Regulatory and Safety perspective in nutraceuticals and functional foods

Regulatory and Safety perspective in nutraceuticals and functional foodsPrepared By: Fatimah A.RIntroductionIndividuals realization on the concept of maintaining healthy diet can diminish the risk of diseases and promote wellbeing created a rewarding business sector of new products called functional foods & nutraceuticalsFunctional Food: conventional food/beverages that offer beneficial function to human healthNutraceuticals: Chemicals obtained as a natural component of food, mainly extracted/purified from food, containing health benefit beyond basic nutrients

4/5/201522Functional Food and NutraceuticalsThe concept of functional food was established in 1984 in Japan In 1991, The Japanese Ministry of Health and Welfare initiated Foods for Other Specific Health Use (FOSHU) to encourage its use as a means to lower down the health care costsIn 1995 International Life Science Institute (ILSI) in Europe promoted functional food as the food which contain additional basic nutrient to human in order to improve the general physical conditions and to reduce the risk of diseases4/5/20153Example of functional food4/5/20154

Consumer perception toward functional food Consumers have began to change aspects of food consumptionThe elements that have most influenced and changed the eating habits are the concerns on increasing their life span, the continuous progressive ageing of population, the threat of chronic disease, the rising of the medical costs and the need for a better standard of livingConcern on the disappearance of nutrients benefits from the processing stage of food product

4/5/20155Consumer perception toward functional foodConsumer acceptance of the concept of functional foods and their consciousness of its benefits has significantly increasedHowever, most of the studies on the consumers attitude toward functional food are only directed on the developed countries such as UK, US and most Europe countries without considering other possible potential marketsIntroducing artificial healthy ingredients in the food production might not be valued as real healthiness by some consumers4/5/20156Consumer perception toward functional food

4/5/20157Health ClaimsHealth claims: any claim made in labelling or advertising of food which suggests the relationship of any substance or ingredient in the food to a disease or health effectsCommunication with the customers on the health benefits of foods containing nutritional formulations can be delivered, creating positive attitude to the consumersRegulations and policies regarding health claims have to be made based on a very high specification of scientific measurement as analysed by the FDA and other public health organizations4/5/20158HEALTH CLAIMS APPROVED BY FDA4/5/20159

Food Safety Issues Issues arise regarding the safety of the products, especially regarding toxicity concernSome industries have exaggerated the benefits of their products to the publics or provide low quality products that might deliver harmful consequences when ingestedlack of proper regulations and knowledge among industries regarding appropriate steps for assuring the products to deliver what is stated in the labelling

4/5/201510FOOD SAFETY REGULATIONSIn1994, US FDA publicise Good Manufacturing Practice (GMP) regulations to develop regulations for dietary supplements under the authority of the Federal Food, Drug and Cosmetic Act, to ensure manufacturers, to produce safe, pure and effective products to the consumersTo ensure manufacturers to continuously comply with the up-to-date regulations, in March 2003 the FDA established Current Good Manufacturing Practice (cGMP) regulations, providing standards to the manufacturers to prevent adulterated or misbranded of the products to be sold4/5/201511GMP Regulations4/5/201512

4/5/201513FOOD SAFETY REGULATIONSMalaysia government under the justification of Ministry of Health Malaysia allocated 3 bodies to supervise the quality and safety of nutraceuticals and functional foodDepartment of Food Quality Control, Ministry of HealthMalaysian National Codex CommitteeNational Pharmaceutical Bureau All food substances products will required to be registered in which the label of the product will be examined to determine the nutrient composition of the productToxicological testingToxicological testing is one of the requirement for functional food products to be taken before food are sold to the marketsAny new potential food ingredients that do not have history of safe use or novel components will need to undergo safety and toxicological testing using case-by-case approach to evaluate the suitable toxicological tests to be conducted on the food4/5/201514The history of the organism from where the food is obtained as a source of toxins and a chemical analysis of its components will be consider for determining the requirements for toxicological testingbased on these determinations, conventional studies of toxicity, including chronic toxicity, developmental toxicity, genotoxicity or carcinogenicity, may need to be conducted on the final food product or its components as applicableto ensure the safety evaluation, toxicological tests are conducted through animal testing, in which the biological effects of a substance can then be studied prior to human trials4/5/201515Toxicological testingNatural Toxins of plants and animals originAside from the useful phytochemical contents found in the plant, natural toxins also present, which mainly provide a certain function to the plant or animal as chemical defence against attack from predators or microorganismsapproximately from more than 300 thousands plant species in the world, around 2 thousands species are categorised to be toxic4/5/2015164/5/201517

