Marc Ullman is a longtime lawyer covering FDA issues for dietary supplements clients. His expertise is in issues relating to FDA compliance, including labels, labeling, claims and GMPs. He’s always been busy with traditional supplements companies, but the hemp CBD world is rife with challenges on all these FDA-related fronts. Ullman will also be on stage at SupplySide West 2019, dispensing wisdom and answering your questions. Here’s five we had for him.
INSIDER: How would you grade the FDA’s work with hemp CBD?
Ullman: The FDA is making itself look very foolish. The FDA is broken. I have concerns.
INSIDER: What’s the main problem?
Ullman: 21 CFR part 111. That’s the dietary supplements Good Manufacturing Practices rule. 111 ensures you understand what you’re making and can make it the same every single time. You know exactly what you’re putting in products and it’s the same every time. You need to have documentation for ingredient identity, test for risks of adulterants including pesticides, and how the product is grown. You need master batch production records. That the representation you’re making about strength and purity is accurate. All of this is based on 111.
INSIDER: Are you seeing different clients in hemp—not supplements companies but brand-new entrepreneurs to the space?
Ullman: I’m seeing guys getting in who have a lot of money and have no clue. There seems to be a group of them out there. They all say they want to sell CBD and be the best. I tell them, well, here’s what’s going to be involved in at least looking like you’re in compliance. How many know exactly what they are selling, and so they make the same thing every time they make a batch. How many have good provenance where their CBD is coming from? Is it certified seed out of the European Union? I’m working with a number of companies importing and marketing hemp oil and how to do this properly. We still have no definition of what seeds are appropriate so the DEA doesn’t think it’s marihuana extract. What if something goes wrong and you become a target so the DEA gets involved with your CBD and it turns out it’s not from industrial hemp? Now you have a DEA problem.
INSIDER: Didn’t the 2018 Farm Bill remove the DEA from the picture?
Ullman: The Farm Bill said DEA is out of the picture. It did nothing to affect FDA authority. That’s a huge misunderstanding. But that example I just gave will never come to light unless you have a consumer problem. And there’s enough quality issues out there that I’d be surprised if we don’t have a consumer problem. CBD from industrial hemp looks the same under HPLC as CBD from marijuana. DEA has an issue with one of those but not the other. So companies need to have a solid provenance on the source material if they really want to make sure that they don’t have to worry about the DEA.
INSIDER: What other ways can companies not run afoul of the FDA?
Ullman: Hemp oil with CBD has a constituent in it, a la red yeast rice. [This from a 1997 FDA case where the agency found supplements maker Pharmanex was selling red yeast rice, which contains a molecule identical to the FDA-approved statin drugs. The agency ruled the supplements had to be removed from the market because if a compound is an approved pharmaceutical first, it cannot later become a supplement.] If you don’t call out the drug ingredient, CBD, then there’s no issues. And the big issue is interstate commerce. If you want to do CBD and not worry about the FDA, let’s say you’re in New York. You get your glass from Corning, someone making packaging filler material in New York, then find somebody who can make your container closures in New York. Now everything is intrastate—not interstate—and you’re selling it just in New York and not on the web. Now you can call it CBD and not have to worry about FDA saying you’re selling an illegal product. That’s pretty big. It removes that question. But you still have to worry about claims. With claims, you have to have a sense of substantiation. How much science have you seen that topical CBD works for arthritis? I’ve heard anecdotal evidence. I haven’t seen anything that qualifies as science.
The SupplySide West trade show happens Oct. 15-19 at the Mandalay Bay hotel in Las Vegas. The daylong hemp CBD conference takes place Wednesday, Oct. 15. Click here for more information.