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15.3 Cosmeceuticals 301
15.3 Cosmeceuticals
15.3.1 Definition and Classification
15.3.1.1 Skin Cosmeceuticals
Cosmeceuticals, blending medicinal benefits with cosmetic allure, exert profound effects on skin biology. Beyond
mere aesthetics, these products enhance skin health by fostering collagen growth, combating free radicals, and preserving keratin structure. Noteworthy formulations, like
those featuring vitamins E, D, C, A, selenium, lycopene,
and minerals like copper and zinc, epitomize the efficacy
of this advanced skincare line. Hormonal interventions,
such as estrogen-based creams, present a compelling avenue for achieving a rejuvenated appearance in treating
aging skin. Notably, Kuno and Matsumoto’s patented
extract from olive plants stands out as an antiaging and
whitening component. Embracing innovation, dry emollient preparations incorporating monounsaturated Jojoba
esters emerge as valuable tools in the cosmeceutical arsenal. Martin’s use of chrysanthemum plant extract further
showcases the diverse botanical resources harnessed for
stimulating skin and hair pigmentation [5].
15.3.1.2 Creams Cosmeceuticals
Creams in the context of cosmeceuticals are versatile formulations designed for topical application on the skin.
These semi-solid emulsions typically combine water and
oil components, offering a balanced texture for easy
absorption. In the skincare category, antiaging creams are
formulated to address signs of aging, moisturizers hydrate
the skin, while facial creams cater to specific facial needs.
In the realm of hair care, creams provide styling versatility and nourishment. The emollient nature of creams
ensures effective delivery of active ingredients, making
them a popular choice for targeted skincare and haircare
applications [18]. Creams play a dual role, acting as facial
cleansers and contributing to antiaging efforts. Effective
cleansing agents, including cleansing cream, soap, and
water, are pivotal for maintaining skin health. Cosmetic
creams, exemplified by Vaseline and Lanolin, act as nourishing agents, softening and lubricating hard or chapped
skin. Additionally, dry creams find utility in soap production and serve as a base for gelatin in skincare formulations (19). Only green and black tea, date, grape seed, soy,
conker tree, pomegranate, pycnogenol, Matricaria chamomilla, comfrey, curcumin, aloe, and glyoxyldiureide, are
excipients that are frequently utilized in skin care cosmeceuticals [28]. (Table 15.2).
Classification of creams [19]:
Formulation type:
O/W type emulsion: these creams are made mostly of
water with little amounts of oil incorporated in them.
They work well with normal to oily skin types and are
lightweight and non-greasy.
W/O type emulsion: creams having an oil basis and water
droplets scattered throughout are known as water-in-oil
(W/O) creams. For dry or sensitive skin types, they are more
intense and occlusive, offering more hydration.
Creams used in cosmetics:
1. Moisturizing cream
2. Antiaging cream
3. Sunscreen cream
4. Antiacne treatment cream
5. Vanishing cream
6. Cold cream
7. Pharmaceutical cream:
8. Analgesic cream
9. Antibacterial cream
10. Emollient cream
11. Antifungal cream
Table 15.2 List of cosmeceutical ingredients [20].
Marketed preparation Ingredient Purported action
Soft cleansing emulsion Allatonin Smoothening
Lotus herbal moisturizers Aloe vera Softens
Garnier anti-wrinkle preparation α-hydroxy
acids (AHA)
Arnica herbal cream Arnica Astringent and soothing
Himalaya Arjuna Arjunolic Antioxidant and anti-inflammatory
Oxymed shampoo β-hydroxyl
acids (BHA)
Environ body cream β-Carotene Decrease lipid peroxidation and cellular antioxidant
Aroma silk Boswellia anti-wrinkle cream Boswellia Anti-inflammatory and antiaging
Calendula paste Calendula Soothes, softens skin, and promotes cell formation
Exfoliation and improves circulation
Antibacterial
302 15 Nutraceuticals and Cosmeceuticals
15.3.1.3 Hair Cosmeceuticals
Hair cosmeceuticals refer to specialized hair care products
that go beyond the cosmetic aspects of traditional hair
care. These formulations typically contain bioactive ingredients, vitamins, and minerals aimed at providing therapeutic benefits to the hair and scalp. Hair cosmeceuticals
encompass a range of products inclusive of shampoos,
conditioners, hair growth stimulators, gels, creams, and
colorants, each designed to treat certain hair issues and
advance general hair health. The focus is on combining
beauty and science to offer effective solutions for issues
like hair loss, damage, and styling needs, providing users
with a more comprehensive approach to hair care [20, 21].
Hair cosmeceuticals encompass a range of products,
including the following:
1. Shampoos: designed with active ingredients to target cer-
tain hair issues, including damage, dandruff, or hair loss.
For the treatment of dandruff, Ayurveda advocates the
use of various natural medications with prominent herbs,
such as henna, neem, amalaki, kapoor(naphthalene),
hirda, and behada. Additionally, magic nut, rosary pea,
bringaraj, cashmere tree, calamus, and mandora also
integral components in the Ayurvedic approach to combating dandruff. These herbs collectively contribute to
effective and natural solutions for managing dandruffrelated concerns [22].
2. Conditioners: packed with nutrients and moisturizing
agents to enhance the general health, manageability,
and texture of hair. Various components are employed,
predominantly fatty substances, hydrolyzed proteins,
silicones, quaternized cationic derivatives, and cationic polymers [21].
Hair growth stimulators: often incorporating chemicals like minoxidil or botanical extracts, these products
are intended to stimulate hair growth and prevent hair
loss.
Gels and creams: hair styling solutions that may
provide nourishing ingredients in addition to holding.
Hair colorants and dyes: these are products that
contain chemicals for nourishing and protecting the
hair shaft in addition to coloring the hair.
3. Hair cosmeceuticals, which include bioactive chemi-
cals, vitamins, and minerals, are designed to target certain hair-related problems and enhance the general
health and appearance of hair.
