How Will FDA Treat CBD from Hemp – Is it a Food or a Drug?

How Will FDA Treat CBD from Hemp – Is it a Food or a Drug?

In a recent discussion of industry thought leaders, our round table participants considered what FDA may do as they consider how to regulate hemp, especially as more and  more consumers find value in hemp-derived CBD use. The question at hand: will FDA determine that CBD will be regulated as a food or a drug?

Patrick McCarthy, ValidCare, asked round table to participants to discuss their perspectives on how FDA may treat CBD from hemp — as a food or drug? I know it’s a crystal ball question, but what’s your take on what we heard and how standards will matter in this area?

Dr. Bob Kaufmann discusses regulation of CBDRobert Kaufmann: Well, anybody that tries to predict what a government agency is going to do is always going to fail. As a physician looking at the science of the issue, I don’t care where CBD comes from, whether it comes from marijuana or whether it comes from hemp because basically, it’s the same plant. It’s just been bred for different characteristics. What’s important to me is, what are the levels of cannabinoids that are present? What are the terpenes? And there are other factors we just don’t know yet. It’s hard to say where they’ll end up on this. The risks that people have if the cannabinoids come from a marijuana plant is to meet the regulation of having less than 0.3% THC. The THC has to be removed, and technically, that’s not always easy to do.

So to answer your question, I don’t have an answer to your question. We’ve been hampered because CBD was a class five drug for so long, so in turn we weren’t able to do the research to keep up with where the public wants to go, to try to determine what is right? What is wrong? What do we need to do now and what needs to be changed? We’re behind the eight ball when it comes to research for cannabidiol or hemp oil at this point and I just hope we can catch up.

Chris Stubbs: There are going to be a lot of discussions about toxicity issues of cannabis doses. The World Health Organization, the University of Kentucky, have both looked at safety of products. And we need to know, what else is in there? Are there particular solvents? Are there carriers or vehicles that have completely different protocols than the CBD itself? We just received preliminary data from a study that showed nothing like what GW Pharmaceuticals reported in the FDA hearing. There are more questions we need to ask about safety in terms of lack of efficacy. Then we can comprehensively consider what we’re talking about. What was the product? If it wasn’t the hemp CBD, it might be the CBD carrier. There are other considerations that can impact the safety profile of that product. We’ve been speaking terminology but we can give more justice to the discussion with more context and specifics about what the issues might be.

Some of the safety studies that we’ve done so far show that a person would literally have to drink almost 50 bottles of a 500mg liter per day to even come close to some kind of hepatotoxicity. That seems like a nonissue. We have to continue to substantiate that data and look at being more comprehensive our discussions. This will really matter future forward. We can’t just take a piece of a publication and turn it into a negative. Or a piece of a publication and turn it into a positive. Instead we need to start saying, “This is an observation,  here is the context and this is what could be done better in the future.”

ValidCare is helping provide information to FDA to support a greater understanding of consumer experiences using CBD products, helping to answer the question: is CBD a food or a drug?

ValidCare is committed to the implementation of standards. With the development and adoption of standards, everyone involved in the industry – from supplier to consumer – can achieve their goals. We aim to provide our clients with data driven solutions to advance research, product development and commercialization of cannabis derived products to improve human and animal health. ValidCare is working to reveal insights from global communities to fuel healthier generations.


This blog post includes excerpts from a recent webinar featuring key industry leaders(1), who came together for a round table discussion on Why Standards Matter.

(1) Round Table Discussion Participants:

  • Steve Bevan, President, GenCanna Global
  • Joy Beckerman, Regulatory Officer and Industry Liaison, Elixinol; President, Hemp Industries Association
  • Robert Kaufmann, Director of Research, Shaman Botanicals
  • Christopher Stubbs, Chief Science Officer, GenCanna Global
  • Marielle Weintraub PhD, US Hemp Authority