In the October 30, 2015, Federal Register, FDA announced a stay of
portions of the final guidance for clinical investigators,
sponsors, and institutional review boards titled "Investigational New Drug
Applications—Determining Whether Human Research Studies Can
Be Conducted Without an IND." Specifically, FDA is staying
portions of subsection VI.D.2, "Conventional Food," and
all of subsection VI.D.3, "Studies Intended to Support a
Health Claim," except as to studies intended to evaluate
whether a food substance reduces the risk of a disease in
individuals less than 12 months old, those with altered immune
systems, and those with serious or life-threatening medical
conditions. FDA took the action in response to public comments
submitted in 2014, which raised questions about application of the
IND requirement to certain clinical studies of conventional foods,
dietary supplements, and cosmetics being investigated for uses
covered by the drug definition in section 201(g)(1)(B) or (C) of
the FDCA. Pursuant to the stay, FDA will allow for further
consideration of the issues raised by these comments. The partial
stay is effective immediately.
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