15.3.1.4 Antiaging Cosmeceuticals
Antiaging cosmeceuticals are applied topically and blend
bioactive compounds like retinoids, peptides, and antioxidants, influencing cellular processes tied to aging [23,
24]. Their effectiveness stems from concentrated potent
ingredients, allowing a detailed and versatile approach to
complex aging processes. These formulations not only
enhance current signs of aging but also actively target
the root molecular causes. Cosmeceuticals offer a sophisticated solution for maintaining healthy, youthful skin,
designed to be potent and comprehensive in addressing
various aspects of skin aging [25]. Being fragile and
prone to early aging, the skin under the eyes lacks oil
glands and subcutaneous fat. Because of environmental
exposure, this skin ages and gets thinner, drier, and
harsher. Antioxidants, chamomile, butcher’s broom,
vitamin E, and other substances included in cosmetic eye
creams nourish and shield the sensitive skin behind the
eyes. Eye care may be approached comprehensively with
specific formulas that address puffiness, inflammation,
and potential skin damage. Seaweed extract is used for
elasticity, while yeast is used to fill out wrinkles [26].
15.3.2 Active Ingredients
15.3.2.1 Retinoid
Vitamin A and its derivatives are effective as antiaging
agents, and the treatment of different cutaneous conditions has been the subject of much investigation.
Antioxidants and the activation of particular genes and
proteins are the two main roles of vitamin A. Structural
alterations lead to improvements in appearance, such as
collagen deposition, improved mitogenesis, new vascular
formation, and correction of epidermal atrophy. By wellestablished processes, topical tretinoin, a derivative, has
been shown to improve aged and photodamaged skin,
reduce wrinkles, laxity, hyperpigmented spots, and encourage a smoother skin surface [27].
15.3.2.2 Peptide
Peptides are messenger molecules that connect DNA to
cellular functions. They are made up of amino acid chains
that originate from DNA transcription and are found in
biological settings. Peptide manipulation can direct cells to
behave more like young ones [20].
15.3.2.3 Hyaluronic Acid
Hyaluronic acid (HA) is a naturally available compound
found in body tissues, especially in the extracellular space
of the face. It fills in the gaps between collagen and elastin
fibers in the dermis to moisturize and separate the skin.
Because the dermis is comprised of 70% water, it needs HA
to sustain and hydrate it, enhancing the youthful appearance of the skin. Dehydration of the extracellular matrix
(ECM) due to aging reduces HA levels and results in surface roughness, flaking, and fine wrinkles. Wrinkles are
caused by reduced HA, collagen, and elastin, but the skin’s
ECM is preserved by HA’s moisturizing framework and
nutrition transfer. Sodium hyaluronate’s smaller molecular
size improves penetration and may hold up to thousands
15.4 Synergies Between Nutraceuticals and Cosmeceuticals 303
times its weight in water, giving skin a smoother, softer
texture, and less wrinkles [20].
15.3.2.4 α-Hydroxy Acids and β-Hydroxy Acids
Owing to their ability to improve skin, hydroxy acids, such
as glycolic, tartaric, malic, pyruvic, lactic,and citric acid are
frequently used in cosmeceuticals [28]. The two primary
groups of these acids are β-hydroxy acids (BHAs), which
include salicylic acid, and α-hydroxy acids (AHAs), which
include lactic and glycolic acid. Hydroxy acids function as
exfoliants in cosmeceutical formulations, encouraging the
dead skin cells removal and increasing cell turnover.
Increased skin radiance, less fine wrinkles, and better skin
texture are the outcomes of this procedure. By treating
problems like hyperpigmentation and uneven skin tone,
hydroxy acids can also contribute to depigmentation. They
are therefore useful in treating aging symptoms, including
wrinkles and elasticity loss [29]. Although hydroxy acids
have many advantages, it is crucial to utilize them with
caution – especially at higher doses, as they can cause irritation to the skin [30]. Using hydroxy acids makes the skin
more susceptible to sunlight, so it is crucial to ensure adequate sun protection. Individuals incorporating these acids
into their skincare routine should prioritize the use of sunscreen to mitigate the heightened sensitivity to sunlight
and reduce the risk of sun damage.
15.3.3 Beauty and Dermatological Benefits
15.3.3.1 Wrinkle Reduction
Antioxidants (such as vitamins and polyphenols) used as
anti-wrinkle formulations prevent collagen deterioration
by decreasing the levels of free radicals. Collagen metabolism is directly influenced by cell regulators, including
growth factors, peptides, and retinols. The skin is penetrated by the essential antioxidants, vitamins B3, E, and C,
which have relatively small molecular weights. L-ascorbic
acid, or vitamin C, at 5–15% stimulates the formation of
collagen and inhibits collagenase, which results in antiaging benefits. Vitamin C and E together improve the antioxidant defense. A 5% dose of niacinamide (vitamin B3)
improves suppleness and decreases erythema by regulating
cell metabolism. Though less effective than vitamins C and
B3, vitamin E (2–20%) helps smooth and retain moisture in
the skin by reducing inflammation [23, 31].
List of plants with antioxidant potentials as well as antiwrinkling and antiaging properties and are commonly
used in diet [20] (Table 15.3):
15.3.3.2 Moisturization and Hydration
Hydration of epidermal cells and an elevation in hydroxylproline levels may be considered contributing factors to
moisturization [24]. Moisturizers, encompassing emollients,
Table 15.3 List of plants with antioxidant potentials as well as
anti-wrinkling and antiaging properties [20].
Source Responsible phytocompound
Tomato Lycopene
Carrot Laserine, vitamin A, and epilaserine
Turmeric Zingiberine and curcumnoid
Sunflower Tocopherol
Lemon Ascorbic acid
Red cabbage L-ascorbic acid and methanol
Custard apple Pinene and alfrutamide
Garlic Diallyl thiosulfonate
Gingo biloba Ginkgolides and bilobalides
occlusives, and humectants, stand as highly beneficial products for managing diverse skin problems, including atopic
dermatitis, psoriasis, pruritus, and aging skin [28].
