How Carl’s Jr. Will Legally Sell a CBD Burger in Spite of FDA Disapproval

On 4/20, Denver residents can buy this burger for $4.20.

Carl's Jr.

Fast-food chain Carl’s Jr. announced on Wednesday that it will release a special 4/20-edition burger with a CBD-infused sauce. To those following the murky legality of cannabidiol, the minimally psychoactive active molecule found in hemp and marijuana, this news might come as a surprise: How can a national chain sell a product containing a substance with such an uncertain legal status?

"…adding CBD to both foods and dietary supplements in interstate commerce are both illegal."

Carl’s Jr., for its part, does not seem fazed by the fact that state and local health authorities cracked down on CBD in multiple regions of the United States earlier this year. Its special-edition Rocky Mountain High: CheeseBurger Delight, which will only be available in one Denver store on 4/20, will slather two beef patties, pickled jalapenos, and waffle fries with a special version of the restaurant’s Santa Fe sauce containing 5 mg of CBD, a relatively low dose. A spokesperson for the company told Inverse:

Part of our strategy centers around being the first quick service restaurant bringing bold and unexpected flavors to the masses. CBD is one of the hottest culinary trends right now, and what better place to test this new burger than in Denver, a city that has been a trailblazer in the CBD movement.
We’re currently testing this product at our Colorado restaurant and are certainly looking for more ways to introduce craveable flavors to our menu.

But regarding the CBD burger, a Food and Drug Administration spokesperson clarified to Inverse that “adding CBD to both foods and dietary supplements in interstate commerce are both illegal.”

The Carl’s Jr. Rocky Mountain High: CheeseBurger Delight will contain 5mg of CBD.

Carl's Jr.

CBD edibles like gummies, lattes, and chocolates are widely available online and in stores across the United States, but FDA messages like this one and this year’s early crackdowns — in which officials banned sales of CBD-containing foods in multiple parts of the country — created a lot of confusion about its legal status. As Inverse outlines below, it appears that Carl’s Jr. and other manufacturers of CBD products are not exactly working in compliance with the FDA, but recent events raise further questions about whether the FDA will enforce its own rules.

The Farm Bill

For most CBD manufacturers and vendors, the Agricultural Improvement Act of 2018 — commonly known as the Farm Bill — marked the dawn of a new age of prosperity when the federal bill was passed in December 2018.

The Farm Bill legalized the interstate sale of hemp, from which CBD can be extracted. Unlike its relative, the marijuana plant, hemp and its derivatives are not classified as Schedule I drugs. Under this bill, industrial hemp must contain less than 0.3 percent tetrahydrocannabinol (THC), the psychoactive compound in cannabis.

The bill has allowed the CBD industry to flourish. “There’s a lot of interest in the CBD space, and with the Farm Bill passing, which legalized hemp production across the country, that’s obviously got everybody really excited about where it’s going,” Smoke Wallin (his real name), the CEO of a CBD product manufacturer called Vertical Wellness, Inc., tells Inverse.

The Farm Bill legalized industrial hemp, which must contain less than 0.3 percent THC.

Flickr / blumenbiene

The 2019 Crackdown

But in January, shortly after the Farm Bill was passed, state and local public health authorities across the US started cracking down on foods that contained CBD, ordering bakeries, coffee shops, bars, and restaurants to “embargo” their products from sale. In a few cases, criminal charges were filed.

In January, Wyoming lawmakers killed a bill that would have decriminalized CBD, and a Nebraska man briefly faced drug dealing charges for selling CBD.

In February, Maine food safety officials banned the addiiton of CBD to food, as did officials in New York City and Ohio. Florida and Georgia followed suit. In Idaho, state police seized a shipment of 7,000 pounds of industrial hemp, claiming that even the 0.3-percent THC content that’s legal under federal law is higher than the zero percent allowed under Idaho law.

This multi-state tightening of restrictions left business owners and individuals feeling confused and uncertain about the legal status of CBD. As various state and local governments embargoed edible CBD products or outright seized hemp shipments, the FDA offered little insight on the future of CBD.

To make matters more confusing, regulators involved in the crackdowns of Maine, Ohio, and New York City cited a crucial FDA rule — even though they themselves were local officials operating at the state or city level. They referred to the federal Food, Drug, & Cosmetic Act, which was central to their ability to crack down on food-based CBD products because it prohibits prescription drugs from being added to food products. And because CBD is the main ingredient in an anti-seizure drug called Epidiolex, it can be classified as a prescription drug. Confusingly, in these three regions, officials embargoed food products while mostly ignoring supplements, even though they both run afoul of the FD&C Act.

The FDA confirmed that it had consulted with state regulators during the local crackdowns. “There is ongoing communication with state and local officials to answer questions about the requirements under the FD&C Act, to better understand the landscape at the state level, and to otherwise engage with our state/local regulatory partners,” an FDA spokesperson told Inverse in February.

