By Bart Schaneman
If you’re going to claim your medical marijuana product can treat a condition or disease, you’d better have the data to back it up.
So says Emily Leongini, an associate at the Arent Fox law firm. She works in the firm’s Food and Drug Administration practice with a focus on highly regulated products like cannabis. Before joining Arent Fox, she spent nearly six years with the FDA, so she’s well-credentialed to work in the marijuana sector.
Marijuana Business Daily spoke with Leongini about her Washington DC-based firm’s particular expertise in counseling emerging companies and helping them with corporate planning and strategies.
She offered advice on how marijuana businesses can avoid catching the eye of FDA regulators by documenting nearly every detail of the production process and supporting every medical treatment claim with rigorous data.
What are some of the key issues you face on the regulatory side when dealing with cannabis clients?
If a product claims to diagnose, mitigate, treat or cure a disease – and disease is interpreted very broadly – it’s technically in violation of the FDA’s implementing statute. That’s the one area where the FDA has issued warning letters to various CBD companies who have marketed their products for a wide variety of claims.
So that’s something I always recommend companies be mindful of when they’re operating in this space – what kind of claims they can make. I’ve seen some products that include “diagnosis,” for example, in the title, or “treatment” in the title of their product. And if you’re creating an entire brand with something that will violate the Food and Drug Cosmetic Act, that’s something we like to point out to clients.
The warning letters from the FDA have not been about the product, but about the claims they’ve been making.
When it specifically comes to good manufacturing practices, any key pieces of advice for marijuana business owners?
One of the mantras – at least in the pharmaceutical industry – is, “If it’s not written down it didn’t happen.”
- Standard operating procedures and make sure the employees who are supposed to be following those SOPs are appropriately trained.
- A “quality system” in place to validate your methods.
- A method to replicate your results.
- Employees within the organization who understand what the rules are and what they need to do.
What are some of the more common mistakes you see your clients making?
Claims about their products. In order to be able to make a claim that your product is effective for X, Y or Z, you need to have data to support that. Anecdotes do not equal data.
As the industry evolves, and as the states’ regulation of the industry evolves, I would not be surprised to see product liability lawsuits like the ones that exist with drug companies and with food companies.
We reported on an Arizona company that’s suing a Colorado-based company over an alleged smear campaign. Should we expect to see more of that as the industry develops?
I expect so.
Any advice on how to sidestep those problems?
Again, have data to support whatever claims you’re making about your product.
For example, when a company goes after another company through the National Advertising Division – which feeds into the Federal Trade Commission – and the NAD reviews those cases to determine if the company being sued has violated the law or has made proper claims about their products, they’re going to look to what kind of studies the company has done to support the claims they’re making. (The NAD of the Council of Better Business Bureaus makes referrals to the FTC.)
So if you’re saying, “Our vape pen is preferred 2-to-1 to our competitor’s vape pen,” then you need to have some sort of study to back up that claim.
Any advice on how a company can back up their claims with research?
There are a lot of consulting companies who do market research. In the more established industries, they typically will contract it out to organizations with expertise in conducting that kind of research. Some sorts of claims would require studies that are more scientifically rigorous. In others, they would still have to be methodologically sound, but it wouldn’t have to be a double-blind, placebo-controlled clinical trial, or anything like that. There are varying ranges of studies that can be done.
Even if you did conduct a rigorous scientific study and you were making claims about treatable conditions, then you would still be in violation of what the FDA considers acceptable?
Yes, unless you were to go through the FDA regulatory pathway. My interpretation is that the FDA is agnostic about cannabis. However, if something is being used to treat a disease, it needs to be safe, first and foremost, and it has to be effective.
The FDA is really doing its best to try and encourage quick and scientifically appropriate studies into the clinical efficacy of the plant. But the agency needs more data. They need more science. And I know there are people in the industry who feel exasperated by that. It sets this insurmountably high bar.
So it’s based on the ailment you’re seeking to treat?
The FDA’s regulatory paradigm is set up to evaluate a product based on what’s called its intended use.
For drugs and devices, a product is effective for a particular use. Think about Advil. Advil is effective to relieve pain. It’s not effective to treat a cold.
So you’ll see, for example, GW Pharmaceutical’s Sativex being tested for specific disease states and tied to a specific indication. So that’s always going to be the driving force in how the FDA is going to view a product that’s being marketed. That goes back to why the claims you make about your product are so critical.
This interview has been edited for length and clarity.
Bart Schaneman can be reached at email@example.com