House committee admonishes FDA to pick up pace on NDI issue

By Hank Schultz

- Last updated on GMT

Related tags Draft guidance Dietary supplement Food and drug administration Ndi

House committee admonishes FDA to pick up pace on NDI issue
The US House of Representatives Appropriations Committee has sent a stern message to the Food and Drug Administration on the subject of the draft New Dietary Ingredients guidance.  The message in a nutshell: Get a move on.

The report from the committee that would, once its finalized, accompany the Fiscal Year 2014 Agriculture/FDA Appropriations bill, includes a list of actions of actions the committee wants FDA to take and deadlines for reporting on its progress.  Included in that list is the following paragraph:

“The Committee notes that FDA has not addressed issues relating to its July 2011 draft guidance on New Dietary Ingredients (NDI) for Dietary Supplements despite this Committee’s urging it to do so last year. The Committee continues to be concerned that this guidance is being utilized by FDA for enforcement activities despite the document only being draft guidance. The Committee directs FDA to report back within 60 days of enactment of this Act with a timeline on how it intends to re-engage the dietary supplement community to develop a final guidance on what constitutes a NDI.”

Troubled history

The NDI guidance has had a convoluted history since it was first introduced in draft form in July 2011. Industry groups raised concerns that the guidance went beyond the language of the Dietary Supplement Health and Education Act language it was meant to interpret and constituted ‘law making by guidance.’

After a series of high level meetings that included Sens. Orrin Hatch and Tom Harkin, FDA agreed to sit down with industry stakeholders to work on possible revisions.  Several meetings between FDA and industry trade organizations have taken place over the past year, with neither side willing to discuss the particulars of those meetings publicly.

Industry observers noted that the message indicates the NDI issue has not been forgotten in the halls of Congress.

 Ivan Wasserman, an attorney with Manatt, Phelps & Phillips, told NutraIngredients-USA: “It’s definitely a strong message from Congress, or at least from  that the group in the House that has the purse strings, that it is concerned about the time it is taking FDA to revisit the NDI guidance.

“I think FDA certainly has been engaging (on the issue), so it is somewhat curious language coming from the committee that appears to suggest that they don’t think they’ve been engaging enough,” ​he said.

“The language in the House of Representative’s Agriculture Appropriations Committee Report reminds the agency that Congress has not lost interest in the NDI issue and expects FDA to continue its good-faith negotiations with the industry to resolve the outstanding matters raised by its original draft guidance,” ​said Steve Mister, president and CEO of Council for Responsible Nutrition.

“We have had three meetings with FDA on the NDI issue in the past year and provided no less than five submissions to the docket. While we are pleased with the discussions we have had with FDA, we have encouraged the agency to move more quickly to address relevant concerns. In fact, our most recent submission urges FDA to proceed with a revised guidance specifically on the matter of what information should be included in an NDI notification,”​ he said.

Industry concerns

Among the concerns of industry that still need to be addressed are these:

  • Synthetic botanicals. FDA specifically excluded these from the sphere of lawful dietary ingredients in the draft guidance. Strong objections to this were raised, including the observation that synthetic versions of vitamins have been on the market for decades without objections from FDA and without safety concerns.
  • Chemical alteration. In the draft guidance, FDA took a very restricted view of what chemical processes can be used to extract an ingredient without changing its chemistry to the point where the ingredient is no longer what it once was and new safety data would need to submitted. Industry responded that the manufacturing advances of the past 20 years do not pose safety concerns and taking FDA’s restricted view, many ingredients on the market would be classified as NDIs.
  • Lists of Old Dietary Ingredients. DSHEA included a grandfather date of Oct. 15, 1994. Anything on the market as of that date was designated as an ODI and was exempted from filing a NDI notification. In the draft guidance, FDA rejected the idea of using any of the several industry lists of what was being sold at that date to establish the NDI/ODI status of ingredients. The agency has since shown more flexibility on this matter.
  • Finished products vs. ingredients. In its present form, the draft guidance appears to call for a NDI notification on new finished products that contain NDIs. Industry stakeholders believe that NDI notifications should be required for ingredients only, with that safety information applying to the finished products containing that ingredient.

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