15.3.3.3 Sun Protection and Acne Management
Cosmeceuticals serve a dual role in providing effective sun
protection and managing acne. These specialized skincare
products often incorporate ultraviolet (UV) filters and
antioxidants to shield the skin from harmful sun rays, preventing photoaging and damage [24]. Additionally, cosmeceuticals designed for acne management may include
ingredients like salicylic acid or benzoyl peroxide, targeting blemishes and promoting clearer skin. Various
sunscreens incorporate natural ingredients alongside conventional ones for enhanced safety and reduced reliance
on inorganic and organic compounds. For example, a
water-soluble sun protective formula, featuring TiO
and
2
5-hydroxy-tryptophan from Griffoniasimplicifolia, offers
UV protection without causing skin disturbances. Another
patented study highlights the combined absorption impact
of Kaempferia galangal (ginger) root extract in sunscreen,
enhancing photostability and efficacy during prolonged
sunlight exposure. Innovative products, like the tomato
lycopene sunscreen from 100% pure and Blossom Kochhar
Aroma Magic’s cucumber-infused sunscreen, leverage
natural elements for pollution protection, antiaging benefits, and a moisturizing feel [5, 28].
15.4 Synergies Between Nutraceuticals and Cosmeceuticals
15.4.1 Nutraceutical and Cosmeceutical (Nutra-cosmetical)
Nutra-cosmetics represent a unique convergence of nutrition and cosmetics. Nutricosmetics, also known as beauty
supplements or ingestible skincare, refers to the concept of
304 15 Nutraceuticals and Cosmeceuticals
enhancing skin well-being and appearance from within by
consuming specialized dietary supplements or functional
foods. These products are frequently promoted as oral cosmetics and contain proteins and enzymes as ingredients or
active components. Nutra-cosmetics offers a comprehensive approach to skincare by fusing the advantages of nutrition with the desire for outward attractiveness [32].
Nutra-cosmetic is not limited to cream, gel, and ointment right now. This offers a whole new generation of skin
care products that are more durable and effective. The
implementation of this method necessitates the combination of nutritional and cosmetic elements. The range of
applications for nutricosmetics is extensive. This means
that although nutricosmetics is designed for skincare, by
offering the right nutritional balance, it will still have an
effect on the health and welfare of hair and nails. Certain
topical cosmetics have the potential to penetrate deeper
than the dermal layer in a given area. However, when compared to creams, nutricosmetics has a better level of precision. It impacts not just the skin but also the hair and nails.
Nutricosmetics, an idea that is starting to gain popularity,
comes in a variety of formulations, such as tablets, drinkable ampoules, sachets, capsules, and more. Nutricosmetics
have the advantage of acting on all areas of the skin where
there is insufficient suppleness, not only the location of
application [33, 34]. Nutri-cosmetics include a lot of trendy
elements, like omega 3 and 6 essential fatty acids, which
enhance skin suppleness and skin barrier function, trace
elements that help to lessen oxidative stress, such as zinc
and selenium, plant extracts like aloe vera, which encourages the formation of collagen, and soy, which is rich in
isoflavones that stimulate cell regeneration, can help minimize indications of aging and enhance skin tone. Probiotics
can also increase the absorption of nutrients [35].
15.4.2 Internal and External Approaches to Health and Beauty
Diet can influence certain skin conditions and cause others.
Food imbalances can have an impact on the skin. Problems
might arise from consuming too much of one food ingredient [36, 37]. The skin manifestations of some vitamin and
mineral deficits can be identified [38, 39]. This commonly
happens to low-calorie dieters who overindulge in carrots
and oranges. Classic examples of nutritional dermatoses are
the cutaneous manifestations of particular deficits of different vitamins and minerals [38]. Hypercarotenemia turns
the palms and soles orange, while diffuse baldness is
brought on by hypervitaminosis A [40].
A number of conditions, including ionizing radiation,
alcohol consumption, extreme physical and mental
stress, poor nutrition, overeating, UV radiation (UVR),
and environmental pollution, can lead to extrinsic skin
damage. When the generation of reactive oxygen species
(ROS) in the skin is greater than the target cell’s capacity
to defend against them, oxidative stress is brought on by
UV exposure. UV radiation is thought to be the most significant environmental component in the progression of
skin cancer and skin aging, accounting for up to 80% of
all environmental influences [41, 42].
The skin abnormalities (xerosis, hair effluvium, nail
alterations, etc.) linked to anorexia nervosa provide more
evidence of the damaging impact of starvation on skin
health. Vitamin deficiencies are linked to a number of dermatological abnormalities, such as pellagra, the characteristic picture of niacin deficiency, or hyperpigmentation,
which is linked to a B12 deficiency. These deficiencies can
result from starvation or other causes, such as malabsorption and hereditary disorders. Additionally, trace elements
are necessary for healthy skin, and a deficiency in them is
linked to changes in the skin [43].
Carotenoids have been shown in recent research to
decrease molecular indicators of oxidative stress, including
matrix metalloproteinase-1, heme-oxygenase-1, intercellular adhesion molecule-1, and others, and to give photoprotection against UVA-induced pigmentation. An increasing
amount of research suggests that taking dietary supplements containing β-carotene, lycopene, lutein, astaxanthin, and mixed carotenoids can strengthen the skin’s
natural defenses against UVB-induced erythema or sunburn [44]. Regular consumption of carotenoids shields
human skin from UVA- and UVB-induced pigmentation
and erythema [45]. In patients with polymorphic light
eruption,nutritional supplements containing β-carotene,
lycopene, and Lactobacillus johnsonii have been demonstrated to reduce skin lesions caused by “photoprovocation” testing [46]. Increasing evidence suggests that
photoprotection can be achieved by oral supplementation
with lycopene and β-carotene [47].
