Table 3.

Assumptions About Bioactives and Achieving Safety

	Regulatory Category
	All categories	Drug	Food	Dietary Supplement	Traditional and Complementary Medicine
Assumption	Highly unsafe	Unsafe until proven safe	Safe until proven unsafe
Goal	Precaution : Apply the precautionary principle to achieve absolute safety, and prohibit until proven safe	Risk Assessment : Assure safety by achieving a low probability of harm	Safe History of Use: Assume that established tradition and long history of safe use ensures safety
Assumption	Bioactives must demonstrate no appreciable risk of harm Avoid uncertain hazards by invoking the precautionary principle when hazards and outcomes are uncertain Permit only new bioactives in foods or supplements only that are highly unlikely to result in significant harm (Stewart, 2002). Do not offset risks with benefits Use the best available technology to minimize risk of harm. Include a margin of safety below the predicted or observed no adverse effect level (NOEL) in regulations. Do not use lack of scientific evidence as an excuse for inaction when damage is predicted to be serious and irreversible	Bioactives possibly pose health risks and therefore risk assessment is necessary to estimate the magnitude and probability of harm by the hazard. Risk management must then demonstrate that potential risks can be avoided or if not eliminated, so greatly attenuated that harm is extremely unlikely	Food contains thousands of bioactives and is inherently safe. Only new ingredients need to be assessed		Includes different traditional ethnobotanical natural products used in some countries to treat various diseases and conditions (some recognized in Western allopathic medical classifications of diseases, others not