This Guidance Document on “Food for Special Dietary Use for Sportspersons” is the outcome of a collaborative effort at the national level to promote the use of dope-free food supplements and nutritional products for sportspersons and to develop and strengthen cooperation in the fields of Sports Nutrition including nutrition practices that enhance lifelong health and fitness of sportspersons.
Food for Special Dietary Use for Sportspersons (FSDU for Sportspersons) contain ingredients required to achieve specific nutritional and performance goals. However, there have been instances where such food may be laced with prohibited substances resulting in unintentional doping. Therefore, it becomes imperative that the sportspersons must have proper guidance on such food and nutritional products so as to ensure that they make informed choices while purchasing these products.
This guidance document attempts to educate the sports fraternity (sportspersons, sports nutritionists, health professionals, and coaches) and the general public on various types and forms of supplements available in the market; their selection criteria as per requirement; dosage; labelling and claims provisions; authenticity, traceability, and source. In addition, the guidance document also provides for:
- Information on the current regulatory framework
- Guidelines that should be followed by Manufacturers, Importers, and Retailers
- World Anti-doping Agency and its list of Prohibited Substances and Methods (2019)
- National Anti-doping Agency, Anti-doping Rules, Strict Liability Clause and Therapeutic Use
- Exemption for sportspersons
- Definitions and Frequently Asked Questions
- Web Links for Nutrient Requirements and Recommended Dietary Allowances for Indians(2010), Dietary Guidelines for Indians-A Manual (2011), IOC- Consensus Statement: Dietary Supplements and the High-Performance Athlete;
- Recognized Sports in India.
Sports: an activity involving physical exertion and skill in which an individual or team competes against another or others for entertainment;
Sportsperson: means an individual who is involved in various types of sports activities as approved by Sports Authority of India (Ministry of Youth Affairs & Sports);
Food for Special Dietary Uses (FSDU) for Sportspersons: FSDU for Sportsperson is a specifically processed or formulated product that satisfies particular dietary requirements which may exist or arise because of certain sports and related physical activities;
Ergogenic aid: a physical, mechanical, nutritional, psychological or pharmacological substance or treatment that either directly improves physiological variables associated with exercise performance or removes subjective restraints which may limit physiological capacity;
Nutritional ergogenic aid: substance found in the diet that is ingested in an effort to produce improved or enhanced sport, exercise, and physical performance.
Nutrient Ingredient: means a vitamin, mineral, or amino acid as specified in Schedule I and Schedule II of the FSS (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical Purpose, Functional Foods, and Novel Food)Regulations, 2016.
Prohibited Substance. Substance/ ingredient /drug prohibited by WADA for use by sports persons.
Current Regulatory Framework and Status:
Food Safety and Standards Act, 2006/ Regulations:Section 22 of the Food Safety and Standards Act, 2006 defines “Food for special dietary uses or functional foods or nutraceuticals or health supplements” as “ food which are specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition or specific diseases and disorders and which are presented as such, wherein 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 ingredient….. . Further, Section 22, Subsections b(i),(ii) & (iv) lay down the following provisions: –
- a product that is labelled as which is not representing a conventional food and where such products may be formulated in the form of powders, granules, tablets, capsules, liquids, jelly and other forms and are meant for oral administration (not parenteral)
- such product does not include a drug as defined in clause (b)and ayurvedic, Siddha and Unani drugs as defined in clauses (a) and (h) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and rules made there under
- does not include a narcotic drug or a psychotropic substance as defined in the Schedule of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) and rules made there under and substances listed in Schedules E and EI of the Drugs and Cosmetics Rules, 1945.
The Food for Special Dietary Use is also covered in the Food, Safety and Standards (Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical Purpose, Functional Foods, and Novel Food) Regulations, 2016 which covers eight categories of foods, namely, Health Supplements, Nutraceuticals, Food for Special DietaryUse, Food for Special Medical Purpose, Speciality Food containing plant or botanicals, Foods containing Probiotics, Foods containing Prebiotics and Novel Foods. Requirements for such foods as detailed in these regulations pertain to essential composition; claims and labelling provisions. These standards also include the essential composition, requirements related to claims, labelling, permitted the use of additives and the permissible limits of contaminants, toxins, and residues. The regulations do not allow the use of hormones or steroids or psychotropic ingredients in any of the articles of food.
