcinogenicity, and reproductive and developmental toxicity of soy isoflavones. Whereas results in some studies are limited or conflicting, when viewed in its entirety, the current literature supports the safety of isoflavones as typically consumed in diets based on soy or containing soy products.