Journal:Risk assessment of over-the-counter cannabinoid-based cosmetics: Legal and regulatory issues governing the safety of cannabinoid-based cosmetics in the UAE

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Full article title Risk assessment of over-the-counter cannabinoid-based cosmetics: Legal and regulatory issues governing the safety of cannabinoid-based cosmetics in the UAE
Journal Cosmetics
Author(s) Jairoun, Ammar A.; Al-Hemyari, Sabaa S.; Shahwan, Moyad; Ibrahim, Baharudin; Hassali, Mohamed A.; Zyoud, Sa’ed H.
Author affiliation(s) Universiti Sains Malaysia, Dubai Health and Safety Department, Dubai Ministry of Health and Prevention, Ajman University, Universiti Malaya, An-Najah National University, An-Najah National University Hospital
Primary contact Email: Dr_ammar_91_ at hotmail dot com
Editors Carreño, Amparo S.; Veiga, Juan L.B.
Year published 2021
Volume and issue 18(3)
Article # 57
DOI 10.3390/cosmetics8030057
ISSN 2079-9284
Distribution license Creative Commons Attribution 4.0 International
Website https://www.mdpi.com/2079-9284/8/3/57/htm
Download https://www.mdpi.com/2079-9284/8/3/57/pdf (PDF)
Emblem-important-yellow.svg This article should be considered a work in progress and incomplete. Consider this article incomplete until this notice is removed.

Abstract

Purpose: The lack of scientific evidence of the safety and efficacy of over-the-counter topical cannabinoid-based cosmetics remains a concern. The current study attempted to assess the quality of cannabinoid-based cosmetic products available on the United Arab Emirates (U.A.E.) market. In particular, the study attempted to quantify the presence of undeclared tetrahydrocannabinol—specifically delta-9-tetrahydrocannabinol (Δ9-THC) and delta-9-tetrahydrocannabinolic acid (Δ9-THCA)—in these products.

Methods: A total of 18 cannabinoid-based cosmetics were collected and analyzed in this study. Gas chromatography–mass spectrometry (GC-MS) analysis was used to determine the presence of total undeclared tetrahydrocannabinol.

Results: The estimate for the average tetrahydrocannabinol content was 0.011%, with a 95% CI (0.004−0.019). Leave-on cosmetics products are more likely to contain total tetrahydrocannabinol compared to rinse-off cosmetics (p = 0.041). Although there was no statistically significant difference in the total tetrahydrocannabinol according to cosmetic category, there was a tendency towards higher tetrahydrocannabinol content in hand-care products, baby products, and body care preparations.

Conclusion: The current study reveals the need for producers of cannabinoid-based cosmetic products to issue quality certificates for each batch produced to inform users of the tested levels of tetrahydrocannabinol.

Keywords: tetrahydrocannabinol, over-the-counter, Cannabis sativa, cannabidiol

Introduction

Although it is best known as the source of a recreational drug, the Cannabis sativa plant has a large variety of other uses, e.g., as an ingredient in food and cosmetics, a textile material, and a medicinal product.[1] The Cannabis plant contains various chemical compounds known as cannabinoids, a term that initially only encompassed those substances produced by the plant, namely, phytocannabinoids. One of these compounds is tetrahydrocannabinol (THC), which causes the psychoactive effects typically known from the recreational use of cannabis. Moreover, endocannabinoids (endogenous cannabinoids) refer to cannabinoids that are naturally produced within the body as part of the endocannabinoid system, while synthetic cannabinoids are manufactured substances that have similar properties to phytocannabinoids.[2] One phytocannabinoid that has been the focus of attention due to its neurological and anti-inflammatory effects is cannabidiol (CBD).[3][4][5] Products containing CBD are often sold over the counter, e.g., as dietary supplements, to circumvent the laws regulating medicinal products.

