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The market for functional ingredients is clearly expanding. Different reports highlight the high business figures that are beginning to move and the sustained and constant growth that is expected for the coming years. Today we will talk about functional foods and nutraceuticals.
New nutritional trends and the need to meet growing social and health demands have driven the increasingly demanded concept of functional foods and nutraceuticals that, in addition to their general nutritional functions, have certain properties for maintaining health. .
One of the main challenges facing this revolution in functional foods and nutraceuticals is the absence of a single and universal definition, as well as legal regulations for them. In addition to the strict regulation of the different "claims" (allegations, considerations or declarations) of nutritional properties, health properties and disease risk reduction.
This conceptual vacuum has generated a great confusion of terms on the part of the consumer, which has been taken advantage of in certain advertising marketing campaigns, which is why, at Innofood, dedicated to the research and development of new foods, we consider it very important to publicize the meaning of these concepts.
What is a functional food?
Within the many existing definitions, according to the International Food Information Council, it is "any food similar in physical appearance to conventional food, consumed as part of the daily diet, but capable of producing demonstrated metabolic or physiological effects, useful in the maintenance of good physical and mental health, in reducing the risk of chronic-degenerative diseases, in addition to its basic nutritional functions”. Therefore, we can consider functional foods to be those natural or processed foods that, beyond providing nutrients, have been scientifically shown to beneficially affect one or more functions of the body, in such a way that they provide a better state of health and well-being, by exerting a preventive role, reducing the risk factors that cause the appearance of diseases.
What is a nutraceutical?
A nutraceutical compound can be defined as a dietary supplement or complement, presented in a non-food matrix (pills, capsules, powder, etc.), of a concentrated bioactive natural substance, usually present in food and that, taken in a higher dose to that existing in these foods, it has a favorable effect on health greater than that which the food itself could have. In other words, nutraceuticals are food components or parts thereof that provide a proven and added benefit for health, capable of providing medical improvements, in the prevention and treatment of diseases.
Therefore, a nutraceutical differs from medicines, since these are usually synthetic products and most of them do not have a natural biological origin. And it differs from herbal extracts and infusions in the concentration of its components and in that the latter do not have to have a therapeutic action.
In a functional food there is a nutraceutical value that refers to those components that are attributed health maintenance and enhancement functions.
As we have seen, there is a wide range of meanings ("functional foods", "nutraceuticals", "foods", "design foods", etc.), which are handled indistinctly by the population in general, which, at For practical purposes, they could be considered synonyms, although they present certain specific nuances:
It is an increasingly confirmed fact that the new habits of the consumer for health occupy a central place, so that the food industry needs to renew and promote this linear in constant evolution. At Innofood, we join this trend and are committed to the design and development of all kinds of healthy foods and all their consumption possibilities, supporting the industry and providing clear and accessible food information to the final consumer.
DEFINITION
The term cosmeceutical, coined in the late 1990s, is a term halfway between cosmetic and pharmaceutical. While the cosmetic is a product whose use is exclusively for beautification, the cosmeceutical is a product that incorporates biological and/or natural products that have an effect on the user. Examples of cosmetics are lipsticks, blushes, etc., while anti-wrinkle products, products to combat baldness, sunscreens, etc. are cosmeceuticals. These products are causing problems for the Regulatory Administrations, since the line of separation between a cosmeceutical and a pharmaceutical dermatological product is very thin and, sometimes, it only depends on the indications that have been requested.
In recent years, the Pharmaceutical and Cosmetic Industry is turning to cosmeceuticals because the administrative requirements for their development and marketing are much lower than those required for a pharmaceutical product.
Although cosmeceuticals (like cosmetics) must be tested on volunteers to demonstrate their safety, proof that manufacturers' recommendations are true is generally not required. Vitamins, oils of all kinds, botanical extracts and plants are often used, but the manufacturer cannot guarantee that these products penetrate beyond the skin or that they have therapeutic effects.
Products used for cosmeceuticals include teas, soybeans, pomegranate, grape seeds, pycnogenol, chamomile, curcumin, allantoin, and aloe. Although some of these ingredients have been clinically studied in the treatment of some parameters related to aging, few cosmeceuticals are supported by clinical evidence.
INGREDIENTS OF COSMECEUTICS
Humectants: the permeability of the skin is due to the interstices located in the stratum corneum, composed of laminar bilayers based on cholesterol, free fatty acids and ceramides. When water is applied for very long periods, the skin wrinkles and inflammatory cytokines are released that induce edema and vasodilation. For this reason, water alone alters the structure and function of the skin and for the same reason moisturizing products that soften and make the stratum corneum more flexible by increasing its hydration status can be considered cosmeceuticals.
Retinoids: retinoids are derivatives of vitamin A, present in all living organisms, either in the form of vitamin A itself, or as carotenoids. Vitamin A is essential for maintaining the integrity of the skin and mucous membranes and serious systemic diseases (eg night blindness) and dermatological diseases (follicular hyperkeratosis, phrynoderma, etc.) occur in its deficiency. Numerous synthetic products derived from the vitamin have shown their utility in many skin diseases including ichthyosis, acne, and psoriasis. Numerous researches have also been conducted on the anti-aging properties of the skin. Vitamin A and its derivatives have two well-known functions: as antioxidants, they protect the skin from oxidative damage by scavenging free radicals, and as activators of several genes, acting as a kind of hormone on the skin. Vitamin A is capable of binding to nuclear receptors (so-called retinoic acid receptors -RAR-) which activate the transcription of some genes that, in turn, produce growth factors, activate oncogenes, keratins and transglutaminases.
Vitamin A and its derivatives induce thickening of the epidermis, increase mitosis and differentiation of keratinocytes, and reduce the number of sebocytes. The amounts of glycosaminoglycans and anchoring fibrils increase, which causes a correction of skin atrophy, with deposits of new collagen and generation of new vessels. The increase in mitosis causes the keratinocytes full of melanin to be replaced by new ones, eliminating the spots. Tretinoin, one of the most widely used vitamin A derivatives in dermatology.
The effects of many retinoid-containing cosmetics and cosmeceuticals have been studied histologically and clinically, and there is no doubt that many of the structural changes in the skin caused by excessive sun exposure can be reversed. However, due to the poor quality of the clinical studies carried out, many authors point out that the anti-aging effects of retinoids could only be marginal.
Antioxidants: the skin is continually subjected to aggression from the external environment, but also from within the body. In addition to UV radiation, atmospheric pollutants, air, cold and heat, the skin is also subject to the action of endogenous mitogens and especially free radicals and reactive oxygen species. To counteract these effects, the skin has protection mechanisms in particular the antioxidant system that intervenes at different levels.
Some of the endogenous antioxidants present in most animals are vitamin C (ascorbic acid), vitamin E (tocopherols), glutathione, cyanamide, lipoic acid, ubiquinone, etc. Additionally, in the plant kingdom there are numerous antioxidants such as resveratrol, anthocyanins and anthocyanidins, etc.
