Awaiting Regulations, FDA Plays Whack-A-Mole With CBD Brands

Slow boats to China are speed demons compared to the Food & Drug Administration’s glacial pace of releasing a regulatory framework for products containing cannabidiol. In the meantime, it’s a free-for-all, as CBD can be found in gummies, cocktails, beauty products, pet food, vape pens, burgers and ice cream — the list seems endless.

Right now, only FDA-regulated drugs can be legally marketed for use in the diagnosis, cure, mitigation, treatment or prevention of disease and/or those intended to affect the structure or any function of the body. But this hasn’t stopped scores of companies from selling misbranded products containing CBD while the FDA engages in a whack-a-mole approach to enforcement. 

On July 22, the FDA issued a warning letter to Curaleaf Inc. for CBD claims on its website and social media platforms regarding everything from Alzheimer’s and anxiety to chronic pain, Parkinson’s and PTSD. Four days later, Curaleaf Hemp, the company's hemp-based CBD product line, announced it had begun an extensive review of its website and social media platforms to remove all statements that FDA identified as noncompliant. 

Market research data provider GlobalWebIndex recently conducted a survey on U.S. and U.K. consumer perceptions of CBD. 

CBG FYI spoke with the company’s strategic insights manager, Virna Sekuj, who explained some of the findings and discussed how the synthetic manufacture of CBD might help speed up the establishment of regulatory standards.

CBG FYI: What’s the bottom line on your findings?

Virna Sekuj: There is a lot of confusion out there, and we’re seeing that most people don’t understand the level of regulation. People can’t accurately judge the effectiveness of products because there’s not anything like a seal of approval, if you will.

CBG FYI: So we have two tiers of companies right now: mostly unknowns selling anything and everything, and then the big CPG conglomerates.

Sekuj: So you have this market that has essentially been created and developed and built up to a very high value by a ton of independent little brands. 

Because there’s so many of them, the FDA obviously doesn’t have the resources to police everybody, so they’re able to get away with creating products that are not regulated and the quality control isn’t necessarily there.

CBG FYI: What’s the upshot of that?

Sekuj: No one can really be sure of the true levels of THC that are in some of these products, which has led to other problems — like people taking CBD supplements and failing drug tests associated with their jobs because they have been thinking they don’t have too much THC in them, but in reality they do.

CBG FYI: Why are some companies holding back?

Sekuj: The lack of regulations means some of the big companies are wary to get involved because the fines and penalties that will hit them would be huge and could be really destructive to their reputation.

CBG FYI: What we can expect once the FDA gets its act together?

Sekuj: What will probably end up happening is, once the FDA does create a proper regulatory framework, it will cull some of these independent brands from the marketplace because they just won’t be able to create a product that holds up to that scrutiny.

CBG FYI: Tell us about pharmaceutical companies exploring synthetic CBD.

Sekuj: Some experts actually are anticipating that the only way forward eventually for CBD to be used properly in medical products will be to create it synthetically, like other pharmaceutical compounds are. This is because synthetics may be the only way to guarantee the true quality control and precise levels of the compound.

CBG FYI: So what is your advice for companies in the CBD space?

Sekuj: For brands that really want to stick around and not just make the quick money during this Wild West of the industry, they’re going to have to be especially careful in how they produce their products and how they communicate.

CBG FYI: Your research shows that in the United States, the levels of trust that people have in CBD companies is basically the same, if not a little bit higher, than people trusting what pharmaceutical companies say.

Sekuj: That’s interesting because CBD companies don’t have FDA approval. They don’t have research and clinical trials behind them to stand behind their claims. 

It really points to how powerful this industry and the marketing around it has been. People will kind of believe what they are reading if there’s enough voices in the game and enough of a trend.

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