CHAPTER One

INTRODUCTION

The primary goal of this study project is to substantially determine the impact of negligence of regulation on skincare formulations in Nigeria, South Korea and the United States, identify major advances in the area, and give a possible future agenda for them and recommend a framework for mitigating the impacts.

Theprimemotiveofanyregulatorycomplianceistoprovidequalityproductwhichissafeand effective to the human use. With the same notion of quality, safety and efficacy along with some prime regulatory requirements like nomenclature & labeling comprises the cosmetic legislationsinordertoregulatethecosmeticproductsinthemarket.Thesafetyassessmentsof cosmetic products are affected by the differences outlined by the regulatory authorities across globe.

Cosmetics are not only important to influence the global GDP about also give a freedom to enhance the social lives of humans across the nations. The use of cosmetics is not new rather the roots has already been transplanted as early as Egyptian, Greek, and Roman eras. Some unique examples from the books of history suggested that Neanderthal man painted his face with reds, browns, and yellows derived from clay, mud, and arsenic. Bones were used to curl hair. Makeup, tattoos, and adornments conveyed necessary social information. Galen, an ancient Greek physician, invented cold cream. The Romans used oil-based perfumes on their bodies, in their baths and fountains, and applied them to their weapons. Crusaders of the 13th century brought fragrances back to Europe from the Far East. The perfumes developed during the16thcenturywerepowdersorgelatinouspastes.Naturalperfumesweremadefromavariety ofingredients containin garoma. Here,with thisarticle wewilltry to coverthe different aspects related to cosmetic regulations in different countries and unions sideways we will also try to compare the market scenario and latest innovations in the world of cosmetics.

INTRODUCTION

The primary goal of this study project is to substantially determine the impact of negligence of regulation on skincare formulations in Nigeria, South Korea and the United States, identify major advances in the area, and give a possible future agenda for them and recommend a framework for mitigating the impacts.

Theprimemotiveofanyregulatorycomplianceistoprovidequalityproductwhichissafeand effective to the human use. With the same notion of quality, safety and efficacy along with some prime regulatory requirements like nomenclature & labeling comprises the cosmetic legislationsinordertoregulatethecosmeticproductsinthemarket.Thesafetyassessmentsof cosmetic products are affected by the differences outlined by the regulatory authorities across globe.

CHAPTER Two

LITERATURE REVIEW

SKINCARE CREAMS

Now, a variety of skincare products are available for almostany beauty concern one can have, including body washes,gels, lotions, exfoliants, moisturizers, toners and sun protection. There is mainly a focus on helping skin from theinside out. The existence of the FDA keeps known toxicingredients from being used, though many skincare productsstill do unfortunately have side effects. From timeimmemorial creams as, topical preparations are consideredan important part of cosmetic products. Creams may beconsidered pharmaceutical products as even cosmeticcreams are based on techniques developed by pharmacy andun-medicated creams are highly used in a variety of skinconditions in ancient times, creams were simply prepared bymixing of two or more ingredients using water as thesolvent. With the advancement in technology, newermethods are used for formulation of creams. These semisolid preparations are elegant to use by the public and society.They show versatility in their functions. Creams can beapplied to any part of the body with ease. It is convenient touse cream by all the age group of people. Although it may beequally well applied to non-aqueous products such as wax-solvent based mascaras, liquid eye shadows and ointments.If an emulsion is sufficiently low viscosity to be pourable(flow under influence of gravity alone) is referred to aslotion. Creams are emulsions of oil and water. In comingfuture, more advanced technologies and methods will beused for preparation, formulation and evaluation of creams.Also, the demand of herbal constituents-based creams isincreasing day by day.

Fig 1: Types of Skincare Creams

SKIN CARE PROCEDURES AND SKIN CAREPRODUCTS

The information of  skin care procedures is plentiful but littlescientifically documented and the number of productsavailable for cleansing, soothing, restoring, reinforcing and protecting is of an almost infinite variety. Nonetheless theirfunctionalities may be described as:

•         Removal of dirt, sebum, microorganisms, exfoliatedcorneocytes and other non-wanted substances from theskin.