Vitamin C
Vitamin C (ascorbic acid) is essential for life, carrying out several very important functions. The vitamin is necessary for the hydroxylation of procollagen, proline and lysine, compounds necessary for skin repair. Vitamin deficiency produces scurvy, characterized by purpura, keratolytic follicles, and bleeding gums. After intense exposure to UV radiation, plasma levels of vitamin C are greatly reduced. The administration of vitamin C normalizes skin alterations caused by radiation, being used to stimulate collagen repair. However, vitamin C is easily degraded by light and heat, making it difficult to incorporate into cosmetic or cosmetic formulations.
Vitamin E.
Vitamin E (alpha-tocopherol) is the main lipophilic antioxidant in plasma, membranes and tissues. The term vitamin E refers collectively to 8 naturally occurring molecules, all of which exhibit vitamin activity. Its function is to stop the chain of lipid peroxidation reactions by sequestering peroxidyl free radicals, preventing the destruction of membranes. Various vitamin-based cosmeceuticals reduce erythema, edema, and immunosuppression caused by excessive sun exposure.
Glutathione
Glutathione is a tripeptide based on glutamic acid, cysteine and glycine present in all animal tissues. It plays the role of antioxidant and its plasma levels are significantly reduced after prolonged exposure to the sun.
lipoic acid
Lipoic acid is a lipid- and water-soluble free radical scavenger. Once lipoic acid crosses the cell membrane, it degrades to dihydrofolic acid, also with antioxidant properties. Lipoic acid also allows the regeneration of other antioxidants such as vitamin C, vitamin E and glutathione.
Coenzyme Q10
Coenzyme Q10 or Ubiquininone is a fat-soluble quinone present in the mitochondria where it generates ATP (adenosine triphosphate), one of the most important sources of cellular energy. Coenzyme Q10 reduces LDL peroxidation more efficiently than vitamin E.
Niacinamide
Niacinamide (or nicotinamide) is a member of the B vitamin family used in the prevention and treatment of pellagra. Its main utility in the formulation of cosmeceuticals is its stability in the presence of oxygen, high temperatures and an acid medium, while at the same time stimulating the exfoliation and renewal of epithelial cells. An anti-aging effect is attributed to cyanamide.
panthenol
Panthenol is a water-soluble analog of vitamin B5, which is often incorporated as a moisturizer in lipsticks, skin creams, lotions, and shampoos. In contact with the skin, panthenol is converted to pantothenic acid, an important component of coenzyme A essential for normal cell metabolism.
L- Carnosine
L-carnosine (SS-alanyl-L-histidine) is a dipeptide composed of the two amino acids, ß-histidine and L-alanine. Even though it is a small molecule, carnosine exhibits a remarkable variety of functions, displaying antioxidant properties, acting as a buffer to maintain pH, and sequestering metal cations, particularly copper. However, perhaps its most interesting property is that of inhibiting protein glycosylation.
Carnosine is present in almost all tissues, but its concentrations are especially high in the muscles and brain. In particular, muscle concentrations of carnosine are very high in athletes and gymnasts. Muscle carnosine concentrations have been correlated with lifespan because the rat shows carnosine concentrations 3-fold higher than the mouse and man 10-fold higher than the rat. L-carnosine is also used in the formulation of nutriceuticals (functional foods).
Topical and antipuritic anesthetics: Some local anesthetics are used in products for cosmeceutical use: hand lotions, hair lotions, aftershave balms, to relieve itching and to reduce sunburn.
The mechanism of local anesthetics is well known. These compounds act by blocking membrane depolarization and preventing nerve impulse transmission. Less well known is the mechanism of the antipruritic action of some essential oils and terpenes present in some plants. The modulation of TPR receptors (Transient Potential Receptors), inhibiting some and stimulating others, would affect the sensory transmission of the nerve endings of the skin involved in itching.
Menthol
Menthol is widely used in toothpastes, balms, and other cosmetics for its cooling effects. Menthol is a potent activator of TRPM8 receptors (Transient receptor potential cation channel subfamily Melastatin member 8) also called cold and menthol receptors (Cold and menthol receptor 1 - CMR1). Formulated with other ingredients that act on other TPR receptors, menthol has been shown to significantly reduce various types of pruritus, particularly uremic pruritus in dialysis patients and scrotal pruritus.
capsaicin
Capsaicin is the main pungent component of cayenne, chili and other hot peppers. All these plants are solanaceous, with Capsicum annum (Guindilla de las Indias) being the most important with 1.5% of an oleoresin composed mainly of capsaicin. Capsaicin depletes and prevents the accumulation of substance P in peripheral sensory neurons. Substance P is an 11-amino acid peptide that is believed to be the primary mediator of pain in the peripheral nervous system. Peptide P is released in the joints where it activates other inflammatory mediators involved in the development of rheumatoid arthritis. By depleting substance P from nerve endings in the skin and joints, capsaicin blocks pain impulse transmission. When capsaicin treatment is discontinued, substance P accumulates again, returning nerve sensitivity to normal. Recently, a type of receptor specific for capsaicin, present in type C sensory neurons, has been described. This receptor, called TRPV1 (Transient Receptor Potential Vanillin 1), belongs to a broad family of receptors that participate in numerous sensory processes. Activation of this receptor first excites type C neurons by initiating ion fluxes with corresponding action potentials and subsequent release of neuropeptides. With higher doses and longer contact times, capsaicin induces desensitization of afferent neuromas.
clove oil
Highly appreciated as a condiment, the oil extracted from the clove is used for its local anesthetic and antiseptic properties. In some countries, it is added to tobacco as a flavoring agent.
Clove oil contains mostly eugenol (72-90%). Eugenol is an agonist of TRPV1 and TRPV3 receptors, which would explain its analgesic and antipruritic effects of this terpene. Associated with other essential oils and terpenes from plants, clove oil is part of a formulation specially designed for the treatment of itching.
Hydroxy Acids: Hydroxy acids are probably one of the most widely used ingredients in cosmeceuticals. According to their chemical structure they are classified as alpha-hydroxy acids and beta-hydroxy acids. Among the former are a series of products isolated from fruits (glycolic acid, citric acid, mandelic acid, tartaric acid, malic acid, etc.). These acids reduce the signs of skin aging, producing a stretching of the skin and reducing wrinkles. Although some studies seem to indicate that alpha-hydroxy acids increase the synthesis of glycosaminoglycans and collagen density, improving skin elasticity, these properties are controversial and there are no evidence-based clinical studies to support them.
Beta hydroxy acids are aromatic acids, the most widely used being salicylic acid, well known for its keratolytic properties. It has been used for decades to remove warts and in peeling creams. Other beta acids are beta-lipohydroxy acid and tropic acid.
