Tom Harkin: “I rise in opposition to the amendment offered by the Senator from Kentucky, and I oppose it for several reasons. I…”

“I rise in opposition to the amendment offered by the Senator from Kentucky, and I oppose it for several reasons. I believe I am in the court of equity now: I come with clean hands because I am one of the authors of the Dietary Supplement and Health Education Act, along with Senator Hatch, in 1994. We worked in tandem over a period of a couple of years to get the legislation through. A lot of compromises were made at that time, not only here in the Senate but also with the House when we went to conference. I believe the right balance was struck, and I think it has proven its worth over the years. We have done some minor modifications to it over the years. As I have often said, when we write laws around here they are not chiseled in stone for all eternity. These aren't the Ten Commandments, they are laws, and sometimes they need to be modified and changed a little bit, usually tweaking. But this amendment basically turns the whole law that we had since 1994 on its head. We have a process now where the FDA regulates the supplements as foods. These are foods, not drugs. So as we hammered out this agreement, supplements can make nutrient, structure, function claims without any FDA preapproval. If they want to make a health claim, then it has to be approved by FDA, and FDA has to find that it is supported by appropriate scientific evidence.…”