Fabricant on NDI draft guidance: Thanks for your 146,000 pages of comments. We’ll get back to you…

22-Dec-2011 - Last updated on 22-Dec-2011 at 14:42 GMT

Fabricant: DSHEA is ‘pretty explicit’ that NDI submissions are for supplements, not ingredients

Those hoping the Food and Drug Administration (FDA) is preparing for a major climb down on its draft guidance on new dietary ingredients (NDIs) will draw little comfort from comments made by the agency's supplements chief yesterday.

During a webinar hosted by the United Natural Products Alliance (UNPA), Dr Fabricant thanked stakeholders for their comments – all 146,000 pages of them – but continued to defend the document's most controveral points.

He acknowledged that many commentators wanted him to tear up the document and start again, but implied this was firmly off the table: “Withdrawal is certainly somewhat unique, especially when it is a draft guidance and the purpose of a draft is for receiving comment.”

Given the large number of comments submitted (7,000 unique entries), the FDA could not yet give a timeline for what happened next, he added. "The timeline is really up in the air."

DSHEA is ‘pretty explicit’ that NDI submissions are for supplements

On the contentious issue of whether NDI notifications should be for ingredients or supplements, he said that the Dietary Supplement Health and Education Act (DSHEA) was “pretty explicit” on this point.

The “plain reading” of DSHEA is that NDI notifications must show reasonable evidence of the safety of dietary supplements containing NDIs, and not just the NDI itself, he insisted.

However, an ingredients supplier could submit this information about finished supplements, he said. “Maybe the burden is met by the supplier. Maybe they submitted for a broad range of use with other ingredients and other amounts of that ingredient?

“There are examples in the docket where ingredients suppliers have submitted for a broad range of use with that ingredient and also uses of that ingredient with other ingredients across a broad range of use [in end products].”

Guidance vs law

He repeatedly stressed that the draft guidance did “not establish legally enforceable rights and responsibilities” (although UNPA president Loren Israelsen did note that it had already been cited in civil litigation this week over the use of DMMA in supplements).

With this in mind, the agency was “more than willing to discuss alternative approaches [to meeting the requirements laid out in the statute]" he said.

The numbers don't add up

Interestingly, few respondents commenting on the draft guidance addressed what Fabricant said was the elephant in the room on this issue.

“If you look at the numbers [NDI submissions vs the number of supplements introduced to the market since 1994], it would appear there is a significant lag in compliance.

“I think this is critical and [yet] it wasn’t really an underlying theme in the comments.”