FSSAI has published a guidance document on the use of supplements/ products intended for sportspersons
- so as to provide information about their use
- for labeling and claims on these products
The guidance document will also provide an overview of the regulatory status of such supplements as there have been reports that the supplements contain banned substances. Most consumers are unaware of banned substances and so they can unintentionally use the prohibited substances which may also be harmful to health.
FSSAI has asked for objections & suggestions, if any, within three weeks (i.e. up to 6th April 2018).
This guidance document is an outcome of the Memorandum of Understanding (MoU) signed between Food Safety and Standards Authority of India (FSSAI) and NADA in an effort to protect the rights of sportspersons health and to promote fair play. This collaboration enables both the regulatory bodies to come together to provide a healthy ecosystem for sportspersons to make informed choices. In this effort, the overview of anti-doping rules/ regulations and FSSAI existing rules/ regulations governing the manufacture, import, distribution, and provisions made under the regulations are discussed. Under the collaboration, FSSAI has already issued a circular to all Food Safety Commissioner for appropriate enforcement and surveillance to ensure the compliance with regard to Food Safety Regulations.
The consumers will be able to understand the available provisions for supplements made in the FSSAI regulations as well as in NADA’s Anti-doping rule which employs the Strict Liability Clause for the sportspersons; where the use of prohibited substances is strictly prohibited and considered unethical. In India, it is National Anti-Doping Agency (NADA) which ensures the implementation of anti-doping program in the country. The supplements are available both online and in the offline mode and cover various types of supplements intended for use by sportsperson and also to maintain normal health of the public. The FSSAI regulations will categorize the supplements based upon their composition and use; however, there is no specific category of supplements meant for sports person mentioned in the regulation.
The guidance document is meant for
- Sports Fraternity – Sportspersons, Sports Nutritionists, Health professionals and coaches Manufacturers- Domestic and international
- Online retailer
- Sellers in marketplaces
- General Public
Food Safety and Standards Authority of India (FSSAI) Act/ Regulations:
- Under the FSS Act, there are FSS (Licensing & Registration) Regulations, 201I wherein, every manufacturer and importer of sports supplements will have to register or obtain a license from the Food Authority.
- The food manufacturing units must comply with Schedule IV General Hygiene and Sanitary Practices
- In case the manufacturers or importers fail to comply with the regulations, their license is liable to be suspended.
- 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 has standards for health supplements, novel foods, foods for special dietary uses (FSDU) and foods for special medical purposes. The subcategory under FSDU will cover health supplements for sportspersons considering their special needs.
- The manufacturers must comply with FSS Regulations on Labelling, Packaging, Claims, and Advertisement with regard to labels, claims, and packaging of the health supplements.
National Anti-Doping Agency (NADA): Anti-Doping Rules and Regulations
The government of India (GOI) has signed the UNESCO Copenhagen Convention on
Anti-Doping and accepted the World Anti-Doping Code on 7th March 2008. National Anti-Doping Agency (NADA) of India was established in 2009 and is mandated for dope free sports in India. New Anti-Doping rules came into operation on 1st January 2015. 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.
The Prohibited List
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
- 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 the 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
Sports Fraternity: The sportspersons look to sports foods and supplements in addition to regular diet for many benefits which include promoting adaptations to training, increasing energy supply, allowing more 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.
There is no universal system to categorize supplements used by athletes, but it can be helpful to divide them (or their uses) into
- products that address specific nutrient deficiencies
- sports foods
- performance supplements
- supplements for health
- adaptation or physique change
Safe, Legal and Effective
Some supplements are supported for use in sport specific situations using evidence-based protocols and so are considered safe, legal and effective in improving sports performance. These supplements are classified as follows:
- Sports foods: Specialised products used to provide a practical source of nutrients when it is impractical to consume everyday foods. Examples are the sports drink, sports gel, sports confectionery, sports bar, liquid meal, whey protein, electrolyte replacement.
- Medical supplements: These are used to treat clinical issues, including diagnosed nutrient deficiencies. It requires individual dispensing and supervision by sports nutritionist/sports physician. Examples are an iron supplement, calcium supplement, multivitamin/mineral, Vitamin D, probiotics.
