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WILL CBD FOODS GET THE FDA’S OK?

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Could CBD soon be legally sold as a dietary supplement or food in the US? The answer depends on how quickly the federal regulatory framework on cannabis in general and CBD in particular can be eased – and that’s a big question, according to experts contacted by CBD-Intel.

Former FDA commissioner Scott Gottlieb said it could take two to three years, before stepping down earlier this month. That now appears to be a best case scenario.

The details of regulation are likely to depend on the type of cannabinoid product, the source, how the product will be used, potency and drug-to-drug interactions.

Nobody knows exactly what acting commissioner Ned Sharpless will do with policy on cannabis in general or CBD in particular. The FDA is scheduled to hold a public hearing on products containing cannabis or cannabis-derived compounds such as CBD on 31st May.

Steve Fox of the Cannabis Trade Federation told CBD-Intel: “There are some discussions in Congress about potentially trying to speed up the [regulatory] process in some way or direct the FDA to work through the issues more quickly. The bottom line is there is some uncertainty about how quickly the FDA will be able to issue regulations.”

According to Gottlieb the agency could issue a regulation allowing CBD to be marketed as a dietary supplement and/or conventional food. For the time being, however, this remains illegal as the substance is already the active ingredient in an FDA-approved drug, GW Pharmaceuticals’ Epidiolex.

“There are definitely some challenges here in terms of the approval of CBD as a dietary supplement,” Fox said. “There are some tricky aspects of the law they need to figure out in terms of how to regulate it.”

Studies showing health implications would also be taken into consideration.

“We don’t have studies to show CBD is dangerous, but we don’t have scientific studies to show it is absolutely safe,” said David Feldman of law firm Duane Morris. “It would be nice to have both of those.

“In the meantime, there is widespread belief CBD, with no psychoactive properties, could have benefits for wellbeing and other potential medical benefits.”

Advocates and opponents both want to see more research, he added.

For now, research is most likely to focus on hemp-derived CBD, which faces far fewer legal obstacles in the marketplace following passage of the Farm Bill.

Hoban Law Group’s Garrett Graff said he does not expect the FDA to move as quickly as the Department of Agriculture (USDA) did over implementing the Farm Bill. Nor does the FDA have the same sort of seasonal concerns for hemp farming as the USDA has in terms of having regulations in place before planting season.

 

“FDA took decades to implement vape regulations,” said Graff, perhaps referring to the nearly 15 years that will have elapsed between the agency’s first attempts to impose its authority in 2009 and the final deadline for e-cigarette premarket applications in 2022. “I don’t want the FDA to take that long.”

Waiting for the wheels of regulation to turn slowly may be a frustration, but it is far from being a uniquely American experience. During recent discussions on medical cannabis in the European Parliament, members said they expected regulations to take at least five years.

CBD-Intel (www.CBD-Intel.com) provides impartial, independent and premium market and regulatory analysis, legal tracking, and quantitative data for the cannabidiol (CBD) sector, with a focus on non-US markets.

We provide our clients with the tools to navigate this fast-moving sector, tailor their business strategy, optimise resources and make informed decisions. In addition, we offer customised research and consultancy support.

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