After numerous warning shots in the direction of the hemp industry by the U.S. Food and Drug Administration regarding the continued prohibition of CBD as a food and beverage additive, a potential silver lining has arisen. The FDA finally showed signs on Tuesday that it will be giving serious consideration to the possibility of clearing a path for the use of the hemp-derived supplement in foods for consumers who want their CBD and companies hoping to cash in on the hot market.
In an official notice posted Tuesday in the Federal Register, the agency said it will be hosting a public hearing on the topic May 31, at which it will be collecting intelligence on CBD's safety to be utilized in preparing regulations related to manufacturing, marketing, and labeling of CBD-infused foods and beverages.
According to the statement, the FDA has formed an internal working group tasked with exploring “potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed".
The FDA’s concerns regarding CBD
Some of the safety considerations on the FDA’s list include the potential side effects for consumers using multiple CBD-infused products, how the method of consumption influences its effects, and potential interactions with other active compounds found in prescription drugs and over-the-counter medications.
In the statement, signed by Outgoing FDA Commissioner Scott Gottlieb (whose last day at the agency is this Friday), the agency declared, "It's critical that we address these unanswered questions about CBD and other cannabis and cannabis-derived products to help inform the FDA's regulatory oversight of these products—especially as the agency considers whether it could be appropriate to exercise its authority to allow the use of CBD in dietary supplements and other foods."
It was not long ago that the FDA fired a warning shot across the bow of CBD sellers advising that it was unlawful to add CBD to foods and beverages. As a result, states such as New York, Maine, and Ohio—states that seem to have very little concern about defying the federal government by legalizing medical or recreational marijuana—suddenly took umbrage toward cafes offering CBD-infused cookies and teas. Products were confiscated, hands were slapped, and public complaints ensued prompting members of Congress to press the FDA on the issue.
"This is a complicated topic and we expect that it could take some time to resolve fully. Nevertheless, we're deeply focused on this issue and committed to continuing to engage relevant stakeholders as we consider potential paths forward." — Outgoing FDA Head Scott Gottlieb
What’s at stake for the CBD industry
Since the FDA approved a CBD-based drug called Epidiolex for the treatment of certain cases of epilepsy, fears have been raised that the compound might remain heavily regulated, even though since the 2018 farm appropriations bill was signed by President Trump at the end of December, CBD is no longer a Schedule I controlled substance.
Very few experts in the industry now expect the FDA will allow unfettered use of CBD in food products. More likely, the agency will specify an upper limit to the amount of CBD that will be allowed in edibles, beverages, topicals, and other CBD-infused products.
In the statement announcing the upcoming powwow on the topic, FDA officials mentioned “open questions about whether some threshold level of CBD could be allowed in foods without undermining the drug approval process or diminishing commercial incentives for the further clinical study of the relevant drug substance.”
The agency’s decision to allow the addition of CBD to foods, one way or the other, could mean the difference between a potential estimated $16 billion market for the hemp-derived supplement by 2025 or perhaps a figure substantially lower than that, should the agency severely curtail the use of CBD in foods and health supplements.
Health claims unlikely to be allowed any time soon
Although there is no other reason to purchase and consume CBD aside from treating a medical condition or improving one’s health, the FDA is unlikely to give a green light to marketing CBD as a health supplement or for the treatment of any disease, at least for some time, until extensive research is undertaken.
This is regardless of the fact that the FDA recently approved a CBD-based drug called Epidiolex for the treatment of certain cases of epilepsy. Its maker G.W. Pharmaceuticals put the drug through multiple clinical trials to prove its safety and efficacy in treating the condition.
In a recent interview with PotNetwork, cannabis industry attorney Seth Golberg stated, “I think it is still unclear with respect to the FDA. I think the FDA has said that CBD is an active pharmaceutical ingredient and views CBD to be a drug product and to be restricted as such. It has said it will exercise enforcement discretion and scrutinize over the line ‘health claims,' and I would expect FDA might even do so with respect to those kinds of products.”
More recently, America’s two largest drugstore chains, CVS and Walgreens, announced that they would be offering CBD products in hundreds of stores located within hemp-friendly states. This move prompted Gottlieb to reveal his anxiety on the issue to a House appropriations committee Wednesday saying, "We expressed concern yesterday, I did, about Walgreens and CVS stepping into this market. So you now see big box stores seeking to market CBD products for some uses where the claims seem to be potentially over the line, for the treatment of pain for example."
Moreover, within the past week the FDA, in concert with the Federal Trade Commission, sent threatening letters to a handful of CBD makers pointing out health claims violations. "The FDA continues to be concerned about the proliferation of egregious medical claims being made about products asserting to contain CBD that haven't been approved by the FDA, such as the products and companies receiving warning letters today," Gottlieb said regarding the letters.
According to CNBC, CJ Montgomery, president of Nutra Pure, one of the companies which received the notice, said in an email to the national financial news outlet, his company’s claims were “quite minor” compared with "many other CBD-related companies making over-the-top health claims,” and that company promptly removed the offending claims "out of an abundance of caution."
What the future holds for CBD
Although the FDA is expected to provide more clarity in the coming months, there’s no guarantee that everyone will be happy with their determinations.
With respect to where all of this is leading, Goldberg stated, “We expect that that regulatory framework over the next year will become more certain and provide clarity, but until then the federal framework is uncertain. So you can’t be sure that there won’t be some federal enforcement action . . . CVS’s approach by doing this in select states demonstrates that from a state standpoint, there’s still a risk.”
And regardless of what the FDA decides, states will still have the right to further regulate the production and sale of CBD.
“The state regulatory framework also presents uncertainty and risk,” said Goldberg. “For one thing, states regulate hemp differently from state to state, and no state has had [their hemp regulations] federally approved under the 2018 Farm Bill . . . I think what you see in the way CVS and Walgreens have done this is they’ve obviously been very careful to identify those states that they think would be hemp-friendly, states where they think they can market these products with less risk.”
Principal Deputy Commissioner Amy Abernethy and Principal Associate Commissioner for Policy Lowell Schiller were named by Gottlieb to co-chair a high-level working group to evaluate these issues. Gottlieb officially leaves his post on Friday.