NPA’s Fabricant talks DSHEA 2.0, mandatory product listing, user fees, and CBD
Speaking with NutraIngredients-USA at SupplySide West, Dr Fabricant said: “Unlike Pharma, where you have very few [ie. a limited number of] people paying user fees, I think anytime you have a user fee system with so many people paying in [as would be the case for products regulated as foods] it’s rife for a lot of misrepresentation.
“Also, with the make-up of this Congress right now, you have people on both sides of the aisle who are strict ‘there will never be user fees on food’. It has certainly worked very well for the drug side of the house at FDA, so it’s probably a good discussion to have.
“Our organization isn’t opposed to looking at user fees, but what do we want for it?”
Talking about mandatory product listing, Dr Fabricant said that NPA is not opposed to this, but, again, what is the goal?
“Is the goal credibility? Is it to arm FDA with what they need to be armed with? We’ve got to have a candid dialogue with them [FDA] about why and what they actually want. Regulators always want stuff but there’s got to be a reason.
“I think the Agency wants this listing because they want to get into spiked products. If that’s their motivation then that’s fine – we want to get spiked products off the damn shelves, too - but I don’t think that is necessarily the best tool for the job.”
On the topic of cannabidiol (CBD), Fabricant said the situation is akin to wine spilling on the table: It’s out of the bottle and it’s not going back in.
“We have to have some assurance that there is a level at which we don’t have side effects. That’s step one.
“[The CBD situation] has shown a lack of willpower by the Agency. It also showed a lack of impulse control by the industry. And that’s not a good combination.
“Someone has to own this [CBD] at the Agency. That’s one of the internal challenges they have: where does it belong? It’s a drug ingredient so is it CDER [The Center for Drug Evaluation and Research] running point and we should be using the drug authorities to inspect facilities, or if it’s a food / dietary supplement then how many inspections are we doing?”
Watch the video for much more.