- Performance supplements: These are used to directly contribute to optimal performance. They should be used in individualized protocols under the direction of a sports nutritionist/sports physician. While there may be a general evidence base for these products, additional research may often be required to fine-tune protocols for individualized and event-specific use. Examples are caffeine, B-alanine, bicarbonate, beetroot juice, creatine.
The Ministry of Youth Affairs and Sports has notified following Generic Names of health supplements meant for sportspersons
|Sr. No||Name of the Supplement|
|6.||Sports drink including AAs, CHO, Protein, and Electrolyte|
|10.||Combination of arginine, glutamine, Branched Chain Amino Acids|
Sports supplements available in the market in the form of pills, capsules, potions, powders, drinks, bars and gels are widely used by sportspersons, but only a few products are supported by evidence-based research and some of them may even be harmful to the sportspersons.
Sportsperson should have awareness of, when, how, how much and how long to use sports supplements so that they can achieve their sports nutrition goals. They should carefully examine the risks and benefits of individual supplements before using them, be aware of the misconceptions of ‘having higher doses giving better results’ and ensure consumption under the guidance of well-informed sports nutritionists, health professionals, and coaches.
- Hence, it is imperative that the Sports Fraternity i.e. sportspersons, coaches, nutritionists, dieticians, and physiotherapists should be aware of what is prohibited in and out of the competition by looking into the WADA list of prohibited substances.
- The use of supplements does not compensate for poor food choices and an inadequate diet. A Sports person ought to choose food first to ensure that their nutritional needs are met. However, to meet the short-term nutritional demands of the sports, the sportsperson may use supplements.
- In this context, the sportspersons 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.
- Serving Size / Recommended Dosage.
- Authenticity: One must ensure authentication 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 authorized sellers/distributors before purchasing sports supplement in order to ensure a source of the product. A complete visibility of the supply chain on retail bills could be provided
- Customer Care: In case of any query, customer care should be contacted.
It is important for the manufacturing companies to be aware of the prohibited substances listed by WADA so that these substances are not used as ingredients. The Good Hygienic Practices (GHP) and Hazard Analysis Critical Control Points (HACCP) must be developed and incorporated into the various stages of the production process.
The manufacturer and importer must comply with the Food Safety and Standards Act,
2006 and various Regulations enacted under the Act like Food Safety and Standards (Licensing and Registration of Food Businesses) Regulation, 2011, Food Safety and Standards (Packaging and Labelling) Regulation, 2011, Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical Purpose, Functional Foods and Novel Food) Regulations, 2016, Food Safety and Standards (Import) Regulation, 2017.
Registration& Licensing of Manufacturer with FSSAI (Domestic or International):
- Manufacturer (Domestic or International) should have an Indian registered office and local contact details for consumer grievances.
- Manufacturing facility should be periodically audited as per FSSAI Regulations.
Labels and Claims
The manufacturer should ensure that the following be printed on the Sports Supplement products
- Label – “Intended for Sports Persons”
- Disclaimer – “Not Recommended for infants/children”
- Declaration – “Does not contain any Prohibited Substances as per WADA”
- Manufacturer’s authentication to the consumer (each individual pack should have an independent marking which the end user can validate on their own from manufacturer)
- The manufacturer should ensure packing to be tamper proof/tamper evident;
- The manufacturer should authenticate the seller/distributors and should publish a list of authorized seller details through their website, journals, etc.
- The manufacturer should provide access to complete visibility of the entire supply chain (e.g. through bills);
- The manufacturer should also ensure visibility of Expiry / Best Before Date when selling products under this category through online marketplaces.
Following parameters must be ensured before claiming that the Sports Supplement “Does not contain any Prohibited Substances as per WADA
- Periodical tests to be conducted by the manufacturer (bi-annually) through FSSAI approved labs
- Repository of Certificate of Analysis (COA’s) of periodical tests should be maintained by a manufacturer for ready reference
- Declaration from vendors for ingredients going into the formulation as per WADA/ NADA to be maintained
- Control samples to be properly maintained and stored as per regulation
Since the market in this category is dominated by imported products, it makes it imperative for this market to be regulated. The importers must exercise due diligence and ensure to self-regulate themselves when importing sports supplement into the country. It is vital that an importer must ensure to import only such products which comply with FSSAI defined standards and regulations. Specifically, the importer can ensure the following:
- Should register himself / obtain a license in respect of the product
- Must ensure and keep records that manufacturer has License as per FSSAI standards when importing goods into India
- Must ensure that the imported products are as per FSSAI defined standard. This needs to be ensured (by getting the products tested) through testing in FSSAI approved labs as per FSSAI defined limits and records to be maintained
- Must ensure that he has all the relevant documents/information in respect of the entire supply chain of the product being imported and while importing products under this category.
