On April 23, Texas’s Health and Human Services Commission proposed new rules to see “consumable hemp and hemp-derived products" such as hemp cannabidiol (CBD) regulated as food. Daniel Fabricant, PhD, CEO of the Natural Products Association (NPA; Washington, DC), explains that the new proposal in Texas would authorize CBD products to be sold where food is sold, no longer restricting it to being sold in dispensaries.
“Before, you could sell CBD within a hemp shop, such as in California and Colorado,” Fabricant explains. The new Texas proposal “is effectively making CBD a lawful commodity that you could have anywhere retail food is sold.”
This move by states to begin regulating hemp cannabinoids like CBD as food is a game changer, Fabricant explains. Most importantly, he says, it could lead to a patchwork of similar nationwide policies. Texas is the second state to propose state rules for CBD products. In April, Virginia Governor Ralph Northam signed a bill to classify hemp extracts as food. Fabricant says West Virginia has entertained similar proposals, but so far has not acted on them.
According to Fabricant, the fact that FDA at the federal level still does not authorize CBD consumable retail products has created a regulatory vacuum that states are now trying to fill themselves by releasing their own policy proposals. For instance, he says, it’s been nearly a year since FDA first held a public meeting to discuss regulatory issues related to cannabis compounds. “That was the end of last May,” Fabricant says. “Nothing’s happened since then.”
This inaction is now causing states to take matters into their own hands, Fabricant tells Nutritional Outlook. In an interview with the Associated Press following news of Virginia’s signed bill, Kyle Shreve, executive director of the Virginia Agribusiness Council, stated: “If the FDA does not start approving CBD products people are going to take them without regulation. That’s what the bill says, we are going to treat them like they are approved by the FDA so we can start regulating them.”
Fabricant says he expects more states in the coming months to start proposing their own CBD regulatory policies. “I think the dominos are going to start falling,” he says. “I think you’ll see more and more states follow suit because they realize there’s been a demand [for these products], they realize there’s an interest, and they also realize that FDA’s asleep at the wheel.”
Fabricant says that while he understands why states feel the need to act on their own, whether or not these state regulations are beneficial depends on what the regulations entail. “The devil is in the details,” he says. Of Texas’s regulations, which cover not only retail rules but also regulations related to manufacturing and testing, Fabricant says: “They seem fairly reasonable. The issue is how they are implemented.”
As states construct their own policies, there are numerous concerns including how complicated it will become for those who manufacture and sell CBD products to navigate a patchwork of regulations. Take testing standards, he says. “If Virginia is going to have a different set of testing standards or say, ‘Hey, you can only use this lab in Virginia,’ and Texas does the same thing, it’s going to be challenging.”
A regulatory patchwork will also impact consumers, who may have trouble making sense of the rules, he adds. “You could have labeling requirements for one state that you don’t have in another state. That’s going to make it crazy for consumers. How do they know what product is what?”
The ideal, he says, would be for FDA to issue federal regulations. “There should only be one set of rules. We don’t need a patchwork of 50 sets of rules,” Fabricant says. “That’s where there’s really an environment for confusion, and the consumer loses out.”
He continues: “We’ve really got to be careful on details because you could end up with really very different provisions in two different areas. So, we’ll look forward to working with the states. We certainly applaud and understand why they did what they did, because FDA’s just been completely slow, but ultimately, we’re going to need one set of standards on this. One set of rules…It’s time for FDA to get in the game and act, because otherwise I think you’re just going to see more and more states follow suit.”
FDA says that part of the reason it has not yet made a decision on whether to move forward with legalizing CBD supplements and food is that the agency believes there still is not enough safety data available to determine whether CBD is safe for human consumption, and at what usage level. Fabricant, however, points out that regulators in other countries, such as in areas of Europe, have already been able to set CBD policies based on existing science. NPA has been a vocal advocate asking FDA to set a safe consumer usage level for CBD.
“Some people’s argument is that if FDA gets it wrong, isn’t that just going to cripple the industry? They act like if they get it wrong, that there’s no way to resolve that issue,” Fabricant says.
He continues: “The science is the science. If people have the toxicological data, that’s the toxicological data. If the agency sets a level that people believe is too low or too high, someone could sue the agency. But is it set in stone? No. Again, this has to be a scientifically confronted issue. Can there be more science out there? Sure, there can always be more science out there. But what do we know right now about CBD and the exposure levels? We know a lot. There’s some good documents out there. The World Health Organization is one.”
“There’s enough science to make that decision,” Fabricant says. “We’ve already seen that in Europe, and so I don’t know why we’re not seeing it from our own government.”