Furthermore, these regulations provide various Schedules dealing with the use of vitamins and minerals, amino acids, ingredients of plants or botanical origin, nutraceuticals, probiotics and prebiotics in these products. The subcategory under FSDU shall cover FSDU for Sports persons considering their special needs.
The Food Safety and Standards Act, 2006 also requires that FBOs (Manufacturers/ Importers/ Retailers) comply with the following regulations:
(i) Food Safety and Standards (Licensing and Registration of Food Businesses) Regulation, 2011: These regulations stipulate the procedure for food license and registration. The Licenses/Registrations are issued to Food Business Operators to commence or carry on any food business as per eligibility criteria for central License, State License, and Registration. A Unique License Number is granted for a different kind of business for carrying out food business at a particular premise for which license has been granted. The FBOs are required to buy and sell food products only from or to, licensed/registered vendors and maintain record thereof
(ii) Food Safety and Standards (Packaging and Labelling) Regulation, 2011:
These regulations specify general labelling requirements for all pre-packaged foods which includes declaration of list of ingredients, best before date, date of manufacture, date of packaging on packaged food, use by date, expiry date, vegetarian/non-vegetarian food etc. It also provides for some product specific labelling requirements.
(iii) Food Safety and Standards (Import) Regulation, 2017: As per Section 25 of the Food Safety and Standard Act, 2006, all imports of articles of food are subject to this Act. It stipulates that no person shall import into India any article of food in contravention of any provision of this Act or any rule and regulation made there under. As provided in the Act, and for the purpose of streamlining the process of clearance of imported food in an efficient and transparent manner, the FSSAI has notified this regulation which lays down the procedure for clearance of food products imported into India and include various provision related to licensing of food importer; clearance of imported food by the Food Authority; food import clearance for specific purposes; storage, inspection and sampling of imported food; laboratory analysis of samples of imported food article and prohibition and restriction on food imports, amenable food labelling provision for ease of trade and privilege for importer to get their concerns, if any, address in respect of theclearance of their food products.
(iv) Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food-sand Novel Foods) Regulations, 2016: An amendment in the FSS (Health Supplements, Nutraceuticals, Food for special Dietary Use, Food for Special medical purpose, Functional food and Novel Food) Regulations, 2016 is currently underway to accommodate standards on sport supplements in the category of Food for Special Dietary Use. This has specified the following requirement –
- Statement and Logo on the label of the food products of FSDU of Sports persons;
- Declaration on the label related to consumption of product by pregnant,nursing and lactating women or by infants, children under 5 years and elderly
- Restriction on advertisement of FSDU for sportsperson to general public
- Prohibit the use of Prohibited substances declared by World Anti-Doping Agency (WADA) in any of the articles of food specified for sport persons.
National Anti-Doping Agency: Anti-Doping Rules and Regulations:
Establishment: Government of India (GOI) is one of the Founder Membersof World Anti-Doping Agency (WADA) (1999-2002). GOI has signed the UNESCOCopenhagen Convention on Anti-Doping and accepted the World Anti-Doping Codeon 7th March 2008. National Anti-Doping Agency (NADA) of India was established in2009 and is mandated for Dope free sports in India. New Anti-Doping Rules cameinto operation w.e.f. 1st January 2015.
Objectives: NADA’s primary objectives are to adopt and implement the antidoping rules and policies, which conform to the World Anti-Doping Code, regulate dope control programme by sample collection, result management of adverseanalytical findings and imposing sanctions/ ban on athletes’/ athlete sports personnel who have violated anti-doping rules and to promote education, research and create awareness about doping and its ill effects.
Anti-Doping Rule Violations: Doping is defined as the occurrence of one or more of the anti-doping rule violations, set forth in Article 2.1 through Article 2.10 of the Anti-Doping Rules. The purpose of Article 2 is to specify the circumstances and conduct which constitute anti-doping rule violations. Hearing on doping cases will proceed based on the assertion that one or more of these specific rules have been violated. Athletes and other stakeholders shall be responsible for knowing what constitutes an anti-doping rule violation and the substances and methods, which have been included on the Prohibited List.
Prohibited Substances and Methods: WADA’s determination of the Prohibited Substances and Prohibited Methods that will be included on the Prohibited List, the classification of substances into categories on the Prohibited List, and the classification of a substance as prohibited at all times or in competition only, is final and shall not be subject to challenge by an athlete or other person based on an argument that the substance or method was not a masking agent or did not have the potential to enhance performance, represent a health risk or violate the spirit of sport. The Prohibited List is published on an annual basis for effective implementation from respective calendar year.