•         Reduction of unpleasant skin symptoms (e.g. pruritus, burning, odor).

•         Restoration of (sub-clinically) damaged skin (e.g. dryand inflamed skin).

•         Reinforcement of undamaged but vulnerable skin (e.g.skin surface pH balance, germ reduction).

•         Protection of damaged, undamaged and vulnerable skinfrom various noxious factors.

•         Providing a pleasant skin feel (well-being)

Regulations

Nigeria’s National Agency for Food & Drug Administration & Control (NAFDAC) has issued new regulations prohibiting the use and trade, in skin bleaching agents and certain other chemicals used in formulating beauty products. In many ways, the New Regulation signals the seriousness with which the NAFDAC now wants to pursue the prosecution of persons involved in the trade and personal use of prohibited bleaching agents. Perhaps the most telling signal from NAFDAC is the expansion of the scope of persons that are criminally liable under the New Regulation. Under the New Regulation, the class of people that are now personally criminally liable, in additional to individuals acting alone, include, (a) every director, manager, secretary or officer of a company (b) every partner or officer in a partnership (c) every trustee of any associations or similar bodies (d) every person concerned in the management of an association (e) anyone purporting to act in the capacities specified in (a) to (d). Penalty for offences under the New Regulation includes fines, imprisonment and seizure.

The New Regulations have implications for directors, managers and shareholders (Key Persons) of grocery stores/supermarkets, pharmacies and importers/manufacturers of cosmetics and beauty products in Nigeria. In Ghana, where a zero-hydroquinone policy was introduced, the local cosmetics association, challenged Ghana’s Food & Drug Agency in court, albeit without much success.

The New Regulation of Nigeria’s Beauty & Cosmetics Industry in Nigeria prohibits the use of cosmetic products that contain more than 2% of hydroquinone alone or 1% in combination with other lightening ingredients, as well as any substance which when used according to the direction on the label accompanying the cosmetic product is likely to cause injury to the health of the user. It also criminalizes the “use” of the prohibited cosmetics products, making those who do not engage in any of the prohibited trading activities but apply the prohibited products on their skin criminally liable. The New Regulation defines “cosmetics” as any substance or mixture of substances intended to be rubbed, poured, sprinkled or sprayed, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the complexion, skin, hair or teeth.

The NAFDAC has issued Advertising Regulations which prescribe minimum standards for advertising beauty/cosmetic products in Nigeria. These standards include containing more than a trace of mercury or any mercury salt calculated as the metal or preservative, containing beyond 1% of hydroquinone and any of the three forms of arbutin, having poisonous or deleterious substances that will render it injurious to a user, being prepared, packed or held under unsanitary conditions, containing more than the permissible limit of an ingredient, and validating any information originally indicated on its label or container by the manufacturer. Grocery stores/supermarkets and pharmacies will be exposed to a higher degree of legal risk due to their non-core beauty industry players and stock a variety of personal care products. The current practice where suppliers merely fill out forms and submit sample products for internal approval leaves much to be desired.

The Cosmetics & Beauty Care Products industry in Nigeria is largely import driven and requires contractual mechanisms to manage and shift the burden of legal risk. There will be progressive regulation of beauty chemicals in line with global regulatory trends around skin bleaching agents. There is an emerging class of beauty entrepreneurs in Nigeria who engage in the formulation and/or mixture of different organic products and beauty chemicals. There is a need to review their commercial and go-to-market strategy to secure legal protection of unique beauty formulations and negotiate the appropriate commercial agreements necessary to extract value from their intellectual property. Generally, the Beauty & Cosmetics industry is on a growth trajectory driven by the growth of its middle-class and more strategic partnerships and joint ventures between global beauty firms and local entrepreneurs with unique formulations or knowledge of the local market.

NATURAL PRODUCTS AND ORGANIC PRODUCTS

Advantages of organic products

Absence of traces of pesticides in the products: its production requires more labor than the production of conventional ones and this greatly benefits the rural and local environment. The benefits are obvious.

Increase in biodiversity: as it is a production that uses natural biodiversity as an essential tool in farm management.

