cosmetics

Article
Analysis of Fluoride Concentration in Toothpastes in the United
Arab Emirates: Closing the Gap between Local Regulation
and Practice
Ammar Abdulrahman Jairoun 1,2, * , Sabaa Saleh Al-Hemyari 1,3 , Moyad Shahwan 4,5 , Obaida Jairoun 6
and Sa’ed H. Zyoud 7,8

1 Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences,

Universiti Sains Malaysia, Pulau Pinang 1800, Malaysia; [email protected]
2 Health and Safety Department, Dubai Municipality, Dubai 67, United Arab Emirates
3 Pharmacy Department, Emirates Health Services, Dubai 1853, United Arab Emirates
4 Department of Clinical Sciences, College of Pharmacy and Health Sciences, Ajman University,
Ajman 346, United Arab Emirates; [email protected]
5 Center of Medical and Bio-Allied Health Sciences Research, Ajman University,
Ajman 346, United Arab Emirates
6 College of Dentistry, Clinical Sciences Department, Ajman University, Ajman 346, United Arab Emirates;
[email protected]
7 Poison Control and Drug Information Center (PCDIC), College of Medicine and Health Sciences,
An-Najah National University, Nablus 44839, Palestine; [email protected]
8 Clinical Research Centre, An-Najah National University Hospital, Nablus 44839, Palestine



* Correspondence: [email protected] or [email protected]; Tel.: +971-558099957



Citation: Jairoun, A.A.; Al-Hemyari, Abstract: Background: While there is much scientific evidence supporting the benefits of fluoride for
S.S.; Shahwan, M.; Jairoun, O.; Zyoud, oral health, the concentration of fluoride in over-the-counter fluoride toothpaste should meet United
S.H. Analysis of Fluoride
Arab Emirates (UAE) regulations of a fluoride concentration not exceeding 0.15%. Objectives: The
Concentration in Toothpastes in the
current study examines the fluoridated toothpaste products available on the UAE market and aims to
United Arab Emirates: Closing the
quantify their total fluoride content. Methods: A total of 50 toothpaste products were collected and
Gap between Local Regulation and
analyzed in this study. Ion Chromatography (IC) conductivity analysis was performed to determine
Practice. Cosmetics 2021, 8, 113.
https://doi.org/10.3390/
the total fluoride content. Results: Among the 50 products tested, 10 exceeded the recommended
cosmetics8040113 concentration of total fluoride of less than 0.15%, while 12 had a total fluoride concentration that
was less than was declared on their labels. Moreover, this study has revealed that 22 of the sampled
Academic Editors: Helena Ribeiro products had a total fluoride concentration below 1000 ppm fluoride. An increased risk of higher
and Joana Marques Marto total fluoride content was observed in the toothpaste products with monofluorophosphate active
ingredients than in products with potassium nitrate/sodium fluoride and sodium fluoride (p = 0.011).
Received: 13 October 2021 Conclusions: There is a need to reassess the effectiveness of current regulations in the UAE to ensure
Accepted: 17 November 2021
that all fluoridated toothpastes available on the market are safe and effective for the consumer.
Published: 30 November 2021
Specifically, appropriate guidelines should be established on the basis of the risks and benefits
inherent in fluoride exposure. Moreover, fluoridated toothpastes need to be subject to stricter
Publisher’s Note: MDPI stays neutral
monitoring and control regarding their safety and quality through good manufacturing practices
with regard to jurisdictional claims in
(GMPs), education, research, and adverse event reporting.
published maps and institutional affil-
iations.
Keywords: toothpaste; fluoridated oral care products; fluoride; cavities; anti-caries

Copyright: © 2021 by the authors.

1. Introduction
Licensee MDPI, Basel, Switzerland.
This article is an open access article
In the 1930s, it was first noted that communities with access to naturally fluoridated
distributed under the terms and water experienced lower rates of tooth decay than those that did not, which thereby
conditions of the Creative Commons indicated the benefits of fluoride for dental health [1]. Consequently, fluoride began to be
Attribution (CC BY) license (https:// used in the field of dentistry during the 1940s, and it eventually became incorporated into a
creativecommons.org/licenses/by/ variety of consumer products. Caries, which is the most prevalent oral disease, results from
4.0/). an imbalance in the dynamic equilibrium between dental hard tissue demineralization

