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Cure-all cannabidiol? The cannabidiol content of commercial products

Authors:

Abstract

Background The recent easing of regulations around the world regarding Cannabis sativa and its main active compounds, such as cannabidiol (CBD), led to an explosion in the number of over-the-counter consumer products. The number of product types is surpassed by the vast quantity of products of each type, but even this is exceeded by the associated health claims which range from the benign, such as ‘fighting inflammation’, to the completely asinine such as ‘fighting the tyranny of the urgent’ or ‘shedding light on your inner darkness’. Any health claim should in the first instance be supported by the product containing the correct actives at the correct dosage. Purpose The purpose of this study was to test a diverse range of commercially available product types including soft drinks, honey, coffee, oils, gummy bears, chocolate, etc. that claim to contain CBD and compare the results to their label claims. Study design Forty commercially available products were extracted and quantitatively analyzed. Methods Extraction efficiency for all product types was conducted over a 1 h period using acetonitrile and ultrasonication. Samples were taken every five min and analyzed using a validated HPLC method. All products were then extracted in triplicate using the applicable extraction time and quantitatively analyzed. Results Fifteen min of sonication was found to be adequate for the oils and drinks samples. The honey, chocolate and gummies samples required initial dissolution in water followed by extraction with acetonitrile. The remaining products required sonication of 45 min. It was found that only three products (7.5 %) contained CBD levels within 90–110 % of their label claim. Two products had trace amounts of delta-9-tetrahydrocannabinol and some of the products were completely devoid of CBD. Conclusion Mislabeling is of serious concern and this study shows that the problem not only includes problems with the content of CBD, but also regarding the chemical properties such as containing “water-soluble CBD” while it is insoluble in water, and the diverse number of health claims that in some cases have no foundation in reality. This highlights not only the lax attitude of producers but also of the regulatory authorities in ensuring the consistent quality of these products.
Phytomedicine Plus 4 (2024) 100520
Available online 29 November 2023
2667-0313/© 2023 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Cure-All cannabidiol? The cannabidiol content of commercial products
Michaela Mouton , Minja Gerber , Frank Van der Kooy
*
Centre of Excellence for Pharmaceutical Sciences (Pharmacen), North-West University, Private Bag X6001, Potchefstroom 2520, South Africa
ARTICLE INFO
Keywords:
Cannabidiol
Cannabis sativa
CBD
Consumer products
Label claims
Δ
9
-THC
ABSTRACT
Background: The recent easing of regulations around the world regarding Cannabis sativa and its main active
compounds, such as cannabidiol (CBD), led to an explosion in the number of over-the-counter consumer prod-
ucts. The number of product types is surpassed by the vast quantity of products of each type, but even this is
exceeded by the associated health claims which range from the benign, such as ‘ghting inammation, to the
completely asinine such as ‘ghting the tyranny of the urgent or ‘shedding light on your inner darkness. Any
health claim should in the rst instance be supported by the product containing the correct actives at the correct
dosage.
Purpose: The purpose of this study was to test a diverse range of commercially available product types including
soft drinks, honey, coffee, oils, gummy bears, chocolate, etc. that claim to contain CBD and compare the results to
their label claims.
Study design: Forty commercially available products were extracted and quantitatively analyzed.
Methods: Extraction efciency for all product types was conducted over a 1 h period using acetonitrile and
ultrasonication. Samples were taken every ve min and analyzed using a validated HPLC method. All products
were then extracted in triplicate using the applicable extraction time and quantitatively analyzed.
Results: Fifteen min of sonication was found to be adequate for the oils and drinks samples. The honey, chocolate
and gummies samples required initial dissolution in water followed by extraction with acetonitrile. The
remaining products required sonication of 45 min. It was found that only three products (7.5 %) contained CBD
levels within 90110 % of their label claim. Two products had trace amounts of delta-9-tetrahydrocannabinol
and some of the products were completely devoid of CBD.
Conclusion: Mislabeling is of serious concern and this study shows that the problem not only includes problems
with the content of CBD, but also regarding the chemical properties such as containing water-soluble CBD
while it is insoluble in water, and the diverse number of health claims that in some cases have no foundation in
reality. This highlights not only the lax attitude of producers but also of the regulatory authorities in ensuring the
consistent quality of these products.
