Speaking to NutraIngredients-USA via video, Fabricant also called for a unified standard for certification bodies for natural products.
CBD
The US Food and Drug Administration recently said it has made “substantial progress” on forging a regulatory path for ingestible CBD products. The agency did release guidance this week for clinical research of cannabis compounds, and just this week submitted draft CBD enforcement guidance to the White House Office of Management and Budget (OMB) for review this week, titled, “Cannabidiol Enforcement Policy; Draft Guidance for Industry”.
It is not clear what is covered in that document, and “everyone’s trying to get their hands on that to see what that entails,” said Fabricant. “That could be very significant for the industry if they actually lay out guidelines on how much you can use a day, on how you test for THC, on how you label…
“The big thing is are they going to do inspections and are they going to test. That big report to Congress a few weeks ago, contained some pretty scary stuff in there. Products were testing high for THC, but why wasn’t that information released publicly? If those are products were labeled for kids or pregnant women, that could be a public health issue.”
Asked whether the industry was coalescing around the position that hemp and CBD are not the same article, Fabricant said the question is about exposure.
“CBD is a flat molecule. If you can make it synthetically, it has the same effects as what’s produced in nature and you could make it without THC then that might have an advantage for some populations, some people may want that. You cannot split the baby on this one. It’s really about exposure to CBD.”
FDA GMP inspections resume
Fabricant welcomed the resumption of FDA inspections of facilities for GMP compliance.
“They [the inspections] are for-cause, they’re not randomized, and I cannot wait to see fiscal year 2020 numbers because there’s going to be a huge hole in the map. It’s a good start but how do you catch up from here? They’re also still not doing foreign inspections, and who knows when that will begin, so there’s a hole.”
Dr Fabricant said that, while there haven’t been any high-profile GMP issues, but he said that NPA has seen cases like products labeled as elderberry that contain no elderberry.
“That’s an easy one for FDA to button up a for-cause inspection, and say, ‘hey, you guys have a lot of product labels with elderberry on them, but you don’t have any elderberry in your facility’.”
The NDI- import alert issue
Using import alerts to help with the enforcement of the new dietary ingredient (NDI) provision has also been a hot-button issue for NPA, with the association last month calling for FDA to use import alerts to stop nutritional supplements that fail to comply with NDI regulations.
“Domestically, you wouldn’t take products off the shelf, but you could send a letter, but on imports FDA has a lot greater authority. If something comes in to the country then the Agency could say, ‘we have a question about the compliance here’, especially for ingredients that are made by biotech.
“We want to see FDA get in the game. They say they want a robust NDI system. I cannot think of a greater way that if a firm invests in an NDI that anyone who wants to ride on that has to at least show their specifications to the Agency to remedy that they are the same, if they’re going to borrow their safety science.”
Fabricant and NPA have also been pushing for expanded participation in the Supplement Safety & Compliance Initiative (SSCI).
The association this week submitted comments with FDA calling for a unified standard for certification bodies for natural products. In the comments, NPA expressed concerns that multiple third-party certification programs could create confusion in the industry.
“SSCI is the only comprehensive program to provide end-to-end transparency in the natural products supply chain,” said Fabricant. “We created a system understanding that the FDA can’t solve all our problems. We set out to demonstrate to consumers and regulators that they can have confidence in the industry, and SSCI is the way we are going to achieve that.”