Cosmetics 2021, 8, 113. https://doi.org/10.3390/cosmetics8040113 https://www.mdpi.com/journal/cosmetics

Cosmetics 2021, 8, 113 2 of 12

and remineralization, which is caused by bacterial biofilms degrading dietary sugars and
fermentable carbohydrates into acid, among other causes [2–4]. The fluoride contained
in fluoridated toothpaste combats caries by retarding bacterial metabolism while also
reducing demineralization and enhancing the remineralization of dental enamel [5–8].
Research has proven the effectiveness of fluoridated toothpaste, which is produced through
the addition of sodium fluoride monofluorophosphate, stannous fluoride, and similar
fluoride compounds, in the management of dental caries. Specifically, the demineralization
rate of both permanent and deciduous enamel, as well as root dentin, is directly and
negatively associated with the level of fluoride in toothpaste [8–10]. Fluoride is either
absorbed and used in enamel demineralization or incorporated into a calcium fluoride
reservoir that can be sustained for long periods of time. If the tooth surface reaches a pH
level below 6, calcium fluoride releases fluoride ions, eventually leading to the formation
of hydroxyapatite (HA), which drives enamel remineralization [11,12]. Overall, fluoridated
toothpaste can increase fluoride levels on the tooth surface as well as within the oral cavity
for up to 10 h after application via tooth brushing [13]. Notably, there is a large body of
evidence-based research demonstrating that fluoridated toothpaste is an effective method
to address dental caries [5,8–10]. However, despite these anti-caries properties, it has also
been proven that the excessive intake of fluoridated toothpaste can have adverse side effects,
including dental fluorosis and skeletal fluorosis [14,15]. Dental fluorosis refers to a systemic
overexposure to fluoride that adversely affects the development of enamel, particularly
during the first six years of a person’s life, as this is when the enamel of permanent teeth
crowns form. Enamel affected by dental fluorosis is opaque and porous and has more
protein, and the condition can manifest clinically as white to light-brown narrow horizontal
lines or patches, as areas of porous enamel, or as reductions in enamel [16]. Meanwhile,
research has shown that when children accidentally swallow fluoridated toothpaste it may
lead to an exposure level of two or three times what is considered safe, meaning that the use
of fluoridated toothpaste by children could represent a dental fluorosis risk factor [17,18].
Hence, the use of fluoridated toothpaste must be carefully evaluated in terms of the risks
and benefits to oral health.
EU Regulation (EC) N◦ 1223/2009 on cosmetic products permits the addition of
fluoride compounds to oral care products with a fluoride concentration of up to 0.15% [19].
While similar regulations concerning fluoridated oral care products have been adopted
in the UAE, with the same maximum concentration of 0.15%, research has revealed the
presence of adulterated or contaminated cosmetic products in the UAE [20]. Moreover, any
toothpaste product with ingredients containing fluoride with concentration ranges from
0.1 to 0.15% should be labelled with “for children of six years and less: use a pea-sized
amount of toothpaste or less depending on age, and parents/guardians should supervise
tooth brushing to reduce the risk of swallowing too much fluoride”. Against this backdrop,
the current study examines the fluoridated toothpastes available on the UAE market with
the aim of quantifying their total fluoride content. To the best of our knowledge, ours is the
first study to perform an evaluation of fluoridated toothpastes offered on the UAE market.
The results will contribute to the strengthening of current regulations by showing whether
or not they are sufficiently effective while also paving the way for the development of
alternative methods in identifying excessive fluoride exposure to safeguard the anti-caries
effect while mitigating the risk of dental fluorosis.

2. Materials and Methods

2.1. Sampling Method
Outlets offering fluoridated oral care products were identified through a search of
local business directories that contained details on all United Arab Emirates (UAE) phar-
macies, parapharmacies, and health care outlets. The search revealed 2183 locations, which
were entered into a sampling framework consisting of an Excel spreadsheet containing
pertinent details such as business names, phone numbers, emails, and addresses. The study
sample was then generated using a basic random-sample selection method based on the ID
Cosmetics 2021, 8, 113 3 of 12

