For a CBD company looking to see its products sold alongside traditional supplements and functional foods, what better place to look than a longtime executive from the natural-products world?
In late March, San Diego-based CBD manufacturer CV Sciences brought on Douglas Mackay, a naturopathic doctor and former senior vice president with the Council for Responsible Nutrition, a Washington, DC-based trade association that represents all segments of the supplement industry.
CV Sciences, which trades on over-the-counter markets as CVSI, is selling its products in roughly 800 CVS Pharmacy stores.
Over the past few years, Mackay, CV Sciences’ senior vice president of scientific and regulatory affairs, has been working to navigate the new terrain that has come with hemp and CBD entering the market.
In this interview with Hemp Industry Daily – the first of two parts – Mackay offers his take on what the U.S. Food and Drug Administration (FDA) will be looking for when it convenes this month to talk about regulating CBD in food, beverages, cosmetics and dietary supplements as well as what the agency may require of businesses developing products containing hemp derivatives.
What do you hope to accomplish in your new role at CV Sciences?
One of the sayings in Washington DC is that you have to be at the table, or you’re on the plate, meaning you’ve got to be part of the conversation that shapes your regulatory future, or you may find yourself being the pivot.
CV Sciences has conducted the appropriate toxicology tests on extracts to make sure they meet the FDA’s definition of safety for supplements. I’m preparing the company for the oncoming regulatory framework on products labeled as foods, dietary supplements and cosmetics.
My role is understanding how CV Sciences does things with regard to sourcing hemp and extracting, making sure it has the adequate science in its portfolio work and encouraging regulators to develop sound policies that will allow responsible companies to continue to be successful in the mainstream marketplaces.
With the development of the U.S. Department of Agriculture (USDA) rules based on the 2018 Farm Bill, could different hemp varieties be regulated based on use?
European countries use the term food/fiber hemp to define various cultivars of cannabis sativa that are typically tall in stature, low in resin and relatively low in cannabinoids.
Currently, people (in the United States) are very excited about CBD and getting higher levels of CBD in products, and they’re hybridizing marijuana cultivars with varieties of hemp to try to get high-CBD, low-THC crops.
It’s very creative, but that is not the kind of hemp that Sen. Mitch McConnell envisioned in the Farm Bill.
So, a big X-factor is, will the USDA create a seed-registration licensing scheme similar to Europe’s, focusing on food/fiber hemp?
If that’s the case, that’s where regulation starts. We think the USDA is going to make efforts to define hemp beyond what is in the Farm Bill.
What are some areas the FDA will consider in developing regulations for hemp-derived extracts?
The FDA will lean heavily on identity-testing specifications.
So, anybody making a supplement right now will have an obligation to identify and prove that the botanical coming into your facility is true food-fiber hemp (and not marijuana) before you use it.
The FDA is going to draw very clear lines about not allowing controlled substances into food facilities for extraction.
The second thing is going to be safety.
How do you know that your extract – with all of the cannabinoids, terpenes, phytonutrients and other bioactive compounds in that extract – are safe in the food supply?
In your opinion, will the FDA establish different allowable formulations of CBD for pharmaceuticals versus food, beverages and dietary supplements?
The FDA is going to be evaluating not only the potency but the purity.
And then (the agency) may conclude that, because a company has already taken a highly refined and isolated CBD through the drug-approval process, that’s off-limits.
I think the FDA will say, “If you can show us that your bona fide hemp extracts that happen to contain CBD are safe, we get that those are natural products and we’ll allow those. However, when you start focusing on manufacturing to purify CBD levels, you’re starting to compete with this drug.”
This interview has been edited for length and clarity.
In Part 2 on Wednesday, Mackay will address how CBD compares to FDA-regulated drugs and their competitive products, among other topics.
Laura Drotleff can be reached at [email protected]