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NDIsOK, really. what now?

Waiting for FDA to make the next new dietary ingredient (NDI) move can be agonizing, but without further direction from the agency, what's a natural product company to do?

The point of the United Natural Products Alliance's (UNPA) post new dietary ingredient (NDI) comment webinar was to answer the question, "What Now?" but it seems no one can truthfully answer that question at the moment.  From here, industry has to wait on FDA to make the next move. Companies and trade organizations can request meetings with FDA, and Daniel Fabricant, Ph.D., Director, Division of Dietary Supplement Programs, FDA, said the agency is open to discussions. Steak holders can submit more comments, but can't be assured FDA will be able to read them before it makes its next move.

Basically, now we get to wait. And we've already been waiting for almost 20 years.  "This is the last piece of DSHEA to be implemented," said Loren Israelsen, executive director,  UNPA, in a post webinar interview. "I would very much like this issue to be resolved before the 20th anniversary of DSHEA. It's a stunning fact to have a law of this significance not to be fully implemented in 20 years."

However, hearing from Fabricant during the webinar did make one thing clear: FDA isn't budging on its view that the Dietary Supplement Health and Education Act of 1994 (DSHEA) calls for supplement notification. Industry believes the statue calls for ingredient notification. "Both sides have dug in, and that's the biggest issue," Israelsen said.

Israelsen said it's unlikely FDA will back down on this issue, especially given the regulatory environment we find ourselves in. Increased FDA GMP (good manufacturing practice) inspections have shown less-than-stellar compliance, and Israelsen said he expects FDA to focus on its only premarket preventative controlNDI notifications (NDINs)to help increase consumer safety. "FDA believes, because a lack of industry compliance in other key areas, particularly GMPs, the NDI issues becomes even more important," he said. "As a dietary supplement-driven process, it would give FDA insights into manufacturing controls, supply chain management and verification, and so on, which underscores the fact that the NDI issue is an important one, a really important one."

But industry isn't backing down either. "We agreed to disagree," Israelsen said, adding that he was in the room when DSHEA was being drafted. "I know what we were trying to accomplish."  In its NDI Draft Guidance comments, UNPA said DSHEA calls for a dietary ingredient process, and its a universally held view within the industry. "I'm not persuaded by Dan's perspective, and he's not persuaded by ours," Israelsen said.

OK, given that, what happens now? Of course, FDA has to go through the 176,000 pages of comments, which could take months in the best-case scenario. In the meantime, Israelsen said we need to move past the big debate question  of "Did FDA fundamentally misunderstand the statue?"

Companies now are looking at a slew of questions and need to make decisions based on the statue. Should they file ingredient NDINs? Should they file notifications for products already on the market? Do they do nothing and wait for FDA to make a move? Should they continue to file additional comments with FDA? Sadly, I don't know.

Israelsen  said FDA will look at the comments and respond in some fashion, in the form a further guidance update or something else. The agency should then invite further comments, he said. He also said some parties may try to litigate the question. Of course, a judge might say a company doesnt have standing to litigate a draft guidance.

FDA has some intense conversations ahead, both within the agency and with industry. NPA noted that it has already requested meetings with FDA, and Israelsen  said the UNPA NDI working group will create a plan early next year. "Then, we will have an all-member discussion about what we think will be appropriate steps that we can and should take: engagement with FDA, additional ideas, discussions with other stakeholders, etc." he said.

On the whole, the webinar highlighted that FDA isn't going to budge on its view, and industry isn't either. As far as next steps, I can only suggest everyone have a happy holiday with friends and family. We'll need the rest for the upcoming decisions and discussions we'll face in the new year.

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