“Scientific andRegulatory Aspects of Nutraceuticals” Manish Sharma
Contents1. Introduction2. Indias dietary patterns3. Market of nutraceuticals4. Classification of nutraceuticals5. Scientific aspects of nutraceuticals6. Regulatory aspects of nutraceuticals in India7. Improvements provided for FSSA
IntroductionQuality healthcare is the foundation of anyprosperous nation. Today, food alone is unableto fully service the nutrition needs of the body.Nutrition is a fundamental need. It contributeto more than 40% of deaths and 30% of theoverall disease burden in developing countries.Hence, the requirement of externalintervention, that can supplement diet to helpprevent nutrition-related disorders andpromote wellness over treatment of illness, hasbecome critical. Such products are collectivelycalled as “nutraceuticals”.
The term "nutraceutical" was coined from"nutrition" and "pharmaceutical" in 1989 byStephen De Felice, MD, founder and chairmanof the Foundation for Inno-vation in Medicine(FIM), Cranford, NJ. According to De Felice,nutraceutical can be defined as, "a food (orpart of a food) that provides medical or healthbenefits, including the prevention and/ortreatment of a disease."
Concept of Nutraceuticals Pharmaceutical Nutrition remedy forrequired for sickness or health injury Nutraceuticals preventive Medical Approach
India’s dietary pattern Sufficient excess Over nourished 80 million ICMR norm for fruits and Under nourished vegetablesMicronutrient intake 380 million Calorie sufficient, nutrient Deﬁcient deﬁcient population- 570 million Deﬁcient Adequate/excess 80% of norm Calorie level as deﬁned consumption by NSSO
Position of nutraceuticals Curative Traditional Pharmaceuticals MedicinesUsage Preventive food Nutraceuticals Nature- Man Natural like made Sources
Market of nuatraceuticals In 2008, the Nutraceuticals market in India was Rs 18.75 billion. It is growing at the CAGR of 21.23%. India’s nutritional supplement market is expected to more than double to Rs 9,500 crore by 2013.
Drivers for growth of nutraceuticals 21.23 % Accessibility Awareness Increased accessibility due to emergence of newer channels Affordability Increasing physician awareness and media penetration Reducing affordabilityAffluence of sick care, driving consumers towards wellness Affluence of working population with changing lifestyles
Critical impediments for growth of nutraceuticals market Regulatory framework Resources for enforcement Lack of credibility Prices of nutraceuticals
Prices of nutraceuticals Percentage increase in Price of price for functional foodProduct Quantity conventional food/ functional beverages/ pharmaceutical dietary supplementConventional and functional foodsSalt 1 Kg INR 11 73% for low sodium variantConventional and functional beveragesChilled beverages 330 ml INR 20 350% for energy drinkPharmaceuticals and dietary supplementsMultivitamin 10 tablets INR 15 233 % for vitamins in the formtablets of dietary supplements
Classification of nutraceuticals (As par US-FDA)1) Dietary supplements “A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandular, and metabolites, extracts or concentrates, and may be found in many forms such as tablets, capsules, soft gels, gel caps, liquids, or powders. E.g. iron supplement capsules.
2) Functional foods: Functional foods are designed foods which provide enriched foods close to their natural state to consumer, rather than manufactured dietary supplements in liquid or capsule form.e.g. table salt fortified with iodine.3) Medical foods: In order to be considered a medical food the product must, at a minimum: • be a food for oral ingestion or tube feeding (nasogastric tube)
• be labeled for the dietary management of a specific medical disorder, disease or condition for which there are distinctive nutritional requirements, and • be intended to be used under medical supervisione.g. Medical foods for management of diabetes mellitus generally contain slowly digested carbohydrates, which helps minimize peaks in blood sugar. Consistent maintenance of optimal blood sugar levels (avoiding highs and lows) over time can help reduce the complications of diabetes.
Scientific aspects of nutraceuticals1. HIV/ AIDS: United States Patent Application 20120195988; 2012, granted to inventors Rezai-Fard and Ali describes a saponin or sapogenin from the capsicum genus may be used • in the treatment of HIV infection, or AIDS, • to alleviate the symptoms of HIV or AIDS, • to delay the onset of HIV infection, or • to stop an HIV infection developing into AIDS.2. Cancer: United States Patent Application 20120195988, 2012; granted to Rezai-Fard and Ali mention a saponin or sapogenin as described herein can be used directly as a chemotherapeutic agent • in the treatment of tumors and cancer in the human or animal body.
• to shrink tumors and kill cancer cells as part of chemotherapy. • to decrease the swelling caused by cancers. • to alleviate many of the side effects and symptoms caused by cancer and by various cancer treatments such as chemotherapy and radiation therapy.Saponin and sapogenin from the capsicum genus, alongwith their derivatives, may be used to treat any form ofcancer including but not limited to breast, liver, lung,prostate, testicular, ovarian, cervical, uterus, brain,skin, colon, throat, mouth, bone, pancreas, stomachand lymph node cancer.
