NPA CEO Daniel Fabricant, PhD, said new aspects of the guidance mean that the extra time would help industry make a cogent response. The draft guidance is an important and formidable document—it runs to 102 pages—and every lines needs careful scrutiny, Fabricant said.
“The devil is in the details,” Fabricant said. “We need to look at the way they wordsmith things, and how does that tie into previous policies and how that ties into the statute.”
Fabricant said that some significant changes in the revised guidance will need particular attention. Some of the changes were brought up in the series of meeting that industry stakeholders had with the Food and Drug Administration. Among those changes is the agency’s willingness signaled in the revised draft guidance to develop a list of ingredients could be officially be recognized as Old Dietary Ingredients, i.e. those that had been on the market prior to October 15, 1994, and thus not subject to the requirement for a NDI notification.
“In response to comments, we are prepared to develop an authoritative list of pre-DSHEA ingredients, based on independent and verifiable data. Because FDA does not generally have access to marketing records for dietary ingredients and dietary supplements, the documentation of pre-DSHEA marketing would have to be supplied by industry,” the draft guidance reads.
Digging into records
This change will require some time to respond to effectively, Fabricant said.
“For the list, we want to put together some prototypes and submit that to the agency and say, this is how we’re approaching this; what do you think?” Fabricant said. That prototype list could run to many hundreds of entries, each with its own evidence backing it presence in the market in the early 90s. That could be the work of several months, Fabricant said.
For example, the guidance states that acceptable documentation for placement of an ingredient on the ODI list could include: “written business records, promotional materials, or press reports with a contemporaneous date prior to October 15, 1994. Examples include sales records, bills of lading, sales contracts, manufacturing records, commercial invoices, magazine advertisements, mail order catalogs, or sales brochures.”
The draft guidance also commented that such documentation needs to include a detailed description of the ingredient in question. This might be difficult to demonstrate for some ingredients that industry stakeholders would otherwise be confident should be ODIs. The industry was far less sophisticated back in the early 90s and many ingredients, including a number of legacy botanicals, were marketed and denoted under traditional names without further detail. So finding records that would satisfy FDA’s guidelines could take some detailed digging.
“They had what, four, four-and-a-half years to work on this? We don’t think an additional 30 days for comment is unreasonable,” Fabricant said.