The external approach to health and beauty mainly
focuses on the application of cosmetic formulations on the
skin to give a local action to improve skin health or appearance. Cosmetics are a broad category of products, most of
which are meant to be used externally. They are used to
clean, scent, alter the appearance of, mask unpleasant
smells from, or maintain the health of the part of the body
they are applied to. There are three primary physical states
in which skincare products can be found: liquid (such as
serums, solutions, or suspensions), solid (such as powders), or semisolid (such as creams, lotions, gels, and emulsions) [48]. Cosmetic surgery has gained a lot of popularity
recently because it enhances a person’s appearance. Unlike
cosmetic surgery, which is considered purely elective and
performed solely to enhance appearance, reconstructive
15.5 Regulatory Considerations 305
surgery is aimed at repairing deformities caused by trauma,
congenital conditions, or cancer damage. It is perceived as
restoring a somewhat altered appearance rather than solely
improving the top of Form [49].
15.4.3 Complementary Benefits
15.4.3.1 Skin Health from Within
There is ample evidence supporting the positive impact of
bacteria found in the gut on skin health and look. The gut
microbiota, as a key regulator of the gut shin axis, interacts with the skin, affecting skin differentiation and
keratinization [50]. The use of probiotic supplements has
grown in popularity, as evidenced by the abundance of
commercially accessible products in beverage, food, powder, and capsule forms. According to definitions, probiotics are “live microorganisms that, when given in sufficient
amounts, confer a health benefit on the host.” The
Lactobacillus and Bifidobacterium genera of bacteria are
the most commonly utilized [51].
15.4.3.2 Holistic Approaches to Beauty and Wellness
In recent years, holistic approaches to wellness and
beauty have become increasingly popular, with an
emphasis on the connection between mental, emotional,
and physical health. In order to achieve true beauty and
complete wellness, this integrated approach views lifestyle, nutrition, mindfulness, and skincare as crucial
components.
Mind–Body Connection in Beauty Numerous skin illnesses
might begin or worsen as a result of psychological stress,
according to recent clinical observations [52].
Clinical evidence and personal experience have long suggested that stress might trigger breakouts of acne [53]. The
mind–body link places a strong emphasis on techniques
like yoga, meditation, and mindfulness that enhance general beauty and reduce stress in addition to promoting a
glowing complexion. One of the positive psychology concepts that is most frequently researched is mindfulness,
which has been demonstrated to have good benefits for
human well-being [54].
Daily practice of inner beauty yoga and meditation has
been shown to radiate inner beauty energy, resulting in a
youthful, healthy, and attractive body [55]. Breathing exercises boost oxygen flow, which promotes cell regeneration
and can help reduce stress and enhance body repair.
Breathing deeply allows your lungs to hold more oxygen,
which will help blood get to your skin cells more easily.
Rich in regenerative qualities, this oxygenated blood
repairs skin damage brought on by free radicals and prolonged sun exposure [56].
Nutrition and Skin Health “The skin is the first line of
defense between the entire body and its surroundings, and
it also serves as a mirror for the soul.” The patient’s way of
life, particularly their diet, is vital for healthy skin as skin
does, need the right nutrients, in the right amounts. The
food must meet the macronutrient, such as proteins (for
immunity, enzymatic catalysis, structural support, and
amino acids), lipids (management of the inflammatory
process and the integrity of the skin’s barrier), vitamins and
oligoelements (for antioxidant defenses and skin and hair
repair). Food supplements may be helpful for those with
cosmetic and dermatological issues. A good supplement
regimen can help avoid sunburns, reduce the signs of age
on the skin and various dermatoses, and promote the health
and attractiveness of the hair and nails [57].
Herbs and spices like oregano, cloves, cinnamon, ginger,
and garlic, together with naturally occurring compounds
like lipoic acid in some fruits and vegetables, can help prevent skin from becoming too rigid and less elastic [58].
15.5 Regulatory Considerations
The worldwide projections suggest forecasted growth in the
cosmetics market to attain a value of USD 805.61 billion by
2023, with a 7.14% compound annual growth rate. To ensure
the safety of clients and protect their well-being, it is crucial
to establish appropriate regulatory requirements for personalized products. The Indian cosmetics industry has
experienced rapid growth in terms of regulatory issues,
with foreign brands benefiting from the expanding market.
The Central Drug Standard Control Organization (CDSCO)
enforces the Drug and Cosmetics Act and Rules, while the
Bureau of Indian Standards (BIS) has authority over label
information.
The Indian government has provided financial support to
academic institutions, universities, public research labs,
and start-up firms with research and development departments in nanoscience and technology. The Ministry of
Health and Family Welfare plays a vital role in managing
and preventing medical issues in India. The Nanotechnology
Sectional Committee regulates the standards of products
based on nanotechnology and ensures the safety of specialists associated with various research foundations and
associations.
Regulatory challenges related to nanomaterials require
focused attention to enhance public safety. In Canada,
regulatory challenges revolve around the customization of
pharmacological therapy for individual patients or small
patient groups. The European Food Safety Authority
(EFSA) created a scientific community to evaluate the
risks associated with the use of nanotechnologies and
306 15 Nutraceuticals and Cosmeceuticals
nanomaterials in food and feed. The regulatory approach
of the USFDA acknowledges that all developing technologies come with potential benefits, risks, and uncertainties
but refrains from implementing novel laws only for
nanomaterials.