Pollution of water and the environment: with the use of this cultivation method, contamination of groundwater and soils is reduced since low solubility organic fertilizers are used, always used in adequate quantities. At the same time, as no pesticides are used, they help improve air quality.

Nutritive content: products from organic farming contain more nutritional principles than those from conventional farms, although this statement has yet to be proven by experts.

The main added value of organic products is their respect for the environment and their commitment to sustainable development, in addition to the continuation of traditions.

Disadvantages of organic products

Physical appearance: in general, organic foods are of inferior quality to the eye, however, what really matters is the nutritional content of the foods that make up our daily diet.

Conservation or shelf life: its shelf life is somewhat shorter in some cases than conventional foods.

Price: organic food is a bit more expensive since production systems are slower and labor needs are higher.

Natural products, whose main advantage is that they do not offer any harmful consequences. The most amazing thing to use natural products is that they are always beneficial.While natural products have been verified as being highly advantageous, some people are still doubtful about the uses of natural male enhancers over consulted medication.

One should be knowledgeable about the fact that more than half of the constituents used in consulted medicines are taken from nature but their natural features are totally damaged through the process of customization. Some of the many advantages of natural male enhancers as compared to consulted medicines are described as follow.Neither natural products do not need any recommendation like the prescribed skincare products nor are they managed by FDA rules and directions. You can always order a natural medicine to be shipped from an internet store to your doorstep without having a checkup from a doctor

Cosmetics are not only important to influence the global GDP about also give a freedom to enhance the social lives of humans across the nations. The use of cosmetics is not new rather the roots has already been transplanted as early as Egyptian, Greek, and Roman eras. Some unique examples from the books of history suggested that Neanderthal man painted his face with reds, browns, and yellows derived from clay, mud, and arsenic. Bones were used to curl hair. Makeup, tattoos, and adornments conveyed necessary social information. Galen, an ancient Greek physician, invented cold cream. The Romans used oil-based perfumes on their bodies, in their baths and fountains, and applied them to their weapons. Crusaders of the 13th century brought fragrances back to Europe from the Far East. The perfumes developed during the16thcenturywerepowdersorgelatinouspastes.Naturalperfumesweremadefromavariety ofingredientscontainingaroma.Here,withthisarticlewewilltrytocoverthedifferentaspects related to cosmetic regulations in different countries and unions sideways we will also try to compare the market scenario and latest innovations in the world ofcosmetics.

Natural

The term natural means, they are the naturally produced and minimally processed foods. The important feature of the natural skincare products is that they do not contain manufactured ingredients such as introduced hormones, antibiotics, sweeteners, colourings, and flavourings. Therefore, it does not have to meet standards set up by an approved board of certification. However, most of the standards were based according to the constituents and actives. People usually prefer natural skincare products, because they believe excessive processing could sometimes disturb the intrinsic value of the product. The water content of the natural product is high and available almost all across the country. Since, it involves no or minimal steps for the processing, their shelf life is not long.

Organic

Organic products are made up using modern techniques and synthetic chemicals to improve the quality of the product. Organic products should go through special authorities for certification before reaching the public to consume. Only if, the standards are met, the product could reach the public. In addition, the labelling is another important step to consider, as it involves some important rules and regulations by each government or authorised agents of the governments. However, there is an increasing demand for organic skincare actives, because of the high nutrient content. Organic actives could give an assurance about the content, manufactured and expiry dates. It is also convenient for the consumer with easy handling designs. Organic skincare products however, are not available everywhere, but in super markets or in recognized shops only. Usually, organic skincare actives have a long shelf life.

Cosmetic regulations around the globe

TAIWO VICTORIA ANUOLUWAPO

Cosmetic goods are regulated by various regulatory bodies around the globe and all havetheir own rules and regulations. To understand the view point of the regulatory requirement in differentcountriesweneedtounderstandhowthesecountriesaredefiningthecosmeticsasper theirlegislation.

  • India: As per Drugs and Cosmetics Act 1940 and Rules 1945, Cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component ofcosmetic.
    • UnitedStates:Definescosmeticsas“articlesintendedtoberubbed,poured,sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereofforcleansing,beautifying,promotingattractiveness,oralteringtheappearance, andarticlesintendedforuseasacomponentofanysucharticles;exceptthatsuchterm shall not includesoap”.
    • European Union: Defines cosmetics as “any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in goodcondition”.

