Dear Colleagues --
For those of you involved in research and clinical trials for your products and ingredients, please note this e-mail.
Peter and Trish forwarded this announcement of FDA's intention to develop a proposed rule to broaden the regulatory criteria for studies exempt from IND requirements and provide clarity and consistency regarding when studies evaluating drug uses of products that are lawfully marketed as conventional foods, dietary supplements, or cosmetics, are subject to IND review.
We are well aware of the continued confusion and lack of clarity around this question of when is an IND required when conducting clinical trials on DI/DS. We will investigate further -- perhaps even contacting the internal HHS staffer noted in the link.
We would be happy to form a discussion group for those of our members who would like to be a part of this discussion and to stay informed of developments. Please indicate your interest to Heidi (email@example.com) by return e-mail.