Therapeutic Use Exemptions (“TUEs”): The presence of a Prohibited Substance or its Metabolites or Markers, and/or the Use or Attempted Use,Possession or Administration or Attempted Administration of a Prohibited Substance or Prohibited Method shall not be considered an anti-doping rule violation if it is consistent with the provisions of a TUE granted in accordance with the International Standard for TUE.
Guidance for Sports Fraternity, Manufacturers, Importers, Retailers & General Public
FSDU for Sportsperson may be required to help sportsperson to meet the expenditure of energy during intense muscular effort, to improve exercise performance capacity, improve the efficiency of exercise, enhance recovery from exercise, tolerate intensive training and remain healthy. FSDU for Sportsperson can be broadly divided into the following categories:
- Carbohydrate-rich energy food products: products high in glycaemic carbohydrates essential before, during and after exercise for providing energy and refuelling glycogen storage.
- Carbohydrate-electrolyte fluids: Fluids providing carbohydrates as the major energy source and effective in maintaining or restoring hydration status.
- Protein and protein components: high protein and essential amino acids products ensuring endogenous synthesis of proteins, muscle maintenance/gain, and glycogen synthesis when combined with carbohydrates.
- Enriched foods with supplements such caffeine or creatine: some dietary ergogenic aids
- Enriched foods with vitamin and mineral supplements
Specifically, the stakeholders may follow the following guidelines to ensure that the FSDU for Sports persons are genuine products.
The sports persons look to food supplements and nutritional products in addition to the irregular diet for deriving many benefits which include promoting adaptation to training, increasing energy supply, enhancing consistent and intensive training by promoting recovery between training sessions, maintaining good health and reducing interruptions to training due to chronic fatigue, illness, or injury, facilitating competitive performance, providing a convenient source of nutrients. Supported for use in sport specific situations using evidence-based protocols some supplements are considered safe, legal and effective in improving sports performance.
Currently, there is no universal system to categorise supplements used by athletes. However, it can be helpful to categorise supplements (or their uses) 1.
The Ministry of Youth Affairs and Sports has notified following Generic Names of health supplements meant for sports persons:
|Sr. No||Name of the Supplement|
|6.||Sports drink including AAs, CHO, Protein and Electrolyte|
|10.||Combination of arginine, glutamine, Branched Chain Amino Acids|
*for further information please refer Appendix VI– IOC Consensus Statement and the supplements normally used by sports persons.
The supplements for sports persons are available in the market in the form of pills, capsules,potions, powders, drinks, bars and gels, which are widely used by sports persons, however only a few products are supported by evidence- based research and some of them may even be harmful to the sports persons. Hence, it is imperative that the Sports Fraternity i.e. sports persons, coaches,nutritionists, dieticians and physiotherapists are aware of what is prohibited in as per the WADA list of prohibited substances.
Sportsperson should also carefully examine the risks and benefits of individual supplements before using them and be aware about the misconceptions of ‘having higher doses giving better results. Sportsperson should ensure that supplements be consumed under the guidance of well-informed sports nutritionists, health professionals and coaches. Sports person should be aware of dosage, frequency and duration of use of supplements so that the specific sports goals can be achieved.
A Sportsperson ought to choose food first to ensure that their nutritional needs are met.
The use of food supplements does not compensate for poor food choices and an inadequate diet.However, to augment diet and to complement additional nutritional needs, the sportsperson may use supplements. In this context, the sportsperson should carefully examine the label of the product for the following: –
- Ingredients List/ Composition
- Date Marking: Expiry/ Best Before Date should be checked before purchasing (both offline and online).
- Package Integrity: It should be ensured that the supplement is properly packed/sealed and there is no evidence of tampering of package.
- Serving Size / Recommended Dosage.
- Authenticity: Sport-persons must ensure the authenticity of the supplement before purchasing each individual pack. This can be done through an independent marking which the end user can validate on their own from the manufacturer through Bar Code/QR Code.
- Traceability: Complete visibility of the entire supply chain should be accessed to be aware of the distributor, storage and retailer. It is necessary to confirm the details of the authorised sellers/distributors before purchasing supplements for sportsperson in order to ensure the original source of the product. A complete visibility of the supply chain on retail bills should be available
- Customer Care: for the purpose of making Customer care service details should be available.
It is important for the FBOs to be aware of the prohibited substances listed by WADA so that these substances are not used as ingredients. The Good Hygienic Practices (GHP), Good Manufacturing Practices (GMP) and Hazard Analysis Critical Control Points (HACCP) must be developed and incorporated into the various stages of the production process for supplements.
