The FDA today published a Federal Register notice reopening the comment period on the Final Guidance entitled “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can be Conducted Without an IND.” FDA published the IND guidance document in draft form in October 2010. FDA then released a significantly expanded version of the document as Final Guidance in September 2013.
The expanded Final Guidance includes new sections indicating that FDA intends to enforce IND requirements when certain types of research are conducted involving food, dietary supplements, or cosmetics. Regarding cosmetics, the Guidance provides that “[a]s a general matter, studies of ingredients or products marketed as cosmetics require an IND if the ingredient is being studied for use to affect the structure or function of the body or to prevent, treat, mitigate, cure, or diagnose a disease.” Similarly, the Guidance provides that “a clinical investigation intended to evaluate the effect of a food on a disease would require in IND under part 312.” The Final Guidance indicates that FDA would enforce the expanded interpretation of IND requirements for food, dietary supplement, and cosmetic studies, notwithstanding the absence of any labeling or marketing claims that would state or imply that the article is intended for use as a drug.
In the notice published today, FDA explained that it has reopened the Final Guidance for public comment only with respect to sections VI.C and VI.D to allow more time for public review of the sections of the Final Guidance concerning foods, dietary supplements, and cosmetics, and consideration of its effects on researchers, health care providers, and others. Comments must be submitted by April 7th.