Wallin acknowledges that the Farm Bill was never going to be the beginning and the end of the golden age of CBD. “It’s not as simple as, ‘now it passed and now it’s going to be everywhere,’ because there’s been a crackdown since the passing, and we think that’s a normal, logical, and necessary step,” he says.

Just one hydroxyl group distinguishes THC from CBD

Analytical Cannabis 

Where Is the FDA?

As the multi-state crackdowns occurred within just a few weeks of each other, the FDA maintained that its role was just one of support and advice to local officials and would not comment on whether it coordinated the crackdown.

In the time since those embargoes and seizures, things have calmed down considerably. The FDA remained mostly silent regarding CBD until early April, when it announced that the first public hearing on the matter will take place at the end of May. In a statement released at that time, the FDA expressed its willingness to figure out how CBD can be safely distributed and sold.

For now, CBD itself is legal for interstate commerce under the Farm Bill, but supplements and food containing CBD are still illegal under the FD&C Act. The FDA doesn’t appear to be doing anything independently to enforce these regulations, but it has given state and local regulators enough knowledge to crack down on CBD where they see fit. The enforcement of the FD&C rule by those regulators, however, remains variable.

Without Federal Guidance, CBD Is the “Wild West”

In spite of the crackdowns, some aspects of the CBD industry have continued to thrive, and some business owners have taken it upon themselves to self-regulate CBD.

In January, Missouri regulators announced they had no authority to regulate THC-free CBD oil in alcoholic beverages, and Michigan officially legalized CBD. Illinois lawmakers are moving forward with plans to legalize hemp, and Indiana will soon host CBD retail stores. Montana lawmakers are pushing bills to incentivize hemp farming. Even more recently, the Iowa Board of Medicine expanded medical uses for CBD on Friday. On Wednesday, the nationwide retail chain Vitamin Shoppe announced it would start selling CBD products.

"In a lot of industries, you can trust the supply chain. In this industry, you can’t."

Some CBD industry figures welcome government scrutiny and regulation as a way to rein in a grey- and black-market industry that has a bad track record when it comes to transparency and consistency. A 2017 JAMA study of commercially available CBD products revealed that the amount of CBD they contained widely varied —and some even contained THC. Only 31 percent of the products tested contained anywhere close to the dose indicated on the label.

Wallin likens the state of the CBD industry in early 2019 to the “Wild West,” noting the existence of unscrupulous manufacturers. If the FDA is the sheriff, he’s nowhere to be seen.

“Knowing where your hemp was grown, what happened along the process, is really important to credibility for the whole industry,” says Wallin, noting that his company provides access to test results for specific product batches via QR code — an increasingly popular tactic among reputable brands. “In a lot of industries, you can trust the supply chain. In this industry, you can’t.”

“We obviously aren’t bound to follow any regulations at this point, but when we founded the company, we wanted to do things right, so we produce our product in an FDA-regulated facility,” Matt Kennicott, co-founder of Glo CBD, told Inverse.

CBD isn't just marketed to humans.

Stack Commerce

Steven Phan, the founder of New York City CBD retailer Come Back Daily, is similarly ready for regulation and is not worried about the CBD crackdown. “I’m not as critical about what’s happening because I think it’s necessary,” he told Inverse in February. “We’re signing off on things that are being put into people’s bodies, and that means regulation is necessary. I welcome it.”

Wallin and Kennicott believe that Congress didn’t pass the Farm Bill just to make CBD illegal and are confident that the FDA will ultimately help the industry develop a regulatory regime. The rules the FDA comes up with are “probably going to be similar to what we’re already doing with over-the-counter pharmaceutical production,” predicts Kennicott.

CBD does not have the same intoxicating effects as THC, but the FDA still doesn't quite know how to regulate it.


CBD, Consumers, and Carl’s Jr.

In Denver, the weed-friendly city where the Rocky Mountain High: CheeseBurger Delight will be sold, the likelihood of state or local regulators intervening seems slim. When it comes to food products containing CBD, the FDA has seemed content to leave regulation up to local authorities.

In response to Inverse’s questions about the burger, an FDA spokesperson referred to a recent annoucement reiterating the agency’s past statement on adding CBD to food or drinks for interstate commerce. However, they also noted that “there are 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 further clinical study of the relevant drug substance.”

So, even if Carl’s Jr.’s 4/20 promotion is running afoul of the FDA, the regulator has its reasons not to enforce its own rules.

Based on the FDA’s recent inaction toward Carl’s Jr., not to mention all the stores and restaurants still selling CBD products all over the US, it seems that stockpiling CBD won’t be necessary for people in most US states. However, it remains unclear when the sheriff will show up — or what the sheriff will do when he arrives.

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