The US Food and Drug Administration (FDA) stated in its Aug. 2004 website section titled "Protecting Consumers, Promoting Public Health":

“At the heart of all FDA’s regulatory activities is a judgment about whether a new product’s benefits to users will outweigh its risks. Science-based, efficient risk management allows the agency to provide the most health promotion and protection at the least cost to the public.

No regulated product is totally risk-free, so these judgments are important. FDA will allow a product to present more of a risk when its potential benefit is great — especially for products used to treat serious, life-threatening conditions.”

Aug. 2004