Introduction
The use of cannabidiol (CBD) containing products has gained interest
in recent years since it has been legalized in many countries. In 2019, the
World Health Organization (WHO) also proposed several changes be
made when cannabis preparations do not contain the psychoactive
compound, Δ
9
-tetrahydrocannabinol (Δ
9
-THC) since CBD is not intox-
icating and has little evidence that it is of a public health concern
(McGregor et al., 2020).
Since legalization and the recommendations by the WHO were made,
a vast array of CBD products has been produced and can be purchased in
almost all health stores. Various product types are available including
cosmetics, personal hygiene products, edibles, oils, vaporizer products,
veterinary products, and a large number of health products making an
equally large number of (low-level) health claims. There has been a
marked increase in the popularity of these CBD products, devoid of the
psychoactive compound Δ
9
-THC, for its purported health benets to
such an extent that the market was valued at $3.67 billion in 2021 vs
only $2.8 billion in 2020 and is expected to grow at a compounded
annual rate of 47.5 % from 2022 to 2028 (Fortune Business Insights,
Abbreviations: ACN, acetonitrile; CBD, cannabidiol; CBDA, cannabidiolic acid; FDA, Food and Drug Administration; WHO, World Health Organization; Δ
9
-THC,
Δ
9
-tetrahydrocannabinol; Δ
9
-THCA, Δ
9
-tetrahydrocannabinolic acid; U.A.E, United Arab Emirates,.
* Corresponding author at: Center of Excellence for Pharmaceutical Sciences, North-West University, Private Bag X6001, Potchefstroom, 2520, South Africa.
E-mail address: frank.vanderkooy@nwu.ac.za (F. Van der Kooy).
Contents lists available at ScienceDirect
Phytomedicine Plus
journal homepage: www.sciencedirect.com/journal/phytomedicine-plus
https://doi.org/10.1016/j.phyplu.2023.100520
Phytomedicine Plus 4 (2024) 100520
2
2021).
Many users of these products consider it as a cure-all medication,
which is mainly attributed to poor consumer education (Zenone et al.,
2021). One of the problems that has come to light is the many
misleading and false claims regarding the health benets of CBD prod-
ucts. Even though CBD is considered safe, these misleading claims can
potentially lead to some consumers, who suffer from serious ailments,
not getting the correct medication or treatment that they need (FDA,
2019; FDA 2020a).
With this rapidly increasing interest in CBD-containing products, the
need for proper regulations as well as quality control of these products
has become essential. For example, in a recent study, 80 CBD products
were tested, and it was shown that Δ
9
-THC was detected above the legal
limit in 52 of these products (Johnson et al., 2022a). In another study, 25
commercially available products were tested for Δ
9
-THC and CBD and
only three products were close to the label claim, 13 products contained
less than 50 % of the label claim, three products had Δ
9
-THC levels that
exceeded 0.3 % and one product consisted of 45 % Δ
9
-THC (Gurley
et al., 2020). Most of the non-prescription products have a relatively low
CBD daily dose, varying from 10 to 50 mg or 50100 mg/ml in con-
centration. These doses were found to be therapeutically suboptimal in
clinical trials (Miller et al., 2020). Currently, in the United States of
America, CBD is regulated through intended use. Since CBD is a natural
product biosynthesized by Cannabis sativa L. (Cannabaceae) it is regu-
lated as either hemp or marijuana and is categorized as such based on
the Δ
9
-THC content. Products that are derived from hemp, which is
dened in the Agricultural Marketing Act as a cannabis plant that con-
tains less than 0.3 % Δ
9
-THC, are legal to sell, however, products that are
derived from marijuana are illegal to buy, sell or possess unless under a
Schedule I license (Li et al., 2021). In 2018, the Food and Drug
Administration (FDA) approved the drug Epidiolex for the treatment of
seizures in Lennox-Gastaut syndrome and Dravet syndrome and it was
also approved for treatment in tuberous sclerosis complex in 2020 (FDA,
2018, 2020b).