Depigmenting: hyperpigmentation or the appearance of spots on the skin is a condition that affects a large part of people from a certain age. It is combated by cosmeceutical products that contain ingredients capable of discoloring the spots or camouflaging them. Hyperpigmentation is due to increased melanin synthesis in the epidermis or dermis and is divided into two pathophysiological processes: increased number of melanocytes (melanocytosis) or increased melanin synthesis (melanosis). Depigmenting agents are more effective when hyperpigmentation is localized to the epidermis, and act by inhibiting tyrosinase, a key enzyme for melanin synthesis.
For many years hydroquinone has been the depigmenting agent of choice, although other less aggressive substances are now preferred. Some of these are azelaic acid, arbutin, ascorbic acid, kojic acid, and acetyl-glucosamine.
Another technique to remove hyperpigmentation is chemical "peeling".
This article analyzes the phytochemical, pharmacological and therapeutic characteristics of a well-known medicinal plant such as valerian. Used since ancient times, its effectiveness as a sedative, hypnotic and relaxant is still fully valid today.
Some mental illnesses that require treatment with psychotropics can be treated with a combination of valerian and hypericum
Before proceeding to the chemical, pharmacological and therapeutic analysis of valerian, some data on its origin and popular uses are offered.
SOURCE
Valeriana officinalis L. is a plant belonging to the Valerianaceae family. The underground organs (rhizomes, roots and stolons), which constitute the drug, are used for the treatment of neurotonic states, especially in cases of anxiety and sleep disorders. The drug is listed in numerous pharmacopoeias1.
In the supplement to the 1st edition of the Royal Spanish Pharmacopoeia published in 1998, it is defined: «The valerian root consists of the entire underground organs of Valeriana officinalis L. s.l., including the rhizome accompanied by the roots and the stolons, or well, by fragments of these organs»2.
Known by the common name of cat grass (when the drug is fresh it has no odor, but when it dries it develops a strong and characteristic unpleasant odor due to the hydrolysis of some of the components of its essential oil that release acid isovaleric, hence the popular name), valerian, originally from northern Europe and Asia, is cultivated in various European countries. It is a herbaceous, perennial species, with leaves grouped in a rosette at the base and opposite on the stem3,4.
Other species of the Valeriana genus are also used to obtain active ingredients: V. edulis Nutt. spp. procera or Mexican valerian and V. wallichii DC. or valerian from India.
POPULAR USES
Valerian has been known and used since ancient times. Already the Greek and Roman doctors prescribed it as a diuretic, analgesic and against cough. In the middle of the 18th century, Hill (an English doctor) pointed out its nervous sedative effects4. It has traditionally been used in cases of anxiety, excitability and insomnia and as an antispasmodic. But it has also been used to combat headaches, intestinal colic, rheumatic pain, dysmenorrhea; topically on cuts, small inflammations and for acne. Traditional Chinese medicine also includes its usefulness in colds, bruises and menstruation problems5.
CHEMICAL COMPOSITION
The chemical composition of valerian root includes mainly sesquiterpenes and iridoids, all of them compounds of a terpene nature.
Sesquiterpenes are oxygenated and can be ketones (valeranone), alcohols (valerianol, kesyl alcohol), esters (valerianol ester), aldehydes (valerenal), and acids (valerenic, acetoxyvalerenic, and hydroxyvalerenic acids).
Iridoids are triesters of alcohols derived from iridan with low molecular weight acids, acetic, isovaleric, etc. The structural differences between them lie in the nature of the aliphatic acids that esterify the hydroxyl functions at 1, 7 and 11. Among them are valtrate, isovaltrate, acevaltrate, dihydrovaltrate and isovaleroxyhydroxydihydrovaltrate. The total valepotriate content is generally between 0.5 and 1.2%, the majority (80%) being valtrate. All these compounds are very unstable, especially in acid medium (pH<3); they are also altered by the effect of humidity or heat (>40 ºC), giving rise to unsaturated aldehydes (baldrinal, homobaldrinal, etc.).
In addition to the compounds mentioned, valerian root contains carbohydrates, starch, fatty acids, phenolic acids, GABA, glutamine and arginine, traces of alkaloids, resin, flavonoids, triterpenes and essential oil (0.3-2%) rich in monoterpenes. (borneol and its esters, camphene and pinenes) and which also contains sesquiterpenes (in addition to those mentioned above, caryophyllene, cadinene, etc.)3,6,7,8,9. According to the Royal Spanish Pharmacopoeia: "it contains no less than 5 ml/kg of essential oil for the whole drug and no less than 3 ml/kg of essential oil for the cut drug, in both cases calculated with respect to the dried drug"2.
The species of the Valeriana genus can be differentiated by their sesquiterpene content. In V. wallichii and V. edulis no valerenic acids have been detected, but a high content of valepotriates (more than 8% in V. edulis)10,11.
There may also be seasonal differences in the content of essential oil, valerenic acid and derivatives, and valepotriates12.
PHARMACOLOGICAL ACTION
Valerian root has sedative and hypnotic activity, so it is indicated in cases of nervousness or anxiety and sleep disorders. It has also been shown that it has spasmolytic and muscle relaxant activity.
There is extensive literature on the pharmacological activity of valerian, although it is not yet known exactly which compound or compounds are responsible for said activity. In 1995, a review on the use of valerian was published, evaluating its activity and highlighting that V. officinalis has sedative and antispasmodic properties. The activity on the central nervous system has been demonstrated by various pharmacological tests. Biochemical studies on receptors show the interaction of the extracts and some purified fractions with GABA. A series of clinical trials13 are also included in the same review.
The European Scientific Cooperative on Phytotherapy (ESCOP) is a working group founded in 1989 that brings together experts from various countries and that, among other things, publishes monographs on medicinal plants with the requirements for their marketing authorization in the European Union. They include pharmacopoeia standards and phytochemical, pharmacological and clinical information, and detail not only the beneficial effects of the species but also adverse reactions, contraindications, etc. The monograph on valerian root (Valerianae radix) dates from July 1997. It specifies the chemical constituents of the drug and later the clinical properties are collected, citing tension, restlessness and irritability, with difficulty falling asleep.
Pharmacological properties are widely included in the aforementioned monograph, excluding those of valepotriates, since these iridoids, as has been commented, are very unstable and are generally not found in finished products; In addition, its absorption orally is very poor.
Valerian has been shown to have spasmolytic activity on rabbit ileum. The group of valepotriates is more active than papaverine on guinea pig ileum stimulated with histamine14. Didrovaltrate and valeranone have a musculotropic-type action, relax the ileum contracted by potassium salts and inhibit spasms induced by barium chloride, this effect being comparable to that of papaverine, but there does not seem to be interaction with receptors of the autonomic nervous system15.
It was thought that the valepotriates (characterized in 1966 by Thies and Funke in V. wallichii) would be the compounds with activity on the central nervous system and it has actually been possible to demonstrate through tests in experimental animals that valepotriates and homobaldrinal decrease locomotor activity in the mouse16 and aggressiveness in the cat.
The symptoms of valerian intoxication in cases of overdose are benign and disappear within 24 hours.
