The informal, small-scale poll conducted by the United Natural Products Alliance (UNPA) was intended more as a feeler of what supplement industry professionals thought about FDA’s new NDI draft guidance.
Polling was done in a casual setting at the beginning of UNPA’s ‘NDI Guidance II and Substances Generally Recognized as Safe Workshop,’ which took place Sept. 8 in Salt Lake City. The small sample included around 70 formulators, QA/QC, R&D, and regulatory personnel. “It was really more to get a pulse on what the audience was thinking about the 2016 NDI guidance,” Frank Lampe, VP, communications and industry relations at UNPA, told NutraIngredients-USA.
Results from the poll show that the industry may have to scramble for NDIs if FDA’s new NDI draft guidance proceeds as is—for example, 51% said they don’t have business records predating Oct. 1994, and 63% produce or sell synthetic botanicals.
The industry wants more training
Polling results also revealed a steep learning curve that might ensue, and an overall feeling of unpreparedness for industry changes proposed by the latest NDI draft guidance.
Around 76% of respondents said that their company has no experience with FDA drug master files. An overwhelming majority (88%) felt like they need an NDI notification tutorial, and 85% said they wanted a GRAS affirmation tutorial.
If dietary supplement regulation were to include master files, as the new NDI draft guidance indicates, 90% of the respondents said they wanted master files 101.
GRAS affirmation vs. animal cruelty
Another interesting data point from the poll was that only 39% of respondents’s companies completed a GRAS affirmation, and more than half of those respondents (57%) said the GRAS affirmation was without FDA notice.
“So if it’s with notice, then FDA has some idea what the field of GRAS affirmation ingredients looks like,” UNPA president Loren Israelsen said while presenting the poll results at the Rocky Mountain Dietary Supplements Forum in Boulder, CO, last week. “If it’s without notice, then nobody knows.”
With a majority of GRAS affirmations being without notice, Israelsen argued that the FDA can say “’Listen, we really don’t know what’s out there’—on the GRAS side, you’re sending a press release about it, but we don’t know the data, we don’t know if it’s safe or not.”
Complicating matters, attaining GRAS affirmation often includes clinical trials conducted on animals, at odds with the worldview of many dietary supplement consumers and its manufacturers. About 67% of the poll’s respondents said that they are concerned about doing animal studies from an ethical or reputation point of view.
“We’re the natural products industry, our consumers have a particular worldview and animal cruelty is part of the issue,” Israelsen said. “That may not go well with a lot of our consumers, something to think about.”