Since the passage of the Dietary Supplement Health & Education Act (DSHEA) in 1994, there has been a requirement for companies to provide FDA with information on the safety of any new dietary ingredients (NDIs) being introduced to the U.S. market. However, Tony Young, an attorney with Kleinfeld, Kaplan and Becker and counsel to the American Herbal Products Association (AHPA), sees a disconnect in the industry regarding the NDI process in the statute. Young spoke on the topic of NDIs at SupplySide West in October 2010, and chatted with Virgo Publishing's Jon Benninger on the issue.

He noted FDA has indicated in 2007 it would provide guidance to industry explaining how the agency interprets the NDI provision; however, while the agency has done a significant portion of drafting, there is no timetable set for release. One major reason, he added, is that the industry hasn’t had any major safety issue with an NDI and, as FDA operates on a risk-based assessment to allocate resources, it has focused more on food safety at this point.