The clock is ticking on the 90-day comment window on FDA's draft NDI guidance. And, while a DSHEA-style grassroots campaign won't happen again, industry sources say it is imperative that as many companies as possible weigh in with careful, considered and coordinated feedback.
"Industry needs to comment. Companies need to comment," said Marc Ullman, a principal in the law firm Ullman, Shapiro & Ullman. "If FDA only receives comment only from [industry associations] because no company wants to expend the resources, FDA is going to think we don't take this seriously."
"[Companies] can't afford to sit back and say 'The trade associations will save me once again,'" he said.
"I thing FDA needs hear from a lot of different companies to understand the magnitude of what they have done. But I think [those companies] need to be working with and through the trade associations to have a uniform message," said Steve Mister president and CEO for the Council for Responsible Nutrition.
"It's important for the industry trade associations who represent their members and the industry as a whole to respond to the clarification of the New Dietary Ingredient Notification process," said John Endres, chief scientific officer for AIBMR, a regulatory and scientific consulting firm. "It might not be a bad idea to also hear from companies and how they feel this will impact their businesses."
Comments need to be in the form of well-thought-out legal and economic arguments, Ullman said. These would include arguments addressing specific clauses in the document as well as well-documented enumerations of jobs lost, taxes that won't be paid as a result, etc.
Ullman is quite clear that he believes the NDI draft guidance is an example of regulatory overreach, and that he was not surprised. "I expected this document to have an incredibly overbroad view of what's new while having an equally incredibly narrow view of what would qualify as a dietary ingredient."
"I'm not shocked by this. I am taken aback by the disregard for what seems to be the pretty clear intent of DSHEA as repeatedly expressed by Senators Hatch and Harkin."
Endres was not surprised, either, but takes a less dim view of the guidance than does Ullman. "Although the clarification seems to indicate some new action by the FDA, most of the guidance refers to the way the NDI process was intended to work in the first place," he said.
As an example of overreach, Ullman cited the clause in the guidance saying that synthetic versions of constituents of botanicals (he cited synthetic lycopene as example) do not qualify as dietary ingredients.
"There is no basis in science for this," Ullman said. "If the substance is nature-identical, if it behaves exactly the same in the body, there is no basis for this distinction."
"There is nothing in DSHEA that indicates a nature-identical substance cannot be a dietary ingredient," he said.
Ullman also voiced concern over language in the guidance that would seem to put many of the probiotics on the market in jeopardy.
Flood of NDI filings
Ullman doesn't deny that there are some snakes in the grass when it comes to the issue of NDIs. He acknowledged that there are companies marketing ingredients for which they should have filed NDI notifications and didn't. And he said there are ingredients manufacturers who appear to have used self-affirmed GRAS status as an end run on the process. But he said practical effect of the guidance as written, requiring as it does NDI notifications on formulations of ingredients in addition to the ingredients themselves, would be to innundate the agency with NDI submissions.
"As woefully inadequate as the numbers of NDI filings are now, they can't process efficiently what they get today. What are they going to do when they get this mountain of paperwork? It's nonsensical," he said.
It will take staff time, and in many cases money paid to counsel, to prepare these comments, Ullman acknowledged. But he suggested that companies with similar businesses and concerns could band together to share costs, as some of his clients are considering doing.
"Industry should be delving into the statutory history of DSHEA to point out the clear expressions of Congressional intent," Ullman said. "We need to focus on the language of the statue and the practical results [of this guidance.]"