Manufacturers and Importers must comply with the Food Safety and Standards Act, 2006 and various Regulations there under including: –
(a) Food Safety and Standards (Licensing and Registration of Food Businesses) Regulation,2011,
(b) Food Safety and Standards (Packaging and Labelling) Regulation, 2011,
(c) Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for SpecialDietary Uses, Foods for Special Medical Purpose, Functional Foods and Novel Food)Regulations, 2016,
(d) Food Safety and Standards (Import) Regulation, 2017.
FBOs are required to adopt the following practices: –
1. Registration and Licensing of Manufacturer with FSSAI:
- Manufacturer (Domestic or International) should have an Indian registered office with local contact details for addressing consumer grievances.
- Manufacturing facility should be periodically audited as per FSSAI Regulations.
2. Labels and Claims: FBOs should ensure that the following declaration are printed on label of the package containing FSDU for Sportspersons: –
- “FOR SPORTSPERSON ONLY”
- Logo (This logo is a part of amendment proposed in the Food Safety and Standards
(Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2016 and this will be implemented on the date of publication of said final amendment)
- “Recommended to be used under medical advice or dietetic supervision only”
- “the product is not to be used by pregnant, nursing and lactating women or by infants, children under 5 years and elderly except when medically advised”
- “the food is not a sole source of nutrition and should be consumed in conjunction with a nutritious diet’ for the article of food specially prepared for sportsperson;”
- the food should be used in conjunction with an appropriate physical training or exercise regime.” “for oral consumption only”
- Manufacturer’s product authentication for the consumer (each individual pack should have an independent marking which the end user can validate on their own);
- Manufacturer should ensure that packing is tamper proof/tamper evident;
- Manufacturer should authenticate the seller/distributors and should publish detailsof authorized seller through their website, advertisements.
- Manufacturer should provide complete visibility of the entire supply chain.
5. Date Marking:
- Manufacturer should ensure visibility of Expiry / Best Before Date when sellingproducts through online market places.
The following precautions must be taken before claiming that theFSDU for Sportspersons does not contain any prohibited substance as per WADA”: –
1) Periodical tests, preferably bi-annually should be conducted by FBO through FSSAI approved labs;
2) Repository of Certificate of Analysis (COA’s) of periodical tests should be maintained by FBO for ready reference;
3) Control samples should be properly preserved and stored as per the FSS Regulations;
The FBOs/ importers must exercise due diligence and self-regulate while importing FSDU for Sports persons into the country. Importer must ensure that they import only such products which comply with FSSAI specified standards and regulations. Specifically, the importer should:
- register to obtain license under FSS Act,2006 in respect of the product;
- ensure to keep records of Manufacturer’s License while importing goods into India;
- ensure that the imported products are as per FSSAI specified standard by getting the products tested in FSSAI approved labs
- ensure that all relevant documents / information in respect of the entire supply chain of the product being imported are available
- maintain proper records of other relevant information/documents (e.g. Date marking, date of import, place of origin, port/place of import into India, storage,inspection and sampling of imported food, reports of laboratory analysis of samples of imported food article, amenable food labelling provision, etc) are available.
Retailer: Person involved in retail sale of these products either through online or offline channel should follow or ensure the following:
- Best before/ Expiry date of the products under this category should be visible when offered for sale through online channel;
- An online marketplace should be able to provide details as to traceability of the products. This can be ensured through visibility of the supply chain through online invoicing;
- A dedicated customer support should be provided in respect of any online sales; and
- Information of the Manufacturer’s/Importer’s License should be visible when selling products online.
- Requisite License under the FSS Act,2006;
- Traceability of the supply chain. This can be ensured through retail invoicing;
- Maintain records of the products/inventory for audit
- Ensure proper storage conditions
E. General Public:
Consumers must be aware about the difference between general health or food supplements and the food supplements for sports persons. They must read the label and claims,and must be aware of the prohibited substances as per WADA. In addition to this, consumers should: –
- Choose/select supplements as per their requirements or recommendation by sports nutritionists, health professionals or coaches.
- Confirm the dosage required by them as per their daily activity, gender and age.
- Check Expiry Date/Best Before Date before buying online and offline;
- Look for tamper proof /tamper evident packing;
- Use authentication system provided by Manufacturer;
- In case of grievances/query, customer, contact the manufacturer as per the given customer grievance details.