One can also harness the definitions of cosmetics as a legal line between cosmetics & drugs, determine labelling requirements and standards. Although regulations applicable to cosmetic products are increasingly being harmonized to reduce international barriers to trade, there are still important differences to take into account when marketing or selling cosmetics in major markets around the world.

COSMETIC REGULATIONS IN SOUTH KOREA

Cosmetics Good Manufacturing Practices (CGMP)

CGMP certification is granted by the MFDS to the cosmetics manufacturers who apply for an inspection and comply with CGMP standards. (MFDS Notification ‘Standards on Cosmetics GMP’)

Introduction of Personalized Cosmetics Regulation

Definition: cosmetics that are manufactured and sold for a single consumer, reflecting skin condition, taste and etc. – cosmetics mixed with contents of finished products, or spiked with the ingredients which are safely used in cosmetics – cosmetics subdivided from the bulk or finished products preparation (mixing and subdividing), and comply with the facility and safety management standards Those who intend to sell personalized cosmetics shall register with the MFDS, hire a person qualified for on-site

Regulations for Cosmetics Manufacturers

Cosmetics manufacturers shall register with the MFDS as a cosmetics manufacturer (With the regional office that has jurisdiction over where the manufacturing facility is located).

guidances, supervisions and requests from a Cosmetics Responsible Person shall be respected and followed in line with quality management standards.

Manufacturing sites, facilities and instruments shall be managed in a hygienic and numbers sanitary manner to prevent risks to public health

Written manufacture management standards, manufacture management records and quality control records shall be prepared and retained (Including an electronic copy).

Facilities and instruments used to manufacture cosmetics shall be inspected regularly to ensure manufacturing operations.

Regulations for Cosmetic Responsible Person

To comply with the standards for quality control Any article that could cause harm at workplaces shall not be left behind, and no material jeopardizing public health shall be emited/leaked into the environment. To distribute products after conducting a thorough quality inspection thoroughly by manufacturer batch. To prepare and maintain written manufacture management standards, written manufacture management records and written quality control records To comply with standards for safety management after manufacturing and selling Facilities and instruments used to manufacture cosmetics shall be inspected regularly to ensure manufacturing operations.

To report a list of raw materials before sales, and manufactured & imported amount to the Minister by the end of Feburary of the following year “Cosmetics manufacturer/seller” is changed to “Cosmetics Responsible Person (Brand Holder)” starting in March 2019. Cosmetics Responsible Person (Brand Holder)

For domestically manufactured products : report to the Korea Cosmetic Association(KCA)

For imported products: to Korea Pharmaceutical Trades Association (KPTA) through Entry Notice of Imported Products : Entry Notice of Imported Products

Cosmetic Regulations in the United States of America

The Food, Drugs and Cosmetics Act (FD&C Act) defines two main categories of products:

  1. Cosmetics
  2. Drugs,includingthespecificsub-categoryofover-the-counter(OTC)drugs,whichcan be sold withoutprescription.

According to the FD&C Act, a product may be regarded solely as a drug, solely as a cosmetic or (in contrast to the position in the EU) as both a drug and a cosmetic.

Thelatterareproductsthatmeetthedefinitionsofbothcosmeticsanddrugs.Thismayhappen when a product has two intended uses. For example: An anti-dandruff shampoo is a cosmetic because its claims indicate that the product’s intended use is to clean the hair; but It is also considered to be a drug because it contains recognised anti-dandruff ingredients and itsclaims indicate that it is intended to be used to treat dandruff. Products classified as both cosmetics and drugs must meet the requirements of regulations for both categories ofproducts.

In the USA, cosmetic products are not subject to pre-market approval and companies are not required to submit information on their products or to register cosmetic manufacturing establishments. Manufacturers or distributors of cosmetics may, however, submit information on their products voluntarily through the Food and Drug Administration’s (FDA) Voluntary Cosmetic Registration Program (VCRP).

