One of the fundamental disconnects in the dietary supplement world is that despite the fact that manufacturers of dietary supplements are not allowed to make claims regarding effects on diseases, much of the clinical data used to substantiate dietary supplement claims comes from studies in populations of patients with diseases.
The issue of clinical trials of dietary supplements and FDA regulation of these studies was addressed in the draft 2010 FDA guidance on “Determining Whether Human Research Studies Can Be Conducted Without an IND.” This guidance drew public comments requesting clarification on the conditions under which dietary supplement studies in humans required an IND. For example, would a study of dietary supplements in individuals with abnormal cholesterol levels require an IND to support a claim about maintaining healthy cholesterol levels? The final version of the guidance, “Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND,” published in September 2013, did little to address these comments. Most of the text regarding dietary supplements is taken verbatim from the draft guidance.
From the FDA’s perspective, submitting an IND is not an onerous task and is important for protecting subjects enrolled in a study. The IND is intended to provide essential information demonstrating that: (1) an investigator understands and can control what is in the test material to be used in the clinical trial, and (2) that that the materials to be tested are reasonably expected to be safe in the proposed study population. However, a larger question is how a substance would be classified should an investigator submit an IND for a particular clinical study? If an investigator wants to test a dietary supplement for joint health in a population with osteoarthritis and opens an IND for this study, does the substance automatically become a prospective drug even if the intent is never to market the product as a drug?
A Federal Register notice published today announces that FDA is reopening the comment period on the September 2013 guidance. The reopening of the comment period applies only to comments regarding the conditions under which cosmetics and foods (including dietary supplements) are required to submit an IND before conducting human clinical trials. Whether the submitted comments in this round address this conundrum, and how FDA might respond, still remains to be seen.
At ProPharma Group, we are accustomed to dealing with the difficult questions in drug and dietary supplement development. Companies who need assistance now in evaluating the need for, or opening, an IND for their products are encouraged to contact ProPharma Group.
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