Author’s Note:
Who does not wish to look beautiful? Beauty covers numerous aspects of skincare, hair care, face care, body care, and so on. Are you having concerns related to your skin, face, hair, or body lately? Do you opt for personal care products like creams, lotions, and shampoos, or do you prefer to use medicated products prescribed by your doctor when you face such concerns? Cosmetics are products that are intended to beautify, promote attractiveness, alter your appearance, and cleanse, however, they are not approved by the US Food and Drug Administration (FDA) for sale nor do they intend to affect the structure and function of the body. On the other hand, a drug is typically defined as a pharmaceutical compound or synthetic pharmaceutical molecule used for the treatment, mitigation, cure, or prevention of disease. Drugs are any substance (other than food) intended to affect the structure or any function of the body, according to the broad definition provided by the U.S. Food and Drug Administration (FDA). If deciding between going for a cosmetic or pharmaceutical product is confusing for you, here’s another option – COSMECEUTICALS! Everyone seems to be talking about cosmeceuticals these days. It is a hybrid product category that falls between cosmetics and drugs.
Introduction To Cosmeceuticals
The natural personal care industry’s most important segment is cosmeceuticals. In essence, cosmeceuticals are nothing more than a blend of cosmetics and pharmaceuticals. Cosmeceuticals, also known as cosmetic-pharmaceutical hybrids, are topical products that combine ingredients from both the cosmetic and pharmaceutical industries with the goal of enhancing beauty.
Although they are applied topically, they contain ingredients that affect the biological function of the skin. The term “Cosmeceutical” was coined in 1961 by Raymond Reed, and it was reintroduced in 1971 by Albert Klingman when he created a formula using retinoic acid to improve the appearance of skin that had been damaged by UV light and wrinkles.
The word “cosmeceutical” has no legal definition. Although the term “cosmeceutical” is not recognized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), the cosmetics industry uses it to describe cosmetic products that have therapeutic or drug-like effects. The term “cosmeceuticals” refers to substances that have both therapeutic and cosmetic effects.
Alternative terms described for cosmeceuticals include active cosmetics, performance cosmetics, functional cosmetics, Nutri cosmetics, and derma cosmetics.
Classification of Cosmeceuticals
Skin Cosmeceuticals:
To maintain good health, the skin must be preserved and protected. The largest organ in the human body, the skin, serves to protect and separate the internal environment from the external one. Cumulative damage to the DNA, collagen, and cell membrane, is a result of environmental factors, air pollution, sun exposure, and the natural ageing process.
Skin cosmeceutical products enhance collagen growth while reducing the damaging effects of free radicals, which improves the texture of the skin. This makes the skin healthier and preserves the integrity of the keratin structure. The following are the most commonly used skin cosmeceuticals;
Hydroxy Acid – These contain alpha-hydroxy acids (AHAs) such as glycolic acid, and lactic acid, and beta-hydroxy acids (BHAs) like salicylic acid. The primary mode of action of hydroxy acid is still unknown and highly debatable. According to some experts, the use of AHAs increases the production of glycosaminoglycans (GAGs), which improves the elastic fibres’ quality and collagen density. BHAs, on the other hand, have dermolytic qualities and aid in a number of xerotic (dry skin) and ichthyotic (dry, itchy skin that appears scaly and rough) disorders.
Sunscreen agents – These are highly recommended by dermatologists. UVA and UVB radiation from the Sun disrupts the extracellular matrix. Broad-spectrum UVA and UVB sunscreens combat photoaging. Enzophenones, such as dioxybenzone, oxybenzone, and sulisobenzone, provide UVB and UVA protection (320–340 nm). The single most important step toward maintaining healthy, youthful-looking skin is to use an effective sunscreen on a regular basis.
Traditional chemical sunscreens work primarily by binding to skin proteins and absorbing ultraviolet B (UVB) photons (280–320 nm), and the majority are based on para-aminobenzoic acid (or its derivatives), cinnamates, salicylates, benzophenones, etc. A benzophenone with superior ultraviolet A (UVA) protection is avobenzone (Parsol-1789).
Sunblocks or physical agents serve as barriers that scatter or reflect radiation. Compounds that contain metals like iron, zinc, titanium, and bismuth are examples of direct physical blockers. and zinc oxide. Although titanium dioxide is a white powder that is highly reflective, submicron zinc oxide or titanium dioxide powder particles transmit visible light while still maintaining their UV-blocking capabilities, making the sunblock invisible on the skin.