IfacosmeticmanufacturerfilesaproductformulationwiththeVCRP,theFDAcanadvisethe companyifitisinadvertentlyusingprohibitedorrestrictedingredients.Manufacturerscanthus correct their formulations before attempting to market them in the USA, thereby avoiding the riskofhavingtheirproductsdetainedand/ordeniedentryintotheUSAbecauseofaprohibited ingredient. Manufacturers may also report any adversereactions.

Cosmetic labelling is regulated under the FD&C Act as well as the FPLA (Fair Packagingand LabellingAct).Cosmeticingredientsmustbelistedbytheirestablishedname(INCInames)as laid out in the Cosmetics, Toiletries and Fragrances Association (CTFA) International CosmeticIngredientDictionary.TheregulationsforlabellingofcosmeticsinUnitedStatesare controlled by FDA under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labelling Act (FP&LAct).

The safety of cosmetic products in the US is the responsibility of the manufacturer, supported by an in-market surveillance system. The FD&C Act prohibits the distribution of adulterated and misbranded cosmetics and requires that cosmetics must be safe for their intended use before being placed on the market. The Act authorises the FDA to conduct inspections of cosmeticfirms(onthebasisofcomplaintsorsuspicionofviolationoflaw)withoutpriornotice in order to assure compliance with theregulations.

A voluntary process, the Cosmetics Ingredients Review (CIR), was established in 1976. The CIR is funded by the CTFA, with support from the FDA and the Consumer Federation of America. It reviews and assesses the safety of ingredients used in cosmetics and publishes the results in the scientific literature. Ingredients are selected for review on the basis of theirpotential biological activity, frequency of use in cosmetics and extent of skin penetration, amongst other factors.

FDA strongly urges cosmetic manufacturers to conduct whatever toxicological or other tests are appropriate to substantiate the safety of their cosmetics. However, they are notmandatory.

In the current amendment, on 2010 July 7 Human Resources (HR) 5786 Chapter VI of the Food, Drug and Cosmetic Act, which concerns adulterated and misbranded cosmetics, by adding a subchapter on the regulation of cosmetics.

Act to expand the regulation of cosmetics, including requiring:

  • Annual registration of any establishment engaged in manufacturing, packaging, or distributing cosmetics for use in the UnitedStates;
    • New fees to provide for oversight and enforcement of cosmeticsregulations;
    • Ingredient labelling and disclosure of information on ingredients;and
    • Adverse eventreporting

IMPACTS OF ORGANIC SKINCARE FORMULATOR’S NEGLIGENCE

Devoting one’s time as a formulator in researching the basis of skincare formulation, helps a lot with the know-how technology, what it’s about, the to-do and the dont’s, but endangering people’s health on not so perfect research is the problem. If you rely on personal research and produce it for yourself to test run and that it’s ok but making not approved research and selling it to the public that they don’t even know if it will work for their skin type if the wrong thing here.

However, this practice only results in concoctions being produced and sold by these hustlers who have no idea what healthy skin care is all about. Many of these fake skin care producers rely on YouTube videos for procedures on how to produce either soap, cream, or other products they consider to be pure organic products. Without the prerequisite, they create goods that could hurt the skin.

Women all around the world who use soaps and creams they believe to be natural, chemical-free products instead lose their skin to imitation items. They look for skin tone creams and hyperpigmentation and dark spot lightening solutions with really potent activities.

Burnt skin

Some of the creams are designed to treat sunburn, rejuvenate skin that has been sun damaged, mend and hydrate dry, rusty skin, and keep skin moisturized all day. These and many more factors influence women to disregard the dangers that lie behind the pursuit of artificial beauty, leading to deteriorating health.

They occasionally try to get glow creams to make their skin look more radiant. These creams, which contain vitamin C, glutathione, niacinamide, and arbutin, might occasionally be too harsh for the skin of those people, resulting in dullness, discoloration, and sunburn.

Why female users of social media should be wary of phony skin care items

In a conversation with women who have used these organic products, they stated that purchasing skin care items from unidentified sellers on Facebook and Instagram is wholly unacceptable. They advised women to ensure that the products they choose for purchase contain healthy active ingredients and to exercise caution when choosing the type of organic skin care to purchase from any seller on social media platforms.