15.5.1 FDA Guidelines for Nutraceuticals
Nutraceuticals are defined by the USFDA as dietary supplements, and the laws governing them were established in
1994. The FDA governs the regulation of dietary supplements and their components through a distinct set of rules
and regulations. According to the DSHEA, manufacturers
and distributors of dietary supplements and dietary ingredients are not allowed to promote or sell items that are contaminated or have incorrect labeling. Consequently, these
companies have the duty to assess the safety and labeling
of their products prior to marketing, ensuring adherence to
the regulations set by DSHEA and FDA. On the other hand,
the FDA is accountable for taking appropriate measures
against any dietary supplement product that is found to be
impure or inaccurately labeled, but only after it has been
released into the market.
The World Health Organization (WHO) and the Food
and Agricultural Organization (FAO) of the United
Nations established guidelines in the Codex Alimentarius
to assess food safety and use. According to these recommendations, health claims are defined in terms of
improved function, decreased risk, and nutrient function.
Nutraceutical and food supplement regulatory systems
have evolved slowly in contrast to the increasing array of
products available in the market all over the world. In the
United States of America, the FDA acknowledges nutraceuticals and applies different regulations than conventional foods and drugs. Manufacturers are accountable for
making sure a nutraceuticals safety before its marketing.
The Food and Drug Administration Modernization Act of
1997 permits the use of authoritative statements from the
Academy of Sciences or other federal authorities to support health and nutritional content claims on food labels,
provided that the FDA is informed at least four months
before the supplement release into the market.
Only dietary supplements that adhere to the definition
provided by the DSHEA are eligible for registration as dietary supplements. The active component should also comply with the regulations outlined in 21 CFR 190, which
pertains to dietary supplements. During registration, two
factors must be considered: if it is an active or an inactive
ingredient.
Throughout the registration process, it is important to
determine if the dietary supplement being registered is
an existing or new product. If a dietary supplement is
advertised prior to October 15th, it is considered an Old
Dietary Ingredient (ODI). If it is marketed after this date,
it is classified as a New Dietary Ingredient (NDI). The
Center for Food Safety and Applied Nutrition (CFSAN)
conducts pre-market surveillance to assure about the
safety of products in the US market, including those
linked to NDI. All required documentation must be delivered to the designated address.
The necessary documents are as follows:
1. Applicant’s name and residential address.
2. The product’s name, including its botanical name, can
be included.
3. Indicate if the dietary supplement is classified as an
ODI or NDI kind.
4. Documentation of implemented safety protocols, if
applicable.
5. Manufacturer and distributor’s signatures [59].
In India, nutraceuticals are referred to as “foods for special dietary uses.” The Food Safety and Standards Authority
(FSSA) provides a definition for “foods for special dietary
uses or functional foods or nutraceuticals or health
supplements.”
The Food Safety and Standards Authority of India
(FSSAI) was created in India under the Food Safety and
Standards Act of 2006. This act brought together different
laws and regulations from numerous ministries and departments that were previously responsible for addressing
food-related matters. The purpose of FSSAI is to establish
evidence-based criteria for food products and oversee their
production, warehousing, distribution, retail, and importation in order to guarantee the availability of safe and nutritious food for human consumption. Therefore, it is also
applicable to products, such as dietary supplements and
nutraceuticals. Since the FSS Act of 2006 went into effect, a
number of important acts have been repealed, including
the Fruit Products Order of 1955, the Prevention of Food
Adulteration Act of 1954, the Edible Oils Packaging
(Regulation) Order of 1988, the Meat Food Products Order
of 1973, the Vegetable Oil Products (Control) Order of
1947, the Solvent Extracted Oil, the Milk and Milk Products
Order of 1992, and De-Oiled Meal and Edible Flour
(Control) Order of 1967.
15.5.2 Cosmetic Regulations and Approvals
The cosmetics business has undergone substantial worldwide expansion, with marketing playing a pivotal role in
driving this growth. Global trade is important for economic expansion and advancement, although guaranteeing adherence to regulations in many regions poses an
enormous task. In order to tackle this issue, initiatives
15.5 Regulatory Considerations 307
have been undertaken to synchronize regulatory frameworks on a global scale. Within the EU, all member states
adhere to identical legislation as outlined in Regulation
(EC) No. 1223/2009 issued by the European Commission.
Nevertheless, there has been a lack of improvement in
other geographical areas, like the United States, Canada,
Japan, and China. Japan has enforced the Pharmaceutical
and Medical Devices Law since 2014, whereas China is
now undertaking institutional change. The Brazilian
Health Regulatory Agency (ANVISA), the Hygiene,
Perfume, Cosmetics, and Sanitizing Products Management
(GHCOS), and the Ministry of Health are in charge of regulating the country’s cosmetics sector [68].
Within the EU, it is the role of the authority to guarantee
the safety of a cosmetic product prior to its introduction
into the market [60].
This entails a safety evaluation conducted by a safety
assessor (SA), who is designated by the RP and possesses
expertise in a related field. The Cosmetic Product Safety
Report (CPSR) is located within the product information
file (PIF) and composed of two sections: safety information
regarding cosmetic products and the assessment of cosmetic product safety [4]. Both need to be revised and
adjusted as new knowledge emerges [61, 62].
The notification process is uniform for all cosmetic
goods, with the exception of those that include nanomaterials, which necessitate a separate protocol. Pre-market
approval of cosmetics by the FDA is not mandatory, except
for color additives, which must undergo approval for their
intended application.
In the United States, it is not obligatory for producers or
distributors to file product information or register their
establishments. However, they have the option to submit
the online information to the agency voluntarily through
the Voluntary Cosmetic Registration Program. In Canada,
it is the manufacturer’s duty to assure the safety of their
formulations. This entails notifying the Health in Canada
and submit a Cosmetic Notification Form (CNF) for each
cosmetic formulation that is sold. The notification does not
imply endorsement for sale or confirmation that the formulation meets all legal obligations, as those are the manufacturer’s responsibility.
