Assembling ODI list far from sure thing, FDA’s Welch says
Despite recent movement in the push to come up with a list of Old Dietary Ingredients, the effort is a complicated and potentially long one, an FDA official said at an industry meeting last week.
Cara Welch, PhD, a senior advisor in FDA’s Office of Dietary Supplement Programs, gave her assessment of the process at a meeting in Boulder, CO on Wednesday of last week. The meeting, titled the Rocky Mountain Dietary Supplement Forum, was put on by the consulting firm FDA Compliance Group. Welch said that too much hangs in the balance to be able to say definitively whether such a list can be assembled.
ODIs are just old, nothing more
Old Dietary Ingredients, or ODIs, are defined as those ingredients that were on the market on or prior to the DSHEA (Dietary Supplements Health and Education Act) grandfather date of Oct. 15, 1994. ODIs were ‘defined’ by default; what the regulation really pertains to are those ingredients which are not subject to the requirement to file a New Dietary Ingredient Notification.
It’s wise to focus on definitions at the outset and to be clear about what landing on the ODI list could mean for an ingredient. Some promoters who have brought new ingredients to market under the aegis of those ingredients’ purported ODI status have relied on this attribute as if it confers some sort of halo of safety and goodness. It doesn’t, Welch said.
“An old ingredient is just that: old. An Old Dietary Ingredient is not necessarily safe,” Welch cautioned.
“You are always responsible for ensuring your product is safe. A good example is caffeine. Caffeine is an old dietary ingredient, but we have seen powdered caffeine products show up marketed as dietary supplements. It’s really hard to use a product like that safely,” she said.
What are the listing qualifications?
Among the issues in assembling an ODI list are what kinds of information might be accepted as showing conclusively that a product was on the market. Industry sources have suggested using sales sheets or product information sheets or bills of sale, if such exist. The issue there is that few companies have been in continuous operation for the past 23 years, and for those that have been, even fewer have kept those kinds of records all these years. A search conducted by this reporter of back issues of a legacy industry magazine that has been in continuous publication throughout the period indicates that advertisements for finished goods from that era are unlikely to provide the kind of detail about ingredient specifications that FDA seems to be looking for. And ad from that era referring to an herbal extract would be highly unlikely to specify the concentration, the standardization nor the solvents used, for example.
The American Herbal Products Association suggested after a meeting on the subject a couple of weeks ago in Washington, DC that industry consensus about what was on the market ought to be part of the process. If everyone is in agreement that echinacea, to pluck an example out of the hat, was in one form or another on the market then and the adverse events associated with this substance have been few or none, why isn’t that good enough? Why create an exercise in which industry is put in the position of having to prove a 1994 apple equates to a 2017 apple, so to speak?
Welch responded that FDA’s primary responsibility is to consumers and to ensure safe products are on the market. The establishment of this list could be a tool for smoother agency/industry interaction, but there is no requirement for this activity spelled out in a statute, she said.
“It would have been nice if this had been done 23 years ago, but it wasn’t,” Welch said. “We are not required to put together this list. This is something that was suggested in the comments to the 2011 draft of the NDI guidance.”
“But we can’t make a successful list without industry’s help. We are looking for comment on what the standard of evidence should be for inclusion on the list. When that process is a little more established we will make those standards transparent,” she said.
End game still up in air
Welch said the agency is also looking for comments on how the process should go forward, either through a formal rule making procedure (a years-long process), a guidance, or recommendations from an advisory panel. Also, the goal is to get a feel for how extensive the eventual list might be. If only a relatively few ingredients could prove their ODI status, depending on what qualifying information is agreed upon, how useful might such a list prove to be? When all that is put together, a decision will be made about whether taking the process all the way to the end makes sense.
“We think this is something that everyone could benefit from, having a list of pre-DSHEA ingredients. But if at the end of comment period the overwhelming majority of comments say this is not worth our resources or your resources then it wouldn’t go forward,” she said.