numbers of the businesses, and stratification was applied according to location and type.
In sampling the fluoridated toothpastes, the main selection criterion was that the product
label listed a form of fluoride as an ingredient, e.g., sodium fluoride, stannous fluoride, or
sodium monofluorophosphate. At each selected business location, one package of each
available fluoridated oral care product was randomly chosen; the manufacturing origin
was not taken into consideration. Each sampled product was assigned a code reference
number to preclude replication and permit tracking. For each sampled product, the follow-
ing details were recorded: product name, brand name, country of origin/manufacturer,
item category, subcategory, batch number, barcode, dosage form, size/volume, and the
recommended dose as well as the location of the outlet. If the same product (i.e., identical
name, manufacturer, formulation, barcode, and size/volume) was available at more than
one location, only the first product chosen was tested while the remaining samples were
returned. If products had identical names yet were from different manufacturers, or were
available in different formats (e.g., emulsion vs. cream), they were considered distinct
products and tested separately. All products were sent to the laboratory for testing on the
day of collection.

2.2. Instrumentation
The following are the materials used in the sample analysis, with the purchase location,
company, and country listed [21].
Ion Chromatography (IC) consisting of 930 Compact IC Flex, conductivity detector,
suppressor module, and MagIC Net software. Make: Metrohm, Switzerland.
Metrosep A Supp 7–250/4.0 mm column (P.N. 61006630) and guard column (Metrosep
A Supp 16 Guard/4.0 (P.N. 61031500)) with a 20 µL sample loop. Make: Metrohm, Switzerland.
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.
A set of 0.20 µm nylon syringe filters. Make: Biomed Scientific Ltd., Guangdong, China.
A set of 50 mL test tubes with cap. Make: Tarsons, Kolkata, India.
A set of 100 mL volumetric flasks. Make: Gulf scientific glass, Al Hidd, Bahrain.
Reagents: all reagents were of analytical purity, and included ultrapure water (deion-
ized water, NLT resistivity 18 MΩ m, and less than 20 ppb total organic carbon at 20 ◦ C),
sodium carbonate, and sulfuric acid.

2.3. Acquisition Conditions

IC-conductivity analysis was performed with the Metrohm 930 Compact IC Flex. For
quantification, the Metrosep A Supp 7–250/4.0 mm column, P.N. 61006630 and guard
column (Metrosep A Supp 16 Guard/4.0 (P.N. 61031500)) were used, and conductivity
detection after sequential suppression was performed with mobility-allowing (3.6 mM
sodium carbonate in ultrapure water) and conductivity-suppression (100 mM sulfuric
acid) solutions. Chromatographic separation was achieved with isocratic elution (20 µL of
sample was injected into the chromatographic system) at a flow rate of 0.7 mL/min and
column temperature of 30 ◦ C. The peaks of the determined components were identified by
their retention time compared with that of the standards, and the run time was 35 min.

2.4. Preparation of Test Portions

Powered semisolids and liquids were homogenized by stirring with spatulas or glass
rods. The homogenized material was used for sample preparation.

2.5. Sample Preparations

Preparation for fluoride content (added as sodium fluoride):
Cosmetics 2021, 8, 113 4 of 12

A total of 1.0 g of sample was extracted in 80 mL ultrapure water under sonication, and
the solution was made up to 100 mL, centrifuged for 5 min at 6000 rpm, and subsequently
filtered through a 0.2 µm nylon syringe filter.
Preparation for fluoride content (added as calcium fluoride):
Samples of 0.2 g were extracted in 80 mL ultrapure water under sonication and heated
at 65 ◦ C for 30 min. The solution was made up to 100 mL, centrifuged for 5 min at 6000 rpm,
and subsequently filtered through a 0.2 µm nylon syringe filter. Samples diluted 10 times
were injected if fluoride was present.

2.6. Calibration Standard

2.6.1. Reference Materials
A 1000 mg/L fluoride standard was used for IC-(Cat log no-77365-100 mL). Ultrapure
water was used as a diluent.

2.6.2. Linearity Procedure

Calibration standards of fluoride at concentrations of 0.04, 0.10, 0.20, 0.50, 1.0, and
2.0 mg/L were prepared in ultrapure water by serial dilution of the stock solution.

2.7. Validation Methodology for Quantitative Procedures

The method was fully validated according to the International Conference on Harmo-
nization (ICH) guidelines by a determination of the linearity, precision, accuracy, limit of
detection, and limit of quantification.
The selectivity of the method was proven with the chromatographic peak resolution
of fluoride.
The linearity of the method was tested in the range of 0.04–2.0 mg/L with a correlation
coefficient value greater than 0.995.
The limit of detection (LOD) was determined on analyte-free samples with a signal-to-
noise ratio of at least 3:1. The limit of detection and limit of quantification of the method
were tested in the range of 2 to 4 mg/kg. The limits of the method were 2 mg/kg and
4 mg/kg for limit of detection and limit of quantification, respectively.

