NDI Draft Guidance: Uncertain Times

Dan Fabricant, PhD, director of FDA’s division of dietary supplement programs, took audience questions about FDA’s new dietary ingredient (NDI) draft guidance during a December webcast. As expected, the most popular question asked was how long FDA expects it will take to finish reviewing the draft guidance comments it received. Fabricant’s answer? “How do you eat an elephant? One bite at a time.”

In fact, he said, FDA is still just in the process of trying to organize the approximately 146,000 pages worth of draft guidance comments received so far. “We’ve got to meet our burdens under Good Guidance Practices. We’ve got a lot of pages to go through so in terms of time line, we’re really not in a position to say.”

Yes, FDA has a lot to do-but then again, so does industry, reminds Loren Israelsen, executive director of the United Natural Products Alliance (UNPA; Salt Lake City), which hosted the December webcast.

“Many industry members are asking what happens now that the NDI comment period has closed,” says Israelsen. He says now is the time for the dietary supplements industry to continue voicing its criticisms of the guidance, ensuring the problem areas remain top of mind with the public and FDA.

“The wrong step is to do nothing,” he says. “Industry has vociferously objected to the Guidance. An equally vigorous demonstration of our intention to adhere to the statutory requirement of Section 413 of DSHEA [the Dietary Supplements Health and Education Act] is now equally important.”

Despite such resolve, there is an undeniable feeling of uncertainty right now. Given the guidance controversy, companies may hesitate to file NDI notifications now-especially because it’s not clear whether or not FDA is now applying its draft guidance thinking as it evaluates notifications. Many believe the agency is already doing so.

Unfortunately for companies feeling apprehensive about filing, the draft guidance dispute doesn’t absolve companies from the legal requirement to file.

Fabricant reminded webcast attendees of this fact. “I think the key thing here is that regardless of what people think of the guidance, there is a statutory obligation there [to file notifications] per the plain reading of the law. I hope people remember that. There’s a lot of focus on the guidance, and maybe some of that energy might be better spent in meeting the statute and complying with everything the statute directs.”

On industry’s side, Steve Mister, president and CEO of the Council for Responsible Nutrition (Washington, DC), advised, “I think that for a company bringing a new ingredient to market that is unquestionably a new ingredient by anybody’s standards, they absolutely should be filing their NDI notification, just the way the statute requires. For ingredients where there is some disagreement because of our comments or disagreement on whether the ingredient is a grandfathered ingredient or not, I think companies need to talk to their own counsel and make some business decisions armed with legal judgment as to whether that’s a risk they’re willing to tolerate, or whether they believe they need to file the NDI anyway.”

In light of the aforementioned uncertainties, industry members have asked FDA to formally withdraw the current version of the guidance-to strike its existence and draft anew. But even if FDA does withdraw the guidance document, will it really mean that the agency has changed its thinking in the meantime as it continues evaluating notifications?

The draft guidance reveals FDA interpretation of DSHEA’s laws. And, at least for now, FDA believes its interpretation is correct. During the UNPA webcast, Fabricant stated, “A large part of the guidance is based on our experience and what’s in the FDA docket....I think [the guidance] is very consistent with what’s in the docket.”

For industry, the core of the battle is changing FDA’s thinking. The fight is nowhere near over. “December 3 [the day after the comments deadline] just means we’ve moved on to the next chapter,” Mister declares.

Jennifer Grebow
Editor-in-Chief