Causes of Formulators Negligence

§  Unemployment,

§  Failing to get proper training,

§  Limited standard beauty schools in Nigeria

·         Also university and polytechnic not having an accredited department that focus on formulation are some of the reasons for this

IMPACT OF END USERS NEGLIGENCE

Customer Carelessness

·         Failing to conduct independent research or consult a professional before using a product.

·         Most people aren’t even aware of the actives in the product, whether or not they are allergic to it.

·         Comparing their skin to that of others, thinking that if something works for someone else, it must also work for them (bleaching)

·         Customers also mistake Pure Organic skincare and what most formulators in Nigeria this days does called Promixing or synthetic with each other

When using actives, one must know the desired usage, if it’s not up to, one won’t get the result and if it’s over also, it will give the users reaction and lastly there are some product that shouldn’t be used for long cause of the active(like it has duration of use), after getting desired result, you have to stop. It’s just like one using paracetamol for headache

Nigerians, sadly, struggle with a lack of knowledge and awareness of the skin, including what to apply to it, what not to apply to it, and the proper ratio or quantity to use. Many individuals are uninformed about how to care for the skin, and many women only desire particular outcomes without thinking about the repercussions, which could harm their skin.

CHAPTER THREE

Methodology

Research Philosophy and Approach: Pragmatism mixed method

This study is suited to the use of mixed techniques (inductive/deductive). This opens up the possibility of many methodologies, assumptions and data harvests that will allow for the most accurate understanding of consumer satisfaction with device financing. (Cherryholmes, 1992, Dainty, 2008 ).

Research Strategy  and Methods: Explanatory Sequential Mixed Method

The explantory sequential mixed method which involves conducting survey first using questionnaire, analyzing the result, and then using the qualitative survey(semi-structured interview) to collect detailed view of the customers to explain the initial quantitative survey chosen for this study (Creswell & Clark, 2011; Tashakori and Teddlie (2010a); basing the claims on a pragmatic stance (Denscombe, 2008). The questionnaire survey will assess respondents’ opinions about device financing. The semi-structured interview (Sinkovics & Alfoldi 2012) will allow customers to speak in a conversational way (Britten 1995, Lewis 2015).

Phases for explanatory sequential design

Figure 2 shows all aspects of the explicatory sequential design. These include: establishing ontological and epistemological positions; developing a strategy for inquiry; collecting data; analyzing quantitative data; evaluating qualitative data; and integrating and presenting conclusions.

MMR’s explanation sequential design highlights the quantitative phase, followed by the qualitative phase (Creswell 2011,). The second phase of the qualitative phase is designed to clarify the results from the first phase. It also aims to identify outliers and other data that may not be compatible. The term ‘explanatory’ means that qualitative data analysis is used to explain the conclusions of the quantitative phase. Researchers who are mathematically-minded and feel comfortable conducting research in this way often choose this strategy.

Fig 2 : Workflow of Explanatory Sequential Design of MMR (Creswell & Clark, 2017)

Sampling Method : Non-Probability. Purposive sampling

We used sampling techniques in this study to help us reduce the number of participants and still maintain the credibility of our research. (Marshall and colleagues, 2013, Bala, Etikan, 2017,). Participation must have been based on skincare use. It does not give equal chances of selection, which is the weakness of the sampling study. (Kumar, 2011).

SAMPLE SIZE

Our research will focus on respondents based in Nigeria who are active users of one or two skincare routine. We have a total of 50 respondents from these universities. It is sometimes not possible to collect data from all units of the population (Kumar and Sekaran, 2013). Since this is a popular choice over many decades, we will use the Roscoe (1975), for our sample size. Roscoe recommended that studies should have a minimum of 30 samples and a maximum of 500.

