Mead Johnson Nutrition clarifies issues on Philippine FDA order2:33 PM
Were you worried about giving Sustagen Junior® and AlactaGrow® to your child after reading/hearing the news about the recall? Mead Johnson Nutrition assures the public that the said products are safe for human consumption.
The company has issued clarifications on the Philippine FDA order that was imposed on the two brands just recently. Here are some facts that you should know:
The Philippine FDA has issued a Class III order, the lowest level, which is used for products that have technical compliance issues. The regulatory definition of a Class III order specifically states that the use of or exposure to the product “is not likely to cause adverse health consequences.”
According to Paul Richards, President and General Manager of Mead Johnson Nutrition Philippines, all of the company’s products are "produced in accordance with the CODEX Code of Hygienic Practice for Foods for Infants and Children.” CODEX is an international organization that develops and promotes food standards. The Philippine FDA said it was issuing the order because the fat content in the products is below the new standard listed in the revised CODEX Standards for Follow-Up Formula, which it has recently adopted in the Philippines.
In fairness to Mead Johnson, and I watched the Philippine FDA official say this in the news this morning, it has proactively cooperated and has stayed in frequent communication with the Philippine FDA to ensure that their products would continue to be available for the families that use them, and in compliance with the new regulations.
However, it should be understood that the process of reformulating the said products according to the new CODEX regulations requires a considerable amount of time. Because of this, Mead Johnson requested a renewed Certificate of Product Registration (CPR) prior to the end of the product’s term. Richards said they were surprised by the recall orders, but said they are committed to resolving the issue with the Philippine FDA so that Mead Johnson can continue to offer the children in the Philippines the many nutritional benefits of AlactaGrow and Sustagen Junior.
While the fat level requirement does not relate to the safety or quality of the product, Mead Johnson is taking steps to meet that requirement also.
A reformulated version of AlactaGrow® that meets the new regulatory requirements is being launched today. Meanwhile, work is underway to develop a version of Sustagen Junior® that will meet the revised standards.
Richards emphasized that Mead Johnson is committed to its mission to nourish the world’s children for the best start in life. Mead Johnson is involved in efforts to address malnutrition through a country-wide feeding and growth-monitoring program called Feeding Hope in partnership with Department of Social Welfare and Development (DSWD) and the non-government organization Kabisig ng Kalahi. In addition, since 1991 Mead Johnson has provided sustained support to children afflicted with rare metabolic diseases.
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