Congress on the Future of Traditional Medicines

Guiding Assumptions

October 7, 2005

... remembering the agreed upon Purpose of this Congress: To benefit public health by ensuring access to traditional medicines in a manner that provides a reasonable expectation of public safety

Assumptions Re: Reasons to Act

• There is value in preserving access to a full range of traditional medicines.
• Current regulations in the United States do not adequately assure continued access to and safety of traditional medicines.

Assumptions Re: Reasons to Create a Traditional Medicine Category

• The current definitions of "food" and "drug" under the Federal Food, Drug and Cosmetic Act (FFDCA) do not provide an adequate regulatory category for traditional medicines.
• The Dietary Supplement Health and Education Act (DSHEA) provides a regulatory framework for dietary supplements, which may not be marketed as medicines. Thus, DSHEA does not provide a regulatory framework for traditional medicines.
• A traditional medicine category will preserve access by professionals to traditional medicines that state or federal regulatory agencies have withdrawn, or may withdraw, from the market under current regulatory frameworks.
• A traditional medicine category will support the use of traditional medicines, by both health professionals and consumers.
• A traditional medicine category will ensure the public's access to traditional medicines and to truthful information about them.
• A traditional medicine category will ensure practitioner access to traditional medicines that, for safety reasons, should not be directly accessible to the public.
• Accurate information about traditional uses and indications for traditional medicines will improve public safety.
• Distribution of restricted traditional medicines by qualified professionals will improve public safety.
• A traditional medicine category will provide a contribution to repair the U.S. health care crisis.
• Creation of a traditional medicine category in the U.S. will be harmonious with international models.

Assumptions Re: An Ideal Regulatory Model

• Establishment of a new regulatory structure for traditional medicines may require amending the Federal Food, Drug and Cosmetic Act (FFDCA).
• This TM Congress does not intend to propose amendments to the Dietary Supplement Health and Education Act (DSHEA).
• The focus for development of the envisioned ideal regulatory model is limited to the United States.
• Most traditional medicine ingredients and products will remain directly accessible to the public.
• Some traditional medicine ingredients and products will be accessible to practitioners only (and so not accessible to the public without practitioner supervision).
• Many ingredients and products that fall into a new traditional medicine regulatory category will also be able to be marketed as dietary supplements under DSHEA.
• Any regulatory structure must address safety, efficacy and product quality.

Assumptions Re: The Long-Term Process

• This may not be a short-term process; it may take several years to pass legislation and to implement regulations.
• Additional losses to traditional medicine materia medica may be incurred in the time that it takes to create a traditional medicine category.
• Recognizing that professional practice of medicine is regulated at the state level, this TM Congress intends to maintain awareness of the potential impact on all stakeholders at state levels.
• This Congress will subject its work product to significant review by broad communities of interested persons.
• This Congress will invite and welcome significant input from sectors of the industry and professional practitioner communities.
• Some current trends in national politics create a window of opportunity favorable to creation of a traditional medicine category.