The essential oil extracted from valerian root and some oxygenated compounds isolated from it, administered ip in mice, produce central depression and/or muscle relaxant activity17.
An extensive study by Hiller and Zetler (1996) carried out a neuropharmacological and anticonvulsant study of the ethanolic extract of Valeriana officinalis. The tests are carried out in mice and the activity is compared with that of diazepam and the anticonvulsant against picrotoxin. From the set of results, the authors suggest that the effects observed for the extract could be due to an interaction with the GABA-A-benzodiazepine receptor, which may be different from that of diazepam.
From the in vitro trials published on the mechanism of action of the drug or its components, it can be summarized: the anxiolytic-sedative-hypnotic activity of valerian and its active ingredients seems to be mediated mainly through the GABA receptor complex. The active principles of valerian act on the GABA-A receptor, enhancing GABAergic activity in a similar way to that of barbiturates. But the possibility that they act at the presynaptic level in the GABAergic neuronal system, inhibiting the reuptake and metabolism of GABA, is also postulated. The aqueous and hydroalcoholic extracts of valerian have a concentration of GABA high enough to justify their activity, and may be a direct cause of sedation18,19,20. Likewise, the presence of a lignan, hydroxypinoresinol, capable of binding to benzodiazepine receptors21 has been detected.
CLINICAL EXPERIENCES
An extensive bibliography of clinical studies has also been published, most of which relate to the treatment of insomnia and sleep quality. Of them we will include only some comments.
Sometimes the tests have been carried out by administering aqueous extracts of the root, other times ethanolic extracts and also isolated compounds.
Studies with various doses of aqueous extracts on healthy volunteers have shown a mild hypnotic action, with a significant reduction in sleep induction time and a significant improvement in sleep quality22,23.
Among the tests carried out by administering alcoholic extracts, Schulz et al. compared, in a randomized crossover study on patients with sleep disorders, valerian extract with diazepam, with other plant extracts and against placebo, observing changes in the CEE, which do not have a clear clinical interpretation24.
Previously, a double-blind study against placebo had been carried out, with 121 patients also with sleep problems, who were administered the alcoholic extract of valerian, evaluating the results using 4 types of standard scales. Measurements were made before starting treatment, 14 days later and 28 days later. It is deduced from this study that the effects of valerian are probably not immediate, but that it is necessary to wait between 2 and 4 weeks to appreciate the effects, especially with regard to behavior. This should not be an inconvenience, although patients should be warned not to interrupt treatment25.
The results of a clinical trial with valerian extract, carried out with patients with psychophysiological insomnia, have recently been published. The treatment has led to positive effects on the structure and perception of sleep, so it can be recommended in patients with mild psychophysiological insomnia26.
The administration of valepotriates orally does not produce easily registered effects, which may be due to the rapid decomposition or poor absorption by the gastrointestinal tract of said compounds27, for which reason it has been shown that aqueous extracts of valerian reduce sleep time and improve sleep. quality, its action cannot be attributed to valepotriates, since these are not soluble in water as well as being very unstable.
There are also some trials in the bibliography in which the effect on sleep of the association of valerian with other plant species such as lemon balm28 or hops29 is verified; however, the use of associations for these purposes will be the subject of a subsequent specific publication.
THERAPEUTIC USES
Valerian root has sedative properties and is therefore indicated in cases of nervousness or anxiety and in sleep disorders, improving sleep latency and quality30.
Despite the extensive published literature, activity cannot be attributed with certainty to any of the components. It mainly contains compounds of a terpene nature, sesquiterpenes and iridoids, which would possibly be, together with some water-soluble components, responsible for the activity, acting, according to some authors, in a synergistic manner.
In 1991, Reuter analyzed the possibilities and limits of European natural drug therapy in modern clinical medicine. He comments on the use of phytopharmaceuticals in the hospital, such as in the treatment of constipation or sleep problems and states of restlessness. Valerian preparations, as a single drug or in combinations, can provide adequate treatment and make the use of psychotropic drugs unnecessary.
He also thinks that in general medical practice, many mental problems and sleep disorders are controlled by the doctor. In these cases, according to the author, treatment with valerian, hops, lemon balm and passionflower can provide complete relief. Mental illnesses that require treatment with psychotropics can be treated with a combination of valerian and hypericum, which have shown their effectiveness as synthetic drugs31.
Valerian and its preparations are recommended in the treatment of autonomic dystonia and sleep disorders.
Valepotriates are used in some countries, notably Germany, as anxiolytics and antidepressants. Although they are destroyed by gastric acidity, their degradation products (baldrinal and derivatives) retain some activity. The activity of valerian preparations cannot be attributed to these principles since, as mentioned above, most valerian preparations do not contain valepotriates or only traces of them.
A commercial mixture containing didrovaltrate, valtrate, and acevaltrate has been used as a sedative. Isolated valtrate is also used as an anxiolytic.
TOXICITY AND ADVERSE EFFECTS
Virtually all published articles and reference works consider the drug to be nontoxic. Acute and subacute toxicity is very low both in mice (valerian root ethanolic extract, LD50 of 3.3 g/kg, after ip administration) and in rats (subacute also by ip route, dose of 400-600 mg/kg). kg/day for 45 days). In another study, doses of 300 and 600 mg/kg/day for 30 days did not produce significant changes in the usual parameters32,33.
In man, the acute toxicity of valerian is very low. The administration of approximately 20 times the recommended therapeutic dose of valerian root causes benign symptoms (fatigue, abdominal cramps, chest tightness, dizziness, hand tremor and mydriasis) that disappear within 24 hours34.
The essential oil obtained from valerian root is quite toxic (DL50: 1500 mg/100 g of body weight, in rats)35.
Valeranone is not very toxic: its LD50 was greater than 3 g/kg in rats and mice36.
Valepotriates have shown cytotoxicity in in vitro assays, but this does not appear to have been demonstrated in vivo. As has already been mentioned, valepotriates are very unstable, which is why they are not usually found in commercial phytopharmaceutical preparations and have very little absorption.
Valtrate has shown very high toxicity on rat hepatoma cells; in vivo, the administration of didrovaltrate (ip, mouse) produces improvement and even remission in a high percentage of cases of ascitic Krebs II tumor 37. The diene-type valepotriates (valtrate, isovaltrate and acevaltrate) show the greatest cytotoxicity, while the monoenic type (didrovaltrate and isovaleroxyhydroxydidrovaltrate) were two to three times less toxic. Regarding the products that come from the decomposition of the valepotriates (baldrinal and homobaldrinal), they were much less toxic than the valepotriates.
Isovaltral, derived from isovaltrate, was as cytotoxic as the latter. Valerenic acids showed little toxicity. A relationship between the content of valepotriates in recently prepared tinctures and their toxicity is very clearly observed. During storage, valepotriates decompose, which translates into a decrease in the cytotoxic effect38.
Valepotriates are used in some countries as anxiolytics and antidepressants.
Baldrinal and homobaldrinal, compounds that result from the breakdown of valepotriates, have shown in vitro mutagenic activity against various strains of Salmonella8.
