NEW YORK, Sep 20 (Reuters Health) -- Charging that the health of the public is at stake, a US scientist is urging the US Food and Drug Administration (FDA) to step up regulation of dietary supplements and "nutraceuticals" -- foods promoted as containing active substances that improve health.
"Until a few years ago, most companies in (the nutraceuticals) field were relatively small," Dr. Steven H. Zeisel, of the University of North Carolina School of Public Health at Chapel Hill, writes in the current issue of the journal Science. But, he notes that "now multibillion-dollar companies (like Monsanto, Bristol-Myers Squibb, Lipton, Johnson & Johnson, DuPont, Procter & Gamble, and Novartis) commit major resources to discover health-enhancing activities within the foods we eat and to change traditional foods so they contain more active ingredients."
Zeisel suggests that products that contain ingredients in dosages that could exert a pharmaceutical effect should be regulated much the way synthetic drugs are regulated.
A first step would be to more accurately define nutraceuticals. Zeisel proposes defining nutraceuticals as "dietary supplements that deliver a concentrated form of a presumed bioactive agent from a food, presented in a nonfood matrix, and used to enhance health in dosages that exceed those that could be obtained from normal foods."
Current regulations require manufacturers who want to use a new food additive or drug to supply the FDA with adequate safety data. Dietary supplements are "legally in a class by themselves; they can be marketed without the manufacturers satisfying the FDA that they are safe," Zeisel notes.
He calls for the creation of a regulatory "category of nutraceuticals for dietary supplements administered in large dosages in order to obtain pharmacological effects." This category would require manufacturers to submit safety data for nutraceuticals similar to the data required for approval of over-the-counter drugs, such as cold remedies.
"The benefits and risks of nutraceuticals should be considered much more carefully than those for foods," Zeisel advises, adding that while it may not be appropriate to classify all nutraceuticals as drugs, "clearly we should require more rigorous safety evaluation than we do for foods."
Regulators are moving in that direction. In 1997, the FDA proposed "reasonable rules for Current Good Manufacturing Practices for dietary supplement ingredients," according to Zeisel. A public meeting on the subject took place this past July and "further action is expected shortly."
"The concept that dietary supplements are natural and therefore must be safe is fallacious," Zeisel writes.
