CBD Oil – Uses and Regulation
Launching a new product containing CBD Oil? In this post we outline the uses of CBD Oil, its current and future regulation and best practice for companies seeking to launch new products containing Cannabidiol (CBD).
The CBD based products market is growing rapidly. It has been estimated that the market size will increase to more than $20 Billion by 2025 from $270 Million in 2018. Regulation is rapidly being brought in to protect consumers from spurious claims. Brands and manufacturers will need to anticipate the requirement for effective testing of products containing CBD.
What is CBD Oil?
Cannabidiol or CBD is a chemical compound derived from the cannabis plant family (the two most commonly known plants being marijuana and hemp). CBD is one of over 100 identified cannabinoids in cannabis plants. The Hemp plant accounts for up to 40% of the plants’ CBD extract.
CBD is the second most prevalent of the active ingredients of a marijuana or hemp plant after Tetrahydrocannabinol or THC. THC is a psychoactive compound and accounts for up to 40% of marijuana plants’ total extract. CBD, however, has no psychoactive effects.
CBD Oil Regulation in the USA
In the United States the 2018 Farm Bill lifted a federal ban on hemp production, this is significant because it had previously classified hemp as a controlled substance on-par with heroin. The lifting of the ban has meant CBD oil containing less than 0.3% THC is now legal.
The bill also preserves the FDA’s authority to regulate any product containing cannabis or cannabis-derived compounds, meaning they are subject to the same authorities and requirements as other FDA-regulated products.
A source of confusion for CBD cosmetics and skincare brands is such that under the Food Drug & Cosmetic act, cosmetic products and their ingredients(unlike food and drugs) do not require pre-market approval by the FDA.
The FDA is still working to create an official regulatory pathway for brands who wish to be compliant and market their CBD products lawfully. In the meantime, brands can include CBD in their cosmetics products once they can substantiate any claims made and do not market them as medicines.
CBD Oil Regulation in the EU
The EU has recently taken steps to control the rapid growth of new cosmetic and personal care products containing CBD. Rule 21 of the 2017 EU MDR 2017/745 (medical devices directive) means that products such as cosmetics and skincare containing ingredients which are absorbed into the skin are classified as a medical device. As such these require strict clinical testing and proof of efficacy. There are also standards in place through EU Regulation 1223/2009 (Cosmetics Regulation) whereby any substance included in a cosmetic product must be fully tested for safety in human use.
Annex II of that regulation sets out a list of substances which are prohibited for use in cosmetics. Cannabis is one of these substances as it is classified as a drug. However, this classification is limited to the flower or flowering buds from the plant. Seeds and leaves of the plant are not prohibited once they are not accompanied by parts of the flower.
From the current EU regulatory perspective CBD is therefore permitted for use in skincare and cosmetics products when it has been obtained from cannabis, cannabis resin, cannabis tinctures and cannabis extracts from the seeds and leaves.
What claims are currently being made about CBD?
Marijuana and Hemp have been used for millennia to alleviate pain and inflammation, but scientists have only recently been allowed to study the medicinal properties of CBD as laws loosened on hemp and marijuana production in the US and EU.
Both the EU and US are clamping down on what are regarded as exaggerated or “spurious” claims (e.g. CBD/THC “curing cancer” or its ability to “reduce the onset of Alzheimer’s”) which lack rigorous scientific research. This may cause issues in the future for companies who do not take steps to ensure they have complete proof of what they claim their products can do, and who do not act within regulations set out by the FDA and the EU.
How does CBD Oil work?
The human body contains the endocannabinoid system or ECS which regulates a variety of functions including sleep, appetite, pain and immune system responses. The body produces endocannabinoids which are neurotransmitters that bind the cannabinoids in the nervous system.
There are many ailments that are either already proven to respond positively to Cannabidiol (CBD) and others which have shown early markers of the same.
Recent scientific studies have shown that CBD oil may be used to help treat acne, due to its anti-inflammatory properties and ability to reduce sebum production. Acne is believed to affect almost 10% of the worlds’ population. It is widely understood to be caused by several factors including genetics, bacteria, underlying inflammation and over production of sebum. Further studies are now required to determine the efficacy and safety of CBD use in treating acne.
Psoriasis is an auto-immune disease for which scientists have not been able to determine the exact root cause. It is characterised by areas of inflamed red skin, plaques, which are covered by a layer of sliver-white scales. Research has confirmed the positive effect of cannabinoids in the treatment of psoriasis through CBD oil in topical creams. Cannabinoids have anti-inflammatory effects and inhibit the growth of keratinocytes – cells which renew the epidermis with new cells. These keratinocytes are produced too quickly in psoriasis sufferers.