In South Africa, Δ
9
-THC is still regarded as an illicit substance unless
it is found in registered medications for therapeutic use, whereupon it is
regarded as a schedule 6 substance that can be obtained with a valid
prescription. Products that are processed from cannabis seeds may not
contain more than 0.001 % of Δ
9
-THC and are regarded as industrial
hemp. CBD is listed as a Schedule 4 or Schedule 0 substance depending
on whether it adheres to the following regulations: the maximum total
amount of CBD per sales pack is 600 mg and the maximum daily dose of
CBD is set out to be 20 mg with acceptable low-level health claims. For
preparations that are derived from processed cannabis plant material
Table 1
Categories of CBD products, dosages and country of origin.
Product ID Claimed CBD per dose (mg) Dose (mL) Δ
9
-THC content claim Lab tested Country of origin
Oils
1 8.30 1.00 No claim Yes USA
2 10.00 1.00 Δ
9
-THC free Yes RSA
3 20.00 1.00 No claim No RSA
4 2.50 0.75 No claim No RSA
5 16.70 1.00 No claim No USA
6 10.00 1.00 Δ
9
-THC free No USA
7 6.00 1.00 No claim No RSA
8 6.00 1.00 No claim No RSA
9 10.00 1.00 No claim No RSA
10 nas nas No claim No Spain
11 5.00 0.50 No claim No RSA
12 6.25 1.00 No claim No RSA
13 50.00* 1.00* Δ
9
-THC free No Spain
14 nas nas No claim No Spain
15 19.99 1.00 Δ
9
-THC free Yes RSA
16 nas nas No claim No Spain
Topicals
17 nas nas Δ
9
-THC free No RSA
18 15.00 8.00 No claim No Netherlands
19 nas nas No claim No RSA
20 nas nas No claim No Dubai
21 nas nas No claim No RSA
Drinks
22 5.00 50.00 Δ
9
-THC free No RSA
23 5.00 50.00 No claim No RSA
24 5.00 15.00 Δ
9
-THC free No RSA
25 5.00 7.00 No claim No RSA
26 10.00 300.00 No claim No RSA
27 5.00 500.00 No claim No RSA
28 6.00 300.00 No claim No RSA
29 6.00 300.00 No claim No RSA
30 20.00 100.00 Δ
9
-THC free No RSA
31 20.00 100.00 Δ
9
-THC free No RSA
32 20.00 100.00 Δ
9
-THC free No RSA
33 5.00 1.00 No claim No RSA
Other
34 Sachet 10.00 1.00 g No claim No RSA
35 Honey 5.00 5.00 g No claim No RSA
36 Coffee 20.00 5.00 g No claim No RSA
37 Chocolate 20.00 50.00 g Δ
9
-THC free No Indonesia
38 Coffee 4.00 10.00 g Δ
9
-THC Free No RSA
39 Gummies 20.00 5.00 g No claim No USA
40 Capsules 5.00 1 capsule No claim No RSA
nas =no amount stated.
* =total CBD mg/mL.
M. Mouton et al.
Phytomedicine Plus 4 (2024) 100520
3
and only contain the number of cannabinoids that are naturally present
in the source material, the nal product may not exceed 0.001 % of Δ
9
-
THC and a total of 0.0075 % CBD (Viviers et al., 2021).
Since the change in legislation in 2018, the South African market has
been ooded with different CBD-containing products. The aim of this
study was to test a variety of commercially available products to
determine if the CBD content correlates with the label claim and test for
the presence\absence of Δ
9
-THC. This study was conducted due to
various other international studies that have shown discrepancies be-
tween the products label claims and the actual CBD content (Gurley
et al., 2020; Johnson et al., 2022a). This may lead to further evidence for
the need for stricter legislation regarding the quality control of
CBD-containing products.
Material and methods
Product selection and categorization
All CBD products were purchased at local retail stores in South Africa
of which 29 were produced in South Africa and the remaining 11 in the
USA (4), Spain (4), U.A.E. (1), the Netherlands (1) and Indonesia (1)
(Table 1). Products were selected based on claims of CBD content which
included products that were listed as containing "hemp", "Cannabis sativa
seed" and "Cannabis Extract". No duplicate products were analyzed;
however, products from the same manufacturer were included. Upon
arrival, all products were inspected for packaging integrity to ensure all
products received were in original packaging and not tampered with. All
products were given a unique product ID. The purchased products were
categorized based on product type namely, "Oils, Drinks, Topicals
and "Other". All products were stored as per labelled storage instructions
and products that did not provide labeling instructions, were stored at
room temperature away from direct light.