2.7.1. Accuracy and Precision

The accuracy and precision procedure was conducted by spiking 6 individually spiked
solutions with concentrations ranging from limit of quantification (LOQ) to medium and
high levels of calibration concentrations. In this method validation, fluoride was spiked
at 4.0 mg/kg, 20 mg/kg, and 160 mg/kg in analyte-free products such as fluoride-free
toothpastes, mouthwash, and herbal toothpastes, which were prepared and analyzed for
each of the six spike levels. The RSD was not more 20%, and the recovery was 80 to 120%.

2.7.2. Quality Control and Quality Assurance (QC/QA) Procedures

Quality control samples were prepared as follows (QCS-known value of 1500 mg/kg):
1.0 g of QCS sample was extracted in 80 mL ultrapure water under sonication, and the
solution was made up to 100 mL, centrifuged for 5 min at 6000 rpm, and subsequently
filtered through a 0.2 µm nylon syringe filter. The sample injected was 10 times diluted.
Quality control and quality assurance (QC/QA) were evaluated from the following:
Quality control sample: A known value of sample was prepared. The percent recovery
was within 90–110%.
Duplicate sample preparation: Unknown samples were taken in duplicate. The
variation was not more than 20%.
Spike sample preparation: An unknown sample spike was prepared with a 20.0 mg/kg
concentration and was prepared in the same method as sample preparation. The recovery
was found to be 80–120%.
Check Standard: The same standard preparation of 0.2 mg/L was injected as a check
at the end of the sequence. The percent recovery was found to be 90–110%.
Cosmetics 2021, 8, 113 5 of 12

2.8. Limit of Quantification (LOQ)

The limit of quantification (LOQ) was estimated based on the signal-to-noise ratio of
at least 10 times. Using this method, the limit of quantification value obtained for fluoride
was 0.04%

2.9. Reporting Results

A calibration curve was used to understand the instrumental response to an analyte
and predict the concentration in an unknown sample. Generally, a set of standard samples
were made at various concentrations with a range than includes the unknown of interest
and the instrumental response at each concentration is recorded. The analyte concentration
in the test sample was calculated using Y = MX + C.

2.10. Ethical Consideration

This study received approval from the Institutional Review Board of An-Najah Na-
tional University under reference number (lnt.R. March.2021/12).

2.11. Statistical Analysis

The data were analyzed using SPSS version 24 (Chicago, IL, USA). The qualitative
variables were summarized as frequencies and percentages. For each fluoridated oral care
product sampled, the total fluoride content (%) was measured and compared with both EU
and UAE S/GSO regulations, which state that all finished fluoridated toothpastes must
contain no more than 0.15% (1500 ppm) fluoride. Kruskal–Wallis and Mann–Whitney U
tests were used to determine the median total fluoride content, and a p-value less than 0.05
was considered to be statistically significant.

3. Results
3.1. Sample Description
The sample baseline characteristics are shown in Table 1. A total of 50 toothpaste
products were collected and analyzed in this study. Of the total, 30 (60%) of the active ingre-
dients indicated in the formulation were sodium fluoride, 4 (8%) potassium nitrate/sodium
fluoride, and 16 (32%) were sodium monofluorophosphate. The countries of origin of the
sampled toothpastes were as follows: 20 (40%) were made in the European Union, 12
(24%) were made in India, 10 (20%) were made in the Middle East, and 8 (16%) were made
in Russia.

Table 1. Number and Percentages of Sample Baseline Characteristics (n = 50).

Characteristics Groups Frequency Percentage

Sodium Fluoride 30 60%

Labeled active Potassium

4 8%
ingredient Nitrate/sodium fluoride
Sodium
16 32%
Monofluorophosphate
European Union 20 40%
India 12 24%
Country of origin
Middle East 10 20%
Russia 8 16%

3.2. Estimation of Total Fluoride Concentration in Toothpaste Products

Estimates of the mean concentration with the confidence interval (CI) and standard
deviation for the total fluoride content of toothpaste products are summarized in Table 2.
Compared to the maximum allowable limit of ≤0.15%, the estimate for the average total
Cosmetics 2021, 8, 113 6 of 12

fluoride content was 0.193 with a 95% CI (0.11–0.27). Of the 50 tested toothpastes, 10
(20%) exceeded the recommended total fluoride level (≤0.15%). The relevant maximum
allowable limits are displayed as vertical “cutoff” limits. The results of the total fluoride
content stratified by sample characteristics of each sample are provided in Table 3.