In Japan, the registration process for cosmetic products
necessitates acquiring both a Cosmetic Manufacturing
and Marketing License, each of which has distinct prerequisites. In China, specific cosmetics must undergo
registration and obtain approval from the National
Medical Products Administration (NMPA) before being
manufactured. On the other hand, general cosmetics are
allowed to be made available in the market after a simple
notification process. In Brazil, the registration procedures
vary depending on the item, and certain items, such as
grade II cosmetics, are required to undergo pre-market
approval procedures. Within the EU, cosmetic laws follow a risk-based approach for components. The Scientific
Committee on Consumer Safety (SCCS) is responsible for
routinely reviewing and updating the “Notes of Guidance
for the Testing of Cosmetic Ingredients and Their Safety
Evaluation.”
Within the EU, cosmetic laws follow a risk-based
approach for components. The SCCS is responsible for routinely reviewing and updating the “Notes of Guidance for
the Testing of Cosmetic Ingredients and Their Safety
Evaluation.” The inclusion of nanomaterials, preservatives, colorants, and UV filters in cosmetic goods is
restricted to those substances that are listed in the approved
positive lists. In order to include a novel nanomaterial in a
cosmetic manufacture as a preservative, colorant, or UV
filter, it is necessary to obtain a license from the EC.
Subsequently, the EC will request the SCCS to conduct a
comprehensive safety evaluation. The labeling of a cosmetic product must clearly specify all components that are
present in nano form.
The EU mandates that the Commission publish a comprehensive list of all nanomaterials utilized in cosmetic
products. This list must specify the types of cosmetic items
and the anticipated conditions of exposure. The legislation
also forbids the utilization of compounds categorized as
CMR substances of 1A, 1B, or 2, categories as outlined in
Part 3 of Annex VI of legislation (EC) No 1272/2008.
Nevertheless, a material categorized as category 2 can be
incorporated into cosmetic goods provided it has undergone assessment by the SCCS and is deemed suitable for
usage [63].
Regions in Brazil, Japan, and China adopt a comparable
strategy by implementing negative and positive lists to regulate the use of substances in cosmetics. In China, cosmetic components are categorized as either “existing” or
“new,” and are further classified into several risk classifications. The FDA and Health Canada maintain lists for regulating cosmetic ingredients, although their scope is not as
extensive as the lists maintained by the EU [64].
Cosmetic product packaging serves as a multifunctional
platform that aims to allure consumers, convey details
regarding the product’s composition, and ensure the product’s safeguarding, transportation, and storage. Within the
EU, the assessment of cosmetic safety includes a crucial
examination of cosmetic packaging. It is obligatory to evaluate the packaging to validate the security of the product.
Cosmetic claims serve as strategic marketing instruments
employed by cosmetic companies to distinguish their products from rivals and foster innovation. According to the EU
Regulation, it is prohibited to use language, names, trademarks, photographs, and other signs in a way that suggests
308 15 Nutraceuticals and Cosmeceuticals
false features or functionalities of items. The Commission
Regulation (EU) No 655/2013, implemented in 2013, set out
six specific criteria that must be followed in order to justify
claims made about cosmetic products. These criteria
include adherence to legal requirements, accuracy, provision of supporting evidence, integrity, fairness, and enabling consumers to make educated choices [62].
The absence of legislation allows certain corporations to
engage in unfair commercial tactics, such as making hypoallergenic cosmetics and cruelty-free promises. The recent
cosmetic law in China mandates stricter regulations for efficacy claims in order to safeguard consumers from deceptive
and inaccurate information. The individual with the duty of
responsibility is required to publicly disclose the condensed
version of the evidence on a specific website specified by
the NMPA, in order to allow for public oversight.
15.5.3 Challenges and Opportunities in Compliance
Nutraceuticals and nutrition supplements are designed to
enhance health, optimize performance, and enhance
physical appearance. They are commonly regarded as safe
and less prone to causing adverse reactions. Nevertheless,
the scientific investigation of nutraceuticals and nutrition
supplements is often incorrectly understood or exaggerated to serve commercial interests, driven by the significant demands of consumers. The manufacturing and
marketing of supplements encounter difficulties, such as
confirming the authentic origin of raw materials, ensuring
purity and quality, absence of empirical proof, deceptive
advertising, poisoning by heavy metals, and the interplay
between supplements and medications. For instance, ginseng, a widely used herb, exhibits diverse strains, and supplements that are not manufactured in adherence to
stringent good manufacturing practice (GMP) standards
may contain unintended impurities. Ensuring the consistency of nutraceuticals is difficult because of the fluctuation in phytochemistry and the potential interaction
between herbal supplements and pharmaceutical medications. The lack of randomized controlled clinical research
for most nutraceuticals raises substantial concerns among
consumers [65].
15.6 Future Trends and Innovations
15.6.1 Advances in Nutraceutical Research
In developing countries, cancer has become an important
public health problem. The World Cancer Report (2018)
states that there will be 15 million new instances of cancer
in 2020, a 50% rise, due to increasing cancer rates.
However, the anticipated number of new cases is expected
to decrease by 14.5% with the usage of nutraceuticals.
Cancer can be prevented in part with a nutritious diet and
a lifestyle that promotes living. A class of phytochemicals
called carotenoids is in charge of giving food its various
colors. They successfully prevent cancer and have antioxidant properties. Lycopene’s importance for human health,
particularly in relation to cancer, has drawn attention to
carotenoids recently [66]. Plants rich in genistein, isoflavones, biochanin, and daidzein suppress the proliferation
of prostate cancer cells. Lycopene’s unsaturated form
serves as an effective singlet oxygen quencher and antioxidant. Lycopene is abundant in the testes, adrenal glands,
prostate, and skin, where it protects from cancer. The link
between coronary heart disease and carotenoids and cancer prevention has highlighted the significance of fruits
and vegetables in a person’s diet. Lycopene-rich fruits and
vegetables can help prevent cancer by reducing oxidative
stress and DNA damage. β-carotene contains antioxidant
properties and helps prevent cancer and other disorders.
