FDA republished the Guidance with the stayed sections marked, a move that suggests that the Agency does not plan to amend the stay in the near future. The stay is effective immediately. FDA provides the following examples as the types of studies not subject to the IND requirement:
- Clinical studies designed to evaluate whether a conventional food may reduce the risk of a disease, intended to support a new or expanded health claim, and conducted in a population that does not include individuals less than 12 months old, those with altered immune systems, or those with serious or life-threatening medical conditions.
- Clinical studies designed to evaluate a non-nutritional effect of a conventional food on the structure or function of the body.
- Clinical studies designed to evaluate whether a dietary supplement may reduce the risk of a disease, intended to support a new or expanded health claim, and conducted in a population that does not include individuals less than 12 months old, those with altered immune systems, or those with serious or life-threatening medical conditions.
At the same time, FDA’s announcement leaves a degree of ambiguity around conventional food and dietary supplement studies that have disease endpoints, an area addressed in detail in certain comments. FDA relies on definitional distinctions between disease claims, which may be permitted for foods and supplements as health claims, and drug claims, which would not.
This stay does not affect investigations of conventional foods or dietary supplements studied for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Products intended for such uses meet the definition of a “drug” at section 201(g)(1)(B) of the FD&C Act; such investigations will continue to be subject to IND requirements. For example, dietary supplements containing bacteria have been given to infants born prematurely for prevention of necrotizing enterocolitis. (emphasis added).
Thus, FDA makes a distinction between clinical studies designed to evaluate whether a conventional food or dietary supplement “may reduce the risk of disease” and conventional foods or dietary supplements “studied for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” This is a distinction that may be hard to put into practice for IRBs reviewing study protocols, as they may not be well versed in the distinctions FDA is trying to make based upon statutory definitions. Studies designed to evaluate the reduction of risk of disease seem, in most cases, to bear on disease prevention and endpoints described in a study protocol are likely to overlap. This point may be worth additional comments to FDA.
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Diane C. McEnroe
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Sidley Food, Drug and Medical Device Regulatory Practice
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