In a significant concession to industry outcry, FDA has agreed to revise the New Dietary Ingredients (NDI) draft guidance, sources close to the issue have confirmed. The revised guidance would be reissued with a renewed comment period on the new document. No timeline for the reissue process was immediately available.
The agreement to reissue the guidance reportedly resulted from a meeting Tuesday between Senate supplement-industry champions Tom Harkin (D-IA) and Orrin Hatch (R-UT) with the top three FDA officials Commissioner Margaret Hamburg, Assistant Commissioner for Legislation Jeanne Ireland and Deputy Commissioner for Foods Michael Taylor.
Harkin and Hatch are the original authors of Dietary Supplement Health and Education Act of 1994 (DSHEA) and were outspoken on the subject of how the draft guidance in its present form went well beyond the scope of the law as they saw it. This was the second high-level meeting the pair has had with FDA on the subject; the first happened in late January.
In the comments filed during the original comment period that ended in December, industry trade associations were unanimous in calling for the guidance to be withdrawn. Hatch and Harkin and a number of other members of Congress sent letters to FDA expressing similar views.
"It is deeply gratifying to hear that FDA has decided to rethink its approach to good guidance on this important element of DSHEA," said Michael McGuffin, president of the American Herbal Products Association (AHPA). "We look forward to working more closely with the agency in the development of the kind of guidance that is needed by the supplement trade to ensure compliance with this important safety feature of the law."
“It would be premature for industry to celebrate, but we should be buoyant,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN). “This is an indication that FDA has heard the industry and will work with the industry.”
Harkin and Hatch had lots of input
The authors of DSHEA were amply supplied with input by industry associations like AHPA and CRN as they prepared for the meeting.
“We worked very hard with Harkin’s and Hatch's staffs to articulate the specific issues,” McGuffin said.
“All five of the major issues that CRN raised in our comments to FDA were raised during the meeting. There will be some modification, clarification or compromise on all of these issues,” Mister said.
What was wrong with the first draft
A reissued guidance would have to deal with the bones of contention in the first draft. They were many.
The key complaint was that the draft guidance required notifications on new products containing NDIs rather than solely on the new ingredients themselves; in other words, a product-centric process, rather than an ingredient-centric one. It could have called for many filings on the same ingredient, each one pertaining to a different finished product.
"They need to reassess their use of resources. We hear this from FDA all the time. They don't have the budget to police every product on the market," McGuffin said. "Our sector of the market has limited safety issues, and we have a good notification system for those issues."
Another key issue concerned the narrow view expressed in the guidance about what constitutes chemical alteration. The language in the draft guidance as it stands seemed as if it would move many ingredients that at first glance would easily qualify as Old Dietary Ingredients (ODI) into the NDI realm and thus require the generation of new safety dossiers.
Industry critics said the guidance did not address the many manufacturing advances, such as supercritical CO2 extraction, that have occurred since the ODI grandfather date specified in DSHEA of Oct. 15, 1994, and would have required a great deal of expense and red tape on this account without any significant increase in safety.
“Hamburg, Taylor and Ireland, they want a non-redundant process,” said McGuffin. “They shouldn't want 30 submissions for the same ingredient. They want efficiency, both for their staff and for the regulated industry.”
Another major issue concerned who owns the burden of proof on whether an ingredient qualified as an ODI in the first place. Industry sources were adamant that it was FDA’s responsibility to disprove the status of a putative ODI, not the other way around.
“We have heard that the first issue they'll address is who has the burden to prove whether an ingredient is grandfathered and accept industry's list,” Mister said. “We have been notified by [Dr. Daniel] Fabricant [FDA’s Director of the Division of Dietary Supplement Programs] that FDA will be reaching out to industry on that issue in the near future.”
Other criticisms centered on the status of probiotics and so-called synthetic botanicals. Issues were also raised about the protection of intellectual property in NDI filings.
Next steps for the new guidance?
It’s impossible to say now how long the new process might take. The existing draft guidance was some years in the making.
At a CRN conference in October, 2010, Joshua Sharfstein, then deputy commissioner, told attendees the agency was close to issuing the guidance; it didn’t actually come out for another eight months. Tack on the extended comment window and the gestation period of the existing draft guidance came in at about 15 months from “almost ready” to “comments closed.”
It’s anyone’s guess how much ripping up and rewriting will satisfy both industry and the regulators, but an issue date of mid- to late-2013 at the earliest seems a safe bet for a revised NDI draft guidance. And that doesn't even count what could happen if a new presidential administration is elected in November 2012.
“It’s very clear that we have a new opportunity to address this,” McGuffin said. “I'm not going to break out the champagne because we have to maintain sobriety. There's a lot of work to do.”
For more on industry's issues with the draft guidance as it stands, visit newhope360's NDI Guidance Center.
Additional reporting by Connor Link.