4/5/201518Plant DescriptionCucurbitacins in Courgettes (Zucchini)Species from cucumber family (Cucurbitacea) Capable to produce a group of highly potent toxins (cucurbitacins) with insecticidal and/or fungicidal propertiesIntensely toxic- 300 mg cucurbitacin-B could cause deathOnly small amounts are being consumed due to its bitter taste- less harmful Glycoalkaloids in PotatoesHighly toxic component in potatoesTaste bitter3 mains glycoalkaloids are -solanine, -chaconine, and solanidine2.5 g -solanine can cause deathConcentration varies between species and plant parts;Tubers 1220 mg -solanine /kg potatoPotato skin 300600 mg/kgPotatoes being consumed are at non-toxic concentrationsLight effect is gastrointestinal upsetThymol in ThymeLow toxicityContain antiseptic The antiseptic properties are used in dental mouth washes or to dress wounds4/5/201519AnimalDescriptionTetrodotoxin and SashimiHighly poisonous fish toxin produced by a puffer fishPotential fatal neurotoxinStill widely consume to produce tingling sensationParalytic Shellfish PoisoningCaused by a different microscopic plant; dinoflagellate growth where shellfish growConsuming this cause poisoning with the symptoms of tingling of the face, numbness, headache, weakness, partial paralysis, and rarely deathToxin cannot be remove by washing or destroyed by heatCiguatera poisoningAssociated with tropical reef fish contaminated by toxin from dinoflagellate Toxin concentrates up the food chain, causing large predatory fish (e.g. Barracuda) to harbour more of the toxic levels Highly toxic0.1 g can cause illness & 27 g could kill a person Include symptoms such as gastrointestinal disorders, neurological problems and, in severe cases deathIslamic perspectiveFor every Muslim, all aspects of life, including the selection of food for consumption need to be carried out according to the divine laws, the Holy Quran in which it has to be Halal (permissible) & Toyyiban (Wholesome)Alteration or modification to foods for the purpose of enhancing the nutritional values of substances for welfare of human are considered permissible as long as the Halal components are taken into accountsIngredients which are based from plants or animals and their derivations are also considered lawful as long as not contaminated with the prohibited ingredients, not intoxicants/hazardous to human as well as from the permissible procedures

4/5/201520The Holy- Quran stated that,

O mankind, eat from whatever is on earth [that is] lawful (Halal) and good (Tayyib) and do not follow the footsteps of Satan. Indeed, he is to you a clear enemy

Thus, to attract Muslim consumers, food industry should cover not only safety but also religious aspects of the food products4/5/201521Islamic perspectiveReferencesAddeen, A., Benjakul, S., Wattanachant, S., & Maqsood, S. (2014). Effect of Islamic slaughtering on chemical compositions and post-mortem quality changes of broiler chicken meat. International Food Research Journal, 21(3). Agriculture and Agri-Food Canada. (2009). Consumer Trends: Functional Foods. Ottawa: Agriculture and Agri-Food Canada.Arshad, F. (2002). Functional foods from the dietetic perspective. Jurnal Kesihatan Masyarakat, 8(S), 8-13. Clydesdale, F. (2004). Functional foods: opportunities and challenges. Food Tech, 58(12), 35-40. Hasler, C. M. (2008). Regulation of functional foods and nutraceuticals: a global perspective: John Wiley & Sons.Health Canada. (2006). Guidelines for the Safety Assessment of Novel Foods. Canada: Health Products and Food Branch Health Canada.International Food Information Council. (2013). Functional Foods Consumer Survey 2013. Washington DC: International Food Information Council.Khattak, J. Z. K., Mir, A., Anwar, Z., Wahedi, H. M., Abbas, G., Khattak, H. Z. K., & Ismatullah, H. (2011). Concept of Halal Food and Biotechnology. Advance Journal of Food Science & Technology, 3(5). Kroes, R., & Walker, R. (2004). Safety issues of botanicals and botanical preparations in functional foods. Toxicology, 198(13), 213-220. doi: http://dx.doi.org/10.1016/j.tox.2004.01.0284/5/201522Niva, M. (2007). All foods affect health: understandings of functional foods and healthy eating among health-oriented Finns. Appetite, 48(3), 384-393. Riaz, M. N., & Chaudry, M. M. (2004). The Value of Halal Food Production. Inform, 15(11), 698. Shaw, I. (2005). Natural Toxins in Food. Is it Safe to Eat? Enjoy Eating and Minimize Food Risks, 121-148. Spence, J. T. (2006). Challenges related to the composition of functional foods. Journal of Food Composition and Analysis, 19, Supplement(0), S4-S6. doi: http://dx.doi.org/10.1016/j.jfca.2005.11.007Tang, A. S. P. (2007). An Overview of Natural Toxins in Food. Food Safety Focus(11). Valls, J., Pasamontes, N., Pantalen, A., Vinaixa, S., Vaqu, M., Soler, A., . . . Gmez, X. (2013). Prospects of Functional Foods/Nutraceuticals and Markets Natural Products (pp. 2491-2525): Springer.van Egmond, H. P. (2004). Natural toxins: risks, regulations and the analytical situation in Europe. Anal Bioanal Chem, 378(5), 1152-1160. Williams, P. (2002). Food toxicity and safety. Essentials of Human Nutrition, 2. Mortality and global health estimates (2014).4/5/201523ReferencesTHANK YOU !!4/5/201524