MAHARASHTRA’S Food and Drug Administration (FDA) has filed a chargesheet against Complan, a health drink by Heinz Indian Pvt Ltd, over its advertising claim that it can help children “grow twice as fast”.
FDA’s chargesheet names seven officials of Heinz in its petition, describing the commercial as an “exaggerated advertisement on television channels”. It states that FDA had demanded an explanation of its claim of fast growth, but the information furnished by Heinz was not satisfactory. FDA then approached the Mazgaon chief metropolitan magistrate court in Mumbai.
Heinz quoted a study, “Effect of supplementation of health drink on growth and cognitive development of school children”, in its promotion of Complan. The year-long study, released in December 2008, by Avinashilingam Deemed University for Women in Coimbatore involved 900 Indian children in the seven-to-12-year age group who were divided into three groups.
One group was put on a full diet, the second one got a full diet plus Complan prepared in water and the third got a full diet plus Complan prepared in milk. The study showed that children in the third group grew twice as faster than those in the first one. Complan-fed children’s overall health also improved, the Heinz-funded study claimed.
R K Anand, head of department of paediatrics and neonatology at Mumbai’s Jaslok Hospital and Research Centre, analysed the study after frequent complaints from mothers that their children were not growing fast despite consuming Complan regularly.
In November 2009, Anand wrote to Heinz demanding clarification and simultaneously complained to FDA. Neither of the two replied. He also approached the Indian Academy of Paediatrics for its opinion on the study. He again wrote to FDA officials in January 2010 reminding them of his complaint. In April, he filed a right to information (RTI) application asking FDA what action has been taken on his complaint. On May 3, FDA filed a chargesheet against Heinz.
The academy had asked its senior doctors to review the study. H P S Sachdev, former professor at the department of paediatrics, Maulana Azad Medical College in Delhi, found several caveats in it. First, no comparison can be drawn because the study did not include a group of children who were given only milk and routine diet, Sachdev said. Scientifically, the increase in height because of Complan cannot be proved, Sachdev added. He pointed out all trials have to be registered with Clinical Trial Registry-India (CTRI), but that was not done in Complan’s case.
Since Heinz funded the study, its results cannot be trusted, he added. “The study covered children in the age group of seven-12 years of certain economic segment, but its results have been wrongly extrapolated for children across India. The phrase, twice faster, also carries no scientific meaning. The study’s design, randomisation and analyses show it is h ighly prone to bias,” Sachdev added. He presented his analysis to the academy, which, in turn, showed them to FDA. The watchdog then filed a chargesheet against the company officials for violating provisions of the Prevention of Food Adulteration Act 1954 and Rules.
“Heinz India stands by its position,” a company spokesperson said. “We look forward to proving that our claims of Complan are based on independent scientific studies. Given this is now a legal matter, it would be inappropriate to comment further,” he added. Anand said FDA should not wait for consumers to file complaints to take action against violators.
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