Table 2. Descriptive Statistics of Total Fluoride in Toothpaste Products (n = 50).

Products
Maximum Exceeding
Allowable Maximum Limit Estimates of Concentration
Limit
N %
Mean ±SD 95% CI Median
Total
≤0.15% 10 20% 0.193 0.284 0.11 0.27 0.107
Fluoride
Notes: Maximum allowable limits according to the EU regulation and UAE S. GSO, Abbreviations: LOD; limit of
detection; LOD = 0.04% m/m, SD; standard deviation.

Table 3. List of Tested Toothpaste Products According to Total Fluoride Content and Sample Characteristics.

Sample Code Claim in the Label Active Ingredient Country of Origin Total Fluoride(%)
Supports the comforts
1 Sodium Fluoride EU 0.04
of the gum
2 Cleans and cools the mouth Sodium Fluoride EU 0.04
3 Cleans and cools the mouth Sodium Fluoride Russia 0.04
Cavity protection and
4 Sodium Fluoride Russia 0.04
teething aid
5 Cavity protection Sodium Fluoride EU 0.04
6 Cavity protection Sodium Fluoride EU 0.04
7 Cavity protection Sodium Fluoride Middle East 0.04
8 Cavity protection Sodium Fluoride India 0.04
9 Cavity protection Sodium Fluoride EU 0.04
10 Helps to strengthen the gums Sodium Fluoride EU 0.04
11 Cavity protection Sodium Fluoride EU 0.04
Tooth decay protection and
12 helps prevent the appearance Sodium Fluoride EU 0.048
of dental plaque
13 Cavity protection Sodium Fluoride EU 0.0497
Helps strengthen the tooth
14 enamel and promote the Sodium Fluoride EU 0.0497
prevention of cavities
Whitening and enamel
15 Sodium Fluoride EU 0.04975
protection
Potassium
Whitening and enamel
16 Nitrate/sodium EU 0.05
protection
fluoride
Cosmetics 2021, 8, 113 7 of 12

Table 3. Cont.

Sample Code Claim in the Label Active Ingredient Country of Origin Total Fluoride(%)
Protects and strengthens the Sodium Monofluo-
17 EU 0.051
milk teeth rophosphate
18 Protection against caries Sodium Fluoride EU 0.064
19 Cavity protection Sodium Fluoride EU 0.09
Reinforces the gums, anti-
Sodium Monofluo-
20 tartar action, and contains EU 0.093
rophosphate
hydroxyapatite
Cleans teeth, whitening, and
21 Sodium Fluoride EU 0.094
enamel protection
Protection and strengthens
22 Sodium Fluoride EU 0.094
enamel
Whitening, enamel Potassium
23 protection, and reduces Nitrate/sodium EU 0.1
painful tooth sensitivity fluoride
Whitening and enamel
24 Sodium Fluoride EU 0.103
protection
Cleans teeth and freshens the
Sodium Monofluo-
25 breath, antiseptic and EU 0.106
rophosphate
antibacterial properties
Tooth decay protection, helps
26 prevent the appearance of Sodium Fluoride EU 0.108
dental plaque
Helps strengthen the tooth
27 enamel and promote the Sodium Fluoride EU 0.11
prevention of cavities
Sodium Monofluo-
28 Cavity protection EU 0.116
rophosphate
Sodium Monofluo-
29 Cavity protection EU 0.116
rophosphate
Sodium Monofluo-
30 Cavity protection EU 0.116
rophosphate
Helps prevent cavities and
31 tooth decay and helps reduce Sodium Fluoride EU 0.119
painful tooth sensitivity
Sodium Monofluo-
32 Cavity protection EU 0.121
rophosphate
Sodium Monofluo-
33 Cavity protection EU 0.122
rophosphate
Sodium Monofluo-
34 Cavity protection EU 0.122
rophosphate
Sodium Monofluo-
35 Cavity protection EU 0.122
rophosphate
Cosmetics 2021, 8, 113 8 of 12

Table 3. Cont.

