The FDA might have spent the past year vigorously defending its much-maligned draft guidance on new dietary ingredients (NDIs), but it appears it has been listening to industry concerns as well.
Indeed, it has taken them so seriously that bosses now plan to ditch the offending document, and replace it with a second, revised, draft.
While FDA supplements division chief Dr Dan Fabricant certainly gave no hints he was considering such a step during recent public appearances , trade associations had described him as “engaged” and “receptive” during recent meetings where they voiced their concerns.
Fabricant: Revised draft will 'address points that may need further clarity to avoid misinterpretation, and possibly being taken out of statutory context'
The news was communicated following a meeting yesterday between the offices of Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) and FDA commissioner Margaret Hamburg, deputy commissioner Michael Taylor and assistant commissioner Jeanne Ireland.
In a note sent to trade asociations after the meeting, Dr Fabricant said: "We are planning on promulgating a revised draft NDI guidance to address points that may need further clarity to avoid misinterpretation, and possibly being taken out of statutory context.
"Please assure your members that the comments received in December are still being administratively reviewed and vetted accordingly."
CRN: A good outcome
Council for Responsible Nutrition (CRN) chief executive Steve Mister told NutraIngredients-USA this was good news for the trade: “The FDA has acknowledged we have some valid concerns, and plans to address all five of the substantive issues we raised in our comments.
As to how unusual it was for the FDA to issue revised draft guidance (which will be subject to public comment - again) instead of final guidance, Mister said: “It’s hard to say. Some pieces of guidance just sit around as a draft for years, others move faster. The important thing is that this is a good outcome.”
The FDA had not said when it plans to issue the revised draft, he said. “But one thing we do know is that in the next few weeks the FDA will be talking to us all about industry lists of grandfathered [pre-1994] dietary ingredients."
UNPA: Is an NDI a single substance or a finished product?
United Natural Products Alliance (UNPA) executive director Loren Israelsen said UNPA was “pleased by the clear progress made at yesterday's meeting” and understood that the “discussion was both cordial and specific” with respect to industry concerns.
He added: “Of particular concern is the definition of a New Dietary Ingredient, whether this is a single substance or a finished product.
“We are advised that this issue was discussed in some detail and will be addressed as a central point. No timetable has yet been laid out for this next phase.”
AHPA: This is deeply gratifying
American Herbal Products Association (AHPA) president Michael McGuffin said it was “deeply gratifying to hear that FDA has decided to rethink its approach to good guidance on this important element of DSHEA (Dietary Supplement Health and Education Act, 1994)”.
Dr Cara Welch, Vice President, Scientific & Regulatory Affairs at the Natural Products Association said the FDA's "decision to issue a second draft for comment as opposed to a final guidance reflects the serious concerns indicated in industry’s comments and the agency’s desire to get it right".
The Alliance for Natural Health USA, which has conducted a high-profile campaign to get the FDA to reconsider its approach to the guidance, also welcomed the move.
Campaigns and communications director Darrel Rogers told NutraIngredients-USA: "The ANH-USA and a small group of supplement companies recently decided to pursue FDA’s House appropriators and worked with the Republican Sub-committee chair Jack Kingston and ranking Democrat Sam Farr to include NDI withdrawal language in a report that accompanies FDA’s budget that was reported out of their committee last week.
"In addition to the sustained efforts of Sens. Hatch and Harkin we believe that the House appropriators report language really contributed to getting FDA back to the negotiating table."
Emord: This is a partial victory, at best
However, Virginia-based food law attorney Jonathan Emord said this was "a partial vistory at best" for the trade.
He added: "The draft guidance revealed the worst in agency statutory construction, interpreting the NDI section to mean the opposite of its plain and intended meaning. The interest in revision is a partial victory, at best. The guidance should be withdrawn.
"The agency should respect the need to defer to Congress on fundamental changes to the NDI provision. FDA occasionally changes its Guidance documents in response to public comments, Court orders, or pressure from Congress, but substantial changes are rare."
Unworkable and unfair
Under DSHEA, firms are required to notify the FDA if they intend to market a dietary supplement in the US that contains a ’new dietary ingredient’ (which has not been marketed in the US dietary supplements market before October 15, 1994) and demonstrate that it is safe.
Although the industry had been asking for guidance on NDIs since DSHEA was passed in 1994, the document the FDA finally produced 17 years later in July 2011 was roundly slammed by the trade as unworkable, unfair, and inconsistent with the legislation it was designed to clarify.
The CRN understands that the agency will revisit the five specific areas of concern that all of the industry's trade associations highlighted as particularly problematic. These include:
- Industry responsibility for proving grandfathered status of particular ingredients;
- The permissibility of using synthetic versions of botanical components in supplements;
- The definition of the term "chemically altered";
- NDI submissions for an ingredient versus finished products; and
- The level of data necessary to demonstrate the safety of NDIs.