As such, the agency should reframe and potentially expand the undertaking to be more useful, they suggested at a public meeting hosted by FDA Oct. 3 at the Center for Food Safety and Applied Nutrition campus just outside of Washington, DC.
The agency’s goal in convening the meeting was to discuss developing a complete list of dietary ingredients that “based on independent and verifiable data” were marketed before the Dietary Supplement and Health and Education Act went into effect and therefore are presumed safe to be marketed without further review.
While industry has drafted several such lists, FDA has never sanctioned them, but it recognizes that “an authoritative list would provide benefits to both industry and FDA” by alleviating industry of submitting unnecessary NDI notifications and freeing up agency resources to focus on enforcement efforts around consumer safety, product integrity and accurate information rather than reviewing applications for ingredients that were not actually new, according to a Federal Register notice announcing the meeting.
Is creating an ODI list too much to ask?
Many stakeholders agreed with FDA’s logic, but argued that more than 20 years after the passage of DSHEA it would be impossible to create a list long enough to justify the time spent compiling it or to provide any relief related to unnecessary NDI notifications.
Loren Israelsen, president of the United Natural Products Alliance outlined two of the major “handicaps” that will hold back creation of an effective ODI list.
“One of them is just the passage of time. We have lost so many records and the ability to know what was there” when DSHEA first passed, he said.
“The second, and probably bigger problem is that FDA has proposed we look at manufacturing changes or because of a change in chemistry somehow” that what would have been an old dietary ingredient is now new, he said.
As a result, he says, industry and FDA must consider how manufacturing changes and chemical alteration related to an ingredient’s potential position on the ‘old’ list.
“Once we understand how that is going to work, then it will be easier, I think, more efficient to make progress in all three areas,” he said.
This concern was echoed by others at the meeting, including the Council for Responsible Nutrition.
“There are some groups really focused on, saying having evidence that something was in the market that doesn’t prove safety, and therefore, we have to get very specific about that evidence and we have to know what kind of manufacturing method was used, what kind of plant part it was and there was no regulatory obligation to collect all this information. So, when we look at the available evidence – magazine ads, old receipts – it is not robust with chemistry and how the ingredient was made and what was the exact composition,” said Duffy Mackay, the senior vice president of scientific and regulatory affairs at CRN.
As a result, he explained, “the concern is we go through a lot of effort and come up with a small list.”
Creating a master list beyond just ODIs
As a potential solution, MacKay suggested FDA and industry work together to create a much larger master list not just of old dietary ingredients but of all permissible ingredients that can be used in dietary supplements.
For example, the list could include those ingredients currently in the food system, and those that have either a recognized NDI notification or generally recognized as safe notice on file.
“The idea is just to instill some commonsense and … be willing to meet half way,” he said, adding, “We have to balance consumer accessibility and the reality that many of these common ingredients [have] a huge safety profile with a reasonable regulatory paradigm that can catch ingredients that we may not know have safety issues.”
If industry and FDA do not consider this approach, he reiterated that “we are not likely to get clarity and transparency around a long list of common dietary ingredients, and that is really what we need.”
Is creating an ODI list a good use of resources?
Given the challenges with creating a comprehensive ODI list, as well as its likely limited functionality if completed as currently outlined, several people at the meeting suggested the undertaking might not be the best use of the agency’s limited resources.
For example, a better use of FDA’s time and funding could be to focus on compliance and inspections of the current good manufacturing practices, said Michael McGuffin, president of the American Herbal Products Association.
“The cGMP regulation effects 100% of products in the marketplace, but it is a system that is still encountering significant difficulties in company compliance. Part of that, we believe, is because there is not clear agreement with FDA on exactly what each section of the rule means,” McGuffin said, explaining companies and inspectors often disagree on the interpretation of different provisions.
“Because we see the cGMP as the one that we are still struggling with and [it] effects all the products, we would put resources there before we put resources on any of the NDI regulations because those only affect [some parts] of the marketplace,” he said.
Laura MacCleery, director of regulatory affairs for the Center for Science in the Public Interest, also indicated that FDA resources might be better spent elsewhere. Specifically, she said the safety dietary supplements, which do not undergo a pre-market review, “is the elephant in the room,” and deserves more of the agency’s resources to identify adverse events associated with products and evaluating whether those products should then be removed from the market quickly.