Benzophenone-8, Neo Heliopan MA and BB, Parsol MCX and HS, and Escalol 557, 587, and 597 are some sunscreens that are available in the market. In their patented sunscreen formula, Govier et al. used activated platelet factor as an ingredient in an acceptable carrier for cosmeceuticals.
Retinoids – Retinoids, which include Vitamin A and its derivatives, function as antioxidants and aid the skin’s normal processes of circulation, exfoliation, and cellular regeneration. They can activate specific genes and proteins. Retinoids can prevent the appearance of wrinkles, fine lines, and other ageing symptoms by smoothing the skin’s surface and restoring a youthful glow to the skin. Retinol, retinaldehyde, and retinoic acid (tretinoin) are important retinoids.
Antioxidants – Antioxidants lessen cellular damage caused by free radicals, thereby preventing dysfunction. Additionally, they inhibit the inflammation that causes collagen to break down. The skin has to contend with endogenous mitogens, most noticeably reactive oxygen species and other free radicals, in addition to external insults like UV radiation, drugs, and air pollutants. Alpha-lipoic acid, L-ascorbic acid, niacinamide, N-acetylglucosamine, -tocopherol, and ubiquinone are typical antioxidants.
Botanicals – They cover a major category of cosmeceutical additives found in the marketplace.
Ferulic acid – This plant-derived substance is regarded as a powerful antioxidant and has been demonstrated to provide skin photoprotection. Ferulic acid offers significant UV protection for human skin when combined with vitamins C and E.
Grapeseed extract – It has been proven to be a strong antioxidant. It has been demonstrated that the extract quickens wound contraction and healing and the topical application of this extract increases people’s sun protection factor.
Depigmenting agents – Depigmenting or skin-lightening substances work to stop melanogenesis (the pigmentation process by which cells produce melanin) and promote the healing of the hyperpigmentation-affected areas. In particular, regulation of melanogenesis with the aid of inhibiting tyrosinase activity, a crucial enzyme in melanin synthesis, is targeted as a treatment for hyperpigmentation.
According to popularity, safety, and efficacy for cosmetic purposes, the top skin-whitening agents are hydroquinone, kojic acid, mono benzyl ether of hydroquinone, gentisic acid, azelaic acid, liquorice, arbutin, retinoids, niacinamide, mequinol, soy, vitamin C, corticosteroids, hydroxystilbene, glutathione, alosein, glycolic acid, n-acetyl glucosamine, botanical extracts, and melatonin. For “bleaching” brown marks, liver spots, melasma, etc., hydroquinone is the most frequently used ingredient.
Exfoliants – Exfoliants encourage skin regrowth. In the stratum corneum, they eliminate supporter cells. Lactic acid, salicylic acid (SA), and glycolic acid are all common exfoliants. The dermis and epidermis may become more vulnerable to UV radiation penetration as a result of the frequent use of SA and AHAs. Patients should be instructed to take adequate sun protection measures as a result. The Cosmetic Ingredient Review Expert Panel determined that SAs are safe to use when designed to prevent skin irritation, be non-photosensitizing, or be applied topically every day to protect against the sun.
Moisturizing agents – Typically, moisturizers replenish the water content of the epidermis, which creates a protective layer that is soothing and improves the appearance and tactile qualities of dry and ageing skin. They also help to reestablish the skin’s normal barrier function and lessen the production of inflammatory cytokines.
Hair Cosmeceuticals:
The appearance of the hair is a physical characteristic of the body that, in contrast to all other land mammals, humans have direct control over. Hair care, colour, and style have a big impact on how people feel about themselves and how they look. Hair setting with mud, and henna colouring were two of the earliest hair cosmetic procedures used in ancient Egypt.
By far, shampooing is the most popular cosmetic hair treatment method. Although shampoos have primarily been products meant to clean the hair and scalp; current formulations are tailored to the variations associated with hair quality, hair care habits, and specific problems like treatment of oily hair, dandruff, and androgenic alopecia related to the superficial condition of the scalp.
Special care ingredients, conditioning agents, and hair growth stimulants are all found in hair cosmeceutical products. Fatty ingredients, quaternized cationic derivatives, hydrolyzed proteins, cationic polymers, and silicons are among the ingredients. Therefore, antifungal agents like octopirox, zinc pyrithione, and ketoconazole are currently used as anti-dandruff ingredients.
