Adact Medical’s History in CBD
Our Journey into CBD
Adact Medical has a long history of working with CBD. Damien the Chief Regulatory Officer at Adact was in the business of contract manufacturing supplements, liquids and E-liquids when he was approached in 2014 to make a CBD vape product. After satisfying himself that the substance extracted from industrial hemp was not illegal, and we received a confirmation letter from the Home Office, whose main concern was the same as it is today, THC and CBN levels. We set about formulating the first CBD vape in the UK market. We did not invent CBD vape as they had been introduced to the USA market a few months before.
Fast forward to the end of 2016 when the MHRA effectively banned non licensed sales of CBD products the story went quiet until September 2017 when the MHRA published clarification that re-opened the market for unlicensed sales provided medical claims are not made, and Adact was once again engaged by companies for testing, validation of supply chains and helping companies formulate new products. Having ceased involvement in contract manufacturing in 2015, we concern ourselves with compliance, product development and the development of new extraction techniques.
CBD product testing: what you need to know.
As we conduct CBD product testing for a lot of companies we have seen some common issues cropping up, the first trend we see is just as you think it might be, when customers send us their own products to test we find the CBD levels are pretty much where they should be, but when companies send us somebody else’s products to test we find that the levels can often be lower than they should be. We put this down to companies that go to the trouble of getting products tested are more likely to get their manufacturing correct. You may have your own theory.
Another issue that we have seen more often than we would like, is with vape products, when we test a vape product and can’t find any cannabinoids at all, yet the product is reported to be effective, ‘its very good this, gives a real buzz’ we conclude that these products contain artificial cannabinoids, other wise known as liquid spice. We get about one a month like this. There are stockpiles of artificial cannabinoids around the world left over from them being widely banned. These stockpiles find there way into CBD vapes. CBD should not be giving you a buzz.
We do see products that have high levels of CBD and CBN in them, these products are illegal under the controlled drugs act.
The other thing to note about cannabinoid testing most testing is a single test and gives you a good idea of CBD and other cannabinoids levels, however in order to be accurate the testing needs to be done in triplicate and the results averaged, this obvious increases the cost of testing. This is why you need to look at single tests with the benefit of the doubt, they are good for quickly establishing product quality. Where results are borderline, you need to do triplicate testing.
When we test final products its often shown that the THC and CBN levels are bellow 0.05%, however this does not demonstrate that the product is legal to sell. Lets for argument sake talk about a 10ml oil drop with 0.05% THC in, 10ml x 0.96 (the specific gravity of MCT) would have 9.6gm or 9600mg 0.05% of this is 4.8mg which is nearly 5 times the legal limit of THC. The legal limit is 1mg in the final packaged product. As the limit of detection is usually between 0.05 and 0.03 you need to test the raw material and then calculate your levels to finished product, this compliments the final product testing.
This is also true of products like drinks that are high volume with a small amount of CBD in them, Limits of Detection can make standard analysis very difficult.
Supply Chain Visibility
When you bring on a new supplier you need to be sure heavy metal and pesticide analysis has been done. In a pharmaceutical world this testing would be done on every batch initially, with some relaxation once a track record of good results has been seen. But for supplements you need to at least do it once a year or once per harvest. You can only be sure that this is done if you can be sure of the origin of your CBD? If your buying through a broker, which most people are you need to be sure that the source of your CBD is the same if your relying on past results to use current batches. Has your supplier changed the source of material, does your broker even know.
There is no substitute to knowing your supply chain and the providence of your product. If your broker is unable to support that then you need to be doing more work on your supply chain.
Supply chain and GAHP (good agricultural and harvesting practice) standards are critical to maintaining product quality, it’s a big subject so we will leave it there for now.
What material can I use?
There are many different terms for CBD (and hemp) extracts. If you don’t want to fall foul of the Novel Foods Legislation you need to be using the correct materials:
- CBD isolate – cant be used in food products without submitting a novel food application (which nobody has done) but can be used in vape and cosmetic products.
- Full Spectrum – depending on how it is extracted may but suitable for food use, if its extracted via C02 you are boarderline but it may be over-processed so fall foul of the novel foods regulation
- Full Spectrum – distillation extraction, good for food use
The rules in this area are Grey, however the Food Standards Agency will be publishing rules on it in 2019/2020, then we will all have clarity.
Cosmetics are tricky, they need to be safety assessed, have stability studies done and the technical file presented to the European Cosmetics Portal, very few of the cosmetic products being sold in the EU have been subject to this process so should not be sold.
I have bounced through the regulation and compliance, there is a lot to discuss so get in touch, or come and see us the CBD & Hemp Expo, we can help you navigate the CBD landscape. www.adactmedical.com