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Evaluation of Two Commercially Available Cannabidiol Formulations for Use in Electronic Cigarettes

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Associated Data

TABLE S1: The Total Ion Chromatographs of SPME-GC/MS analysis from the condensation aerosol of the Easy Rider and Yellow Brick Road e-liquids.

Abstract

Since 24 states and the District of Columbia have legalized marijuana in some form, suppliers of legal marijuana have developed Cannabis sativa products for use in electronic cigarettes (e-cigarettes). Personal battery powered vaporizers, or e-cigarettes, were developed to deliver a nicotine vapor such that smokers could simulate smoking tobacco without the inherent pathology of inhaled tobacco smoke. The liquid formulations used in these devices are comprised of an active ingredient such as nicotine mixed with vegetable glycerin (VG) and/or propylene glycol (PG) and flavorings. A significant active ingredient of C. sativa, cannabidiol (CBD), has been purported to have anti-convulsant, anti-nociceptive, and anti-psychotic properties. These properties have potential medical therapies such as intervention of addictive behaviors, treatments for epilepsy, management of pain for cancer patients, and treatments for schizophrenia. However, CBD extracted from C. sativa remains a DEA Schedule I drug since it has not been approved by the FDA for medical purposes. Two commercially available e-cigarette liquid formulations reported to contain 3.3 mg/mL of CBD as the active ingredient were evaluated. These products are not regulated by the FDA in manufacturing or in labeling of the products and were found to contain 6.5 and 7.6 mg/mL of CBD in VG and PG with a variety of flavoring agents. Presently, while labeled as to content, the quality control of manufacturers and the relative safety of these products is uncertain.

Introduction

Electronic cigarettes (e-cigarettes) were developed as an alternative method for nicotine delivery. Their utility and popularity have transformed them into a general drug-delivery device. They are inexpensive, easy to use, and have some public perception as a healthy alternative. They work by either drawing negative pressure through the mouthpiece or depressing a button to activate a battery that heats a coil, containing a wick saturated with a formulation known as the e-liquid. The e-liquids are made of some ratio of propylene glycol (PG) and vegetable glycerin (VG) and/or a pharmaceutical and/or herbal remedy plus, potentially, a flavoring agent. When the e-cigarette is activated, the e-liquid is vaporized, followed by rapid condensation into an aerosol that the user inhales (Breland et al., 2016; Peace et al., 2016a).

On May 5, 2016, the Food and Drug Administration (FDA) announced the extension of their authority to regulate all tobacco products, including e-cigarettes (U.S. Food and Drug Administration [FDA], 2016). A significant reason to do so was to address the quality assurance of e-cigarette products, from the devices to the nicotine-based e-liquids contained within. The e-liquid formulations have been found to vary significantly from the labeled content around the world (Etter et al., 2013; Goniewicz et al., 2013; Kavvalakis et al., 2015; Pagano et al., 2015; Peace et al., 2016a). Since the legalization of marijuana in some form in 24 states and the U.S. District of Columbia, e-liquids containing cannabinoids have emerged in the market place. As with nicotine e-liquid concentrations, the measured concentration of Δ9-tetrahydrocannabinol (THC) in a commercially available product was found to contain significantly different THC concentration than was labeled (Peace et al., 2016b).

Cannabidiol (CBD) has been purported to have anti-convulsant, anti-nociceptive, and anti-psychotic properties (Brenneisen, 2007; Bhattacharyya et al., 2010). These properties have potential medical therapies such as intervention of addictive behaviors, treatments for epilepsy, management of pain for cancer patients, and treatments for schizophrenia (Johnson et al., 2010; Fischer et al., 2015; Friedman and Devinsky, 2015; Manseau and Goff, 2015). According to the Drug Enforcement Agency (DEA), CBD is a Schedule I substance as defined by the Controlled Substances Act (CSA). Recently, the DEA made it easier for scientists conducting FDA-approved studies to acquire CBD (United States Drug Enforcement Administration [DEA], 2016). Despite the ease of regulation for these research purposes, the CSA still disallows the addition of CBD to products for medicinal benefit since the FDA has not approved it for medical intervention. In 2015 and 2016, the FDA issued warning letters to companies marketing an unapproved drug in their products for therapeutic benefit (United States Food and Drug Administration [FDA], 2015a,b). Some companies selling products containing CBD continue to claim medicinal value for their products. However, some post the FDA disclaimer citing that their products are “not intended for the diagnosis, cure, mitigation, treatment, or prevention of a disease” according to the Federal Food, Drug, and Cosmetic Act and that they do not “distribute any products that are in violation of the U.S. Controlled Substances Act (Cloud 9 Hemp, 2015; Isodiol, 2016).