METHOD OF DATA COLLECTION AND ANALYSIS

 

The appropriate research choice must be used in the data collection and analysis of any study and it is a significant aspect of achieving any research aim. For this study, we will use a combination of quantitative and qualitative techniques and procedure for data analysis. This research will use the mixed-methods approach utilizing quantitative and qualitative techniques and analysis procedures one after the other. The reason for choosing this method is because it offers the benefit of basing knowledge claims on pragmatic grounds (Creswell, 2003). This study will use closed ended questionnaires to ascertain respondent’s opinion, this is a quantitative method while semi-structured interview which is a qualitative method of data collection will be used to complement the quantitative data. Our descriptive results will be obtained using the mean, standard deviation, and percentage while the inferential statistics will be obtained using correlation, and regression will using Stata 15.

Reliability and Validity

Reliability is focused on the assessment of a questionnaire survey’s internal consistency (Sarantakos, 2013), and our research instrument can only be deemed reliable only when it provides a consistently stable and reliable response over repeated administration (Santos, 1999). For this study, the most commonly used method of measuring internal consistency which is the Cronbach’s alpha coefficient will be used for this study. Especially, since it is suitable multiple for Likert questions contained in our research instrument. According to Pallant (2010), Cronbach’s alpha coefficient of .70 is acceptable level while 0.89 is considered good value and greater internal reliability. Thus, to ascertain the reliability of this questionnaire, the Cronbach’s alpha coefficient test will be conducted on about 20 questionnaires that will be collected using a pilot study of about 20 respondents.

External validity

According to Yin (2014), external validity refers to the extent to which a research finding can be generalized. In this study, the test of external validity will be achieved through review of key literature which comprises questionnaire survey and semi-structured interviews. The questionnaire represents the accurate population of skincare users in Nigeria, this will help to obtain population generalization.

Content validity

Content validity is encompasses the extent to which a questionnaire survey instrument adequately covers all aspect of the research area (Heale and Twycross, 2015). In this study, content validity was achieved through detailed literature which established the key issues to be explored through a questionnaire survey.

ETHICAL QUESTIONS

This research will employ many measures to ensure the safety of respondents. This study will ensure that the following is true: Participants will not be contacted until NAFDAC approves my policy to assail the safety of all participants in research (Belnap and al., 2015).

Potential volunteers will be informed about the study’s goal and problem, as well any potential risks.

After reaching an agreement, participants will need to sign informed consent papers.Participants will be properly treated and informed if they have the right to withdraw from the study at any point during the course of the study.

APPENDIX

SECTION A: BASIC INFORMATION

1.                                                                                                                           Gender

Male [   ]                  Female [   ]

2.                                                                                                                           Age Range

10-12 [   ]                 12-15 [   ]                   16-19 [   ]                  20-25 [   ]            

25 above [   ]

5.                                                                                                                           Period of Buying Skin Care Products

Less than 2 years [   ]           3-5 years [   ]          6-10 years [   ]

SECTION B: SEMI STRUCTURED QUESTIONS

1. How did you know about the Skincare Industry?

3. What motivates you to buy a Skincare Products?

4. Do you think skincare products are harmful?

5. What have been your experiences since you started using skincare products?

6. What impact does Skincare Products have on your personality?

7. What benefits do you derive from using Skincare Products?

8. What is your general perception of the negligence amongst skincare formulators?

9. What is your general perception of the negligence amongst regulatory bodies in Nigeria?

10. What is your general perception of the negligence amongst end users of skincae products?

11. Do you think you sometimes become negligent when choosing a skincare routine for yourself?

SECTION C: QUANTITATIVE ANALYSIS QUESTIONS

1. What is your preferred means of purchasing skincare products?

a. Online b. Going to a Physical Store

2. Do you ever re-patronize a skincare formulator even when the first products damages your skin further?

3. Has your mind ever being changed because the skincare formulator promised they have fixed the problems associated with the skincare products they manufacture?

4. What adverse effect of skincare products have you experienced?

5. As a regulatory body what steps have you taken to combat negligence on your own end?

6. As a skincare formulator, what steps have you taken to combat negligence on your own end?

7. As a skincare user, what steps have you taken to combat negligence on your own end?

Items were measured using a seven-point Likert scale, ranging from 1 = very unlikely to 7 = very likely. All others were measured using a seven-point Likert scale, ranging from 1 = strongly disagree to 7 = strongly agree.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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