Sample Code Claim in the Label Active Ingredient Country of Origin Total Fluoride(%)
Sodium Monofluo-
36 Cavity protection EU 0.122
rophosphate
37 Cavity protection Sodium Fluoride EU 0.123
Sodium Monofluo-
38 Cavity protection EU 0.129
rophosphate
Whitening and enamel
39 Sodium Fluoride EU 0.13
protection
Tooth decay protection, helps
40 prevent the appearance of Sodium Fluoride EU 0.147
dental plaque
Potassium
Helps reduce painful tooth
41 Nitrate/sodium EU 0.3152
sensitivity
fluoride
Potassium
Whitening and enamel
42 Nitrate/sodium EU 0.3152
protection
fluoride
Whitening and enamel
43 Sodium Fluoride EU 0.32
protection
Whitening and enamel
44 Sodium Fluoride EU 0.32
protection
Whitening and enamel
45 Sodium Fluoride EU 0.32
protection
Whitening and enamel
46 Sodium Fluoride EU 0.32
protection
Helps prevent cavities and
Sodium Monofluo-
47 tooth decay and helps reduce EU 1.1
rophosphate
painful tooth sensitivity
Helps prevent cavities and
Sodium Monofluo-
48 tooth decay and helps reduce EU 1.1
rophosphate
painful tooth sensitivity
Whitening and helps reduce Sodium Monofluo-
49 EU 1.1
painful tooth sensitivity rophosphate
Sodium Monofluo-
50 Cavity protection EU 1.12
rophosphate

3.3. Comparison of Total Fluoride Content According to Sample Characteristics

Table 4 presents the distribution of the total fluoride content according to sample
characteristics. The table also provides the estimates along with p-values. These p-values
were provided from the results of the Kruskal–Wallis test. There was a statistically signifi-
cant association between the labeled active ingredient and the total fluoride content. An
increased risk of higher total fluoride content was observed in the toothpaste products
with monofluorophosphate active ingredients compared to those products with potassium
nitrate/sodium fluoride and sodium fluoride (p = 0.011).
Cosmetics 2021, 8, 113 9 of 12

Table 4. Comparison of Total Fluoride Content According to Sample Characteristics.

Total Fluoride Content

Groups N Mean Median ±SD p-Value
Sodium Fluoride 30 0.103 0.057 0.093
Labeled active
Potassium Nitrate/Sodium Fluoride 4 0.195 0.208 0.140 0.011
ingredient
Sodium Monofluorophosphate 16 0.356 0.122 0.445
European Union 20 0.132 0.051 0.053
India 12 0.113 0.121 0.007
Country of origin 0.161
Middle East 10 0.302 0.32 0.099
Russia 8 0.327 0.097 0.169
p-value reported above for comparisons between variable levels (“categories-levels”) using the Kruskal–Wallis test.

4. Discussion
Tooth brushing with fluoride-containing toothpaste is a key measure of public health
to combat dental caries. Specifically, fluoride’s dental caries-preventing properties mean
that it is often added to a variety of dental products, including toothpaste and mouthwashes.
These products have a topical effect on the surface of the teeth, and by using them regularly;
individuals can protect themselves against dental caries. The aim of this study is to
analyze the total concentrations of fluoride of the toothpastes currently available on the
UAE market.
The sampled products evidenced an average total fluoride content of 0.193%, which is
in excess of the level permitted under the current health and safety regulations in the UAE.
Among the 50 products tested, 10 exceeded the recommended concentration of total
fluoride of less than 0.15%, while 12 had a total fluoride concentration that was less than
was declared on their labels. Prior research across different countries has already evidenced
some disparities between a product’s actual concentration of total fluoride, and the concen-
tration it claims to have [22–24]. Another study that analyzed children’s toothpastes from
a variety of countries found that about 85% had total fluoride concentrations that did not
match those listed on their labels [25]. These stark disparities in toothpastes worldwide
concerning their real and declared total fluoride concentrations can lead consumers to over-
or under-consume fluoride, both of which have potentially harmful effects. Based on this,
there is a need to routinely monitor and control dental products such as toothpaste [26].
Recent research in the form of a systematic literature review found that toothpastes
do not have an anti-caries effect unless they contain at least 1000 ppm of fluoride. This
underlines the importance of establishing robust standards on the amount of soluble
fluoride contained in the formulations of toothpaste [15,27–29].
Nevertheless, this study has revealed that 22 of the sampled products had a total
fluoride concentration below 1000 ppm fluoride, meaning that the amount of biologically
active fluoride did not match the claims and indications given on the label.
One of the reasons for the observed mismatch between real and declared total fluoride
concentrations could be the abrasive substances that are often included in toothpastes [30].
It should be noted that the toothpastes in the current study with a concentration of less than
1000 ppm total fluoride used abrasives based on calcium or aluminum. In the presence
of sodium fluoride (NaF), the ions of these abrasive substances are known to reduce the
fluoride content [31]. Specifically, in the presence of sodium monofluorophosphate, fluoride
conjugates with phosphate through covalent bonds. As these bonds are unstable, they
release F ions, which in turn react with the calcium ions [32], triggering the production of
insoluble calcium fluoride (CaF2), which has neither remineralization [33] nor anti-caries
effects [33].
In line with the findings of this study, Filho et al. [34] and Cury et al. [35] demonstrated
that abrasive agents in toothpaste (typically calcium carbonate) and fluoride, generally
Cosmetics 2021, 8, 113 10 of 12