DOSAGE AND METHOD OF ADMINISTRATION
For adults, the dose is 2-3 g of drug (infusion) or the equivalent in dry extract form, or 1-3 ml of tincture (1:5, 70% V/V ethanol). For nervous tension, restlessness and irritability, up to three times a day. To promote sleep, half a single dose one to two hours before bedtime, with one dose in the evening if necessary.
In children aged 3 to 12 years, it should only be administered under medical supervision: proportional dose according to body weight of the adult dose, as an infusion or dry extract.
The route of administration is oral. It does not impose any restrictions regarding the duration of administration, since no dependency or withdrawal syndrome has been recorded.
It should not be administered to children under three years of age6,30.
Regarding special warnings, precautions or interactions with other medications, no precautions or interactions are cited. During pregnancy and lactation, the safety of valerian use has not been established, so it should not be used, at least, without medical supervision. It is known that V. wallichi is considered abortifacient and can affect the menstrual cycle8.
The effect of prolonged administration of valepotriates on mother rats and their offspring has been studied. After administering valepotriates orally for 30 days, there were no changes in the mean duration of the estrous cycle, nor in the number of estrus phases during this period. Nor in fertility rates. Fetotoxicity studies and external examinations show no differences despite the fact that an increase in ossification delay is observed after the administration of the highest doses (12 and 24 mg/kg). No changes were observed in the development of the offspring after treatment during gestation. Valepotriates show a hypothermic effect after ip administration, but not after oral administration39.
The possible effects on the ability to drive or use machinery are also collected. Trials have been carried out, the bibliography of which is incorporated in the ESCOP monograph, comparing the effects of preparations containing valerian root extracts with placebo and benzodiazepines. It is shown that valerian root administered in syrup form (10 ml equivalent to 4 g of drug), or combined with other tranquilizing plant species, does not reduce alertness measured 8 hours after administering the preparation. There are also no effects the next morning. However, it is recommended not to administer valerian root-containing preparations immediately before driving a vehicle or operating dangerous machinery, as some decrease or worsening of alertness appears to have been observed one to two hours after administration of valerian syrup.
No adverse effects or contraindications have been confirmed at the recommended doses and, regarding an overdose, as already mentioned, the risks are minimal.
CONCLUSION
Valerian root is used in cases of nervousness or anxiety and especially in sleep disorders. The activity is probably due to the set of some of its components that, according to various authors, would act synergistically (essential oil, valepotriates and probably some water-soluble compounds)40.
Regarding its mechanism of action, it is assumed that GABA may contribute in vivo to the relaxing activity of valerian extracts in peripheral tissues.
The drug is considered to be non-toxic. Toxicity tests carried out on experimental animals show a very low acute and subchronic toxicity.
Although the cytotoxic and mutagenic effect of valepotriates is known, these compounds, on the one hand, are fat-soluble and are also very unstable and are poorly absorbed at the gastrointestinal level. In general, finished products containing valerian are considered to have no, or only traces, of valepotriates.
The safety of valerian during pregnancy and lactation has not been established, so it should not be used, at least, without medical supervision.
At the recommended therapeutic doses, the drug does not appear to have adverse effects or contraindications. It should be administered with caution before driving vehicles or operating dangerous machinery. In case of overdose (approximately 20 g of valerian root) the symptoms of intoxication are benign and disappear within 24 hours. *
Considered as one of the most ancient techniques, aromatherapy uses essential oils, which have several benefits for health, both physical and psychological, from plants, crusts, herbs and natural flowers.
From lavender to ylang ylang, there are several techniques to apply aromatherapy and relieve body and mind ailments and malaise, however, it is important to know how it works each second if required.
For that, we share what is aromatherapy and what benefits it has in health.
What is aromatherapy and what is it for?
Aromatherapy is an alternative technique that uses essential oils from plants, bark, herbs and flowers to promote both the physical and psychological well-being of people.
How did aromatherapy originate?
Aromatherapy is considered a very ancient technique, since civilizations such as China and Egypt used essential oils for therapeutic purposes and to embalm bodies.
Asimism, this technique was common among doctors in ancient Greece, in the medieval period and in the Renaissance in Europe, and that the hierbas and accepts were only used to fight diseases.
However, the study of pharmacology and chemistry of essential accepts as such has its origin in the eighteenth and nineteenth century, in countries such as France and the United Kingdom.
What benefits does aromatherapy have?
Aromatherapy has several health benefits, depending on the essential oils that are used, it has analgesic, antibiotic, antiseptic, astringent, sedative, expectorant and diuretic properties.
Also, essential oils help calm gastrointestinal discomfort, menstrual pain, stress, mood disorders, circulatory problems and respiratory infections.
As for the psychological benefits, aromatherapy has a calming effect that facilitates relaxation and mental peace.
How to cure diseases with aromatherapy?
Aromatherapy can be applied in different ways to alleviate physical and psychological illnesses and discomfort. Some of the most common are:
inhalation
This is the most common method, which consists of filling a few drops of essential oil in a pan or in a bowl of hot water and gently inhaling the aroma.
massage
This method of direct application consists of diluting the essence in a lotion or vegetable oil such as olive oil, avocado or wheat germ before being applied to the skin to avoid an allergic reaction.
aromatic baths
This technical tool consists of a bath with tibia water and essential oils to produce a relaxation effect. You should avoid using hot water so that it does not evaporate.
application with cream
This method consists of mixing a few drops of essential oil with body cream, in order to apply it directly on the desired skin area.
direct consumption
Some essential oils can be consumed in water or infusions, however, this method must be consulted directly with a doctor, as some oils may be harmful when ingested directly.
Which ones are the best aromatherapy oils?
Although there is an infinity of essential oils with different benefits for health, some of the most used ones are:
bergamot
Relieves stress, restores appetite and relieves depression and anxiety.
cypresses
Calms the nervous system and relieves the symptoms of menopause, allergies and stress.
Geranium
Relieves premenstrual symptoms and depression, calms the nervous system and lifts the spirit.
ginger
It helps to prevent and relieve seas and nausea, stimulates the immune system against colds and flu, relieves the digestive system and improves circulation.
pomelo
Allows you to regulate emotions, relieves stress and anger and helps fight colds and respiratory problems.
Lavender
It regulates arterial hypertension, relieves headaches due to tension or stress and relieves insect bites and burns.
lemon
Reduce mental fatigue, relieve stress, stimulate concentration and improve circulation.
mint
Relax and calm the muscles of the stomach and gastrointestinal tract disorders, respiratory problems and nervous tension.
Romero
Relieves muscular and rheumatic pain, in addition to regulating low blood pressure.
ylang ylang
It is useful in treating sexual problems, preventing hyperventilation, calming anxiety, helping to regulate the pulse, and reducing panic attacks and depression.
