Science and claims of the arena of food bioactives: comparison of drugs, nutrients, supplements, and nutraceuticals.

ABSTRACT

The scientific community and lay press are participating in a heated debate over the usefulness of food bioactives when used as dietary supplements. This debate often ignores hard scientific evidence and the outcomes of proper research in either direction. Some propose that health claims should be awarded based on classic pharmacological parameters of efficacy and safety. Others suggest that a botanical history of their safe use and basic biological evidence in support of their effects should suffice to allow their marketing. The current regulatory impasse does not help solve this conundrum. It is time for scientists, regulators, and legislators to open an epistemological debate on the appropriateness of using classic pharmacological methods for substances that do not share the usual drug profiles and which are, consequently, difficult to study in humans.