If you are reading this article while eating your favorite CBD energy bar (or whatever your CBD snack of choice is), it may surprise you to learn that according to the Food and Drug Administration, “CBD cannot be added to food for humans or animals.”
Interesting. What gives? And how might this new legislation change things for the CBD industry?
Well, for starters, clearly CBD is already being added to food. That has been happening at least since the passing of the 2018 Farm Bill (which legalized hemp and CBD products). In fact, the market for CBD-infused food has grown massively in the last couple of years, despite the, shall we say, regulatory uncertainty over the practice of adding CBD to food.
So what’s the big deal about adding CBD to food when we can clearly take it in oil form?
According to the FDA, the problem lies with the fact that CBD is the active ingredient in an FDA-approved pharmaceutical drug, Epidiolex. The approval of this drug for difficult-to-treat epilepsy was widely celebrated by the CBD industry, but it has created problems as well.
According to the Federal Food, Drug, and Cosmetic Act, once a substance has been approved for use in a pharmaceutical drug, it can no longer be classified as a suitable additive for food or drink for humans. In principle, the logic makes sense. There are lots of pharmaceutical substances we don’t want added willy nilly to our groceries.
However, the CBD industry argues that the rule becomes arbitrary and unhelpful when CBD has already been legalized. If it is legal in oil form, how can it not be legal to add that oil to food or drink?
While the FDA has never penalized companies that sell CBD-infused food or beverages, the lack of regulatory clarity has created huge problems for the CBD industry.
That’s been the argument of the companies that have continued to meet the growing market demand for CBD-infused food and beverages. And since the FDA has continued to drag its feet on publishing its regulatory framework for CBD, these companies have continued to produce and sell their products. So far, the FDA hasn’t penalized them.
But the lack of clarity has had a huge impact on the CBD industry nonetheless. For companies looking for outside funding, having a cloud of uncertainty (regarding future regulation) hanging over your company creates enormous obstacles.
The new legislation, however, would insert an exclusion clause into several sections of the Federal Food, Drug, and Cosmetic Act. This would explicitly exempt “hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp” from rules prohibiting its use in food or drink.
Senator Ron Wyden (D-OR), who drafted the bill hopes the legislation will make things easier for the CBD industry:
“CBD products are legally being used and produced across the nation. Yet because the FDA has failed to update its regulations, consumers and producers remain in a regulatory gray zone,” Wyden said in a press release. “It’s been more than two years since I worked with colleagues to have Congress legalize hemp and hemp-derived products. It’s long past time for the FDA to get with the program, for the sake of American consumers and farmers.”
In a statement, Rand Paul, a Republican co-sponsor of the bill, makes the argument that CBD businesses have been treated unfairly by the FDA: “Hemp-derived CBD products and businesses have earned their recognition in the marketplace, but the FDA, unfortunately, hasn’t treated them like any other food additive or dietary supplement.” According to Paul, the proposed legislation “provides a huge relief to hemp farmers, processors, and merchants.”
The Hemp Roundtable, a hemp lobbying group, has enthusiastically backed the legislation as well: “This bill…will help stabilize hemp markets, open a promising economic opportunity for U.S. farmers, and protect consumers by requiring hemp extract product manufacturers to comply with the entire existing comprehensive regulatory framework for ingestible products.”
That last point is probably the most important takeaway for consumers. The longer the CBD industry remains outside the regulatory framework for other ingestible products, the longer dodgy, badly formulated, unregulated products sit on the shelves next to high-quality ones.
If this new bill is passed into law, the CBD industry will enter a new phase of legitimacy in which it is held to the same standards as other ingestible products.