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Acting on the recommendations of the scientific panel, the apex body regulating the food safety and standards in India has asked four beverage companies to recall 11 of their energy drink brands. This act will go a long way among the industry that it will act tough on the violators. In a span of five days during the second week of May, the Food Safety and Standards Authority of India (FSSAI), slapped orders directing four beverage companies – Akoaroma, Chennai; Monster Energy, Mumbai; Pushpam Foods and Beverages, Pune and Hector Beverages, Gurgaon, to recall their energy drinks from the market, as the products have been declared unsafe for consumption. In a letter dated May 8, 2015, the FSSAI directed Monster Energy India to recall all — Monster Energy and Monster Energy Absolutely Zero — existing products from the market under intimation to it. It also withdrew its No Objection Certificate (NOC) issued to the company dated October 15, 2013 for its brands. It may be noted that the company which has submitted its application for product approval on December 13, 2012, received the product approval or NOC from FSSAI for a period of one year which expired on October 14, 2014. The scientific panel for functional foods, nutraceuticals, dietetic products and other similar products in its 17th meeting on January 1, 2014 for risk assessment/safety of ingredients and limits if any, observed that the rationale for combination of ginseng had been projected primarily as flavouring agent in the Monster Energy drink which is not listed in the FSSR approved list. The panel observed that the title of the product Monster Energy was misleading and added that product contains irrational combination of caffeine and ginseng, which have opposing effect on human body. Hence recommended rejection of product as dietary supplement. Similarly the panel discussed in its 19th meeting held on March 26, 2014 regarding product approval for Monster Energy Absolutely Zero. The panel observed that product is a carbonated caffeinated energy drink and contains caffeine, with ginseng extract and vitamins. 475 ml cans are supplied and not more than one can/day usage level is recommended by the applicant. The panel observed that at this level of usage, all the vitamins (B2, B3, B6 and B12) are above Recommended Daily Allowance (RDA). It is in violation of section 22 of FSS Act 2006. Besides the product contains, Taurine, L-Carnitine in addition to caffeine and ginseng. The panel pointed out that the company has not provided adequate supporting date for use of L-Carnitine and ginseng. Hence it has recommended rejection of the product. While the letter for rejection was sent to the company on September 4, 2014 pertaining to Monster Energy, the company moved the High Court of Bombay, which granted an interim relief vide its order dated September 29, 2014. The FSSAI challenged the interim order passed by the High Court of Bombay by filling an SLP in the Supreme Court of India and the apex court has stayed the orders of the High Court of Bombay vide its order dated May 1, 2015, allowing the FSSAI to issue a letter of withdrawal of NOC to both products of the company. Based in Corona, California, Monster Beverage Corporation is a holding company and conducts no operating business except through its consolidated subsidiaries. Monster Beverage’s net sales for 2014 increased by 9.7% to $2.46 billion, compared to 2013, driven by strong volumes of Monster Energy brand drinks. In its release company noted that it plans to produce Monster Beverage in India very soon. The scientific panel for functional foods, nutraceuticals, dietetic products at the 17th product approval and screening committee meeting, also observed that products manufactured by Pune based beverage contract manufacturing company Pushpam Foods and Beverages for Goldwin Healthcare, contain irrational combination of caffeine and ginseng, which have opposing effect on human body. Hence recommended rejection of products — Cloud 9 Pomegranate Energy Drink; Cloud 9 Red Grapes Energy Drink; Cloud 9 Wild Berry Energy Drink and Cloud 9 Premium Energy Drink — as dietary supplement. The company claims that the product contains carbonated water, sugar, reconstituted Apple juice, citric acid, Trimagnesium Citrate, Taurine, caffeine, glucuronolactone, Vitamin C, Inositol, B group vitamins (B3, B5, B6, B12). Contains permitted artificial colour and added nature identical flavour (mixed fruit). The company noted that Cloud 9 is marketed by Goldwin Healthcare, specialists in the manufacture of 100% Natural Lifestyle Energy Drinks, Caffeine-Free Cola, and Carbonated fruit beverages, using its cutting edge technology and plethora of ingenious solutions and indigenous know-how. The company on its portal observed that Cloud 9, the novelty of the Ganatra family, achieves an exact balance of ’energy, health and refreshments’ through the perfect combination of naturally occurring, energy rich resources with high-tech manufacturing techniques that gives consumers the best of both worlds. Cloud 9 today has grown to become India’s leading energy drink brand. It may be recalled that Goldwin Healthcare has won the ‘The 2011 Frost & Sullivan Product Excellence Award of the Year’ in the Indian Energy Drinks Market category in April 2012. The company has