Healthy Skepticism Library item: 18948

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Chen ST.
Regulation of research: Is it a drug trial or a supplement trial?
Fitoterapia 2010 Nov 9;
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6VSC-51F7PKV-2&_user=10&_coverDate=11/10/2010&_rdoc=1&_fmt=high&_orig=search&_origin=search&_sort=d&_docanchor=&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=0e00e87676d17227b7d5fc77b35d86d4&searchtype=a

Abstract:

Investigators and sponsors of dietary supplement research need to know the relevant regulatory requirements and how to comply with them. This brief review describes how research on dietary supplements is regulated by FDA. In general, whether an FDA sanctioned Investigational New Drug (IND) application is required for a human research project on dietary supplement depends on the intended use and clinical setting of the clinical study, and not on the supplement’s physical or chemical properties. Even if the study product is already available on the market as a dietary supplement, an IND will be required for products that will be used as a drug to treat, mitigate or prevent a disease or its related conditions in the proposed clinical study. On the other hand, for studies on structure and function endpoints, and not on drug use, no IND will be required. The paper also discusses the principles FDA uses to determine whether an IND is needed for clinical studies of surrogate endpoints that do not lead to approvable drug claims. Useful FDA contact information is also provided.