Sample preparation
Products were subjected to extraction testing over a 1-hour period.
This was conducted after it was observed that the honey sample
immediately solidied upon the addition of acetonitrile (ACN) risking
encapsulating CBD which might lead to the inadequate extraction of the
target analyte. ACN was added to all product types and sonicated for one
hour with 2 ml samples taken every 5 min for analysis to determine the
optimal time of extraction. Products such as honey (35), chocolate (37),
and gummies (39) did not dissolve fully in ACN even after sonication for
100 min. These products were rst dissolved in water (50 ml), sonicated
for 15 min after which the same volume of ACN was added followed by
sonication for another 15 min.
Products 116 (oils 1 ml each) and 2233 (drinks 10 ml each)
were extracted with ACN (100 ml), followed by 15 min of sonication.
The samples were ltered with a 0.45 µm syringe lter into HPLC vials
and diluted to a concentration range that falls within the calibration
curve based on the products label claim (Laanet et al., 2022). Products
1721 (topicals 0.5 g each) and products 34, 36, 38 and 40 (0.5 g each)
were extracted with ACN but sonicated for 45 min. Products 3440 were
weighed before extraction and dilution to ensure the correct amount of
product was diluted. All products were prepared in triplicate.
Analytical procedures
A Shimadzu iNexera LC-2040C system consisting of a quaternary
pump, solvent degasser, autosampler, column oven, and photodiode
array detector was used. A validated chromatographic analytical
method was used with separation achieved with a Zorbax Eclipse Plus
C
18
column (2.1 ×50 mm, 1.8 µm), with 0.1 % formic acid (A) and ACN
containing 0.1 % formic acid (B) used as the mobile phase. Gradient
elution was used and started at 65 % B for 2 min, increased to 100 % B at
2.5 min, and was kept at 100 % until 4.5 min, the system then returned
to 65 % until 7.5 min to allow for re-equilibration. The ow rate was set
at 0.4 ml/min and the column oven at 40 C, the autosampler at 6 C,
and the injection volume was 2 µL. The detection and quantication of
the cannabinoids were conducted at 210 nm for CBD and Δ
9
-THC and
221 nm for CBDA and THCA (Mouton et al., 2023).
Conrmation of the presence/absence of Δ
9
-THC was conducted
using the more sensitive Agilent Ultivo triple-quadrupole mass spec-
trometer consisting of a 1260 Innity II autosampler, 1200 quaternary
pump, column oven and the Ultivo TQ. A Multiple reaction monitoring
method for Δ
9
-THC was developed and the MRM transition of 315.2 to
77.1 m/z was used for quantication (MS settings; fragmentor voltage
96 V, collision energy 77 V, Gas temperature 325 C, Gas ow 13 L/min,
nebulizer pressure 45 psi and capillary voltage 5000 V). The chro-
matographic system was the same as described above.
Reference standards of 1,000 µg/ml in ACN were purchased from
LCG standards (London, UK). The reference standards and their dilutions
were stored in vials that were wrapped in Paralm®, protected from
light, and stored at 20 C. Water was obtained from a Rephile direct
Ultrapure & RO Lab water system (Boston, MA, US). HPLC grade
methanol, ACN, and formic acid were purchased from Sigma-Aldrich
(Johannesburg, RSA). The calibration standards were a mixture solu-
tion containing CBD, cannabidiolic acid (CBDA), Δ
9
-THC, and Δ
9
-tet-
rahydrocannabinolic acid (Δ
9
-THCA). This was prepared with an initial
concentration of 200 µg/ml in ACN, and serially diluted to obtain seven
concentrations of: 50.00, 25.00, 12.50, 6.25, 3.13, 1.56 and 0.78 µg/ml.
Calibration standards were prepared fresh before analysis.
Results and discussion
Extraction efciency
All product types were tested for extraction efciency over a 1 h
period. Fig. 1 provides the CBD concentration curve at different times
using 50 % ACN as the extraction solvent. It is clear that the sugary
content of chocolate, honey and gummies played a signicant role in
reducing the extraction efciency of ACN. For these product types, it
seems essential to rst dissolve the product in water after which ACN is
added to extract the hydrophobic CBD. The oils and drinks were
adequately extracted using ACN and sonication for 1015 min whereas
the topicals and products 34, 36, 38 and 40 required sonication of 45
min for adequate extraction (Fig. S1 - Supplementary material).