β-carotene is a carotenoid with the highest antioxidant
activity. Of the two types of carotenoids, α-carotene has
50–54% while epsilon–carotene has 42–50% antioxidant
activity [67, 68].
The correlation between immunosuppression and prolonged inflammation highlights its potential as a carcinogen. Ginseng is an anti-inflammatory chemical that targets
several important players in the inflammation-to-cancer
pathway. Cancer-preventive phytocompounds are currently receiving a lot of attention. Chemopreventive components present in various vegetables and fruits may have
anticarcinogenic and antimutagenic properties, in addition
to other health benefits. A wide spectrum of phytocompounds with a claimed hormonal action, known as “phytoestrogens,” is advised for protection against prostate and
breast cancer. Cancer risk is increased by immunosuppression, which is connected to chronic inflammation [69].
Flavonoids found in citrus fruits function as antioxidants
and may shield against cancer. Foods high in soy include
soy isoflavones, which have been shown to have anticancer properties, as well as epigallocatechin gallate from
tea and curcumin from curry. Soybeans may provide protection against malignancies of the breast, uterus, lung,
colon, and prostate. Anticancer qualities are attributed to
β-carotene, which is present in green leafy vegetables, yellow, and orange, fruits, including oranges, tomatoes, and
sweet potatoes [70].
Tannins also help to detoxify carcinogens and defend
against free radicals. Tannins are a known anticarcinogen
that are used in complementary medicine to prevent cancer. Ellagic acid, renowned for its anticancer properties, is
15.6 Future Trends and Innovations 309
present in a variety of natural sources, such as grapes,
tea, lentils, blackberries, cranberries, and blueberries.
Additionally, this beneficial compound can be found in
walnuts, strawberries, pecans, pomegranates, and red
raspberry seeds [79].
Apples contain soluble fiber called pectin, which inhibits
prostate cancer spread by preventing the adhesion of cancer
cells to other body cells.Various research have demonstrated that pectin lowers blood cholesterol levels. Naturally
found phenolic acid compounds are thought to have anticancer effects. Curcumin, caffeic acid, gallic acids, and ferulic acids have been shown to have anticancer properties.
Lung and colorectal cancer risk has been connected to
the high intake of cruciferous vegetables, as well as glucosinolates and their hydrolyzed products, such as isothiocyanates and indoles. Sulforaphane, isothiocyanates, and
dithiol thiones are among the byproducts of glucosinolate
biotransformation. In the case of liver, colon, lung, breast,
stomach, and esophagus tumors, they specifically inhibit
the enzymes that encourage tumor growth [71].
Nutraceuticals have been found to have various benefits in
various fields, including cancer prevention, diabetes, and
eye disorders. Allicin present in garlic has been shown to
strengthen the immunity power and lower cancer-causing
factors, such as atherogenesis and platelet stickiness.
Sulforaphane, a strong phase 2 enzyme inducer found in
broccoli, has been shown to lower the incidence of prostate
and breast cancer. The polyphenol curcumin, which comes
from the Curcuma longa plant, possesses anti-inflammatory,
anti-carcinogenic, and antioxidant qualities.
Consuming fruits and vegetables rich in phytochemicals,
such as glutathione, cysteine, lycopene, vitamin E, vitamin C,
selenium, and other phytochemicals, can also increase antioxidative capacity. To ensure their positive impacts in cancer
prevention or therapy, more research is necessary [72].
Nutraceuticals have also been proven to be effective in
preventing prostate cancer. However, more elaborate
research is needed to confirm their beneficial effects in the
protection against cancer or treatment. Numerous herbal
dietary nutrients and herbal drugs have been shown in
studies to be beneficial for type 2 diabetes mellitus.
Isoflavones, lipoic acid, omega-3 fatty acids, psyllium fibers, ethyl esters of n−3 fatty acids, and plant extracts have
shown their effectiveness in preventing or treating diabetes
[73]. Omega-3 fatty acids have been proposed as a means to
decrease glucose tolerance in individuals who are at risk
for diabetes.
Consuming foods that are high in antioxidants, such as
PUFAs, zeaxanthin, and lutein, can be beneficial for individuals with age-related macular degeneration (AMD) [74].
Nutraceuticals with abundant polyphenolic flavonoids
exhibit potent antioxidant properties. Herbs and their
extracts, including green tea, carotenoids, vitamins C and
E, coenzyme Q10, and polyphenols, also exhibit antioxidant characteristics. Astaxanthin, a naturally occurring
carotenoid present in marine organisms, safeguards the
eyes, heart, and nervous and immune system from oxidative harm and degenerative ailments, such as AD.
Zeaxanthin and lutein are employed in the treatment of
ocular diseases. Astaxanthin, a naturally occurring carotenoid, is also beneficial in eye disorders and is found in various vegetables and fruits [75].
Nutraceuticals are important for immune function and
disease susceptibility. These include Astragalus mongolicus, coneflower extracts, and herbs in the genus Echinacea,
which both stimulate and depress the immune system.
Phytoestrogens are recommended for preventing diseases
related to hormonal imbalance, with soy isoflavones being
a potential alternative. Morphine and garlic are examples
of nutraceuticals with the potential to stimulate and suppress the immune system [69].
Probiotics have shown promise in the treatment of conditions, such as recurrent Clostridium difficile-induced
infections and infectious diarrhea in children. They contribute to the progression of lymphoid tissue and improve
the balance of pro- and anti-inflammatory cytokines.
Probiotics support the maintenance of a balanced population of pathogenic and nonpathogenic bacteria by altering
the intestinal microbiota. Their excellent safety record
helps to reduce the need for antibiotics and promotes
acceptance of “alternative” or “natural” medicines.