Good manufacturing practice (GMP) regulatory bodies in the United States, Canada, the European Union, Japan, Australia, and China have focused their attention on warehouse storage and distribution practices. This trend is due to a change in the concept of regulation, which has gone from quality-by-test systems to quality-by-design systems, emphasizing the level of risk, product quality and patient safety. Other factors are the increased demand for storage facilities due to the globalization of manufacturing, the rise of temperature-sensitive biopharmaceuticals, and changes in technology.
Regulatory authorities in these countries require 'mapping' of the temperature and relative humidity profiles of environmentally sensitive life science product depots. This step-by-step guide describes how to map a warehouse to meet internationally recognized GMPs, including many recently published or revised. (See the end of this document for links to relevant regulations and guidance documents). This guide is intended for use by any organization carrying out the storage and distribution of temperature and humidity sensitive products in a GMP compliant environment and is based on Vaisala's extensive experience with customers in Europe and throughout the Americas. from North. Vaisala solutions are used in more than 150 countries around the world.
Step By Step – Good Practices For Warehouse Mapping Studies
Step 1: Create a validation plan
The validation plan, or validation master plan, is the document used to specify the company's decisions on the qualification of each aspect of the facility, equipment and processes to maintain a GMP-compliant environment. The plan should adopt an approach that is risk-based, with a foundation based on verifiable data. The plan should focus on where environmentally sensitive products and materials will be stored and should consider whether environmental controls can meet specified storage requirements.
In addition, the plan is a starting point for regulators to assess the rationale for the company's goals and methods.
The validation master plan should:
State the objectives of the validation.
Identify the roles and responsibilities in the process of the quality, metrology and other working groups.
Identify validation activities, including processes, equipment, and space.
Develop documentation and procedures, including the company's response if a deviation in temperature or humidity occurs.
Determine a validation schedule.
Specify the discharge process, especially for adverse events such as temperature deviations.
Create change control protocols to make it clear when changes such as maintenance, new construction, and rack reconfiguration will need to be revalidated.
Regulatory note: GMPs require maintaining temperature and humidity within the storage recommendations printed on product labels or provided by raw material suppliers. These recommendations are derived from known chemical properties and stability tests.
Step 2: Identify risk areas
To map a warehouse or storage space, you must first identify areas where product quality may be at risk due to unacceptable fluctuations in temperature and humidity. Many factors affect the control or variability of your space. (Since relative humidity is dependent on temperature, variations in temperature will affect humidity.) By considering each of these factors, you can more easily identify risks:
volume of space. A large warehouse poses different control tasks than a small one, as it has higher demands on the HVAC system and the potential for greater variations in temperature and humidity at different locations.
The capacity of the diffusers or fans so that the air circulates correctly.
The temperature gradients between the ground and the warmer air near the ceiling.
Independent energy sources, such as space heaters, air conditioners, and fans, which create hotter or cooler places.
Arrangement of supports, shelves and pallets, which obstruct the flow of air.
Location of HVAC control sensors. For example, a thermostat placed near a heat or cold source can cause the room temperature to change too much.
Locations near sources of heat or cold, such as the roof and exterior walls, windows, and cargo areas.
High-traffic areas where products or equipment are frequently moved.
Seasonal temperature changes or unusual weather events.
Regulatory Note: You can be GMP compliant by providing a strong justification for your approach to identifying risk. The more considerations the protocol addresses, the better its rationale.
Step 3: Develop information on protocols
Once the risk zones have been identified, develop a protocol for the mapping study that describes the following, with justifications for each decision:
• Types of data to be generated, for example, temperature, relative humidity, and measurement intervals. Five-minute intervals provide more data to assess trends and modify reservoir settings (see step 8). When you are satisfied that the temperature and humidity remain relatively stable, it may be convenient to move to 15 minute intervals for the final mapping.
• Number of sensors to use (see step 4: Determine the distribution of the sensors).
• Schematic or diagram of sensor locations.
• Duration of the study. Its rationale and protocol can support a series of tests, each lasting two days during normal operations and over a weekend. A different and equally justifiable protocol might specify a single run over a two-week period to account for various activities, such as the opening of loading dock doors, in the warehouse.
Calibration requirements for data loggers.
Acceptable range of variation in time and space, which will depend on the product stored.
Admissible limits for variations in temperature or relative humidity.
Reporting requirements.
Regulatory Note: Once you develop a protocol, you must follow it consistently. If the protocol changes, document the reasons.
Step 4: Determine Sensor Layout
How many sensors will you need to map a given space? Where will you put them? There are no simple answers. To assess temperature uniformity, the sensor layout must be correct. A good practice is to use a sufficient number of sensors to understand the environment, especially the areas where the risk is greatest.
You'll need to place the sensors in a uniform pattern in all three dimensions of space: top to bottom, left to right, and front to back. Add additional sensors where you suspect hot or cold spots, as well as near monitoring and control sensors. The placement of the temperature and relative humidity sensors is a consequence of the risks identified in step 2.
A large walk-in camera or a small warehouse is usually mapped in three dimensions with 15 sensors (See Figure 1). The protocol should include guidelines for the distance between the sensors, for example no more than six meters.
When mapping a large warehouse, place sensors up to 30 meters away, with additional sensors in vulnerable areas affected by:
Heat or cold of external walls, solar heating, windows, lighting
Air circulation or drafts from entrances, traffic, or the HVAC system
Extreme temperatures in poorly insulated areas
Localized Effects of Space Heaters and Air Conditioners
Anticipate that airflow and temperature gradients may vary depending on whether the shelves are empty or full of products. Higher supports will be subject to greater temperature gradients, and this will require more sensors from top to bottom.
You can mount sensors in open areas (for example, outside supports or corridors), wherever it is convenient to install them. However, convenience should not take precedence over effectiveness. The sensors must measure the conditions to which the products are exposed.
If you don't have an adequate number of sensors to map the entire warehouse in one study, you can do this in sections. Mapping by sections takes more time, and it may be desirable to extend the mapping time for each section to compensate for the uncertainty of mapping the space by sections. To decide, weigh the equipment savings from a sectional mapping approach against the additional time needed to complete the project.
If high or low relative humidity can negatively influence product quality, then you should map relative humidity and temperature. There are two approaches to determining the number and location of relative humidity sensors.
Density determination of humidity sensor
The first approach is to use comparatively few humidity sensors distributed around the tank (only one for every six temperature sensors). In this case, you will depend on the uniformity of the temperature so that the humidity is also within limits. This approach should be based on a history of temperature mapping in different seasons with consistent results. With this track record, a specialist who understands moisture measurement can effectively argue to an auditor or inspector that moisture measurements are not necessary at all data points. If you decide to adopt this strategy and reduce the number of humidity sensors, it is critical to place the few humidity sensors you use in areas with poor air circulation, between HVAC fans or diffusers, and where the temperature is most variable.