Aside from volatile organic compounds and other potential degradation products generated by an e-cigarette during aerosolization which may pose health concerns (Flora et al., 2016), condensation aerosols are known to be useful and effective drug delivery systems. If research on CBD demonstrates acceptable therapeutic utility and thereby removed from Schedule I, the inhalation of CBD through an aerosol produced by an e-cigarette may be advantageous over traditional smoking methods and ingestion. THC enriched e-liquid vaporized in an e-cigarette has been demonstrated to be an effective route of administration for cannabinoids (Varlet et al., 2016). Of major import is that these cannabinoid infused e-liquids be subjected to manufacturing standards to ensure safety and quality of product.

Presented is the evaluation of two commercially available e-liquids labeled to contain 3.3 mg/mL CBD in PG and VG with flavorings. The vendor claims that a hemp strain with the highest CBD potency was used in the manufacture of their products (Cloud 9 Hemp, 2015). The products were presumptively evaluated using Direct Analysis in Real Time ion source attached to a time of flight mass spectrometer (DART-MS) for cannabinoids, flavorants, and other possible constituents. Cannabinoids were quantitated by high-performance liquid chromatography–tandem mass spectrometry (HPLC-MS/MS). Alcohols were analyzed by headspace gas chromatography with flame ionization detector (HS-GC-FID). The aerosol produced from the e-liquids with an e-cigarette was analyzed by solid phase microextraction gas chromatograph (SPME-GC/MS).

Materials

Two e-liquids, Cloud 9 Hemp Easy Rider and Yellow Brick Road purported to be infused with CBD, were submitted to the lab for analysis. These products contained no information as to lot number or date of production (Figure ​ Figure1 1 ). All tubing, glassware, and fritted gas dispersion tubes were purchased from Colonial Scientific (Richmond, VA, USA). HPLC-grade methanol used for all dilutions, stock and working solutions was purchased from Pharmco-Aaper (Brookfield, CT, USA). Polyethylene glycol (PEG) with an average molecular mass of 600 Da was used for DART-MS calibration and obtained from ULTRA Inc (North Kingstown, RI, USA). United States Pharmacopiea (USP)-grade PG and VG were obtained from Wizard Labs (Altamonte Springs, FL, USA). Nitrogen and helium gases were acquired from Praxair and Airgas (Richmond, VA, USA). Certified ACS Ammonium acetate, formic acid, HPLC-grade methanol and de-ionized (DI) water, optima grade acetone, ethanol, methanol, n-propanol, and isopropanol were purchased from Fisher Scientific (Hanover Park, IL, USA). Medical-grade nitrogen and helium were purchased from National Welders Supply Company (Richmond, VA, USA). CBD primary reference standard was purchased from Cerilliant (Round Rock, TX, USA). The e-cigarette was a KangerTech Aerotank clearomizer (v2) attached to an eGo-V v2 variable voltage battery, purchased from 101vape.com (Carlsbad, CA, USA). The single coil was wrapped in non-contact configuration with 34 gauge Nichrome wire to 1.8 Ω and a 2 mm diameter silica string was used as a wick. The flow meter was purchased from Cole Palmer (Vernon Hills, IL, USA). Seven micrometers polydimethylsiloxane (PDMS) SPME fibers were purchased from Supelco (Bellefonte, PA, USA).

(A) Easy Rider and Yellow Brick Road CBD e-liquids with (B) the FDA statement regarding the uses of the e-liquid, and (C) the listed ingredients of the e-liquids.

CBD Hemp Oil Market to Worth $55,791.3 Million [2021-2028] | Cannabidiol Industry Share, Revenue, and Forecast Report by Fortune Business Insights™

Companies covered in CBD hemp oil market are Medical Marijuana Inc. (California, U.S.), Cannoid, LLC (Colorado, U.S), Isodiol International Inc. (Vancouver, Canada), ENDOCA (Chicago, U.S.), Folium Biosciences (Texas, U.S.), Nuleaf Naturals Llc. (Colorado, U.S), Pharmahemp d.o.o (Slovenia, Europe), Elixinol Global (Sydney, Australia), CV Sciences (California, U.S.), Medterra CBD (California, U.S.) and more players profiled

February 17, 2022 04:30 ET | Source: Fortune Business Insights Fortune Business Insights

Pune, India, Feb. 17, 2022 (GLOBE NEWSWIRE) — The global CBD hemp oil market size is expected to showcase considerable growth by reaching USD 55,791.3 million by 2028 while exhibiting an exceptional CAGR of 47.49% between 2021 and 2028. This information is published by Fortune Business Insights, in a report, titled “CBD Hemp Oil (CBD) Market, 2021-2028.” The report further mentions that the market stood at USD 2,770.8 million in 2020. Factors such as the increasing product approvals by the FDA and concerned government agencies and the growing demand for CBD amongst the health and fitness enthusiasts will bode well for the growth of the market. For instance, according to a report by the Harvard Health Institute in 2018, CBD can be extensively adopted to provide relief from health issues such as anxiety, insomnia, etc.
The coronavirus emergency has resulted in financial jeopardy for trade and businesses worldwide. The authorities of several countries have initiated lockdown to avert the increase of the disease. Such strategies have resulted in disruption in the production and supply chain. According to the International Facility Management Association (IMFA), 84% of in-store operations got affected due to the pandemic, of which, food services represent a significant share in 2020.

