However, stakeholders must first engage with the FDA via the formal comment process before pursuing these options, agreed delegates at a meeting held at Utah Valley University yesterday by Senator Orrin Hatch.
Loren Israelsen - executive director of the Salt Lake City-based United Natural Products Alliance - was one of a group of representatives from the trade attending yesterday’s meeting, which was called by Hatch to discuss the industry's response to the NDI draft guidance.
He said: “First we file comments, after that it’s less clear what the path to resolution looks like. I said publicly that I hope it doesn’t come to some form of legal action, but if it did, that I hoped Senator Hatch would lead that charge.
“Because it is a draft guidance [which is not legally binding] the question of when is it right to take judicial or administrative action is a difficult one. Can we sue the FSA or seek some other form of administrative redress? But there is a growing view that the guidance should have been issued as rulemaking and there will be challenges on this issue sooner rather than later.”
Plan A… and then plan B
However, there is also a “generally held view that it’s critical that we deal with the substantive issues and first engage with the FDA though the existing comment process, even if at some point we explore other options,” stressed Israelsen.
“So we will file specific, constructive and concrete comments. Where we go from there, I’m not prepared to speculate, but there are three possible avenues.
“One is administrative, the other judicial and the third Congressional. If it becomes clear that the guidance does not reflect Congressional intent and members of Congress feel strongly enough that the guidance would do significant economic damage to our industry and there is no alternative form of resolution, the option could be Congressional oversight.
“That is, bringing in senior FDA officials and asking them to explain and then reconsider the policy”
He added: “There are calls to withdraw the guidance altogether because it violates the Administrative Procedure Act and because it is so deeply flawed. But if the FDA just pulls it back and re-issues it as a proposed regulation, we’ve not resolved our problem.”
Hatch: Increasingly concerned
Hatch, who was one of the authors of the 1994 Dietary Supplements Health and Education Act (DSHEA) that the guidance is designed to clarify, had become increasingly concerned that the guidance did not reflect his understanding of the intent of DSHEA, said Israelsen.
“He made it clear that if it was implemented as it stands it would have a dramatic adverse economic effect on the industry.”
The key question, said Israelsen, was the FDA’s insistence that NDI notifications should relate to every product containing an NDI rather than to the new ingredient itself.
“The critical issue is the dietary supplement vs dietary ingredient issue. Somewhere in the last few years the FDA appears to have changed its mind [and switched from focusing on ingredients to supplements].”
If the FDA continued to insist that the NDI notification process should be supplement-driven it was difficult to see how being flexible on other aspects of the guidance would be of much use, he said.
Legal limbo
While the guidance was not legally binding, FDA’s apparent expansion of the definition of what constitutes an NDI had immediately rendered a large number of supplements already on the market technically unlawful, putting supplement makers in a very difficult position, he added.
“Whether it is already exerting a coercive effect on industry [by making firms believe they must remove products from the market to avoid the risk of being charged with adulteration] I’m not sure, but in a few months’ time, the fear of imminent action from the FDA will only rise. Businesses don’t like uncertainty. We need resolution on this.”
Guidance oversteps DSHEA
Other attendees at the meeting included Council for Responsible Nutrition chief executive Steve Mister, American Herbal Products Association president Michael McGuffin, Natural Products Association chief executive John Gay and Consumer Healthcare Products Association chief executive Scott Melville.
Gay said the meeting was productive, adding: “We wanted to make sure the Utah supplement industry was fully aware of the challenge of the draft NDI guidance, and would engage on the issue; and, from the comments we heard from attendees, it sounds like they will.
"I think it was clear that he [Sen Hatch] views the draft guidance as overstepping DSHEA, and he should know.”
Mister said: “Senator Hatch did stress that DSHEA intended to preserve consumer access to a wide variety of products and the guidance was potentially antithetical to that, but at this stage we are still very hopeful that the FDA will take our concerns seriously.”
McGuffin added: “The attendees can now understand the draft NDI guidance and the need to respond to FDA. AHPA will maintain its close working relationship with Senator Hatch, who continues to exhibit his leadership in ensuring consumer access to safe dietary supplements."