A leading food law expert and the Food and Drug Administration’s (FDA’s) dietary supplements chief agreed to disagree over several key aspects of the FDA’s draft guidance on new dietary ingredients (NDIs) during a spirited conference call with stakeholders yesterday afternoon.
While the FDA’s Dan Fabricant attempted to debunk the “myths and hyperbole” surrounding the document, Scott Bass, who heads the global life sciences team at law firm Sidley Austin, said its uncompromising stance on ‘grandfathered ingredients’ was not in the spirit of the legislation it was designed to clarify.
The two were exchanging views in a webinar/conference call organized by the Natural Products Association to discuss the guidance document, which has provoked a storm of controversy in the trade.
An implicit understanding?
While the FDA had never explicitly said that industry lists of ‘grandfathered’ ingredients used in supplements pre-1994 were authoritative, there was always an “implicit understanding” that they counted for something, claimed Bass, who was a major contributor to the drafting of DSHEA (Dietary Supplements Health and Education Act).
He added: “There just aren’t records for a lot of these ingredients and that was known at the time. If you got in before October 1994 with no known safety problems you were grandfathered in. That’s where we thought things were until the last couple of years.
“There was an implicit understanding that what was on these lists [compiled by industry in the mid to late 1990s] was acceptable evidence.”
The guidance, however, suddenly raised fresh legal questions over the status of “thousands if not tens of thousands of ingredients that have been on the market for 20 years”, he said.
“The industry is surprised that what they thought were acceptable products for 15-20 years now might be on the block.”
But Fabricant responded: “I was surprised that people say they are surprised. These [industry] lists have never been considered to be authoritative… The expectation was that people had records.”
Manufacturing changes and NDI triggers
Other areas in which the two agreed to disagree was on the issues of whether changes to the manufacturing process, new solvents or new extraction methods should trigger an NDI notification, and how much safety data firms should supply to prove their ingredients were safe.
While the dismal number of NDI notifications in comparison with the number of new supplements launched clearly indicated firms had not been filing NDI notifications where they should have been, the answer was not to raise the bar such that they were even less likely to do so, argued Bass.
“I think that the industry has handled this poorly and I think you’re right that we should do something about it, but [the answer] is not to make the requirements so strict that they think it’s not worth doing it in the first place.”
Why, for example, asked one caller in the Q&A session at the end of the webinar, should it be necessary to submit an NDI notification over a small change in the ratios of the long chain omega-3 fatty acids EPA to DHA in one fish oil supplement versus another? Was this really a big safety issue?
Said Fabricant: “If it is a different ingredient, a different chemical entity, then it should trigger an NDI notification.”
Click here to read our interview with Dan Fabricant.