“When we started out we were making herbs available to people who were making health care choices that included herbs. If we go forward 20 years to the discussions around the passage of DSHEA, that’s the issue we were dealing with there from our perspective. We wanted to preserve those choices. We were concerned because the Food and Drug Administration was going in a direction that was restrictive. DSHEA was needed to preserve a right that we already had,” McGuffin told NutraIngredinets-USA at the SupplySide West trade show in Las Vegas, NV recently.
McGuffin said one of the issues around the time of DSHEA was a plan by FDA to regulate herbal products in the same way as food additives. To herbal advocates at the time this didn’t make much sense, he said, given the long history of safe use of herbal products. Nevertheless, the organization went ahead with the preparation of safety dossiers on herbs such as red clover.
“We have been using red clover as an herbal product for hundreds if not thousands of years. So we went ahead with preparing for essentially self affirmations of GRAS for materials like red clover, trying to squeeze a round peg into a square hole and fit hundreds of years of safe use into a food additive box,” he said.
DSHEA overturned this regime and stated clearly that dietary supplements were not to be treated as food addtives. The idea of applying the same process of proving safety for herbal products with thousands of years of use as one would with a brand new chemical entity was just not workable, McGuffin said. New entities should have to prove their safety, while tried and true herbs should fall into a different category, he said.
“We are totally supporting of the New Dietary Ingredients provisions of DSHEA,” McGuffin said. “What we opposed was this idea that ‘Oh, those are herbs, how could we possibly know, they are dangerous.’ ”