in the form of monofluorophosphate (MFP), are incompatible, reducing the total soluble
fluoride concentration.
Further causes for the observed discrepancy between declared and actual total fluoride
concentrations are manufacturing errors in toothpaste production, replacing high-cost
ingredients with less costly alternatives, and higher storage temperature, which is known
to lead to the instability of the fluoride [36].
Furthermore, it also emerged in this study that toothpastes with sodium monoflu-
orophosphate (MFP) showed higher concentrations of total fluoride than products that
were based on sodium fluoride. This is likely due to the fact that the sampled MFP tooth-
pastes used a silica-based abrasive, meaning that the fluoride was in the free ionized form
and thus almost entirely available. This finding highlights the urgent need to investigate
the issues raised by the compatibility between abrasives containing both calcium and
MFP [25]. Condeh et al. similarly demonstrated that dental products using silica-based
abrasives and MFP, or also NaF, contain more total soluble fluoride; our study confirms
these findings [37].
Interestingly, toothpastes claiming to mitigate the pain caused by sensitive teeth
tended to show higher concentrations of total fluoride. This could be linked to the dose–
response relationship between increasing fluoride content and enhanced anti-caries ef-
fects [38–40].
Our study raises concerning questions about the real-life anti-caries effects of the
toothpastes sampled here in that the total fluoride concentration of most products did not
match the labels’ claims. Fluoride-based dental products have two crucial components,
namely the availability fluoride and its stability; however, it has been shown that the
abrasives contained in these products contribute to the inactivation of fluoride ions, leading
to a product with low soluble fluoride that offers a substantially degraded anti-caries effect.
This study raises important implications for the manufacturers of fluoride-based
toothpaste. In particular, they must address discrepancies observed here between the total
fluoride concentration claimed on the label and the actual concentration in the product.
Thus, the current UAE regulations in this regard need to be re-examined in terms of their
effectiveness to mitigate the lack of quality control and compliance among manufacturers.
The relevant authorities should hereby also ensure that such products are in compliance
with the labelling and packaging legislation of the UAE market.

5. Conclusions
By enforcing stricter quality and safety control of fluoridated toothpastes in the
UAE through regulations, good manufacturing practices (GMP), education, research,
and adverse event reporting, it will be possible to promote better oral health among the
population through increased caries protection. In addition, dental practitioners monitoring
the use of fluoridated toothpastes in their patients should enquire about any further sources
of fluoride, thereby ensuring the prevention of caries while reducing the risk of dental
fluorosis in children under 8 years of age whose permanent teeth are developing.

Author Contributions: A.A.J. and O.J. designed and conceptualized the study. M.S. and S.S.A.-H.
responsible for sample collection. A.A.J. and S.H.Z. performed sample testing and analysis. A.A.J.,
M.S. and S.S.A.-H. responsible for data entry, analysis and interpretation. All authors have read and
agreed to the published version of the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement: This study received approval from the Institutional Review
Board of An-Najah National University under reference number (lnt.R. March.2021/12).
Informed Consent Statement: Not applicable.
Data Availability Statement: Data is available from the corresponding author upon reasonable request.
Conflicts of Interest: The authors declare no conflict of interest.
Cosmetics 2021, 8, 113 11 of 12

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