FDA to Tackle Pre-DSHEA Ingredients List at October Meeting

FDA is moving forward with a plan to develop an authoritative list of old dietary ingredients not subject to a safety-related notification requirement in the principal law governing supplements.

The public health agency plans to hold an all-day public meeting on Tuesday, Oct. 3 in College Park, Maryland, home to FDA’s Center for Food Safety and Applied Nutrition (CFSAN), including the Office of Dietary Supplement Programs (ODSP).

The tentatively planned meeting is expected to focus on the development of a list of ingredients exempt from a notification requirement in the Dietary Supplement Health and Education Act of 1994 (DSHEA).

In revised draft NDI (new dietary ingredient) guidance published in August 2016, FDA revealed it was prepared to develop an authoritative list of pre-DSHEA ingredients, but industry would need to provide the marketing records to document ingredients that were marketed before Oct. 15, 1994 because the agency generally does not have access to such records.

“We think the meeting is critical to the efforts to develop an authoritative list," Steven Tave, director of ODSP, told INSIDER in an interview this week.

In comments submitted to FDA, the agency received a generally favorable response concerning its willingness to develop an authoritative list, Tave said. However, he noted commentators weighed in with a range of opinions on how to develop such a list.

“What’s the process?" Tave asked, alluding to one of the issues in which the supplement industry has expressed interest. “What’s the standard? What are the mechanics?"

Rather than act unilaterally, FDA is seeking to engage various stakeholders, such as public health advocates and industry trade associations, to obtain their perspectives on such issues, Tave suggested.

He expressed hope the meeting could help the various stakeholders find common ground, enabling ODSP to establish a path forward.

Additional details of the meeting are expected to be laid out in a Federal Register notice later this month and on the FDA public meetings website.

FDA officials cautioned the scheduled meeting is subject to change, and nothing is official until it’s published in the Federal Register. However, Tave said the agency wanted to announce the tentatively planned meeting as soon as possible to give stakeholders sufficient notice, so they could mark it on their calendars and participate.

FDA intends to allow individuals who cannot physically attend the meeting to participate and listen via webcast. FDA also plans to open a docket, allowing individuals to submit written comments concerning the meeting.

Issues to be Covered

During the all-day event, FDA plans on covering at least two main subjects. The first is the standard of evidence governing a pre-DSHEA ingredient.

“What is the standard of evidence that needs to be cleared in order for an ingredient to be included on this list that … we’d like to develop?" Tave asked.

The question above, he observed, raises different issues, such as the types of materials FDA can rely on in developing the list and how broadly or narrowly an ingredient should be defined.

Tave said he anticipated one panel would weigh in on the standards issue, while a separate panel would discuss a second topic: the process for creating the list.

“Is it something we do on our own?" Tave asked. “Is it something that we do with the assistance of outside parties? If so, who should those parties be? How do ingredients get nominated? What gets evaluated?"

Tave acknowledged industry’s concerns about keeping certain information confidential.

He referenced many individuals in the industry “who believe they have information that would establish that an ingredient belongs on the list, or establishes that the ingredient was on the market pre-DSHEA, but they’re concerned about sharing their proprietary information.

“They want to make sure that they’re protected when they do that," he said.

Tave further observed some ingredients groups, such as the probiotics category perhaps, may face unique considerations, and FDA plans to afford such groups an opportunity to weigh in.

“The purpose of this [meeting] really is to exchange ideas," he said.

Loren Israelsen, a veteran industry leader who helped lobby for passage of DSHEA, welcomed FDA's approach.

“FDA is taking a useful step in receiving public comments and ideas on development of a pre-DSHEA ingredient list," said Israelsen, president of the United Natural Products Alliance (UNPA), in a statement.

"There are important process and technical questions that require vetting, and a public meeting is the preferred way to open a discussion forum to do so," he added. "UNPA will actively participate in this meeting and encourages all interested parties to do the same.”