Regulation of nutraceuticalsIssues with regulatory regime before FSSA- Nine different laws and eight different ministries was governing the food sector Laws framed by different Ministries/Depts. With different perspective and enforcement approach Overlapping laws with different quality standards & labelling requirementsNeed for new law (FSSA)- Removal of multiple regulations Harmonizing with international law Framing regulatory requirements based on science and risk analysis Facilitating trade without compromising consumer safety and bringing in innovation in foods
Food Safety and Standard ActManufacture, storage, distribution, sale and import ofNutraceuticals in India are regulated under the FoodSafety and Standards Act, 2006. This Act consolidated thelaws relating to food and established the Food Safety andStandards Authority of India for laying down sciencebased standards for articles of food.• The Prevention of Food Adulteration Act, 1954• The Fruit Products Order, 1955• The Meat Products Order, 1973• The Vegetable Oil Products (Control) Order, 1947• The Edible Oils Packaging Order, 1998• The Solvent Extracted Oil, De oiled Meal, and Edible Flour (Control) Order, 1967.• The Milk and Milk Products Order, 1992
FSSA & NutraceuticalsChapter IV section 22 of the Act addressesnutraceuticals, functional food, dietary supplements.• According to it “foods for special dietary uses or functional foods or nutraceuticals or health supplements” means: foods which are specially processed or formulated to satisfy particular dietary requirements and the composition of these foodstuffs must differ significantly from the composition of ordinary foods of comparable nature, if such ordinary foods exist, and may contain one or more of the following ingredients, namely:- plants or botanicals or their parts in the form of powder, concentrate or extract in water, ethyl alcohol or hydro alcoholic extract, single or in combination;
minerals or vitamins or proteins or metals or their compounds or amino acids or enzymes; substances from animal origin; a product that is labelled as a “Food for special dietary uses or functional foods or nutraceuticals or health supplements or similar such foods” may be formulated in the form of powders, granules, tablets, capsules, liquids, jelly and other dosage forms but not parenterals, and are meant for oral administration; such product does not include a drug as defined in clause (b) and ayurvedic, sidha and unani drugs; does not claim to cure or mitigate any specific disease, disorder or condition (except for certain health benefit or such promotion claims) as may be permitted by the regulations made under this Act; does not include a narcotic drug or a psychotropic substance.
Salient feature of the act• Movement from multi-level and multi-department control to a single line of command.• FSSAI as a single reference point for all matters relating to Food Safety and Standards, Regulations and Enforcement.• Integrated response to strategic issues like Novel foods, Health Foods, Nutraceuticals, GM foods, international trade etc.• Decentralization of licensing for manufacture of food products.• Achieve high degree of consumer confidence in quality & safety of food.• Investor’s friendly regulatory mechanism with emphasis on self regulations and capacity building.
• Enforcement of the legislation by the State Governments/UTs through the State Commissioner for Food Safety, his officers and Panchayati Raj/Municipal bodies.• Emphasis on gradual shift from regulatory regime to self compliance through food safety management system.• Consistency between domestic and international food policy measures without reducing safeguards to public health and consumer protection• Adequate information dissemination on food to enable consumer to make informed choices.• Compounding and Adjudication of cases – to reduce Court’s workload and expedite the disposal of cases• Graded penalty depending upon the gravity of offences.
New provisions under the act• Regulation of food imported in the country• Provision for food recall• Surveillance• New enforcement structure• Envisages large network of food labs• New justice dispensation system for fast track disposal of cases• Harmonization of domestic standards with international food standards• Covering Health Foods, supplements, Nutraceuticals• Issuing Licenses within a time frame of 2 months• Provision of Improvement Notice by Designated Officers
• Compensation to Victims (for any case of Injury/Grievous injury/ Death): not less than five lakh rupees in case of death; not exceeding three lakh rupees in case of grievous injury; and not exceeding one lakh rupees, in all other cases of injury• Reward to informer (informing about the violators – adulteration etc.) by State Govt.• No License for small food business operators; only registration is mandatory: with an annual turnover not exceeding 12 lakh.• Central licensing from Authority
Notice of improvementDesignated Officer Suspension Improvement NoticeState the grounds Cancellation Specify the mattersSpecify measures which require the food Appeal tobusiness operator commissioner to take
Registration of food businessRegistration is required only for “Petty FoodManufacturer” means any food manufacturer, who• manufactures or sells any article of food himself or a petty retailer, hawker, itinerant vendor or temporary stall holder; or distributes foods including in any religious or social gathering except a caterer; or• such other food businesses including small scale or cottage or such other industries relating to food business or tiny food businesses with an annual turnover not exceeding Rs 12 lakh and/or whose production capacity of food (other than milk and milk products and meat and meat products) does not exceed 100 kg/ltr per day or procurement or handling and collection of milk is up to 500 litres of milk per day or Slaughtering capacity is 2 large animals or 10 small animals or 50 poultry birds per day or less.