Other Cosmeceuticals:
There is very little subcutaneous fat and oil glands in the skin around the eyes. In order to replenish and repair, this delicate skin requires protection as well as a lot of moisture, which helps to delay the onset of premature ageing. The skin gets thinner, drier, and rougher as we age. Environmental pollution and excessive exposure to the elements exacerbate this condition.
Topical skin-soothing products may help here but, they need to be gentle and formulated with special ingredients that work from the inside out, by interacting with the cells below the skin’s surface, while not irritating the eyes.
The skin is nourished by a variety of cosmeceutical eye creams that use natural emollients and nutritious ingredients. The other active ingredients are antioxidants (vitamins A, C, and E); green tea and tiare flower; Ginkgo biloba; butcher’s broom, chamomile, and vitamin E; calendula; and bisabolol, an active component of chamomile, to calm irritated skin.
Emerging Trends And Innovations
With a focus on nonirritating ingredients to enhance skin appearance, recent trends in cosmeceutical development include those that address skin protection from radiation and oxidant damage. The most significant drug class to reverse cutaneous ageing is topical retinoid products, whose clinical efficacy has been established in numerous trials that included histologic analysis.
To control growth and differentiation, prevent tumour growth, lessen inflammation, and boost the immune system, retinoids work through retinol and retinoic acid binding sites. The most prevalent naturally occurring retinoid, vitamin A, works by preventing the formation of oxygen radicals after exposure to ultraviolet light on the skin.
With growing awareness of anti-ageing products, consumers – particularly the ageing population – are increasingly looking for ways to maintain and enhance their appearance so that they appear young and beautiful. A high prevalence of ageing symptoms is making middle-aged people more aware of ageing anxiety. Because they blur the line between cosmetics and pharmaceuticals, most anti-ageing skin care products are cosmeceuticals.
In addition to retinoids, antioxidants like niacinamide, idebenone, and alpha lipoic acid have seen growth in the market. In both topical and ingestible formulations, antioxidants have emerged as the largest general category of active cosmeceutical ingredients and are anticipated to keep holding onto this position for the near future.
A variety of cosmeceutical products can benefit from the inclusion of additional active ingredients like botanicals, enzymes, hyaluronic acid, amino acids, and peptides. The expansion of other industries, like nanotechnology, has also benefited the development of cosmeceuticals.
Key players like Procter & Gamble, Unilever, L’Oreal SA, Shiseido Co. Ltd, and The Estee Lauder Companies Inc. are among the most active businesses in the market. One of the most active businesses in the world, L’Oreal SA has a number of brands that offer a wide selection of cosmeceuticals. Regarding ingredients, functionality, and packaging, the company has improved product quality and innovation.
Global Cosmeceutical Market
The global cosmeceutical market was valued at USD 76,875.0 Mn in 2022 and is predicted to reach around USD 153,318.7 Mn by 2030 at a compound annual growth rate (CAGR) of 9.02% between 2023 and 2030 (Table 1).
The global cosmeceutical market is witnessing significant growth, driven by the increasing demand for advanced skincare products that bridge the gap between cosmetics and pharmaceuticals.
Key market insights:
Market Segmentation: The market is categorized based on product type, distribution channel, and region.
- By product type, skincare products dominate the market, accounting for the largest market share. This segment includes anti-ageing creams, moisturizers, sunscreens, and skin-whitening creams, among others.
- Based on the distribution channel, the market is segmented into online platforms, retail stores, and speciality stores.
- Geographically, North America holds the largest share of the cosmeceutical market, followed by Europe and Asia-Pacific.
Driving Factors: The market growth can be attributed to several factors: - Increasing consumer awareness about personal well-being and the importance of skincare.
- Advancements in technology, leading to the development of innovative and effective cosmeceutical products.
- Rising disposable incomes, particularly in developing economies, enabling consumers to invest in premium skincare products.
- The growing geriatric population, globally, driving the demand for anti-ageing cosmeceuticals.
Regulations And Safety Of Cosmeceuticals
Regulatory scenario:
The FDA does not regulate cosmeceuticals because of their distinct status as neither pharmaceuticals nor cosmetics. The Federal Trade Commission (FTC), whose job it is to look into any advertised claims of pharmaceutical properties or effects for scientific validity, investigates advertising claims made by manufacturers of cosmeceutical products for accuracy. To avoid FTC investigations, manufacturers must support any claims they make about how their products affect the structure or function of the human body with scientific data.
