- In Response to Stakeholder Feedback, FDA Stays Parts of IND Application Guidance Related to Conventional Foods, Health Claims
- December 9, 2015
- Law Firm: Loeb Loeb LLP - Los Angeles Office
- In an effort to encourage scientific research into the relationship between diet and health, and in response to industry feedback, the FDA issued a stay on certain parts of its 2013 guidance on IND applications. The stay applies to trials of conventional foods, as well as studies intended to support health claims.
The FDA decided to stay certain parts of its final guidance on Investigational New Drug Applications, called "Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an IND," which is designed to clarify when researchers or sponsors are required to file IND applications prior to conducting human research trials.
After publishing the final guidance in 2013, the FDA received comments requesting further opportunity for comments related to studies involving cosmetics and foods. In response, the agency reopened the comment period on those subsections in February 2014. During the comment period, the agency said it received feedback from trade organizations, individual companies, scientific associations, public interest organizations and individuals, raising concerns about the application of the IND requirement to studies of conventional foods, dietary supplements and cosmetics being studied for uses covered by the drug definition in section 201(g)(1)(B) or (C) of the FD&C Act.
In response to comments from industry stakeholders, the regulatory authority has now decided to stay parts of the subsection on conventional foods (subsection VI.D.2) as well as the subsection on trials intended to support health claims (subsection VI.D.3).
The stay excludes clinical trials that include children under one year of age, people with compromised immune systems, and those with serious or life-threatening medical conditions. The FDA noted that "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."
During the time the partial stay is in effect, researchers and sponsors of studies designed to support new or expanded health claims conducted in healthy individuals over the age of one year are not required to obtain an IND. Also during the stay, an IND is not required for trials of non-nutritional effects of conventional foods on the structure or function of the body. Trials under the stay that do not require an IND include those evaluating whether conventional foods or dietary supplements may reduce the risk of disease, studies investigating the nutritional effects of conventional foods, and trials assessing a dietary supplement's effects on the structure or function of the body.
The agency said the goal of the stay is to encourage research into the relationship between diet and health, as it considers comments received in response to the final guidance.
The agency republished the final guidance in order to identify the stayed portion to avoid confusion about which parts of the guidance are stayed and which will remain in effect.