FDA Recalls 2 Milk Products; Mead Johnson Says They’re Safe

MANILA, Philippines — The Food and Drugs Administration (FDA) on Tuesday released an advisory ordering the product recall of Mead Johnson milk products “Sustagen Junior Milk Drink Powder Vanilla flavor” and “Alactagrow Bibo” milk supplement, saying these are non-compliant with the standard fat level content as specified by a set of international standards covering food for infants and young children.

But Mead Johnson insists the products are safe for consumption.

“All of our products including Alactagrow and Sustagen Jr. have passed stringent FDA requirements that prove they are safe for consumption and high quality. This recall is neither for the nutrient level nor quality. The use or exposure to the product will not lead you to adverse health consequences. It’s just that there are changes in the past content requirement when we initially applied for the evaluation of the nutrient content level,” Janryll Fernandez, Mead Johnson communications officer said in an interview.

The FDA advisory 2010-010 said they issued the recall order because of the product’s “apparent non-compliance to the standard fat level content per 100 calories set forth in CODEX STAN 156-1987 for milk supplements.”

“The standard required for fat is not less than 3 grams and not more than 6 grams per 100 calories (0.7 and 1.4 grams per 100 available kilojoules, respectively). However, evaluation and determination of the above product’s fat content per 100 calories vis-à-vis the product’s label declaration of 5.1 grams per 100 powder and 380 calories per 100 gram will result only in 1.34 grams per calories thus, indisputably, making the same non-compliant to the standard and of inferior quality,” FDA said describing Alactagrow Bibo milk supplement.

For Sustagen Junior Milk Drink Vanilla powder, FDA said the product’s existing label declaration of 5.9 per 100 grams powder and 392 calories per 100 grams will result only in 1.5 grams fat per 100 calories.

CODEX STAN 156-1987 covers follow-up formula which is a food intended for use as a liquid part of the weaning diet for the infant from the 6th month on and for young children, according to CODEX.

FDA said continuous distribution of the product presents a “gross deception” to the consuming public as it warned of illness and injury to young children drinking the milk.

“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… Safety is Mead Johnson’s highest priority and the company spares no effort to comply with the laws of all of the countries in which it operates. All of the company’s products are produced in accordance with the CODEX Code of Hygienic Practice for Foods for Infants and Children,” Paul Richards, President and General Manager of Mead Johnson Nutrition Philippines explained.

Fernandez lamented that the word “recall” is misleading as there is a different perception about the word.

“It entails a safety issue but the products are safe,” he said.

At age one to three, Fernandez said, a child has other sources of fats aside from the follow-up formula.

But he said Mead Johnson is willing to answer questions from consumers even as they are “managing” the recall order.

Mead Johnson can be reached through 841-8222 and 1800-18885861.

Jenny Manongdo, Manila Bulletin