FDA: Evalua decisiones sobre "legal cannabis & CBD"

 As cannabis becomes legalized in an increasing number of states – New York State is set to open its first legal recreational marijuana dispensary Thursday – the Food and Drug Administration is weighing how it will regulate the substance as well as cannabis-derived CBD.

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The agency plans to make recommendations on how to regulate CBD, or cannabidiol, in food and supplements in the coming months.

While CBD doesn’t cause the “high” that tetrahydrocannabinol, or THC, does, products containing it are still not technically FDA-approved, aside from Epidiolex, a CBD treatment for rare seizure disorders.

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In 2018, Congress removed hemp (and thus hemp-derived CBD) from the federal Controlled Substances Act, leaving it to states to decide whether to allow the sale of CBD products.

As of now, the FDA has dictated that CBD can’t be added to foods or marketed as supplements, and companies must provide evidence from clinical trials if they claim their CBD products are therapeutic. Aside from that, however, companies selling CBD products haven’t had specific federal rules on how to market their products.

The agency is thus preparing to develop clearer ones after investigating whether CBD can be considered a food or supplement as opposed to simply a drug.

In an interview with The Wall Street Journal this week, FDA principal deputy commissioner Janet Woodcock, MD noted that CBD “raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance.”

In particular, the FDA wants to examine whether CBD can be ingested every day and over long-term periods safely, and whether it’s safe during pregnancy. They’re also aiming to better educate consumers on the wide variety of CBD products that are already out there – all of which have different levels of quality and safety.

“The safety profiles around these products are not what they are generally accustomed to and not the same as what they get from other products when they walk into a wellness store or grocery store or even a gas station,” Norman Birenbaum, a senior adviser at the FDA, told The Wall Street Journal.

Still, the CBD and cannabis-derived products industry has expanded in recent years, expected to grow from a $4.6 billion market in 2021 to nearly four times that by 2026.

The National Cannabis Industry Association, a trade group for cannabis businesses, has argued that any federal guidelines should fall into place with current state guidelines that allow the sale of CBD.

“The states are decades ahead of the federal government,” Aaron Smith, CEO of the trade group, told The Wall Street Journal. Medical marketers, meanwhile, have long jumped on the opportunity to begin exploring how to market legal cannabis brands as more states allow the sale of it.