FDA Could Take Months, Years to Process NDI Comments, NPA Says

NPA says it will work to ensure the agency does not allow the high-profile issues fall through the cracks.

Acknowledging that it could take months or even a year or longer for FDA to process all the comments it will receive on its new dietary ingredient (NDI) draft guidance, the Natural Products Association (NPA; Washington, DC) says it will work to ensure the agency does not allow the industry's objections fall through the cracks. The association yesterday submitted its comments to FDA, whose deadline for the NDI comment period is today.

“It’s our job as the Natural Products Association not to let this become forgotten, and we won’t,” said NPA’s CEO and executive director John Gay. “We will be following up with FDA fairly soon-at first just to make sure there are no questions or issues they have with our comments, but I would agree that it’s going to take FDA a while to process all the input they have received. We’re also going to be meeting shortly with our congressional champions to take their temperature and talk about next steps in the House and the Senate side. We have some great champions that will help us keep this from being a forgotten issue.”

NPA has called for a rewrite of the guidance, Gay said. “We determined that the guidance as drafted significantly oversteps the bounds that Congress has laid out in DSHEA [the Dietary Supplement Health and Education Act of 1994], and we are urging a substantial rewrite of that guidance….We call upon and support the call for the FDA to produce draft guidance, but not this guidance. We as an industry need to have guidance that [maintains] DSHEA compliance, and we will work with FDA in order to accomplish that goal.”

He also stated that the industry’s leading trade associations are “united in that view.” Gay stated, “I have not seen final comments from all the other associations, but we have been in regular contact and have exchanged draft versions of our guidance, so I think you’ll see that on all the main substantive points that the industry is together in what it is requesting and demanding from FDA. There may be differences here or there, but overall we are all on the same page.”

Gay also stated that NPA would continue to monitor FDA to ensure the agency does not enforce the guidance as currently written as law. “We’ve heard from FDA officials that they’re not enforcing based on the guidance or making decisions based on the guidance, and we’ve heard anecdotally from some companies that they seem to be doing that. I don’t know when it is we get an answer to that question, but it is an important one that we’ll continue to ask.”

Meanwhile, Cara Welch, PhD, NPA’s director of scientific and regulatory affairs, says that companies should continue submitting NDI notifications if they believe they are required to.

“I think that we still need to follow the regulation that’s out there,” she said. “So if you are bringing a new dietary ingredient to market, you absolutely do need to submit a notification. Additionally, I think that some of the areas really aren’t clear yet. If you have an ingredient that was previously grandfathered but has gone through so many changes that it actually is a different ingredient-we’re looking at a different end-product ingredient-then I would make sure that you discuss with FDA. They do suggest [you] can go through pre-submission conferences with FDA or have a meeting with them to decide [whether] you need to go through a submission or not. So we can’t urge our companies not to submit notifications, especially if they’re dealing with new ingredients because it is the law that you notify FDA. So go through that 75-day premarket notification.”