Assessment of labeling accuracy
Products were assessed on their labeling accuracy, and this was
determined by the United States Pharmacopeia products purity guid-
ance, which sets the acceptable range for the labeling of products as
±10 %. Products were classied as over-labeled <90 %, under-labeled
>110 % and correctly labeled, 90110 % (Table 2) (Allen et al., 2014).
Oils
Of the 16 samples tested in this category, sample 13 had the highest
claimed amount of CBD per ml (50 mg/ml). However, this was also the
product with the biggest variation by having 98.43 % less CBD than
claimed. Product 14 was produced by the same manufacturer and
clearly states that it consists of "essential CBD oil blends". However, the
amount of CBD is not stated, and no detectable levels of CBD could be
measured. Products 79 were produced by the same company with
product 7 claiming to be a CBD Oil Isolate, product 8 a CBD oil Broad
Spectrum, and product 9 Full Spectrum. A broad-spectrum CBD
product is generally produced from hemp extracts with selective
removal of Δ
9
-THC, whilst the other minor cannabinoids are retained.
While full-spectrum CBD products may still contain up to 0.3 % Δ
9
-THC
and other minor cannabinoids after processing, CBD isolates (product 7)
are supposed to only contain CBD. Both broad and full spectrum
M. Mouton et al.
Phytomedicine Plus 4 (2024) 100520
4
products can still contain some of the distinctive terpenes (Berthold
et al., 2023). However, when looking at the chromatogram of these 3
products there is not much of an observable difference between the Oil
Isolate and the Broad Spectrum with similar peaks arising on both
chromatograms (Fig. 2). Only three products out of 16 in this category
were within the range of 90110 %, two of which are produced in USA
and one in South Africa. Eight products were over-labeled and one
product under-labeled. Three products did not state the amount of CBD
and did not have any detectable amount of CBD.
Fig. 1. Extraction efciency of dissolving Honey (A) and chocolate (B) in water followed by extraction with ACN.
Table 2
CBD product test results.
Sample ID Claimed concentration (µg/
mL)
Measured concentration (µg/mL ±
SD)
Product concentration variation (µg/
mL)
% Deviation from label
claim
% Recovery
Oils
1 41.29 45.05 ±1.55 3.76 +9.09 109.01
2 39.84 33.42 ±0.61 6.42 16.11 83.71
3 41.58 39.44 ±0.80 3.11 5.15 94.65
4 33.00 49.31 ±0.67 16.31 +49.42 149.18
5 41.57 43.86 ±1.80 2.29 +5.51 105.35
6 39.84 50.79 ±1.10 10.95 +27.48 126.71
7 20.00 11.42 ±0.08 8.57 42.83 57.09
8 20.00 16.11 ±0.08 3.81 19.06 80.74
9 33.33 17.03 ±0.07 16.31 48.92 50.93
10 nas <LOD na na na
11 33.33 18.37 ±0.08 14.96 44.88 55.18
12 31.25 5.23 ±0.02 26.02 83.26 16.73
13 41.67 0.66 ±0.02 41.01 98.43 1.57
14 nas <LOD na na na
15 33.33 24.08 ±0.07 0.04 27.74 72.14
16 nas <LOD na na na
Topicals
17 nas 1.57 ±0.03 1.57 na na
18 50.68 0.78 ±0.01 49.89 98.29 1.54
19 50.15 24.15 ±0.08 26.00 51.84 48.15
20 2609.73 <LOD na na na
21 44.63 <LOD na na na
Drinks
22 20.00 11.02 ±0.11 8.98 44.89 55.01
23 20.00 2.77 ±0.05 17.23 86.13 13.87
24 16.67 14.56 ±0.05 2.10 12.61 87.15
25 1.85 1.55 ±0.01 0.30 16.24 5.28
26 11.11 2.04 ±0.05 9.07 81.63 18.21
27 2.50 0.09 ±0.02 2.41 96.55 62.25
28 5.00 1.69 ±0.04 3.31 66.21 33.25
29 5.00 1.54 ±0.05 3.46 69.10 30.39
30 10.00 0.43 ±0.03 9.57 95.73 4.22
31 10.00 5.19 ±0.05 4.81 48.07 51.75
32 10.00 5.18 ±0.04 4.82 42.83 51.50
33 16.67 1.32 ±0.01 15.35 92.09 7.91
Other
34 Sachet 50.00 15.70 ±0.05 34.3 68.58 31.41
35 Honey 38.46 18.75 ±0.06 19.7 51.19 48.77
36 Coffee 50.77 <LOD na 100.00 na
37 Chocolate 16.53 3.67 ±0.01 12.85 77.78 22.21
38 Coffee 20.05 7.19 ±0.08 12.86 64.12 35.88
39 Gummies 50.77 <LOD na 100.00 na
40 Capsules 50.00 42.11 ±0.09 7.89 15.77 84.22
nas =no amount stated.
