CBD edibles for sale? Not so fast, says FDA.
CBD edibles seemed to be a slam dunk with the passing of the Farm Bill last year. Even Walmart sells products with CBD in it, although they don’t appear to sell edibles at the moment when you do a quick search on their website.
State governments also seem to be getting onboard this prohibition – Maine, North Carolina, New York and Ohio are among the states that have been reported as sending letters – or inspectors – out to small CBD edibles businesses and basically telling them to cease and desist, or risk facing legal action.
The FDA is also considering limiting the types of CBD supplements that can be sold, at least for the time being. A hearing has been scheduled for later this spring, but the surprise resignation of the department chief is throwing everything into limbo, with no way to know for sure if a hearing will actually be held as scheduled.
Does the FDA have actual authority to prevent sales?
It’s quite likely that they do – the Food, Drug and Cosmetics Act – FD&C for short – gives the FDA the power to regulate food, drugs, cosmetics and medical devices; the law was enacted in 1938, and if you’ve ever read Upton Sinclair’s The Jungle, then you know that it was desperately needed at the time, and judging from the sheer amount of crazy “one weird trick” products out there for sale, it’s still a good thing to have around.
The sticking point in this potential problem for CBD edibles makers – and anyone who deals in CBD products actually – is the fact that CBD is an active ingredient in an approved drug – Epidiolex – which is used to treat seizures in certain individuals. THC is also an active ingredient in a couple of other approved drugs, and it is also on the list of prohibited ingredients at the federal level.
Doesn’t the Farm Bill change all of this?
That depends on who you ask – and if it’s the FDA that you are asking, they don’t seem to think so.
The Agriculture Improvement Act of 2018 changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law. However, Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act and section 351 of the Public Health Service Act. Please see the FDA’s statement on the signing of the Agriculture Improvement Act of 2018.
So we are at yet another standoff between the states, the people, and the federal government. What is a complete unknown at the moment is whether or not the FDA, or specific states, intend to follow up with enforcement action against small business owners who are selling CBD edibles, tinctures, or other consumables.
As always, conspiracy theories abound, most of them centered around how big corporations – especially pharma – want to keep the CBD edibles and other products off the market while they create their own branded supplements, pet products, food products and various other items for distribution. It’s certainly not out of the realm of reality, and the sheer number of big (non pharma) companies who have a dog in this hunt includes giants like Atria, Constellation Brands, Molson Coors, Coca Cola and Inbev.
What should small CBD edibles businesses do in the meantime?
This is the time where we make it clear that we are not attorneys and definitely did not stay in a Holiday Inn Express last night. The nature of the business means that everyone in it gets bounced around between states and the federal government on a regular basis. What’s ok today might be illegal tomorrow and vice versa.
If you’re shipping CBD edibles or other products across state lines, now would also be the time where you should have a serious conversation with your own attorneys and see what input they have for you. Other than some embargoed product in NY, and some confiscated products in AZ, there’s not a lot out there to go on as far as solid evidence of how businesses are being treated on the individual level.
It’s possible that this will all blow over, or be legislated away, but it’s also hard to put trust in a government that can’t manage to keep its’ doors open from day to day, and seems to be constantly embroiled in one scandal after another. The wise option – as always – is to make sure that if you are in the CBD edibles business, or any type of CBD or THC business that doesn’t fall under the guise of medical cannabis, you make sure that your attorney is on a pre-paid retainer in case your assets are seized or frozen.
It’s also likely that banking for CBD edibles is going to become less available, and the rates will increase with the banks who are willing to take the risk. This is going to be especially serious for companies who are shipping product across state lines in finished form, and will likely hit pet products and tablet or capsule type supplement distributors next if there is no resolution.
Frankly we think that it’s completely crazy that Congress can pass a law making something legal but a government agency can claim that it’s still illegal.