FDA’s new NDI draft guidance: ‘Not much that’s surprising’

The US Food and Drug Administration released its revised draft guidance last week​, a full five years after its first release.

According to the FDA, there are over 55,600 dietary supplements on the market, and about 5,500 new dietary supplement products come on the market each year. However, the agency has received fewer than 1,000 NDI notifications since DSHEA was passed in 1994.

“These figures, coupled with recent concern about the presence of undeclared active ingredients in products marketed as dietary supplements, highlights the importance of submitting NDI notifications as a preventive control to ensure that consumers are not exposed to unnecessary public health risks in the form of new dietary ingredients with unknown safety profiles,” ​states the Agency in the draft guidance document.

“A second goal of the guidance is to improve the quality of NDI notifications […] After many years of experience with reviewing NDI notifications and answering questions from industry, we have concluded that a guidance on NDI issues is needed to help the dietary supplement industry understand and comply with section 413 of the FD&C Act and the NDI regulation. We hope that the additional explanation in this guidance will help you decide when an NDI notification is required and what that notification should contain.”​

Commenting on the new draft guidance, Steve Mister told us that the new document shows the “evolution in the Agency’s position”​.

“For example, we were very vigorous with the FDA five years ago about their use of the Red Book and we argued that NDIs are not food additives, so we’re happy to see they backed off of that,” ​he said.

“There’s not much that’s surprising [in the new draft guidance],” ​he added. “Because of the stakeholder meetings we had with the Agency in 2012 and 2013 we had some sense of where we were getting traction and the Master File issue is one of those issues.”​

The Master File issue is a source of positivity, said Mister. “We’re interested to see how Master Files will work,”​ he said. “Brands should be able to rely on ingredient suppliers’ documents and just submit an abbreviated notification. That’s a win for branded ingredient suppliers.”​

Specifics and the need for more clarity​

Digging into the specifics of the new document, Dr Dan Fabricant, who was director of the FDA’s dietary supplement division when the first draft guidance was published in 2011 and who is now CEO and executive director of the Natural Products Association, told us that the Agency hasn’t changed its position much on synthetic botanicals issue. “​We need to have a conversation with the agency about how technology has changed,”​ he said.

For the grandfathered list, Dr Fabricant said he expects the Agency to start with the CFR:  GRAS, food additives, vitamins and minerals, and go from there. “The Agency will be growing this out from there,”​ he said. “We have lots of old magazines with ads that are independent and verifiable, and firms with evidence. If you’re manufacturing, why wouldn’t you want to be on a safe harbour list?”​

For probiotics, the Agency has stated it wants strain information. “This is a compliance driven issue. If a new strain hasn’t been notified then they may detain it at customs. This could be a big issue because a lot of probiotics are imported. Some new strain of L. casei that the agency hasn’t been notified about could be detained. We need clarity on that.”​

Dr Fabricant also said that work has to be done on the economic side. “We’d like FDA to really understand the costs, and be reasonable with industry on that,”​ he said.

Both the NPA and CRN will host webinars in the coming days and weeks to dive more deeply into the new guidance. NPA’s webinar will take place this Wednesday​ and will feature Dr Fabricant, Dr Corey Hilmas, FDA’s Dr Cara Welch, and attorneys Kevin Bell (Porzio, Bromberg & Newman LLP), and Ashish Talati (Amin Talati & Upadhye).

CRN’s webinar, moderated by Dr Duffy MacKay, CRN's Sr VP of Scientific & Regulatory Affairs, will take place on September 7 and will feature: FDA's Dr Welch, Miriam Guggenheim, Partner at Covington & Burling LLP, and Ricardo Carvajal, Director at Hyman, Phelps & McNamara, P.C.