List of the Companies Profiled in the Global CBD Hemp Oil Market:

  • Medical Marijuana Inc. (California, U.S.)
  • Cannoid, LLC (Colorado, U.S)
  • Isodiol International Inc. (Vancouver, Canada)
  • ENDOCA (Chicago, U.S.)
  • Folium Biosciences (Texas, U.S.)
  • Nuleaf Naturals Llc. (Colorado, U.S)
  • Pharmahemp d.o.o (Slovenia, Europe)
  • Elixinol Global (Sydney, Australia)
  • CV Sciences (California, U.S.)
  • Medterra CBD (California, U.S.)

What does the Report Provide?
The global market report provides a detailed analysis of several factors such as the key drivers and restraints that will impact growth. Additionally, the report provides insights into the regional analysis that covers different regions, contributing to the growth of the market. It includes the competitive landscape that involves the leading companies and the adoption of strategies by them to introduce new products, announce partnerships, and collaboration that will further contribute to the market growth. Moreover, the research analyst has adopted several research methodologies such as PORTER’s Five Point Analysis and PESTEL to obtain information about the current trends and industry developments that will drive the market growth between 2021 and 2028. Our well-revised reports help companies to receive in-depth information about the present scenario of every market so that you can adopt the necessary strategies accordingly.

Market Segmentation:
On the basis of source,

based on application

  • food & beverages
  • pharmaceuticals
  • pet care
  • cosmetics

based on region

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle East
  • Africa

DRIVING FACTORS:
Increasing FDA Approvals for CBD Products to Promote Market Growth
The prominent players in the market are focusing on launching novel and advanced products to cater to the high demand for CBD among consumers. The increasing utilization of the product in the manufacturing of medicines and consumer products will create lucrative opportunities for the market. The rising approval grants from the government agencies for various CBD products is further expected to favour the growth of the market. Additionally, the proactive focus of the manufacturers towards the incorporation of CBD in a variety of food products is expected to contribute to the global CBD Hemp Oil market growth during the forecast period.

REGIONAL INSIGHTS

North America – The region stood at USD 1276.7 million in 2020 and is anticipated to hold the highest position in the market in the forthcoming years. This is attributable to the favourable government policies that enable the commercialization of CBD Hemp Oil products in countries such as the U.S. and Canada.

Europe – The market in the region is anticipated to showcase exponential growth backed by the rising sales of CBD products such as vaping, smoking, and edibles in the region between 2021 and 2028.

COMPETITIVE LANDSCAPE
Major Companies Focus on Partnerships to Brighten Their Market Prospects
The global market for CBD Hemp Oil is experiencing healthy competition among key players that are focusing on partnering with other companies to expand their product portfolio and further boost sales revenues. Additionally, the other major companies are striving to maintain their presence by adopting strategies such as merger and acquisition, facility expansion, and collaboration that will bode well for the growth of the market in the forthcoming years.

Industry Development:

  • February 2020 – Colgate-Palmolive Company announced the launch of a new product in the U.S. The company reports that the product, CBD Vegan Lip Balm, will help to expand its cosmetics business in the country.

Table of Content:

  • Introduction
    • Research Scope
    • Market Segmentation
    • Research Methodology
    • Definitions and Assumptions
    • Market Drivers
    • Market Restraints
    • Market Opportunities
    • Emerging Trends
    • Overview on Cannabis Markets
    • Supply Chain and Industry SWOT Analysis
    • Global CBD Hemp Oil Regulatory Analysis
    • Recent Industry Developments – Policies, Mergers & Acquisitions, and New Product Launches
    • Impact of COVID-19
    • Challenges in Supply Chain
    • Efforts to Mitigate the Challenges
    • Key Findings / Summary
    • Market Size Estimates and Forecast
      • By Source
        • Marijuana
        • Hemp
        • Food & Beverages
        • Pharmaceuticals
        • Pet Care
        • Cosmetics
        • Others
        • North America
        • Europe
        • Asia Pacific
        • South America
        • Middle East & Africa

        TOC Continued…!

        Have a Look at Related Research Insights:

        Marijuana Market Size, Share and COVID-19 Impact Analysis, By Type (Flowers/Buds and Concentrates), By Application (Medical, Recreational (Edibles and Topicals), and Industrial Hemp), and Regional Forecast, 2021 – 2028

        Cannabis Beverages Market Size, Share & COVID-19 Impact Analysis, By Type (Alcoholic and Non-alcoholic), Distribution Channel (Mass Merchandisers, Specialty Stores, Online Retail, and Others), and Regional Forecast, 2021-2028

        About Us:

        Fortune Business Insights™ delivers accurate data and innovative corporate analysis, helping organizations of all sizes make appropriate decisions. We tailor novel solutions for our clients, assisting them to address various challenges distinct to their businesses. Our aim is to empower them with holistic market intelligence, providing a granular overview of the market they are operating in.

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        The lockdown is placing pressure on the global economy, and we are on the brink of a serious economic recession.

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