Cosmeceuticals are not regulated as such in the European Union, the United States, or Japan.
Cosmeceuticals are categorized as cosmetics in the EU. They are regarded as drugs in the US that the US Food and Drug Administration has most likely not approved. Cosmeceuticals are regarded as “quasi-drugs” in Japan. There is no legal definition of cosmeceuticals as compared to the legal definition of cosmetics or drugs, anywhere in the world.
The 1940 Drugs and Cosmetics Act governs the production, distribution, storage, and import of drugs as well as cosmetics in India. There is no term like “cosmeceutical”, defined by the act. The laws governing cosmeceuticals are not uniform across the USA, Europe, Asia, and other nations.
Safety and toxicity of cosmeceuticals:
For cosmetics, drugs, or cosmeceuticals to be safe, rigorous testing, quality control and regulatory compliance should be in place. Unfortunately, the consumer and manufacturer zeal for cosmeceuticals has led to the addition of numerous chemicals as additives to the commercially available preparations in an effort to improve their characteristics, significance, performance, and viability.
Many chemicals like 1,4-dioxane (C4H8O2, dioxane), formaldehyde and paraformaldehyde, and parabens may be present in cosmeceuticals, all of which have been shown to have potential toxicity. 1,4-dioxane is a preferred additive in shampoos, mouthwashes, and various types of toothpaste because it is an ether with emulsifying, detergent, and solvent properties. Breast, skin, and liver cancer may develop as a result of accidental significant exposure to this chemical through ingestion or other modes of consumption.
Both paraformaldehyde and formaldehyde, which are frequently used as their 37% concentrated solution “formalin,” are widely used as preservatives in a variety of cosmetic products, such as liquid soaps and shampoos. The risk of myeloid leukaemia, pro-allergenicity, carcinogenicity, mutagenicity, and irritation of the eyes, nose, and throat are just a few of the toxic characteristics of formaldehyde and its derivatives.
P-hydroxybenzoic acid esters include parabens. They are extensively used as preservatives in moisturizers, cleaning products, and cosmetics. They have a good safety record, but if used continuously at high doses, they could be dangerous to human health. They may cause damage to male reproductive health and may lead to breast cancer.
The same molecule may be used as a cosmetic component in one concentration while being used as a cosmeceutical in another. Salicylic acid is used in cosmetics at lower concentrations, but creams containing 2% salicylic acid have a completely different effect. Similar to this, lower concentrations of kojic acid are found in many cosmetic creams, while higher concentrations – between 2 and 5% – make it a cosmeceutical.
What Are Experts Saying About Cosmeceuticals?
According to a seasoned international cosmetic expert, with over three decades of experience in the cosmetics industry, including cosmetic claims development and regulatory compliance, the concept of cosmeceuticals is a confusing misnomer. The expert’s views on cosmeceuticals are as follows;
Legally speaking – at least here in the European Union (EU), they are no more than cosmetics, since either you are selling a cosmetic or a medicine/drug. Since cosmetics require robust evidence to support their claims, and so many brands are non-compliant when it comes to supporting their claims, adding so-called cosmeceuticals will just exasperate the situation.
Cosmeceuticals were meant to be evaluated in vehicle/placebo-controlled studies. As such they would run contrary to the cosmetic legislation, which means they would be classed as a medicine. In the USA it is a little different from that in the EU, and the term is more acceptable. Cosmeceuticals are in no way better than cosmetics since their identity itself is not clear and claims need to be justified. If a product has good performance and safety data, then it should work according to the claims being made. Making medical claims runs the risk of investigation by the authorities.
Until we have better compliance with the legislation we already have, this category of products will go nowhere. The concept of drugs or cosmetics (plus certain criteria for those termed borderline products, e.g., skin lightening) is good enough. What we should be doing is getting rid of the puffery and dreams. The legislative definition of a cosmetic does not include the words “dreams” or “beauty”.
Future Prospects
Future cosmetics and skin-care product formulations are expected to get more complex. Cosmetic companies are figuring out how to put ingredients in lip balms in small doses that don’t need to follow medical regulations, like steroids and hormones, which would lead to the production of cosmetics with the potential to enhance body mass, nail, hair, and steroid growth.
