The FDA & CBD

 

CBD has quickly become a big thing in mainstream medicine. It seems everyone is either eating it, vaping it, drinking it, or smoking it. Which seems out of place, considering the FDA hasn’t approved it for human consumption.

 

There’s a lot of confusion regarding this, and rightly so. This article will simplify the laws down into basic language, but bear with me because there’s a lot to unpack. If there’s one thing I learned, it’s that every answer leads to two new questions. However, this information is critical to know for anyone interested in the CBD industry.

 

The first piece of information we need to understand is the Agricultural Improvement Act of 2018 – or, the 2018 Farm Bill. This bill has made huge headlines in the CBD industry since last December when it was passed. It made cultivating, transporting, and selling hemp and hemp-derived products legal in all 50 states. It also removed hemp and hemp products from their Schedule 1 drug status^[1].

 

It seems this would imply CBD is legal now, too.  But that’s where the confusion comes in.

 

It’s true that CBD is legal – as long as it’s only derived from hemp that was grown compliantly with the bill. To qualify, states have to submit a cultivation plan to the USDA for approval^[2], and all subsequent hemp and hemp products must be under the legal THC limit of 0.3%.

 

But this doesn’t mean CBD is legalized on a general scale, or CBD derived from marijuana cultivators. Still, it’s easy to assume that a CBD edible derived from compliant hemp, and under the THC limit, is good to go.

 

Scott Gottlieb, the former head of the FDA, tells us otherwise in the press speech he delivered shortly after the bill was passed^[3]. In addition to explaining why the FDA is so strict, I found that his speech addressed the biggest concern in the CBD industry – low-quality products and misleading information.

 

Gottlieb expressed his concern about those infamous CBD labels that claim the product has medicinal effects. Such labeling makes those products liable to be considered new drugs, even if it’s for marketing or promotional motives.

A new drug is any product that claims to cure, mitigate, treat, diagnose, or prevent. This includes any food or dietary supplement that contains it. All new drugs must go through the FDA’s approval process before they can be sold to the public.

 

Gottlieb states it’s the FDA’s responsibility to treat CBD as any other product or substance. Fair enough. But then Gottlieb goes on to release another piece of information that suggests the real motive as to why CBD as a new drug is having such a hard time getting approved.

 

“It’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs”

 

What he’s saying here is both CBD and THC are active ingredients in an FDA-approved drug – Epidiolex, which is a medication for rare and severe forms of epilepsy^[4].  And under the Federal Drug and Cosmetic Act Gottlieb refers to, it’s illegal to put any ingredients used in a drug into food.

 

So, all hemp-derived CBD products are legal except those made for consumption. Though I do want to note that oils, proteins, and hulls from hemp seeds are good to go since they contain neither THC or CBD.

 

But that doesn’t change the fact that CBD edibles are still being produced left and right. I noticed Gottlieb said it's unlawful to introduce CBD edibles into “interstate commerce.” Does that have something to do with it? Can a state produce and sell CBD infused items within their own jurisdiction?

 

After a tedious investigation, I found that, theoretically, CBD edibles can be sold within the same state they were produced. It’s not sanctioned, but not necessarily illegal^[5].

 

Imagine it like recreational marijuana. Marijuana is legal on some state levels, but illegal on the federal level. Business and consumers risk the federal government coming in and overriding their state law at any time, however unlikely that may be.

 

After the passing of the bill, many states who hadn’t any laws in place regarding CBD edibles adopted the same direction as the FDA. Other states, like California, rewrote their CBD laws to comply as well. ^[6]

 

It seems compliance is getting a lot of emphasis in CBD. That’s good since compliance will lead to more agreeable regulations. But with all these products in circulation that aren’t compliant by their edible nature, what enforcement is the FDA inflicting to enforce compliance?

 

Besides issuing warning letters that advise companies their product was found to be in violation of the FD&C Act, there have been penalties in the form of hefty fines, and state embargoes^[7]. There are many factors the FDA considers when a product is found to violate the FD&C Act. Unfortunately, those factors are not defined:

 

“Those factors include, among other things, agency resources and the threat to public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action^[8].”

 

The vaguity clearly shows why there is rampant confusion and – as a result – violations. This makes it expensive for the business, and potentially dangerous for the consumer.

 

But if the FDA and business’ alike are serious about helping the populace and not just making money, is there a way for companies to get approval to legally market and sell their CBD edibles? And how did drugs like Epidiolex get approval, and are there any others out there like it?

 

It’s already been established that adding CBD into food or dietary supplements is in violation of the FD&C Act, and therefore must be approved as a new drug. But the process of getting approved as a new drug is complicated, lengthy, and expensive. This implies why only massive pharmaceutical companies like GW Pharmaceuticals, who made Epidiolex, have succeeded.

 

Essentially, the process is proving to the FDA that you did your homework and are serious about health and compliance. A company will need to file a new drug application to the FDA, and if it’s marijuana that they’re researching, they must register with the DEA^[9].  From there they must submit all clinical and non-clinical data to the FDA for approval to pass the three clinical trial phases.

 

Besides Epidiolex and Sativex (another drug by GW Pharmaceuticals for cancer patients), the FDA has approved three other drugs – Marinol, Cesamet, and Syndros ^[10]. They were approved in 1985 for chemotherapy patients, and for weight loss relating to anorexia and AIDS. All three of these drugs are composed of dronabinol, which is a synthetic THC.

 

The FDA wants to see what’s been shown to be effective, which patients are benefited, adverse effects, consumption method, recommended dosage, and how it’s made. But most importantly, they want to see consistency.

 

But consistency is challenging when it comes to botanicals. Nature doesn’t like being controlled. In 1999, the Institute of Medicine even stated that if marijuana has a medicinal future, it will be from its isolated components, cannabinoids, and synthetic derivatives. Twenty years later, we’re the truth to this statement.

 

For anyone seriously interested in the CBD industry, thorough research and an understanding of the laws is critical. The key is looking to where things are going, not where they are. If the investment in resources is made towards getting approval, when the FDA does come in with rigid enforcement, you’ll be in a position to show you’ve taken the initiative to minimize the risks to consumers. And if you’re a consumer, it’s in your best interest to hold the companies accountable as well.

 

 

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