On October 30, 2015, the U.S. Food and Drug Administration announced that it was staying portions of its controversial Final Guidance relating to the types of studies that require compliance with Investigational New Drug procedures. The stay serves to encourage scientific research into the relationship between diet and health while FDA considers numerous comments questioning the novel application of IND rules to foods, dietary supplements, and cosmetics. The stay is effective immediately.
Specifically, the FDA has stayed parts of the subsection on conventional foods (VI.D.2), and all of the subsection on studies intended to support health claims (VI.D.3), with one exception: the stay of the health claim subsection does not apply to clinical studies that include:
- children under one year of age;
- people with altered immune systems; or
- people with serious or life-threatening medical conditions.
As a result of the stay, researchers and sponsors of studies to determine whether a conventional food or dietary supplement may reduce the risk of a disease and that are intended to support a new or expanded health claim do not need to obtain an IND, unless the study population includes members of these sensitive groups. In addition, researchers and sponsors of studies of non-nutritional effects of conventional foods on the structure or function of the body do not need to obtain an IND while the stay is in effect. Importantly, however, the stay does not affect investigations of conventional foods or dietary supplements studied for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Foods and dietary supplements used for those purposes are considered drugs under FDA rules.
Historically, FDA had required Investigational New Drug Applications to be filed prior to clinical research on unapproved “new drugs” primarily to enable pharmaceutical companies to develop the scientific evidence necessary to support FDA approval and commercialization of new drug products. But in September 2013, the Final Guidance broadly expanded the scope of studies subject to the IND requirements, targeting clinical research involving articles of food, dietary supplements, and cosmetics to IND requirements, even though those products are not “drugs” under the Food, Drug, and Cosmetic Act when they are not intended to diagnose, cure, mitigate, treat, or prevent a disease. In response to multiple comments asking for a further opportunity to comment on subsections VI.C (relating to cosmetics) and VI.D (relating to foods), FDA reopened the comment period as to those subsections.
During the comment period, FDA received comments from trade organizations, individual companies, scientific associations, public interest organizations, and individuals discussing the effect of FDA’s expansion of the IND process. Many of these commenters expressed concern over FDA’s statutory ability to expand the IND rules to foods, dietary supplements, and cosmetics, and also over the practical implications of imposing IND requirements on such a broad range of studies. Commenters suggested that the new policy would discourage important health research and shift clinical research outside of the United States. Moreover, the comments questioned whether the new restrictions were justified, considering that the products are subject to existing safety standards, have often been proven safe through years – if not centuries or millenia – of safe consumption, and generally pose less risk than unapproved new drugs.
FDA has said that, during the period of stay, it is taking time to further consider these comments. We will continue to monitor developments on this issue.