Dear Umesh,
I was hoping to get a prescription for edibles, but I have heard they are set to be banned. Is this true, and if so, why?
This is a question that has popped up recently, and it’s a fair question, especially when products go temporarily out of stock, or when rumours fly around that the Medicines and Healthcare products Regulatory Agency (MHRA) won’t approve new products because they “look like sweets.”
Stock issues were down to an equipment failure at the UK’s main cannabis pastille manufacturer.
And the other rumour? As is often the case in healthcare regulation, vacuums get filled with misinformation. As I am always saying when pressed, “where there is an information void, it’s normally filled in with crap”.
Cannabis regulation seems particularly vulnerable to that. The MHRA does not help itself by not offering information. Albeit they [The MHRA] would be right in saying that they are a regulator ensuring medicines/patient safety and not a PR firm.
The reality is more technical and far less dramatic.
We can start by asking the question, “What do you mean by an edible?”
Because that’s where the confusion starts. In the recreational market, “edibles” means brownies, gummies, sweets, chocolates; any kind of cannabis infused food. It’s a lifestyle term. A consumer term.
But in medicine, an edible doesn’t exist.
It’s not a recognised pharmaceutical dosage form. It doesn’t appear in the British Pharmacopoeia. It’s not defined in the Human Medicines Regulations 2012.
So when someone asks whether edibles are being banned, my slightly awkward but honest answer is: You can’t ban something that doesn’t exist in regulatory language.
“But hang on, people are prescribed pastilles. Aren’t those edibles?”
This is where terminology really matters. UK regulations use very specific classifications for medicine forms:
- Tablets
- Capsules
- Oral solutions
- Oral suspensions
- Pastilles
- Lozenges
- Oromucosal sprays
- Modified-release preparations
Each of those has defined manufacturing standards. Defined stability requirements. Defined dosing accuracy. Incidentally, under the definition of a CBPM, dried cannabis flower may qualify if it: Is produced for medicinal use in humans; is a medicinal product or ingredient of one; and is supplied under appropriate prescription controls.
Let’s talk about gummies
When I speak with Canadian manufacturers, they often use the word “gummy.” I have to interrupt gently and say, “You mean pastille?”
A pastille is an established pharmaceutical form. A pastille is a soft, medicated product designed to dissolve slowly in the mouth, releasing an active ingredient in a controlled and measurable way. This distinction may seem minor, gummy versus pastille, but it matters in regulation and patient safety.
In contrast, gummies are not a recognised pharmaceutical dosage form. Gummies are chewy, gelatin-based sweets designed as confectionery. They are brightly coloured, shaped like bears or other fun forms, and are made for recreational consumption, not for medical dosing.
Simply put, gummies are not approved medicinal dosage forms.
All CBPMs must fit within recognised pharmaceutical formats under both the Human Medicines Regulations 2012 and the Misuse of Drugs Regulations 2001.
That means oils, capsules, tablets, pastilles, and dried flower for vaporisation.
If someone were to manufacture a cannabis brownie and try to supply it as a medicine, they would immediately run into questions like:
- Where is the validated assay?
- How is dose uniformity assured?
- What are the degradation pathways?
- What is the shelf-life?
- Is there microbial stability data?
This isn’t a judgment or dismissal of edible cannabis products; it’s simply about pharmaceutical oversight.
“But people eat their medicine, doesn’t that make it edible?”
In a literal sense, yes. A capsule is swallowed. An oil is ingested. But those are recognised medicinal forms with established standards.
The difference isn’t whether you chew or swallow something. The difference is whether it is manufactured and classified as a medicine.
While we’re here, let’s address smoking again
Some readers pushed back on my last article about smoking, questioning the legality of smoking cannabis and the regulations that make smoking medical cannabis illegal, even if it is obtained using the legal route. This topic neatly correlates with why edibles are not allowed.
Dry flower is recognised as a pharmaceutical form as long as it is intended for administration via a medical vaporiser (not combustion), as combustion (or smoking) is not recognised as a route of administration for medical products. In the same way as gummies and edibles are not a recognised dosage form for a Prescription Only Medicine.
Smoking cannabis with or without tobacco is illegal, as it is not a recognised route of administration. Allied to that, under the Misuse of Drugs Regulations 2001 (MDR 2001), the combustion of CBPMs is not permissible and is one of the strict criteria used to define CBPMs. If smoked, the CBPM reverts from being a medical cannabis (Schedule 2, Class B drug) to illegal cannabis (Schedule 1, Class B) and therefore illegal.
Regulation 16A of the MDR 2001, paragraph (3) of the new Regulation, is the specific clause in the regulations that prohibits smoking as a route of administration for legally prescribed cannabis products, as inserted by SI 2018/1055:
“A person shall not self-administer a cannabis-based product for medicinal use in humans by the smoking of the product”
That’s not simply an interpretation; that is the law, as written. Combustion is not a recognised medicinal route of administration. Vaporisation is. Smoking is not. It’s the same principle we’ve just discussed with edibles.
If it isn’t a recognised dosage form or route of administration within the medicinal framework, it doesn’t qualify as lawful medical use.
So, what’s really happening with edibles pastilles?
There is no secret ban or quiet crackdown. There is simply a regulatory framework that is often misunderstood.
In UK medicines law, terminology matters. The term edible belongs to the recreational market and is not recognised in the pharmaceutical market.
Pastilles that adhere to pharmaceutical regulations are not going anywhere. Pastilles have been around since the 17th Century, made by apothecaries using herbs and sugar for throat, respiratory and digestive conditions.
In 1864, the first edition of the British Pharmacopoeia was published. Medicated lozenges (troches) were included as official preparations. What we now call pastilles were essentially soft lozenges made with gelatin, gum, or sugar bases. This formulation has been with us for over 150 years and will be with us for probably another 150 years or more.
There was a brief lull in the supply of pastilles in the UK, due to equipment failure. Currently, there is only one UK manufacturer of medical cannabis pastilles. That machine is now fixed, and production is back to normal. I can attest to this, as we have been dispensing them for the past couple of months and are seeing an increase in demand for them.
If you’re wondering whether you’ll see more pastille options soon? Probably, given that several importers are working through the approval process. But, the timeline depends on MHRA reviews, with some of the problems being that gummies reframed as pastilles do not adhere to some of our UK/EU standards on additives such as colouring, flavours and other non-health-based ingredients. The MHRA are here to ensure patient safety and not convenience.
