Support your claims about MMJ products: Q&A with cannabis attorney Emily Leongini

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.”

So have:

  • 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 protected]

5 comments on “Support your claims about MMJ products: Q&A with cannabis attorney Emily Leongini
  1. Carol Bloodworth on

    I am a big proponent to the legalization of marijuana. But I have ordered CBD oil that claims it heals 16 ailments. I’ve been taking it and I don’t notice a thing. To be honest I invested money in the company I bought the CBD oil from, and I think the product does not help/cure the ailments it says it does. Is the Medical Marijuana industry based on false claims, is there a product that actually helps the ailments it supposed to fix?

    Reply
  2. Glenn Mavros on

    Benefits from ailments is not universal to all patients. You should experiment with a few products hopefully from people you know who got relief.

    Reply
  3. James Reimer on

    Marajuana currently has very few studies showing efficacy which is what healthcare providers look for. Unforunately, there is a federal ban on US studies which is paroted in most scientific countries. Since the Feds said it was bad for us, and provided a bunch of non-scientific studies to “prove” it, then made it illegal for anyone to do scientifically sound studies that would disprove the studies they like the medical community dank the coolaid. Fortunately there are a few studies surfacing that apperar to disprove the studies of half a century ago that the government is backing off of because, many of their studies can be disputed on lack of study integrety. Unfottunately, there are as many non-scientific interpretations of these studies that are as inacurate as the political opposition. This makes things very confusing for those that know how to read a study report or abstract. For those with a license to protect err on the side of caution.

    Current ads for cannabis products are much like diet suppliments that claim to have health benefits. Sure components of marajuana have been shown to be “effective in the treatment of”…….. Doesnt mean it “cures” like much of the literature out there.

    Legalization? Sure! Keep in mind once it’s legal it WILL be REGULATED. If the regulation is anything like the FDA you will be required to provide proof of your marketing statements! I’m looking forward to truth in advertizing. We have over 60% support nationwide for legalization. I beleive this is a critical mass and it WILL happen soon… question is how long?

    Neither industry (cannabis or medical) is serious about medical legitimization. I’m a very experienced RN looking to work within the MMJ industry and working on an interface to bring testing data on patients purchased MMJ to physicians in the standard electronic health record and all I hear are cricket chirps on this product! The industry just doesnt see the need yet.

    Reply
    • James Reimer on

      Keep in mind FDA is ill equiped to deal with cannabis studies! FDA requires study on One Physio or psychoactive substance at one time.
      With THC-A & B CBS’s and Turpines it’s nearly impossible for a whole plant canabinoid to be studied using FDA guidelinesis and impractical at best! The big scientific question is how do you study a large group of phycho and physioavtive substances and manage variables? Very daunting task!

      Reply
  4. Clif Croan on

    Stop guessing- get legitimate treatment. As for all benefits not being universal… hmmm… how many different outcomes does a hammer to the head produce. Perhaps guessing at treatment outcomes might be one.

    Reply

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