Procedure for registration• Registration shall not be refused without giving the applicant an opportunity of being heard.• On completion of the procedures and grant of registration, A registration certificate and a photo identity card shall be issued which shall be displayed at a prominent place.• The Registering Authority or any officer or agency specifically authorized for this purpose shall carry out inspection of the registered establishment.
procedure for registration of food business Filing of an application Application Form A Fees Rs 100/- Processing of an application Either grant or reject Within 7 days registration certificate, of receipt ofissue notice for inspection application If no response Within a After inspection grant period of 30 registration days Food Business operator may start the business
Procedure for licensing• No person (other than petty food businesses) shall commence any food business without obtaining a valid license.• Existing Operator holding valid license/registration shall be granted a license within one year of notification of this Regulation.• No license fee for the remaining period of the validity of the earlier license.• License for businesses mentioned under Schedule 1, shall be granted by the Central Licensing Authority and all others by State licensing Authority.• Importers of food items shall obtain a license from the Central Licensing Authority in addition to license taken for any other food business.
Procedure for licensing of food business Filing of an application Application Form B Documents + Fess Unique application number Improvement Require additional notice information on incomplete application No FBO may improvement Inspection of premises No inspection start after receiving business Suspensioncompleted application & after 60 issue inspection report days No improvement Either grant or rejectlicense within 60 days of Cancelation receipt of completed application or within 30 Fresh days of inspection application after 90 days
Packaging and labelingLabeling is required in the manner as may be specifiedby regulations:• Provided that the labels shall not contain any statement, claim, design or device which is false or misleading in any particular concerning the food products contained in the package or concerning the quantity or the nutritive value implying medicinal or therapeutic claims or in relation to the place of origin of the said food products.• Every food business operator shall ensure that the labeling and presentation of food, including their shape, appearance or packaging, the packaging materials used, the manner in which they are arranged and the setting in which they are displayed, and the information which is made available about them through whatever medium, does not mislead consumers.
AdvertisementSupreme Court of India has held that commercialadvertisement is a fundamental right available toevery citizen under Article 19 (1) (a) of theConstitution of India subject to the requirements ofArticle 19 (2) of the Constitution.The Advertising Standards Council of India (ASCI)has drafted and implemented a Code for Self-Regulation in Advertising (ASCI Code) in India.Advertisement guideline provides that-• It should not be misleading or deceptive.• Advertisements should not disparage good dietary practice or the selection of options, such as fresh fruit and vegetables that accepted dietary opinion recommends should form part of the average diet.
• Advertisements should not encourage excessive consumption or inappropriately large portions of any particular food.• Ensure advertisements do not mislead as to the nutritive value of any food.• The nature of the audience should be taken into account.• Claims shall be specific to the promoted product/s and accurate.• Claims in an advertisement should not be inconsistent with information on the label or packaging of the food.
Panalties¤ Substandard food: Upto Rs. 2.00 lakhs¤ Misbranded: Upto Rs. 3.00 lakhs¤ Misleading advertisement : Upto Rs. 10.00 lakhs¤ Food with extraneous matter: Upto Rs. 1.00 lakhs¤ Fail to meet the requirements as directed by FSO: Upto Rs. 2.00 lakhs¤ Unhygienic / unsanitary preparations: Upto Rs. 1.00 lakhs¤ Adulterant not injurious to health: Upto Rs. 2.00 lakhs¤ Adulterant injurious to health: Upto Rs. 10.00 lakhs¤ Unsafe food – but does not cause immediate injury : 6 months imprisonment with fine of Rs.1.0 lakh
Improvements provided for FSSA• Lay down rules to govern quality and claims of nutraceutical products.• Recognize list of nutritional ingredients with proven health benefits• Define the list of permitted health claims and specify quantity of ingredients required to make those claims• Setup a process for introduction of new nutraceutical products and define the nature and range of evidence required to substantiate product claims.• Revise RDA (Recommended Dietary Allowance) levels to make them applicable for Indian populations current lifestyle.• Take measures to ensure availability of adequate resources for implementation and enforcement of regulations
Summary and conclusionMany nutraceuticals, functional foods and naturallyoccurring compounds that have been investigated andreported in various studies revealed that these productsare extremely active, have profound effect on cellmetabolism and often have little adverse effect. It isnatural that people’s focus is shifting to a positiveapproach for prevention of diseases to stay healthy.Nutraceuticals is scientific area generated all over theworld. In many cases nutraceuticals offer an advantageover the synthetic drugs under development by thepharmaceuticals industry.The concept of "nutraceuticals" is still developing inIndia. It has been defined in the FSSA and it lays downthe suggestive structure of the regulation for Foods forSpecial Purpose and Nutritional Uses. FSS Act based onthe learning from international best practices; the FoodSafety and Standards (Packaging and Labeling)Regulation, 2011, deals with nutrition and health claims.