Trade to FDA: Don’t leave us in limbo on NDI guidance

By Elaine Watson

- Last updated on GMT

Related tags Draft guidance

Trade to FDA: Don’t leave us in limbo on NDI guidance
While the Food and Drug Administration (FDA) will need time to process the expected tidal wave of comments on its draft guidance on new dietary ingredients (NDIs), the supplements industry should not be left in regulatory “limbo” for long, trade associations have warned.

Speaking to NutraIngredients-USA ahead of the Friday (December 2) deadline for comments on the controversial draft guidance, Council for Responsible Nutrition scientific and regulatory affairs vice president Duffy MacKay said:

The FDA is not obligated to respond within a certain timeframe or necessarily publish a final guidance.

“But we absolutely don’t want this to just sit around as a draft for years. That would be the worst outcome. Some people want it to be withdrawn, others want substantial revisions. But doing nothing would be detrimental; it would be unfair to leave the industry in limbo.”

What happens in the meantime?

In the meantime, while firms with a genuinely novel ingredient should file a NDI notification as a matter of course, those worrying about whether to file applications for every supplement/end product that contains and NDI – or for ingredients extracted using a new method, as per the new draft guidance – were in a difficult position, he acknowledged.

“The variable is FDA enforcement. Some firms might look at the law and say the law does not require me to do what the draft guidance says. If the FDA challenges this it will be very interesting to see what happens.

“But it’s more likely that they will pick the low-hanging fruit and focus on cases where an obviously new ingredient has been put on the market without an NDI notification.”

American Herbal Products Association (AHPA) president Michael McGuffin added: “It's important to note that a draft guidance, such as that released by FDA on NDIs, cannot change the law.”

Working with the FDA…

While the trade was very unhappy with the draft guidance, however, Natural Products Association (NPA) vice president, scientific and regulatory affairs Cara Welch said she was confident the FDA would listen to stakeholders’ concerns.

“I think they will take our concerns seriously and we’ll end up with a revised guidance.”

While it would take some time for the FDA to consider all of the comments, the NPA hoped it would be possible to maintain a dialogue with the FDA throughout the process, said Welch.

“We’ve seen in the past on areas like the GMP rule that we can work with the FDA, so while sometimes things happen in the FDA black box, I’d hope that they will be willing to accept our help.”

The goal was to produce something “workable​”, said MacKay. “The industry wants reasonable guidance. The problem with the draft is that it is moving away from the original scope of the legislation, broadening the scope of what’s an NDI.”

Co-ordinated effort?

While the trade associations had co-ordinated closely on this issue so that a consistent message was being given to the FDA, they would submit comments separately, said MacKay.

“The areas of concern overlap but we’ll all have different examples.”

He added: “What we’ll need to do after the comment deadline is keep on talking. Do we need to set up meetings with the FDA on this, what should the next steps be?”

AHPA NDI database

Meanwhile, the AHPA’s New Dietary Ingredient (NDI) database - a compilation of all NDI notifications submitted to the FDA since August 1995 - has added 27 new notifications and now contains details of more than 600 submissions.

"While it's possible to obtain NDI information by Freedom of Information Act requests, doing so is costly and tedious,” ​said​AHPA information analyst Merle Zimmerman.

“AHPA's Silver Spring, Md., location allows us to easily visit FDA's offices when new NDI information is released, saving NDI Database subscribers expense and inconvenience, while providing a much quicker turnaround time between release and posting."

The most recent additions included novel herbal preparations, new chemically combined vitamin-mineral ingredients, and cutting-edge enzymes.

Click here​ to watch a video from lobby group Citizens for Health re-mastered by Australian rapper Jody Lloyd (aka "Trillion") to encourage signatures calling for Congress to demand that the FDA withdraw the draft guidance.

Related topics Regulation NDI draft guidance

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