As many as 70 comments to the draft document, entitled "A Proposed Regulatory Model for Traditional Medicines: Guiding Assumptions and Key Components", have been received since it was made public in November.
The TM Congress is made up of nine organisations active in the traditional medicines arena. It was formed in 2004 with the aim of "benefit[ing] public health by ensuring access to traditional medicines in a manner that provides a reasonable expectation of public safety".
It argues that the current regulatory framework leaves traditional medicines somewhat out on a limb, since they do not completely fit with the Federal Food, Drug and Cosmetics Act description of either 'food' or 'drug'.
While some traditional medicines may fall under the remit of the Dietary Supplements Health and Education Act, they may not be marketed as medicines.
In an effort to stop this gap, the congress drew up the draft document setting out the guiding assumptions and key components of the regulatory model, including definition of traditional medicines, manufacture, safety, claims, adverse events reporting and the establishment of an advisory body.
The comment period was due to end tomorrow, but the congress has announced that it will continue to accept comments up until June 30.
"The model… would completely protect the current law while developing a new option that will benefit marketers who want to sell traditional medicines and practitioners and consumers who want to use them," said Michael McGuffin, president of the American Herbal Products Association, one of the members of the TM Congress, when the draft was first unveiled.
"The TM Congress has always intended to include any and all interested individuals and organizations in this essential review stage," he said yesterday. "We encourage everyone with such an interest to read the draft and provide comments to let us know how it can be improved."
The congress also moved to clarify several aspects of the draft documents, on the basis of comments received to date.
It is not suggesting that herbs currently marketed as dietary supplements under the Dietary Supplement Health & Education Act (DSHEA) be required to be sold as traditional medicines, but rather envisages the creation of an optional category within which products could be labeled with their traditional uses.
The congress said that it is not attempting to influence the practice of medicine or the scope of practice of any therapeutic discipline. The primary focus of the model is on products for retail, with some attention has to the need to ensure that practitioners maintain direct control over traditional medicines that they produce for their patients.
Moreover, the congress is not taking a position for or against license requirements for practitioners, which is regulated by states.
The full draft proposal is available online.