As more chemicals with real-world applications become available, government regulatory agencies will face new challenges. To accurately evaluate efficacy and safety concerns with significant implications for overall body health, claim substantiation and premarketing testing must advance. It will be necessary to reevaluate substances with an assumed good safety profile because the new vehicles and delivery systems combined with proven ingredients will change percutaneous absorption.
Innovation is essential to the development of cosmeceuticals. There will undoubtedly be a proliferation of cosmeceutical products with wider clinical applications as a result of the discovery of product niches, new active ingredients, and more efficient delivery systems.
Despite the best efforts of the industry, consumers are still doubtful about cosmeceuticals. They are uncertain about the product’s ingredients and sceptical of its claims, which leads them to question whether it is really worth the cost. Consumers are perplexed by vague package labelling for cosmeceuticals that lack specific information, such as the concentration of the main active ingredients. If cosmeceutical products were subject to stricter regulations, many of these issues could be resolved.
Since cosmeceuticals lack the same level of scientific rigour as pharmaceuticals, many dermatologists claim they do not believe in the efficacy of cosmeceuticals. This is a legitimate complaint that can only be addressed if manufacturers conduct objective product testing to back up claims.
The Work Group on Complementary and Alternative Medicine has been established by the American Academy of Dermatology (AAD) to help its physician members gather reliable information about cosmeceuticals. Dermatologists and representatives of the regulatory bodies for cosmetics are included in this group.
Challenges for the future
To increase the size of the cosmeceutical market, new active ingredients must be discovered and developed. To find new actives, it is crucial to study the pathogenesis of skin ageing. These
studies – many of which are carried out by manufacturers are used to pinpoint the stages of the ageing process at which cutting-edge cosmeceutical ingredients might be used as an adjuvant.
Botanical sources will be tapped to provide natural ingredients in view of the consumer’s interest in natural cosmetic products. An exciting new frontier for cosmeceutical producers is represented by the emerging category of naturals known as marine-based cosmeceuticals. The abundance of biologically active compounds found in algae makes them a particularly valuable resource.
In this changing market, new synthetic ingredients will also be important. The category of cosmeceuticals containing biologically active peptides, which have a variety of biological effects, is one of the fastest growing. These artificial ingredients, which have special advantages, resemble the peptides in human skin. And finally, for those who want natural skin care, autologous skin care products will provide the best option. These cosmeceuticals produce growth factors and other skin-rejuvenating substances using the user’s own cells.
Cosmetics manufacturers are currently evaluating the use of lasers, light sources, and other device-based technologies as penetration enhancers. In order to give the consumer access to cutting-edge technologies, these devices will be co-marketed with cosmeceuticals. Cosmetic companies have already marketed electrical appliances for use at home, including those that emit galvanic charges, in conjunction with cosmeceuticals.
Making sure that everything used in the process is returned to the environment in a beneficial way is the aim of sustainable manufacturing. Sustainability applies to both the formulation and packaging of cosmeceuticals. For sustainability, good agricultural practices (GAPs) are crucial. The processing of botanicals must be done in a sustainable manner in addition to the growing methods. The environment may be affected by the solvents used during the extraction process.
Dermatologists are becoming increasingly interested in the field of anti-ageing nutricosmetics. There is an increasing demand for foods and supplements that can be used as part of an all-encompassing program to improve appearance as a result of research linking nutrition, skin ageing, and skin health. The idea of inner beauty, which has already taken hold in nations like China and Japan, is still developing in the US and Europe. The market for beauty, health, and wellness products continues to be led by nutricosmetics, which has enormous growth potential in the US, Europe, and other developed countries.
Conclusion
The pharmaceutical industry is moving toward “cosmetically” oriented medicinal products as part of a modern “lifestyle” ideology, while the cosmetic industry is developing “medicinally” active cosmetics. The use of cosmeceuticals has drastically increased in recent years, which has led to a rise in the number of products available to doctors to improve the aesthetics of patients with dermal lifestyle issues.
A market segment that is still expanding in the personal care industry is cosmeceuticals. Even though demand is rising, so is competition. Manufacturers around the world face difficulties such as discovering new ingredients, developing better delivery systems, and creating greener products. The use of functional foods, dietary supplements, at-home gadgets, and cosmeceuticals in combination with a comprehensive strategy for maintaining overall health are among the new horizons.
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