New botanical entries into the US market are being denied by the Food and Drug Administration for such fickle administrative reasons as not filing notification forms in triplicate, not providing the Latin name of the herb or not signing the form.
As FF&N went to press, trade groups were meeting with the FDA in the hope of getting some guidance from the agency.
?Most notices that have been denied have failed primarily due to the need for guidance,? said Michael McGuffin, president of the American Herbal Products Association. He said in many cases, the FDA never gets around to evaluating the safety aspects. Cases denied for any reason get stamped with the inflammatory word ?adulterated.?
An FDA scientist who works on the notifications said the most important question is what exactly constitutes a new ingredient. For instance, echinacea is traditionally extracted using a 35 per cent ethanol base. But what if a manufacturer uses 38 per cent, or 98 per cent? At what point does it become a new ingredient if an extraction solvent blend is modified?
The comment period ends on Dec 3, but trade groups are looking to extend it for an additional 60 days.