Last week, in a move that has shocked many in the supplement industry, the FDA rejected the request of Senators Orrin Hatch and Tom Harkin asking the FDA to immediately withdraw the New Dietary Ingredients (NDI) Draft Guidance.  This move was more than surprising to many in the industry – especially considering that the Senators were the authors of the Dietary Supplement Health and Education Act (DSHEA)!  According to the Senators, the current Draft Guidance “serves to undermine DSHEA in a number of important aspects” and did not meet their intent when they wrote the law. The Senators had requested an in-person meeting with the FDA back in December to discuss the issue in the hopes that FDA would withdraw the controversial Draft Guidance and replace it with a new one that was consistent with the law and their intent.

The meeting between FDA‘s Dr. Daniel Fabricant and Sens. Hatch and Harkin ended with the FDA, as noted by some in the industry, “sticking to its guns on its interpretation of what the NDI section of DSHEA means, regardless of what the senators say they meant when they wrote the law.”  Sens. Hatch and Harkin’s request to withdraw the controversial Draft Guidance, therefore, was denied – leaving many in the industry to wonder where we go from here.  The FDA clearly seems to be committed to moving forward and using the NDI Draft Guidance process to inch things ever closer to a system approximating premarket approval (which was never the intent and was specifically excluded by DSHEA).

What can we do now, as members of industry who are upset by the FDA’s lack of consideration of the many problems with the current NDI Draft Guidance and the agency’s refusal to listen to the advice of the two leading authors of the law that literally governs the supplement industry?  Many are hoping that writing a new amendment to DSHEA on the topic of NDI’s might be possible – although, considering FDA’s strong position, this looks like it may be something either not in the foreseeable future or a “last ditch effort.”

For now, we can – and should – continue to voice our opposition to this controversial NDI Draft Guidance.  Write a letter to your local congressional representatives noting your strong concerns as a member of the industry. Conveying a stand on this issue to your elected officials, rather than to agency bureaucrats, may eventually bring pressure for the withdrawal of the current Draft Guidance.

There may still be hope, as noted by Loren Israelsen of the United Natural Products Alliance in this week’s New Hope 360° – who has said that he believes that “the issue will rise to a level of significance that both senior FDA and likely HHS officials will take a view on this.”

Let’s hope so – and let’s hope that they’ll listen to the facts, and the voices of reason, when it comes to considering withdrawing this draft guidance … before damage is done to the entire industry. In the meantime, many of our clients have begun re-evaluating their products and ingredients, turning to us for advice as to whether they are in line with FDA’s Draft Guidance. If FDA maintains their interpretation of DSHEA, the next step will be enforcement of that interpretation, which may or may not begin before a final Guidance Document is issued. Responsible dietary supplement companies should be prepared to face future FDA enforcement of their interpretation of DSHEA or the result could be costly.

For more coverage of last week’s meeting and a discussion of the issue as reported in New Hope 360°, click here.