Seborrheic dermatitis occurs as a result of excessive secretion of tallow from the sebaceous glands and because of excessive reproduction of skin cells caused by the malassezia fungus. Clinical studies have shown that the CBD molecule reduces the secretion of tallow from the sebaceous glands and inhibits the rapid reproduction of sebocytes; cells that make up the sebaceous glands.
Eczema, like other skin conditions, can be chronic and pervasive. It is often tied to an underlying bacterial colonisation of the skin yet is also very similar to psoriasis given its roots in auto-immunity. Eczema presents itself as red, dry, itchy skin which sometimes seeps or produces a crusted-over appearance. It is most commonly found behind the knees, hands, ankles, feet and wrists. Various studies have shown that CBD can be seen to support and protect the skins’ barrier function as well as the skins’ delicate balance of bacteria on the surface. While it will not treat all causes of an eczema “flare” it can help soothe and reduce the inflammation.
5. CHRONIC PAIN RELIEF
Studies have shown that CBD may help reduce chronic pain such as Rheumatoid Arthritis and Fibromyalgia. It works by impacting endocannabinoid receptor activity, reducing inflammation and interacting with neurotransmitters to offer pain relief.
Future Regulation and CBD
Regulators in both Europe and the US are looking more closely at the market for food and cosmetic products which contain CBD and are stepping up actions against companies selling CBD products that make spurious or “over the line” claims on their products.
Since CBD is not traditionally part of the cosmetic product function, companies should take care not to make medical claims when making product claims. If in future CBD is reclassified as a medical product that will bring further scrutiny to any such claims being made.
According to a recent CNBC article companies have recently received warning letters from the FDA for allegedly “illegally selling” CBD products. They made “unsubstantiated claims” that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and anxiety.
One such company saw their share price fell more than 6% in trading the day after the news of receipt of their warning broke.
At the time of writing, other than Epidiolex, a drug derived from CBD to treat severe forms of childhood epilepsy, the FDA has not approved any CBD drugs and prohibits companies from making unproven claims about CBD and its benefits.
European regulators may be a bit behind the US in terms of implementing legislation, but the recent reclassification of CBD as a Novel Food suggests they are also looking to regulate quickly and will quickly turn their attention to cosmetics.
Labskin’s CBD expertise
Labskin is a full thickness human skin equivalent incorporating fully-differentiated dermal and epidermal components that functionally models skin. Labskin allows customers to carry out high quality skin research and testing.
Labskin has specific expertise in CBD:
- 2018 – Successfully proved that CBD demonstrated anti-microbial and anti-inflammatory effects in skin-care formulations for group company cosmetic products (Stoer brand).
- 2019 – Validation of CBD expertise by successfully testing CBD infused female hygiene products for a commercial customer.
- 2019/20 – Test program for CBD personal products for a commercial customer.
- 2020 – Pharma grade CBD oil is available via group partner company Cellulac, with whom we are testing CBD effectiveness for wound care.
Standard tests for topical CBD product evaluation on inoculated Labskin include:
- Antimicrobial effect of test materials on Staphylococcus aureus inoculated Labskin.
- Antifungal effect of test materials on Trichophyton rubrum inoculated Labskin by viable counting.
- Evaluation of the antifungal effect of test materials on Candida albicans inoculated Labskin.
- Evaluation of the antifungal effect of test materials on Malassezia globosa inoculated Labskin.
- Evaluation of the moisturising effect of test materials on lower epidermis Labskin.
- Production of Toxic Shock Syndrome Toxin-1 (TSST-1) by S. aureus in broth culture with CBD infused female hygiene products.
- Growth of vaginal microflora (Escherichia coli, Candida albicans and Lactobacillus acidophilus) in broth culture with CBD infused female hygiene products.
Raw data reports are provided online on the secure Labskin AI portal at the end of each test and final analytical reports are presented online 28 days after testing has been completed.
Testing pharmacodynamics on Labskin
Reviews of several clinical studies carried out to determine CBD dosing in relation to positive/negative effect showed the drug was administered orally with ranges of <1 to 50 mg/kg.
The absence of pharmacokinetic/pharmacodynamic modelling studies is notable.
Labskin based testing for the study of different formulations of CBD for topical application allows the study CBD’s pharmacodynamics on Labskin, even when the cellular target is unknown. We use genomics; RNA-Seq (whole transcriptome shotgun sequencing that uses next-generation sequencing to reveal the presence and quantity of RNA in a biological sample at a given moment) and/or proteomics (mass spectrometry) high throughput methods in this process.
Additionally, we can test CBD pharmacokinetics using Franz cells or mass spectrometry imaging. Testing is carried out on skin with microflora (microbiome) to measure how skin microbes could interfere with the drug availability and effects.
Talk to us today to see how Labskin’s human skin model and testing platform can help you launch a CBD Oil related product or service.
Farm Bill 2018 | EU MDR 2017/745 Rule 21 | EU Regulation 1223/2009 (Cosmetics Regulations)