2023 FDA Science Forum
Cardiovascular endpoints for food-related substances: Scoping Review
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- Center:
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Contributing OfficeCenter for Food Safety and Applied Nutrition
Abstract
Cardiovascular diseases (CVD), including heart attacks, strokes, chest pain, and other disorders of the vascular system, affect nearly half of American adults. Some of the major risk factors for CVD include hypertension and cardiometabolic syndrome. The current Office of Food Additive and Safety (OFAS) Redbook 2000 safety testing guidelines for food-related chemicals do not include recommendations for specific studies to assess the potential cardiovascular effects of food additives. The current testing guidelines were not developed to detect either cardiac or cardiovascular acute or chronic adverse effects, except for late-stage disease-related pathological changes. To detect early pathological changes, it is important to have corroborating early signs (e.g., cardiac output, ventricular contractility, vascular resistance) that are associated with adverse cardiovascular effects. The purpose of this review is to scope out scientific publications that discuss cardiac or cardiovascular endpoints that are relevant to food-related chemicals, including food contact substances, food ingredients, and their impurities. In our search, we included publications on animal and human studies, as well as in vitro mechanistic studies, utilizing a free publicly available web-based review tool, the Health Assessment Workspace Collaborative. The results of this scoping review will help the Agency in recommending specific endpoints for in vitro cardiotoxicity new approach methods (NAMs) for safety testing for early signs of cardiovascular disease-related endpoints.
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