The Food and Drug Administration held a public meeting Nov. 15 to discuss requirements for new dietary ingredients. The meeting was part of FDA's newly unveiled "significant steps" in the implementation of the Dietary Supplement Health and Education Act of 1994. The steps included three initiatives announced at a press conference Nov. 4: a regulatory strategy, a draft guidance document for industry; and the Nov. 15 meeting.
All three initiatives relate to FDA's attempts to "improve the evidentiary base FDA uses to make safety and enforcement decisions about dietary ingredients and dietary supplements." The open meeting specifically sought comment on the evidence required for new dietary ingredient notifications.
Judy Blatman, vice president of communications for the Council for Responsible Nutrition, called the meeting a good first step. "We support [FDA] looking for ways to implement DSHEA and to clarify the places where people have questions," Blatman said. "The openness of the agency in welcoming industry to the table is a positive thing. While we expect times we will disagree, we commend this effort."
Anthony Almada, founder and chief science officer of industry think tank Imaginutrition, said FDA still has a way to go. "They abbreviated the meeting by 50 percent, and either all those that had submitted requests to present [comments] were denied or only nine people wanted to present." However, he added, "FDA convened the meeting to express their interest to listen. It's a launch pad for an open dialogue," which would be an improvement to "regulating by fiat."
In a release, American Herbal Products Association President Michael McGuffin said, "Everyone in this business must make it their immediate business to read the documents FDA posted."
In a speech to the Council for Responsible Nutrition, Acting FDA Commissioner Lester M. Crawford said of the initiatives, "With this strategy, we will now have a clear roadmap to share with the dietary supplement industry, and at the same time give consumers a higher level of assurance about the safety of dietary supplement products and the truthfulness of their labeling."