Substances derived from cannabis, such as hemp oil and other cannabis extracts, are becoming increasingly common ingredients in cosmetics.[6] Recent studies have demonstrated the potential use of cannabinoids to treat dermatological conditions such as pruritus, skin cancer, and inflammatory skin diseases.[7] For instance, hemp oil is offered on the market as a cosmetic hair treatment, with product manufacturers claiming that the direct application of the oil can moisturize and protect hair, promote hair growth, and repair damaged hair. Despite the lack of scientific evidence supporting these claims, numerous online outlets sell these products, which range in composition from pure hemp oil to shampoos and similar hair treatments containing lower concentrations of hemp oil.[8]

European Union (E.U.) cosmetics regulations state that all hemp-derived natural raw materials contained in cosmetics must be derived from Cannabis sativa plant parts, including seeds, leaves, or leaves without tops, whereby the total THC content must not exceed 0.2% (notably, the flowering or fruiting parts of Cannabis sativa generally feature higher THC concentrations). The use of nonfibrous cannabis material with an excess of 0.2% THC (e.g., Cannabis indica) is forbidden, and this limit of THC refers only to hemp plants, not to hemp-derived cosmetic ingredients.[9] In contrast, United Arab Emirates (U.A.E.) cosmetic regulations state that the manufacturer of any cosmetic product containing hemp oil (Cannabis sativa seed oil) or cosmetic oil containing CBD must demonstrate that their finished cosmetic products are free from tetrahydrocannabinols by tetrahydrocannabinol content testing in municipal laboratories or accredited laboratories. However, despite these regulations, several cases of contaminated cosmetic products have occurred on the U.A.E. market.[10] For example, a survey of 100 cosmetics and other personal care products available in the U.A.E. found that 13% and 5% of samples were contaminated by yeast/mold and aerobic mesophilic bacteria, respectively.[11] Another study in the same context revealed that 13% (n = 9) of the tested cosmetic and personal care products not only contained formaldehyde above the recommended levels but also did not state on the label that the product contained free formaldehyde or formaldehyde releasers.[12]

To the best of our knowledge, our study is the first to assess the quality of cannabinoid-based cosmetic products available on the U.A.E. market. In particular, it aims to quantify the presence of undeclared tetrahydrocannabinol, specifically THC and THCA, in these products. The findings will contribute to ensuring compliance with current regulations and aid in the development of new methods for identifying adulterants in cannabinoid-based cosmetic protects with the aim of ensuring public safety.

Methods and materials

Sample collection (sampling method)

Stores selling cosmetics and other personal care products were identified via a search of local business directories containing the details of the pharmacies, parapharmacies, and health product sellers in the U.A.E. The search revealed 2,183 separate outlets, which were entered into an Excel spreadsheet that represented the sampling framework, along with all relevant details, e.g., each business name, business address, email address, and phone number. The business ID numbers were subsequently used to generate the study sample via basic random-sample selection. Then, the selected locations were visited to sample the products (see Figure S1 in Supplementary materials). The main selection criteria were cosmetic or personal care products that were labelled as containing either cosmetic oil with CBD (INCI name "Cannabidiol") or hemp oil (INCI name "Cannabis sativa Seed Oil"). One package of each product that met both criteria was randomly chosen at each location regardless of its country of manufacture. To enable tracking and to prevent a product from being sampled more than once, each sample was assigned a code reference number. The following details were recorded for each sample: product name, brand name, batch number, barcode, dosage form, item category, subcategory, size/volume, recommended dose, country of origin/manufacturer, and from which store the product had been purchased. If identical products—i.e., with the same name, formulation, and manufacturer—were being sold at more than one outlet, the first product to be sampled was tested, while the remaining samples were returned. Any products made by different manufacturers but bearing the same name or products offered in different formats, such as an emulsion and a cream, were considered distinct products and tested separately. The products were forwarded to a laboratory for testing on the day of collection.

Instrumentation

The following are the materials used in the sample analysis, with the origin of purchase, company, and country:

  • GC-MS-TQ 8030 and GC-MS solution software; Make: Shimadzu, Japan
  • Rtx-5 MS 15 m × 0.25 mm × 0.25 µm, Cat. log No: 12,620 with a 10 µL sample loop; Make: Restek, Pennsylvania, USA
  • Analytical balance, Max 200 g range; Make: Sartorius, Goettingen, Germany
  • Centrifuge, Max 12,000 rpm; Make: Hamilton, USA
  • Micropipette (100–1000 µL); Make: Transpette, Wertheim, Germany
  • Sonicator; Make: Qualilife, China
  • AT-EV-50 Nitrogen evaporator; Make: Athena Technology, India
  • 50 mL test tubes with cap; Make: Tarsons, Kolkata, India
  • 10 mL volumetric flasks; Make: Gulf Scientific Glass, Al Hidd, Bahrain
  • Reagents: deionised water, methanol, hexane, ethyl acetate, chloroform, methanol, 1 N methanolic KOH, and 1 N HCl (All reagents should be of analytical purity.)

