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.
Federal Food, Drug, and Cosmetic Act (FD&C Act) | FDA | FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers | FDA
Farm Bill 2018 | EU MDR 2017/745 Rule 21 | EU Regulation 1223/2009 (Cosmetics Regulations)
A global perspective on the epidemiology of acne – PubMed – NCBI – Cannabinoids suppress inflammatory and neuropathic pain by targeting α3 glycine receptors.
LaVito, A. (2019). FDA issues warning to companies ‘illegally selling’ CBD products with ‘unsubstantiated claims’.