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Mead Johnson says products safe amid recall order


(Updated 2:20 pm) In the wake of a recall order issued by the Philippine Food and Drug Administration, a producer of formula milk has assured the public that their two affected products are safe for human consumption. In a statement on Tuesday, Mead Johnson Nutrition Philippines downplayed the FDA's recall orders for Sustagen Junior and Alactagrow, saying these were based on non-compliance with certain technicalities and not with safety requirements. "Safety is Mead Johnson's highest priority and the company spares no effort to comply with the laws of all the countries in which it operates," Mead Johnson Philippines president and general manager Paul Richards said. On September 16, the FDA issued recall orders for the two products after finding their fat content to be below standard. "Continuous distribution of the said product(s) presents gross deception to the consuming public and may even present risk of illness or injury to the consuming sector of the public, the young children," the FDA said in Advisories 2010-009 and 2010-010. Acting FDA director Nazarita Tacandong appealed to consumers who had bought the products to return them to Mead Johnson Nutrition Philippines or its licensed distributors. But according to Mead Johnson, “The Philippine FDA has issued a Class III order, the lowest level, which is used for products that have technical compliance issues." The classification means that the use of the product "is not likely to cause adverse health consequences," Richards said. He added that the company was surprised by the recall orders, saying all products of Mead Johnson currently sold in the Philippines, including Alactagrow and Sustagen Junior, have passed stringent Philippine FDA health and safety requirements. Richards said the fat level content does not affect the safety or quality of the product, but added that Mead Johnson is taking steps to meet this requirement. “Non-compliant" with CODEX standards In FDA Advisory 2010-009 covering Sustagen Junior Milk Drink Powder (vanilla), the agency said the standard required for fat is between three and six grams per 100 calories. However, evaluation of the product's fat content resulted in only 1.5 grams fat per 100 calories, compared to the product's label declaration of 5.9 per 100 gram powder and 392 calories per 100 grams, In FDA Advisory 2010-010 for Alactagrow Bibo Trio milk supplement, the agency’s evaluation showed the product's fat content at only 1.34 gram fat per 100 calories, compared to the product's label declaration of 5.1 grams per 100 gram powder and 380 calories per 100 grams. According to the FDA, the findings indicated that the products were “non-compliant to the standard and of inferior quality." In response, Richards said when the FDA recently adopted additional CODEX regulations for follow-up formulas, Mead Johnson cooperated with the agency to ensure that their products would remain available for their consumers. However the reformulation process to comply with the new CODEX regulations was elaborate and took some time, prompting Mead Johnson to request a renewed Certificate of Product Registration prior to the end of the product's term, Richards said. On Tuesday, Mead Johnson is launching a reformulated version of Alactagrow that meets the new regulatory requirements, the company said. Work is also underway to develop an updated version of Sustagen Junior to meet the revised standards. “All of the company's products are produced in accordance with the CODEX Code of Hygienic Practice for Foods for infants and Children," Richards said. CODEX is an international organization that develops and promotes food standards. Richards stressed that Mead Johnson is committed to its “mission to nourish the world’s children." He said the company is helping address malnutrition through the nationwide program Feeding Hope in partnership with Department of Social Welfare and Development and the non-government organization Kabisig ng Kalahi. - with Carmela Lapeña/LBG/RSJ, GMANews.TV
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