na =not applicable.
LOD =limit of detection.
M. Mouton et al.
Phytomedicine Plus 4 (2024) 100520
5
Topicals
This category had a total of ve products. Product 18 is sold as a face-
mask, and states that it was clinically proven as an "anti-aging ingre-
dient". This product had 98.29 % less CBD than stated on the packaging.
Product 20 is of interest because the label claim states that it contains 10
000 mg CBD hemp oil. The ingredient list claims that this product
consists of Cannabis sativa leaf extract", however, no CBD could be
detected. The very distinctive odor of C. sativa could also not be sensed
by ve colleagues and hence, this product is unlikely to contain any
C. sativa extract. Product 21 is marketed as a CBD lip balm but contains
no labeling nor any indication regarding a CBD concentration and no
CBD was detected.
Drinks
Twelve products were tested in this category. None of the products
fell within the 90110 % range stated by the USP; however, this was the
only group where all products were over-labeled. Product 27 showed a
deviation of 96.55 % compared to the label claim. These products all had
relatively low concentrations, which implies that they would probably
not have therapeutic benets when the CBD daily dose is taken into
consideration (Millar et al., 2019).
Products 2225 (1050 ml volumes) are all marketed as CBD shots
that the consumer is supposed to consume in entirety. Product 22 claims
to contain 5 mg CBD in one serving size but only contains approximately
2.76 mg. Product 23 claims to help with energy and focusand also
contains 5 mg CBD per 50 ml but contains 86.13 % less than claimed.
Product 24 states that CBD has 15 x more bioavailabilityand also that
this product is a calming shot. This product was found to have the least
variation in this group with the product containing only 12.61 % less
CBD than claimed. All the products in this category are water-based and
due to the low aqueous solubility of CBD, it might explain the far lower
concentrations detected in all the products.
Other
This category had a total of seven products, which included CBD-
containing coffee, honey, capsules, gummy bears as well as sachets.
Six of the seven products were over-labeled, and 1 product was under-
labeled. Product 34 is sold as "water-soluble CBD sachets". However,
when this product was prepared in water, sonicated, and ltered no CBD
could be detected. By extracting with ACN, CBD could be quantied, and
the amount deviated 68.58 % from the label claim. Product 35 was a
CBD honey, which is said to help with "general well-being and immu-
nity". This product was over-labeled and had 51.19 % less CBD than
stated on the label claim. Two products contained no CBD, product 36
(CBD coffee) and product 39 (Gummies).
Product 36 very boldly proclaims CBD Coffee” “CBD infused instant
coffeeand 20 mg CBD per servingand yet no CBD could be detected.
Product 39 is of interest due to its somewhat outlandish claims such as
Our extra strength CBD gummies are perfect for shedding light on your
inner darkness. Analyzing this product for its CBD content, however,
revealed that it contains none.
Δ
9
-THC content and laboratory testing
Twelve products claim to be Δ
9
-THC-free (Table 1). No Δ
9
-THC
could be detected in any one of these products using LC-PDA and LC-MS
and hence, seems to be correctly labeled in this regard. Two products, 5
and 34 contained trace amounts of Δ
9
-THC. Product 5 is sold as a full
spectrum product and hence, may contain low concentrations of Δ
9
-
THC. Product 34, however, only claims to contain CBD and yet trace
amounts of Δ
9
-THC was detected.
