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What is the Food and Drug Administration’s position on CBD?

What is the Food and Drug Administration’s position on CBD?

According to an internal government letter released earlier this year, the FDA suggested that CBD does not meet the criteria for federal control.

The FDA weighs eight factors when deciding on scheduling recommendations. After considering those eight factors as they relate to CBD, the agency concluded that “CBD does not meet the criteria for placement in any of Schedules II, III, IV, or V under the CSA.”

Industry insider, Dr. Lloyd Covens, organizer of Denver’s CBD-focused CBOutlook conference spoke to AskCBD about the situation.

“In order to have GW's Epidiolex moved to CSA Schedule V, the DEA needed input from the FDA, which agreed that GW's CBD medicine should get moved to a clearly less restrictive area, allowing doctors to prescribe the drug,” said Covens. “But the FDA is saying if not for international treaty restrictions, it would be inclined to de-schedule all forms of CBD.”

CBD Food and Drug Administration

The role of international drug treaties

In its initial recommendation to the DEA, the FDA wrote, “CBD and its salts… do not have a significant potential for abuse and could be removed from the [Controlled Substances Act].”

The DEA’s reply stated that to de-schedule CBD would violate international treaties, at which point the FDA wrote suggesting that the scheduling of CBD should be “revisited promptly” if international treaty obligations change.

There is some hope that international treaties could be revised. After thoroughly investigating the benefits and safety of CBD, the UN-based World Health Organization concluded that CBD has benefits for the world’s population and is safe for human consumption.

Covens says this is an important development for hemp-derived CBD, “especially providing important support for CBD isolates, which were also given the health green-light by the UN's World Health Organization. So, the implication is that international drug treaties might also change to exclude CBD.”

What is the Food and Drug Administration’s position on CBD?

Current FDA restrictions on CBD

However, the FDA’s stance on the scheduling of CBD aside, the agency isn’t yet on board with adding CBD to foods and cosmetics. And there is still an issue surrounding whether or not CBD can be marketed as a dietary supplement.

Because CBD has not been deemed worthy of a GRAS rating — generally regarded as safe to add to foods — it cannot legally be added to any foods according to the FDA. A spokeswoman, Corinne Newhart, said the agency had not received any GRAS notices for the use of CBD oil in foods.

Newhart also referred to an FDA Q&A that outlines the agency’s position regarding CBD in foods and supplements.

“We have concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food to which CBD has been added,” stated the document. “We have also concluded that CBD products are excluded from the dietary supplement definition, and therefore cannot be properly classified as dietary supplements.”

CBD advocates assert that regardless of the guidance in the Q&A document the FDA has no actual ruling on the matter.