Acquisition conditions

Gas chromatography–mass spectrometry (GC-MS) analysis was performed with the Shimadzu TQ 8030. For quantification, the Rtx-5 MS 15 m × 0.25 mm × 0.25 µm column was used under the below-mentioned GC-MS conditions and acquisition parameters (Table 1). The peaks of the chromatogram were identified by their mass and by comparing the retention time with those of the standards, and the run time was 20 minutes.

Table 1. GC-MS and acquisition conditions
Column program 50 °C (hold 0.10 min) @25 °C, 15 °C/min to 260 °C (15.30 min), 20 °C/min to 300 °C (18 min)
280 °C
Splitless


References

  1. ↑ Cherney, J.H.; Small, E. (2016). "Industrial Hemp in North America: Production, Politics and Potential". Agronomy 6 (4): 58. doi:10.3390/agronomy6040058. 
  2. ↑ Pacher, P.; Bátkai, S.; Kunos, G. (2006). "The endocannabinoid system as an emerging target of pharmacotherapy". Pharmacological Reviews 58 (3): 389-462. doi:10.1124/pr.58.3.2. PMC PMC2241751. PMID 16968947. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=PMC2241751. 
  3. ↑ Giacoppo, S.; Galuppo, M.; Pollastro, F. et al. (2015). "A new formulation of cannabidiol in cream shows therapeutic effects in a mouse model of experimental autoimmune encephalomyelitis". Daru 23: 48. doi:10.1186/s40199-015-0131-8. PMC PMC4618347. PMID 26489494. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=PMC4618347. 
  4. ↑ Hammell, D.C.; Zhang, L.P.; Ma, F. et al. (2016). "Transdermal cannabidiol reduces inflammation and pain-related behaviours in a rat model of arthritis". European Journal of Pain 20 (6): 936–48. doi:10.1002/ejp.818. PMC PMC4851925. PMID 26517407. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=PMC4851925. 
  5. ↑ Schicho, R.; Storr, M. (2012). "Topical and systemic cannabidiol improves trinitrobenzene sulfonic acid colitis in mice". Pharmacology 89 (3–4): 149–55. doi:10.1159/000336871. PMC PMC3668621. PMID 22414698. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=PMC3668621. 
  6. ↑ Pless, P.; Leson, G. (March 2001). "Assessing the Impact of THC Uptake from Hemp Oil Cosmetics on Workplace Drug Testing" (PDF). Leson Environmental Consulting. https://kushcreams.com/wp-content/uploads/2014/07/WebPage.pdf. 
  7. ↑ Eagleston, L.R.M.; Kalani, N.K.; Patel, R.R. et al. (2012). "Cannabinoids in dermatology: A scoping review". Dermatology Online Journal 24 (6): 1. doi:10.5070/D3246040706. PMID 30142706. 
  8. ↑ Paul, R.; Williams, R.; Hodson, V. et al. (2019). "Detection of cannabinoids in hair after cosmetic application of hemp oil". Scientific Reports 9 (1): 2582. doi:10.1038/s41598-019-39609-0. PMC PMC6385314. PMID 30796346. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=PMC6385314. 
  9. ↑ European Parliament and the Council of the European Union (2013). "REGULATION (EU) No 1307/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL" (PDF). Official Journal of the European Union 347: 608–670. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:347:0608:0670:EN:PDF. 
  10. ↑ Public Health & Safety Department (2016). "Healthy Supplements Registration Procedures - DM-PH&SD-P5-TG2". Government of Dubai. https://www.scribd.com/document/326591142/DM-PH-SD-P5-TG2-Registration-of-HS-Healthy-Supplements-Registration-Procedures. 
  11. ↑ Jairoun, A.A.; Al-Hemyari, S.S.; Shahwan, M. et al. (2020). "Hidden Formaldehyde Content in Cosmeceuticals Containing Preservatives that Release Formaldehyde and Their Compliance Behaviors: Bridging the Gap between Compliance and Local Regulation". Cosmetics 7 (4): 93. doi:10.3390/cosmetics7040093. 
  12. ↑ Jairoun, A.A.; Al-Hemyari, S.S.; Shahwan, M. et al. (2020). "An Investigation into Incidences of Microbial Contamination in Cosmeceuticals in the UAE: Imbalances between Preservation and Microbial Contamination". Cosmetics 7 (4): 92. doi:10.3390/cosmetics7040092. 

Notes

This presentation is faithful to the original, with only a few minor changes to presentation. Some grammar and punctuation was cleaned up to improve readability. In some cases important information was missing from the references, and that information was added.

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