Three products (1, 2 and 15) claim to be laboratory tested. Claims
such as this are designed to instill consumer condence in the quality of
the product and to distinguish them from competitors. The certicate of
analysis for all three products was requested but only the US-based
producer of product 1 responded, who, coincidentally, was also found
to be the only product to be correctly labeled. Products 2 and 15, pro-
duced in SA, were over-labeled by 16.1 and 27.7 %, respectively.
Conclusions
The results demonstrate as others have also shown, the negligent
mislabeling of CBD products (Johnson et al., 2022b; Liebling et al.,
2022). This mislabeling is not limited to only the actual CBD content, but
also regarding the chemical properties of CBD such as being
water-soluble (product 34). With a logP value of >6, CBD is simply not
soluble in water as was shown by preparing some of these products as
prescribed which led to undetectable levels of CBD upon analysis.
Funding
This research did not receive any specic grant from funding
agencies in the public, commercial, or not-for-prot sectors.
CRediT authorship contribution statement
Michaela Mouton: Investigation, Methodology, Conceptualization,
Validation, Writing original draft, Data curation. Minja Gerber:
Writing review & editing, Supervision. Frank Van der Kooy: Project
administration, Supervision, Funding acquisition, Visualization, Writing
review & editing, Resources, Validation, Methodology.
Declaration of Competing Interest
The authors declare that they have no known competing nancial
interests or personal relationships that could have appeared to inuence
the work reported in this paper.
Acknowledgement
The authors are grateful to Pharmacen, center of Excellence for
Pharmaceutical Sciences, North-West University for nancial support.
Supplementary materials
Supplementary material associated with this article can be found, in
the online version, at doi:10.1016/j.phyplu.2023.100520.
Fig. 2. Overlayed chromatograms from top to bottom; Cannabinoids reference
standards, product 79.
M. Mouton et al.
Phytomedicine Plus 4 (2024) 100520
6
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M. Mouton et al.
... There are other published studies on this topic in other countries. Mouton et al. [15] examined forty commercially available products, conducting quantitative analyses across a varied spectrum of consumer goods, encompassing soft drinks, honey, coffee, oils, gummy bears, chocolate, and other items purported to contain CBD. Their objective was to assess the consistency between the actual CBD content of these products and the values indicated in the labels. ...
... Even in products with verified CBD content, concentrations may fall short of yielding desired pharmacological effects, particularly via oral consumption. Bonn-Miller et al. [17] undertook a similar investigation to that of Mouton et al. [15], opting to source products from online markets to enhance sample diversity and ensure the representation of available products. Analysing approximately 84 products, their findings were unsurprising: concerning CBD labelling, 42.85% of products were under-labelled, 26.19% were over-labelled, and only 30.95% were accurately labelled. ...
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... However, Epidiolex, a treatment for a rare seizure condition, remains the only CBD product approved by the FDA (Sholler, Schoene, and Spindle, 2020). In the broader health and wellness industry, CBD has been found in a plethora of non-prescription products, ranging from cosmetics to infused beverages (Miller et al., 2022;Mouton, Gerber, and Van der Kooy, 2024). CBD products have also been promoted in the pet industry to reduce canine inflammation, stress, and anxiety (Di Salvo, Conti, and Rocca, 2023). ...