Moisture Considerations
Compared to temperature sensors, relative humidity sensors are much more likely to lose accuracy or "drift" over time. The drift may be due to poor design, poor calibration, or contamination from water vapor saturation or chemical vapors. A single wrong reading at recalibration time will call attention to your decision to use fewer moisture sensors. Starting with fewer moisture sensors creates the risk of non-compliance, because if one fails or is out of spec, that single sensor will account for a high percentage of your total moisture measurements. If relative humidity is interpolated from temperature data, it will be necessary for a company employee with this specialized knowledge to meet with the auditor or inspector. Ideally, your company should minimize the number of contacts required during an inspection as a way to streamline the process and minimize the chance of errors.
If you are concerned about relative humidity, a more justifiable mapping strategy is to track temperature and humidity at all locations with data loggers that record both measurements. It is important to use high quality data loggers that are stable and regularly calibrated.
Performing mapping with integrated relative humidity and temperature sensors offers several advantages over deducing humidity from temperature. A mapping of temperature and humidity at all sensor locations provides a more specific map of the entire storage space for inspectors and auditors to easily understand, without the need for detailed explanation. And deviations from relative humidity will be easier to identify with more humidity data points.
Regulatory Note: Understanding the relationships between measured parameters is essential to the success of mapping studies and to managing risks in a GMP storage space.
Step 5: Select the right technology
Use equipment designed for mapping. The software that accompanies the sensors is used to configure the equipment and download data. The software must produce reports in the form of tables and graphs that meet all the requirements of the FDA Title 21 CFR Part 11 and comparable international standards, such as Annex 11 of the European Commission, and those contained in volume 4 of the Guidelines for the EU on good manufacturing practices (GMP).
When choosing data loggers, look for the following features:
Minimal sources of error, i.e. low measurement uncertainty.
High precision in the measurement range. Vaisala DL2000 data loggers, for example, have an accuracy of ± 0.1 °C over a range of +20 °C to +30 °C, with a humidity accuracy of ± 1 %RH over a range of 10 at 80%RH.
Sensitivity to small temperature changes (high resolution). The faster the response, the more closely the data point can be linked to the measurement time.
Long-term stability, particularly for relative humidity sensors. Low-quality equipment must be calibrated before and after each study.
Traceable calibration performed within the measurement range and with equipment using an unbroken chain of comparisons to an internationally recognized standard, such as that of the National Institute of Standards and Technology (NIST).
Clear, complete and accessible calibration records.
Regulatory Note: GMPs require written procedures to calibrate, inspect, and verify automated, mechanical, and electronic equipment (21 CFR 211.68). International standards such as ISO/IEC 17025:2017 “General requirements for the competence of testing and calibration laboratories” are recognized as best practices for calibration.
Step 6: Set Up Mapping Equipment
Once the risk areas have been identified and the sensor layout established, it is time to install the mapping equipment and test the storage space. The purpose of this initial test is to determine where conditions vary and where the temperature and humidity are uniform and adequate to store the product. Work through the following checklist and document each step:
The equipment has been calibrated. Document who has done it, when and the date of the next calibration. This confirms that the data logger is operating within the calibrated measurement range.
The equipment has been validated. Typically, the installation and operation qualification (IQ/OQ) are provided by the mapping system vendor.
Ensure that access to the mapping software has been secured and authenticated. Access privileges restrict who is authorized to use the application.
Verify that the software reads and records the hardware and firmware model, version, and serial number.
Make sure the warehouse area and data logger locations are accurately described. A schematic or diagram is helpful to ensure sensors are placed correctly in upcoming mapping studies,
Regular sampling intervals have been determined. Intervals are usually between 5 and 15 minutes.
The duration of the study has been determined. All data loggers are set to start and end at the same time.
Data loggers are linked to an audit trail file for traceability. This is an essential requirement to demonstrate that the data is reliable.
The data loggers work and are placed in specific positions.
Regulatory Note: GMPs require that calibrated equipment and calibration records be used. If you have collected data electronically, these records must comply with the regulations for electronic records defined in Title 21 CFR Part 11, EC Annex 11, and Volume 4 of the EU Good Practice Guidelines manufacturing (GMP).
Step 7: Run a test and analyze the data
You will need to set the report information that you will use to evaluate the test. Once the test is complete, the software will read the data loggers secure files, display the recorded data, perform calculations and graph the selected results for a mapping study report. Typically, the test document will display the information in Figure 3:
Raw data with times and dates.
Calculated values such as minimum, maximum and average temperature.
A graph of all sensors during the test period.
Instrument settings.
Calibration information.
Date and time of the test.
Space for review and approval signatures on printed reports.
Trend data from each sensor can be compiled into a single graph to provide an overview. Default lines, such as minimum and maximum acceptable limits, can be useful for analysis.
A graphical representation can help identify high-risk locations, especially those places where problems may occur sporadically. For example, a temperature spike may be related to when the cargo doors were open.
That variation could indicate a hazard caused by normal workplace activities or suggest the need for a containment zone.
Regulatory Note: It is better to present a summary graph with a clear conclusion than an overly detailed report that could lead to additional questions.
Step 8: Make Modifications
Use the results of the initial test to identify those places where the product may be exposed to unacceptable conditions. Then make adjustments, for example to storage media or the HVAC system, to correct for this variance. Or just decide in which places the products will not be stored. For example, many warehouses have a mezzanine level designated as off limits for raw materials or finished goods because HVAC controls are not effective there. Name and describe these places and modify the validation plan.
Also, modify your validation protocol in light of the results of your initial mapping test.
Regulatory Note: Modifications to a newly commissioned warehouse need not appear on the inspection log. But once your company approves a validation master plan, it must document all subsequent changes.
Step 9: Document and schedule the mapping study
Once the environmental variability in the warehouse has been adjusted for, it is time to conduct and document a mapping study for approval.
How long should the mapping take?
As with your initial mapping test, there is no hard and fast rule. Your rationale and protocol may support a single large study, or a series of shorter studies. Either way, it is important to measure the environment during a variety of different work activities in the warehouse, such as loading and moving products, and also during periods such as weekends when there may be little activity.
How often should a space be mapped?
Some protocols call for mapping every three months, while others may warrant annual or even less frequent mapping. The validation master plan must anticipate the variables that can alter the storage conditions once the qualification of a deposit is completed. The construction of a warehouse, major changes in the HVAC and other similar changes in the environment, require a new mapping. Seasonal changes and extreme weather conditions may warrant mapping the warehouse more frequently or rescheduling a test for a more "seasonal" temperature. For example, in the northern hemisphere, the validation plan may require a mapping study in July, when temperatures are typically hottest. But if July is unusually cold, it may make sense to delay mapping until a warm spell in August. The validation plan should allow enough flexibility to record weather extremes. For example, depending on the climate in your region, your plan might require mapping when summer temperatures exceed 30°C and winter temperatures drop below 0°C.
Regulatory Note: Keeping useful records is critical to complying with GMP. Records must be stored securely and must be easily accessible for review. They should not have gaps. They must provide an audit trail. Records can be paper, electronic, or a combination of both. If the records are electronic, they must meet the requirements of FDA Title 21 CFR Part 11 and CE Annex 11.
