FSSAI in its order dated 11 June 2015 has asked the manufacturers of ‘Restless Energy Drink’ to immediately recall the drink from the market as it has been found to be unsafe even though FSSAI had earlier issued a no objection certificate (NOC) in December 2013 for the period of one year. Manufactured by M/s Pushpam Foods & Beverages the energy drink was launched in August 2013.
However, the scientific panel of the FSSAI in its meeting on January 21, 2014 found that the “irrational combination of Caffeine and Ginseng has opposing effect on the human body” After this observation of the scientific panel and on its recommendation that the product cannot be termed safe, the FSSAI passed orders for the recall. The Apex Regulator has now directed the company to stop manufacturing, sale, and distribution of its ‘Restless Energy Drink.’
Earlier also M/s Pushpam Foods & Beverages had applied for product approval for other similar energy drinks, namely Cloud 9 Pomegranate Energy Drink, Cloud 9 Red Grapes Energy Drinks, Cloud 9 Wild Berry Energy Drink and Cloud 9 Premium Drink. And similarly, after discussion at the 17th meeting of the Scientific Panel on Functional Foods, Nutraceuticals, Dietetic Products and Other Similar Products, the FSSAI withdrew the NOC from these drinks in November 2014 for the same “irrational combination” of Caffeine and Ginseng in the drinks.
Other energy drinks that have been recalled are Tzinga Energy Drink and its variants ‘Lemon and Mint’, Tropical Trip and ‘Mango and Strawberry’ manufactured by Hector Beverages Pvt Ltd. FSSAI has asked the company to recall its drinks immediately for the following reasons
- Using unsafe ingredient combinations like Caffeine and Ginseng
- Detailed composition and the quantity of the ingredients and additives in the products as per serving size varied in the original application for product approval and the one that was given later when FSSAI asked for clarification.
- Failed to furnish a source of ingredients like Ginseng
- No safety evaluation data has been provided from international agencies like Codex, USAFDA, EU, FSANZ or WHO
The company also introduced two other variants of Tzinga Energy Drink (Mango and Apple) on its own without taking product approval which is not permitted under the regulations and is considered unauthorized. A separate product approval has to be filled for each similar product if the compositions are different in the variants of a similar product.
‘Monster Energy Absolutely Zero’ and ‘Monster Energy’ have also been ordered to be recalled by the FSSAI and the NOC has been canceled as these drinks have failed to meet standards according to the Scientific Panel on Functional Foods, Nutraceuticals, Dietetic Products and Other Similar Products. In its assessment of ‘Monster Energy Absolutely Zero,’ the scientific panel found that the product is not only a carbonated drink but contains Caffeine, Ginseng with Vitamins.
The level of all the vitamins B2, B3, B6, and B12 were found to be above the Recommended Daily Dose even though only one 475ml can per day is recommended for use. The product is also in violation of Section 22 of the FSS Act as the product contains Taurine, L-Carnitine besides Caffeine and Ginseng for which special approval is required from FSSAI but no adequate supporting data has been supplied.
On the other hand ‘Monster Energy’ has been ordered to be recalled by the FSSAI because after a risk assessment, the safety of ingredients and limits if any found that the combination of Ginseng has been added as a flavoring but that is not listed in the FSSR approved list. It also had the unsafe combination of Caffeine and Ginseng. The name ‘Monster Energy’ was found to be misleading and because of these reasons, it was not recommended by the Panel as a dietary supplement.
The manufacturers of the two Monster energy drinks, Monster India Private Limited went in appeal to the Bombay High Court where the matter stayed. However, subsequently, the FSSAI was able to get a stay from the Supreme Court against the order of the Bombay High Court. Therefore it has now issued the recall order to the company on 8th May 2015 and has directed the company to stop the manufacture, sale, and distribution of the two products with immediate effect.
The FSSAI has also asked M/s Akoaroma co to recall their herbal water products Akoaroma – M (Flavoured Concentrate) and Akoaroma Flavour Water as there has been no safety assessment for these products as yet.