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Purpose Cannabidiol products remains largely unregulated in the US. Unlike the Rx formulation of CBD [EpidiolexR], little information is available regarding labeling accuracy (does the product contain what the label says it does), lot to lot variability, nor long-term product stability. Understanding these properties are fundamental if these products are to be used in patients with epilepsy, where product variability of traditional AEDs has been suspected to result in inadequate seizure control. Therefore, we analyzed commercial CBD products, including oils, aqueous products (i.e., beverages), and various Other products for cannabinoid content vs label claims and stability under United States Pharmacopeia (USP) standards. Method Samples were diluted and analyzed by HPLC for CBD, THC, and CBN concentrations in order to assess product label accuracy. Products with <90% of label claim CBD were denoted over-labeled, products with >110% of label claim CBD were denoted under-labeled, and products between 90% and 110% of label claim CBD were denoted appropriately labeled, per USP standards. Results Among commercial CBD Oils (n = 11), mean CBD concentration vs label claim was 91.56% [95% CI, 66.02–117.10%], although 18.18% of oils (n = 2) made nonspecific label claims of “hemp extract” in lieu of CBD. Among all oils, 36.36% (n = 4) were appropriately labeled, another 36.4% (n = 4) of all oils were under-labeled, maximum 128.3% label claim, and finally, 9.09% (n = 1) of oils were over-labeled. The remaining 18.18% (n = 2) of oils lacked specific CBD label claims, minimum of 0.3 mg CBD per 1-ml “dose”. THC was detected in 54.55% (n = 6) of oils with a maximum concentration of 0.2% w/v and a minimum concentration of 0.036% w/v. Cannabinol was detectable in only 9.1% (n = 1) of products at a concentration of 0.00465% w/v. Among aqueous products (n = 21) tested, only 66.67% (n = 14) gave specific CBD label claims, with mean CBD concentration vs label claim of 59.93% [95% CI, 38.24–81.63%]. Only 7.14% (n = 1) of aqueous products with a label claim were appropriately labeled, 14.29% (n = 2) were found to be under-labeled, and 78.57% (n = 11) over-labeled. THC was detected in 23.81% (n = 5) of aqueous products tested with a maximum THC concentration of 0.0005% w/v, and a minimum concentration of 0.0002% w/v. Cannabinol was detected in 9.52% (n = 2) of aqueous products, both at a concentration of 0.0015% w/v. “Other” products (n = 7) tested ranged from chocolate bars to transdermal patches. Some 42.86% (n = 3) gave specific CBD label claims, with mean CBD concentration vs label claim of 67.01% [95% CI, 0.87–133.14%]. Among these three “Other” products with specific label claims, 33% (n = 1) was appropriately labeled, and 66.67% (n = 2) were over-labeled, with CBD concentrations vs label claim ranging from a minimum of 39.30% to a maximum of 101.99%. The remaining 57.14% (n = 5) of “Other” products tested made nonspecific CBD label claims, denoting CBD content in terms of “full spectrum hemp extract” or “activated cannabinoids”. One such product was labeled with a “40–50-mg CBD” range instead of a single, specific value. Tetrahydrocannabinol was detected in 71.43% (n = 5) of Other products tested with a maximum concentration of 0.0046% w/w, and a minimum concentration of 0.0008% w/w. Cannabinol was detected in 14.3% (n = 1) of Other products at a concentration of 0.0001% w/w. Conclusion We demonstrate that commercial CBD products, especially aqueous beverages, can show inconsistent labeling, vary largely from their label claims should they make them, and show lot-to-lot variability making dosing unpredictable.
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The popularity of cannabidiol (CBD) in consumer products is soaring as consumers are using CBD for general health and well-being as well as to seek relief from ailments especially pain, inflammation, anxiety, depression, and sleep disorders. However, there is limited data currently in the public domain that provide support for these benefits. By contrast, a significant amount of safety evaluation data for CBD has been obtained recently from pre-clinical and clinical studies of the CBD therapeutic Epidiolex®. Yet some key data gaps concerning the safe use of CBD still remain. Furthermore, current regulations on CBD use in consumer products remain uncertain and often conflict between the state and federal level. In light of the rapidly expanding popularity of CBD-related products in the marketplace, here we review the current understanding of the benefits, safety, and regulations surrounding CBD in consumer products. This review does not advocate for or against the use of CBD in consumer products. Rather this review seeks to assess the state-of-the-science on the health effects and safety of CBD, to identify critical knowledge gaps for future studies, and to raise the awareness of the current regulations that govern CBD use in consumer products.
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It was the aim of this study to analyse a portion of the South African cannabis-based products market and provide a detailed overview of their THC and CBD profiles. To date, no data of this kind exists in South Africa. Samples were submitted to a contract laboratory. A total of 840 samples were analysed in duplicate (1680 datapoints in total) and reported in an anonymous format. Samples were categorised into 7 different types: Edible, Extract, Infusion, Liquid, Other, Plant material, and Solid. Each category was divided into the following weight by percentage concentration levels: <0.1 wt.-%, 0.1 wt.-% to 1 wt.-% and finally >1 wt.-%. Both HPLC-UV, as well as, GC-MS was employed for analysis with the datasets combined. The results indicated that high amounts of THC are present in most of the cannabis-based products in South Africa. This is of concern due to the health implications of these products, and the current South African legislation related to CBD and THC. Medicines and controlled substance regulators as well as the South African public might be informed about the current state of cannabis-based products in South Africa.