- Should readily keep available details in respect of the expiry of the imported product.
Online: It is imperative that sale of products under this category through online channel should be closely monitored by online marketplace. There is an emergent need to regulate sales of these products through online channels. This can be ensured through 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 this category in respect of any online sales
- Information of the Manufacturer’s License should be visible when selling products online.
Offline: There is a need to control sales of products under this category through physical retail outlets. The following information should be readily available with the retailer when selling through offline channel
- Requisite License should be available with the retailer
- Traceability of the supply chain. This can be ensured through retail invoicing
- Readily available records of the products/inventory for inventory audit sold through retail outlets
- The products sold under this category through retail outlets should ensure proper storage conditions.
Consumers must be aware of the difference between health supplements and sports supplements. They must read the label and claims if any, and also must be aware of the prohibited substances as per WADA. In addition to this, the following should be ensured by the consumers:
- Choose/select supplements as per their requirements or recommendation by sports nutritionists, health professionals or coaches.
- Confirm the dosage required 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 the manufacturer
- In case of grievances/query, the customer should contact the manufacturer as per the given customer grievance details
Appendix II Contains the Following FAQs
What are Sports Supplements?
Sports supplement consists of products designed for and used by sportspersons to improve their nutritional status, some aspect of health, wellbeing, performance, muscle growth and/or recovery after training. They are available in various forms like pills, potions, powders, bars and drinks, tablets, capsules and soft gel that promise to give the athlete a winning edge.
What is the difference between Health Supplement and Sports Supplement?
Health Supplements are dietary substances used to supplement the normal diet of a person (above the age of five years) wherein the number of nutrients added shall not exceed the recommended daily allowance. Sports supplement is a subcategory of health supplement meant only for sportspersons where the RDA limits are higher according to their body composition and physical training.
How are sports supplements helpful?
Sportspersons may find these products valuable in helping them achieve their day to day nutrition goals. They help in meeting specific goals during pre-event, prolonged session or for post-exercise recovery. Products such as sports drinks maintain the hydration and electrolyte balance during high physical activity. When sportspersons are unable to meet all their nutrient needs from food, a specific nutrient supplement may be prescribed by a sports dietician or physician to treat or prevent the nutrient deficiency. When used in the right way – the right amount at the right time on the right occasion – they can help an athlete train and compete at their best. In many cases, they can be shown to directly enhance performance.
Are Sports Supplements Safe?
Sports supplements should be consumed under the guidance of well-informed sports fraternity. If the quality control is done as per NADA specification, and the target-specific supplement is taken in the appropriate dose, sports supplements are safe. But the use of dietary supplements by sportspersons is a serious concern because in many countries the manufacturing and labeling of supplements do not follow strict rules, which may lead to a supplement containing an undeclared substance that is prohibited under anti-doping regulations. A significant number of positive tests have been attributed to the misuse of supplements and attributing an Adverse Analytical Finding to a poorly labeled dietary supplement is not an adequate defense in a doping hearing. The risks of taking supplements should be weighed against the potential benefit that may be obtained, and athletes must appreciate the negative consequences of an Anti-Doping Rule Violation as a result of taking a contaminated supplement. Using a supplement that has been subjected to one of the available quality assurance schemes can help to reduce, but not eliminate, the risk of an inadvertent doping infringement.
Which are the substances banned for sportspersons?
The Category of prohibited substances and commonly used substances in sports are as under Anabolic agents (stanozolol, nandrolone, testosterone, methandienone, methenolone,
Metenolone, Boldenone, Drostanolone, Norandrosterone, Oxandrolone, Trenbolone, clenbuterol, Androsterone, and Etio,); Peptide hormones (Erythropoiesis-stimulating agents); Glucocorticosteroids (Prednisolone, betamethasone) and also the substances as listed in the prohibited substances list by NADA/ WADA from time to time.
What is Strict Liability?