Cardiovascular diseases (CVD) are a major global health
concern. High death rates have been associated with low
fruit and vegetable diet. For prevention and management,
nutraceuticals,such as dietary fibers, vitamins, antioxidants, minerals, and PUFA along with physical activity are
advised. Numerous substances, including dietary indoleamines, tannins, tetrahydro-β-carbolines, flavonoids, anthocyanins, and melatonin, are supposed to provide health
benefits. Ginger has strong anti-inflammatory and antioxidant qualities and is advised for a variety of conditions.
Dietary fibers help reduce cholesterol levels, while phytosterols compete with dietary cholesterol.
Numerous health issues, such as allergies, obesity,
inflammation, Parkinson’s disease, Alzheimer’s disease,
and osteoarthritis, are significantly impacted by nutraceuticals. Allergy is an immune system hypersensitivity illness characterized by allergic reactions brought on by
immunoglobulin E’s excessive stimulation of mast cells
and basophils. The antioxidant quercetin guards against
low-density lipoprotein (LDL-C), a major contributor to
heart disease. The most prevalent type of dementia,
Alzheimer’s disease, has no known treatment and ultimately results in death. By preventing oxidative stress,
310 15 Nutraceuticals and Cosmeceuticals
antioxidants found in nutraceuticals, such as lutein, turmeric, lycopene, curcumin, and β-carotene may be benefi-
cial for some conditions [85].
Motor symptoms are the hallmark of Parkinson’s disease, a degenerative disorder of the central nervous system
caused by a breakdown of dopamine-producing cells in the
substantia nigra. Some nutraceutical supplements, such as
vitamin E, glutathione, and creatine, have shown promising results. Approximately 315 million individuals worldwide suffer from obesity, making it a public health concern,
and nutraceutical interventions are being investigated for
weight management. Caffeine, ephedrine, chitosan, and
green tea are few of the herbal stimulants that are useful in
promoting weight loss [76, 77].
Inflammation is the body’s reaction to irritation or
injury and is typified by swelling, discomfort, redness,
and heat. S-adenosylmethionine, ginger, soybean, unsaponifiable, glucosamine, and chondroitin are among the
nutraceuticals that have an impact on osteoarthritis.
Vitamins C and D, cat’s claw, resveratrol, omega-3 and
omega-6 series, and gamma-linolenic acid (GLA) are all
effective anti-inflammatory agents.
Osteoarthritis is a harmful joint disorder with costs associated with approximately $86 billion in 2004. Because they
control NO and PGE2 generation and gene expression,
nutrients such as chondroitin sulfate and glucosamine are
commonly used to treat osteoarthritis symptoms. This provides a reasonable explanation for their anti-inflammatory
properties [78].
15.6.2 Cutting-edge Cosmeceutical Technologies
Cosmetic products employ several cutting-edge cosmetic
delivery technologies. A cosmetic delivery system refers to
a formulation or procedure that can improve the perceived
or quantifiable effectiveness of a cosmetic product.
Phospholipids are generally recognized as safe (GRAS)
substances, which helps to reduce the occurrence of side
effects. Liposomes have the ability to transport both watersoluble and water-insoluble substances, rendering them
advantageous for the transportation of drugs and cosmetics.
They can exist as either single-layered or multi-layered
structures, with dimensions varying from 15 nm to several
micrometers. Liposomes are employed in aqueous environments to encapsulate perfumes, botanicals, and vitamins.
These substances are prone to instability as a result of oxidation and degradation, but their stability can be enhanced
through the optimization of storage conditions and the
addition of chelators and antioxidants. Phosphatidylcholine,
a primary component, is extensively utilized in skincare
products and shampoos because of its ability to soften and
condition. Because liposomes are simple to prepare and
enhance the skin’s absorption of active chemicals, they are
frequently utilized in the cosmetics business [79, 80].
Marinosomes are liposomes composed of a marine lipid
extract that has a high concentration of PUFAs, such as
eicosapentaenoic acid (EPA, 20:5n-3) and docosahexaenoic
acid (DHA, 22:6n-3). The epidermis of normal skin lacks
these. Nevertheless, skin epidermal enzymes convert them
into compounds that possess anti-inflammatory and antiproliferative properties, which are linked to numerous
advantages in curing skin inflammation of various conditions. Marinosomes can be used as cosmeceuticals for curing and protection against skin disorders [81].
Transferosomes, more elastic than liposomes, have
improved efficiency and can penetrate the skin with spontaneous penetration. Ultrasomes encapsulate an endonuclease enzyme extracted from Micrococcus luteus, which
accelerates UV damage repair and protects the immune
system [82, 83].
Sun-care products feature photosomes, derived from
Anacystis nidulans, activating skin enzymes post-sun exposure. Ethosomes are mostly made of phospholipids and
include water and ethanol (20–50%), aids drug penetration
into deep skin layers non-invasively. Yeast-based liposomes
incorporate vitamin C, restoring and calming the skin,
while asymmetric oxygen carrier system (AOCS) liposomes
deliver oxygen [84].
Niosomes are a type of vesicle based on non-ionic surfactants that can be used as medication and cosmetic carriers by encapsulating aqueous solutes. They offer benefits,
including better skin penetration, higher medication stability, and improved chemical bioavailability. Proniosomes,
derived from an innovative surfactant, are employed in
addition to traditional niosomes to improve medication
delivery. There are two types of them: dry granular powder
and semisolid liquid crystal gel [85, 86].
Active substances can be delivered via silicone vesicles
and matrices. Different actives can be entrapped by crosslinked silicones, such as adhesives and elastomers. Research
has assessed silicone-based technologies’ capacity to accomplish these goals while offering desired characteristics and
advantages [84].
Cosmetic skin treatment materials have great long-term
stability when delivered through multi-walled delivery
methods. These systems are based on structured vesicleforming materials and high-shear processing, providing
stability to liposomes while nourishing and protecting the
skin. They have been used to encapsulate small amino acid
peptide chains and enhance the cutaneous absorption of
peptides in human skin.