A major battle has been won in our war to protect health freedom. If left unchallenged, this clause would have allowed the FDA to regulate many dietary supplements as drugs by harmonizing American law with that of the European Union, where supplements are regulated as drugs.
Harmonization is a technical term derived from trade law.
Some American herb companies don't feel threatened by harmonization because they have entered into partnerships with European pharmaceutical companies. The FDA Reform Bill, if not amended, could have given the FDA the same regulatory authority that now exists in Europe. The odds against us were overwhelming. In addition to fighting the government, we were up against the companies who favor OTC drug status for herbs, as well as organizations funded by these companies. These forces spent a good deal of money trying to convince both Congress and the public that the harmonization clause in the FDA Reform Act posed no threat to the American people.