Dietary supplements are products intended to increase the usual dietary intake, supplementing the incorporation of nutrients in the diet of healthy people who, not being in pathological conditions, have unsatisfied basic dietary needs or greater than usual. Like all foods, they are freely sold.
They may contain in their composition, in simple or combined form, the following ingredients: peptides, proteins, lipids, lipids of marine origin, amino acids, carbohydrates or carbohydrates, vitamins, minerals, dietary fibers and herbs.
It should be clear that, under normal conditions, the diet must provide all the necessary for the maintenance of the functions of the organism. Therefore, a dietary supplement should only be consumed when, due to a particular physiological state, the individual needs an extra supply of a certain nutrient, after consulting a doctor.
It should not be consumed "for fashion" or with the hope of mitigating any ailment, and in this sense advertising has an important importance because, through it, the consumer receives information about the product and the benefits that accompany its consumption. .
The advertising of dietary supplements must comply with the ethical guidelines established by the ANMAT in Provision No. 4980/2005. This rule establishes, among other limitations, that advertisements must NOT include phrases and/or messages that:
They attribute therapeutic actions and/or properties to the dietary supplement, suggest that it is a medicinal product or mention that it diagnoses, cures, calms, mitigates, relieves, prevents or protects from a certain disease. It will only be allowed to include "helps to prevent" or "helps to protect", provided that said statements are beneficial in the face of a classic disease due to nutrient deficiency.
Cause fear or distress, suggesting that a person's health will be affected if the product is not used.
Induce the indiscriminate use of the product.
State that a dietary supplement can be used in replacement of a conventional meal or as the only food in a diet.
Refer to dietary supplements as “natural” when in fact they are semi-synthetic or co-formulated with synthetic components.
They are capable, from the bromatological point of view, of causing error, deception or confusion in the consumer.
Include the expression “free sale”.
The ANMAT performs advertising control tasks in order to reduce the risks for the consumer. When advertisements do not meet the aforementioned ethical guidelines, the corresponding summaries are initiated and sanctions are imposed on the responsible companies.
Presentation Forms. Labeled
Dietary supplements are presented on the market in different forms: tablets, capsules, tablets, liquids or powders.
The label must clearly indicate that it is a "dietary supplement", which is food that provides certain nutrients and NOT a medicine. In addition, the following data will appear:
Brand and/or trade name of the product.
Name that indicates that the product is a dietary supplement that provides certain nutrients.
List of ingredients (including additives/excipients) indicating all those that are present in the composition.
Nutritional information: you must indicate the amount of the nutrients provided from its source, per serving (for example: calcium provided by calcium gluconate).
Name and address of the manufacturer/importer.
Product registration number granted by the health authority (RNPA or RPPA).
Registration number of the manufacturing or importing establishment, granted by the health authority.
Expiration date or “best before…”.
Batch or lot number.
Recommended daily intake, which indicates the amount that should be consumed per day. In no case should this amount be exceeded.
Mode or form of consumption, indicating how it should be consumed (eg: at breakfast, with lunch, with plenty of water, etc.).
Warnings: among them are those that are consigned in a mandatory way: "consult your doctor", "do not use in case of pregnancy, lactation or in children" (unless it is directed towards them), "keep away from children” and others that, depending on their ingredients, instruct the consumer to ingest them after consulting their doctor. Some of the latter are:
In products with a high content of sugars (carbohydrates), the following must be indicated: “this product contains carbohydrates, and should be used with caution by diabetics”.
If the product contains aspartame (sweetener) or phenylalanine (amino acid), the phrase "contains phenylanine: contraindicated for phenylketonurics" must be included.
In the event that it contains iron, it must be stated: “this product contains iron and should only be consumed by healthy individuals; before consuming it consult your doctor”.
If it contains fat-soluble vitamins (A, E, D, K) there is a risk that excessive consumption will cause them to be deposited in the body's fat and generate hypervitaminosis. Therefore, it should be noted that “this product can cause toxic accumulation of fat-soluble vitamins (A, D, E and/or K). Do not consume it again without consulting your doctor”
In addition, in no case should the expression “free sale” appear, since said legend is exclusive for medicines and can lead to a misinterpretation by the consumer about the product they are purchasing.
Energy drinks: dietary supplements that are in fashion
Energy Drinks are dietary supplements that contain ingredients such as taurine, glucuronolactone, caffeine and inositol, accompanied by carbohydrates, vitamins and/or minerals and other authorized ingredients. They provide energy in an approximate amount of 45 kcal/100 ml.
Although they are food and, as such, can be marketed in establishments authorized to sell them, their label must be clearly read before being consumed, in order to verify if the person can eat it, and in what quantity (recommended daily intake). ). The warnings that these products must contain are the following:
“Consult your doctor” or “consult your doctor before consuming”.
"Do not use in case of pregnancy, lactation or in children."
"Keep out of the reach of children".
"This product should not be used by diabetics."
"Elderly or sick people should consult their doctor before consuming this product."
“Alcohol consumption is harmful to health.”
The mandatory inclusion of this last warning arises from ANMAT Provision No. 3634/2005, which was sanctioned as a result of numerous records that demonstrated the inappropriate use of these energy drinks, which were consumed together with alcoholic beverages, generating risks for health. This behavior distorted the true function of these products, which is none other than providing nutrients.
The aforementioned rule also establishes that the advertising of energy drinks should not associate these products, "directly or indirectly, with consumption with alcoholic beverages." Nor should they be presented in advertisements "as producers of well-being or health" In addition, "their consumption should not be linked to concepts of greater success in the affective and/or sexual life of people, or in sports activities, or exalt social prestige , virility or femininity”.
Likewise, the norm, in order to protect the health of consumers, prescribes that the maximum amount of caffeine allowed in these products became 20 mg. per 100 ml., when previously it was 35 mg./100 ml. With respect to the remaining components, maximum values are as follows:
Taurine: 400mg/100ml;
Glucuronolactone: 250 mg./100ml;
Inositol: 20mg/100ml.
Regarding the amount of these beverages that should be consumed daily, it is necessary to respect the daily intake that appears on the product label, since it was established based on the amount of vitamins that the product has and the maximum amount of caffeine allowed.
In summary
From all of the above, we can conclude that dietary supplements are food and that, like all of them, they provide nutrients for healthy people. Therefore, before consuming them, those who suffer from any ailment should consult their doctor. Likewise, everyone, before ingesting it, must carefully read the label, paying close attention to the warnings it contains and respecting the mode of use and daily intake, in order to avoid unwanted effects.
In any case, it should always be clear that, before acquiring them, it is necessary to consult with your doctor and/or nutritionist, so that it is the professional who determines if the diet carried out by the consumer may suffer from deficiencies in any nutrient. .
Reference daily intake table for adults (according to article 1381 of the Argentine Food Code). This table reports the amounts of vitamins and minerals that a normal individual needs to incorporate daily through food so that their body maintains a healthy state.
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