emerged a key innovator and value-for-money provider of energy drinks in an extremely short span of time. The company on its portal http://thecloud9corp.com/ noted that Cloud9 is available in more than 80,000 outlets, 30,000 wine shops and in the country’s finest hotels and bars. Owing to the success of its energy drink, Cloud9 launched the 100% caffeine-free drink. Along with its premium range, the company has ventured into pure packaged drinking water and launched its new carbonated drink, Shout in 4 lip-smacking flavours. The FSSAI has also slapped similar directives to Hector Beverages which is selling Tzinga, an energy drink and Paper Boat drinks to recall its Tzinga Energy Drink (lemon mint), Tzinga Energy Drink (tropical trip), and Tzinga Energy Drink (mango strawberry) from the market as these drinks were declared unsafe by withdrawing its NOC dated September 20, 2012. The FSSAI directed the company not to sell its two additional variants introduced without applying for or obtaining approval from the authority. So FSSAI directed the company to stop manufacturing/sale/distribution of the above products with immediate effect. The panel noted that self-statement about the shelf life stability data sheet of the product is not acceptable since the microbial analysis result is incomplete and storage temperature conditions are not mentioned in the report. The panel observed that the detailed composition with quantity of ingredients and additives added in the products (as per serving size) is at variance with the application dated July 27, 2012 and the label submitted with original application on which the said NOCs were issued. Further the panel found that the company has not furnished complete requisite documents to the clarifications sought with enough time to furnish the same. Chennai based Akoaroma which received product approvals for two its beverages Akoaroma-M (flavour concentrate) and Akoaroma Flavour Water (flavour water) in January 2, 2013 for a period of one year, which was to expire on January 1, 2014. The expert group of the authority sought clarification to renew the NOC for both the products by giving 30 day’s time from September 19, 2014 to do the needful. The FSSAI noted that the company has failed to acknowledge its communication and nor sought extra time for submission of requisite documents even after expiry of the deadline. So FSSAI directed the company to immediately stop manufacturing/sale/distribution of the above products with immediate effect by withdrawing its NOC issued on January 1, 2013. Reacting to the development, Dr R K Sanghavi, Chairman – Nutraceutical Subcommittee, Indian Drug Manufacturers’ Association (IDMA) said, “FSSAI, in general, has not followed the draft new regulations for health supplements and health foods in general, which are intended as guidance for permitting such articles of foods in the country. It is understood that FSSAI has issued initial NOC for products which could have contained higher than upper limits of caffeine specified but at a later date have gone ahead to withdraw their consent without telling/giving opportunity to the Food Business Operators (FBOs) to modify their content as per proscribed limits. It would be prudent that FSSAI give a reasonable timeline to FBOs to change their product content if necessary.” He further said, “for ginseng, there are no RDA laid down as per Indian Council of Medical Research (ICMR). However, there are upper limits specified as per documentary evidence bearing in mind safety considerations. For caffeine, there are limits specified in FSSA and this needs to be adhered to. The specified upper limits for caffeine are not exceeding 145 parts per million in beverages non-alcholic – carbonated (which is 14.5 mg/100 g). Whichever energy drink contain more than this concentration, it should not be permitted.” Naran Limbasiya, Managing Director, Vedantika Herbals, which has been offering five variants of energy drinks from natural sources said that public awareness through various media platform should be launched to educate common man against harmful effects of chemicals. Reacting to the developments, Arvind Varma, Secretary General, Indian Beverage Association (IBA), an association of leading Indian companies with direct and allied interests in the non-alcoholic beverage said “I am afraid I am not aware of the circumstances and reasons on account of which FSSAI has withdrawn the NOC granted to the specified products of the companies named (they are not members of IBA). Hence, it would not be possible or appropriate for me to comment in this matter. I am sure the companies concerned will take measures in this regard that are in their best interests.” Verma further said that the notification of standards for caffeinated beverages by FSSAI has not happened for fairly long on account of a PIL pending in the Bombay High Court. That petition having been disposed of on April 29, 2015, the way would seem to be clear for the requisite notification. IBA has requested FSSAI for expeditious action in this regard. NuFFooDS Spectrum in its earlier story (November 2014) has written about the issues related to risk factors of having high level of caffeine and combination of caffeine and ginseng in energy drinks and suggested the energy drink makers need to invest on innovative products which are harmless to the consumers.