FDA says CBD doesn’t qualify as DEA scheduled substance but restricts uses and claims
A lot is going on in the CBD world right now. One would think with the recent Food and Drug Administration approval of the cannabidiol-based antiseizure drug Epidiolex that the situation regarding the use of CBD in foods and cosmetics would be improving. Although it does look like the situation may continue to clear up in the future, in the present, there are still some gray areas in regards to the use of CBD in foods and cosmetics and the marketing of CBD.
The FDA’s stance on CBD regulations
According to an internal government letter released last week, the FDA suggested that CBD does not meet the criteria for a federally controlled drug.
In its initial report 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 FDA did not say that CBD should be considered a regulated prescription drug.
However, having stated that, the FDA isn’t 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.
When clinical investigations into CBD’s safety and efficacy as an antiseizure medication were initiated by GW Pharmaceuticals, makers of Epidiolex, the FDA began to assert that, under FDA rules, the compound could not be marketed as a dietary supplement. Marketers of CBD-rich hemp extracts beg to differ claiming that hemp-derived CBD was marketed before any substantial clinical investigations began.
(There were, indeed, earlier investigations into CBD’s medicinal benefits, but they were limited in number, preliminary in nature, and were never publicized.)
Furthermore, a number of other compounds which have been involved in clinical trials are commonly marketed as dietary supplements. These include trans-resveratrol, P5P [pyridoxal-5-phosphate] and DHEA [dehydroepiandrosterone].
The above issue aside, the FDA also claims that 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.
However, FDA spokeswoman, Corinne Newhart, said that the agency has not received or reviewed any GRAS notices for the use of CBD oil in foods, and referenced an FDA Q&A on marijuana, which outlines the agency’s position regarding CBD in foods and supplements.
The text she is referring to reads, “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. We have also concluded that CBD products are excluded from the dietary supplement definition, and therefore cannot be properly classified as dietary supplements.”
However, advocates still assert that this is merely a “Q&A” document and that it is incorrect because there is no ruling on the matter.
CV Sciences Inc. recently claimed that its hemp-derived CBD extracts had met rigorous “FDA safety guidelines,” including being self-affirmed as GRAS. However, the FDA could easily disagree with that assessment.
The latest rules describing the criteria for concluding that a substance is GRAS compliant were published in 2016. At that time, the FDA encouraged companies to inform the agency of GRAS conclusions through a notification procedure outlined in the final rule. However, a constituent update on the matter reads, “While the FDA can question the basis for an independent GRAS conclusion, whether notified or not and take action as appropriate, the notification procedure yields important information that aids the agency’s food safety monitoring efforts.” This implies that companies such as CV Sciences are not obligated to notify the FDA of their independent GRAS conclusions.
Furthermore, the few times the FDA received new dietary ingredient notifications for the use of CBD in a supplement, the agency has not taken any action to assess whether these companies meet the safety standards outlined in the Dietary Supplement Health and Education Act of 1994.
In 2017, Robert Durkin, an FDA official, responding to an NDIN filed by HoneyColony for its Superior Hemp Oil product, saying that the FDA concluded CBD products are excluded from the definition of a dietary supplement because, once again, “CBD has been authorized for investigations as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Prior to such authorization, [CBD] was not marketed as a dietary supplement or as a food.” This is patently untrue.
The agency did not, however, comment on the completeness or validity of the NDIN. But experts in the matter have suggested the two NDINs were rudimentary, and that that the agency would have objected to them had it reviewed the safety information to determine if they provided sufficient evidence to prove the products worthy of GRAS status.
Some experts in the industry also point out that the FDA’s position on CBD has not been made formal through any kind of rulemaking proceeding. Nor has the agency produced any guidance document on the issue.
The tide is turning
This all being said, unlike the DEA, the FDA has slowly but surely begun to see the light in regards to the medicinal benefits of cannabis. Although the FDA has, in the past, recommended that marijuana remain a Schedule I drug, at one point, the FDA recommended altering the scheduling system to “identify ways to encourage appropriate scientific research into the potential therapeutic benefits of marijuana and its constituents.”
Also, earlier this year, an anti-legalization group petition calling for further restrictions on cannabis was rejected by the FDA. Furthermore, during an interview earlier this month, FDA Commissioner Scott Gottlieb expressed support for the decriminalization of marijuana.
According to the FDA’s review of CBD, the compound does indeed have accepted medicinal use. Although they claimed CBD has a negligible potential for abuse, they added that its use could conceivably lead to limited physical dependence.
There are eight factors which weigh into the FDA’s decision when making scheduling recommendations. After considering those eight factors, the agency concluded that CBD alone “could be removed from control [under the CSA].”
The report stated, “We reach this conclusion because we find that CBD does not meet the criteria for placement in any of Schedules II, III, IV, or V under the CSA.”
As mentioned above, the DEA nixed this idea saying that it would violate international treaties. The FDA then came back and suggested that the scheduling of CBD should be “revisited promptly” if international treaty obligations change.
On that level, the UN-based World Health Organization has done a thorough investigation into the benefits and safety of CBD and has concluded that CBD has benefits for the world’s population, creating the possibility that international drug treaties could be revised in the coming years to exclude CBD.