The principle of strict liability is applied in situations where urine/blood samples collected from an athlete have produced adverse analytical results. It means that each sportsperson is strictly liable for the substances found in his or her bodily specimen, and that an anti-doping rule violation occurs whenever a prohibited substance (or its metabolites or markers) is found in bodily specimen, whether or not the athlete intentionally or unintentionally used a prohibited substance or was negligent or otherwise at fault.
Dos and Don’ts
- Follow a dietary plan that will allow you to adapt your eating and drinking practices to support your performance.
- Due to your high physical activity and increased nutrient needs, you should seek advice from a well-informed professional such as a Dietician / Nutritionist before taking the sports supplements.
- Make sure that the professional is familiar with the WADA/NADA Prohibited List.
- Always remember that there are no quick fixes for improving sports performance.
- Always keep your supplements under safe custody.
- Do not take a supplement just because a teammate or a competitor is taking it or recommends it.
- Do not take any supplements made by a company which also manufactures substances which are on the WADA/NADA Prohibited List due to the risk of cross-contamination.
- Do not take any supplements that make claims that sound too good to be true. Always validate product claims through non-biased sources.
- Do not take any supplements made by a company which in the past has been associated with positive drugs tests.
- Do not exceed the recommended dose – Remember more is not always better.
Excessive use of one vitamin or mineral can have a negative impact on the availability or absorption of another.
Appendix III contains The World Anti-Doping (WADA) Code International Standard Prohibited List January 2018
SUBSTANCES & METHODS PROHIBITED AT ALL TIMES (IN- AND OUT-OF-COMPETITION)
(the following are just headings under which are listed numerous names of substances)
- NON-APPROVED SUBSTANCES
- ANABOLIC AGENTS
- ANABOLIC ANDROGENIC STEROIDS (AAS)
- Endogenous** AAS when administered exogenously
OTHER ANABOLIC AGENTS
- PEPTIDE HORMONES, GROWTH FACTORS, RELATED SUBSTANCES, AND MIMETICS
- BETA-2 AGONISTS
- HORMONE AND METABOLIC MODULATORS
- DIURETICS AND MASKING AGENTS
M1. MANIPULATION OF BLOOD AND BLOOD COMPONENTS
The following are prohibited:
- The Administration or reintroduction of any quantity of autologous, allogeneic (homologous) or heterologous blood, or red blood cell products of any origin into the circulatory system.
- Artificially enhancing the uptake, transport or delivery of oxygen. Including, but not limited to Perfluorochemicals; efaproxiral (RSR13) and modified hemoglobin products, e.g. hemoglobin-based blood substitutes and microencapsulated hemoglobin products, excluding supplemental oxygen by inhalation.
- Any form of intravascular manipulation of the blood or blood components by physical or chemical means.
M2. CHEMICAL AND PHYSICAL MANIPULATION
The following are prohibited:
- Tampering, or Attempting to Tamper, to alter the integrity and validity of Samples collected during Doping Control. Including, but not limited to Urine substitution and/or adulteration, e.g. proteases.
- Intravenous infusions and/or injections of more than a total of 100 mL per 12 hour period except for those legitimately received in the course of hospital treatments, surgical procedures or clinical diagnostic investigations.
M3. GENE DOPING
The following, with the potential to enhance sports performance, are prohibited:
- The use of polymers of nucleic acids or nucleic acid analogs.
- The use of gene editing agents designed to alter genome sequences and/or the transcriptional or epigenetic regulation of gene expression.
- The use of normal or genetically modified cells.
SUBSTANCES & METHODS PROHIBITED IN-COMPETITION
- Non-specified stimulants
- Specified Stimulants
SUBSTANCES PROHIBITED IN PARTICULAR SPORTS
Beta-blockers are prohibited In-Competition only, in the following sports, and also prohibited Out-of-Competition where indicated.
- Archery (WA)
- Automobile (FIA0
- Billiards (all disciplines) (WCBS)
- Darts (WDF)
- Golf (IGF)
- Shooting (ISSF, IPC)
- Skiing/Snowboarding (FIS) in ski jumping, freestyle aerials/halfpipe, and snowboard halfpipe/big air.
- Underwater sports (CMAS) in constant-weight apnoea with or without fins, dynamic apnoea with and without fins, free immersion apnoea, Jump Blue apnoea, spearfishing, static apnoea, target shooting, and variable weight apnoea.
(This article contains only the highlights of the Sports Supplements Guidance Document)