Menu

Helpful Information about Melamine and Cyanuric Acid

EVANSVILLE, Ind., December 12, 2008 — For more than 100 years, parents and health care professionals have trusted Mead Johnson to help give infants and children the best start in life through science-based nutrition.

Recent media reports about extremely low levels of melamine and cyanuric acid found in certain infant formula products have raised some questions for parents. First and foremost, we want to reassure all our customers that we are confident in the safety of our products. Providing only the safest and highest quality products remains our top priority. It is this commitment that has made Mead Johnson the choice of parents for infant and children's nutritional products for generations.

We want to make sure parents and healthcare professionals have a source for helpful and accurate information about our products and the recent topics in the media. We hope the information provided below will help answer additional questions you may have.

Consumer Contact:
enfamilresourcecenter@enfamil.com
1-800-BABY123

Healthcare Professionals Contact:
MJMedicalAffairs@bms.com
(812)429-6399

Media Contact:
Gail.Wood@bms.com
(812)429-7800

Guidance for Parents

We understand the trust you put in us when you choose Mead Johnson Nutrition products for your infants and children. That is why product safety and quality are so important to us and have remained the focus of our business for over 100 years.

We use only the highest quality ingredients to manufacture our products, and we maintain high standards at all our manufacturing sites around the world. Our products undergo over 2,300 quality control checks throughout the manufacturing process - from raw materials to finished product. That is why Mead Johnson remains confident in the quality and safety of our products.

We have conducted our own testing, using a third party laboratory and published U.S. FDA testing methodology, and have not detected the presence of melamine or cyanuric acid above the safety levels established by numerous regulatory agencies around the world.

Despite these rigorous safety and quality control measures, consumers have asked why very low levels of cyanuric acid were recently reported to have been found by the U.S. FDA in a sampling of Enfamil® infant formula, and melamine was found in many different brands of infant formulas evaluated by Health Canada. The most likely reason is these substances are present in your day-to-day environment because they are approved for use in many commercial applications. Uses of these substances include everything from packaging to countertops, dishes and products used to clean food processing equipment. Additionally, analytical technology continues to evolve, much like newly proposed testing methodologies used by the U.S. FDA and Health Canada, allowing the detection of substances at increasingly lower and lower levels. In the case of Health Canada's testing methodology, the detection level is over 60 times lower than the level able to be detected by U.S. FDA's fully validated published method for infant formula.

It is important to understand what the presence of these substances at such low levels means. Even at maximum daily consumption of formula, the total exposure would fall below the levels deemed safe by numerous regulatory agencies around the world, including Health Canada's recently revised safety level of 0.5 parts per million for combined levels of melamine and cyanuric acid in infant formula. Both the U.S. FDA and Health Canada have definitively stated that infant formula registered for sale in the U.S. and Canada is safe and parents can continue using these infant formulas with confidence.

It is also important to understand that the findings in the United States and Canada are very different than what occurred in China. To put this in additional perspective, the highest level of melamine detected by Health Canada in Mead Johnson infant formula is 36,000 times lower than the highest level detected in infant formula sold in China. Be assured that no Mead Johnson brands were implicated in the China issue and that our brands were recognized as safe and remain in the China market today.

Frequently Asked Questions Have you detected melamine or cyanuric acid in your products?

We have conducted our own testing, using a third party laboratory and published U.S. FDA testing methodology, and have not detected the presence of melamine or cyanuric acid above the safety levels established by numerous regulatory agencies around the world.

Does melamine or cyanuric acid pose a health risk?

The levels detected are extremely low and, even at maximum daily consumption of formula, the total exposure would fall below the levels deemed to be safe by the World Health Organization, U.S. FDA, Health Canada and numerous regulatory agencies around the world. In fact, both U.S. FDA and Health Canada have definitively stated that infant formula is safe and parents should continue using infant formulas with confidence.

How can I be sure Mead Johnson products are safe?

We use only the highest quality ingredients to manufacture our products, and we maintain high standards at all our manufacturing sites around the world.

For example, our products are manufactured under the most sanitary conditions possible and are subjected to over 2300 quality control checks during and after production. We carefully inspect and test raw materials, make in-process checks and thoroughly examine each finished batch to ensure that it meets our high standards for physical appearance and nutrient content.

We would never release a batch if it did not meet our stringent specifications for quality and safety.

What are melamine and cyanuric acid?

Both cyanuric acid and melamine are present in your day-to-day environment as a result of their approved uses in many commercial applications. These substances are found in everything from packaging to countertops, dishes, and products used to clean food processing equipment.

Do you test for melamine and cyanuric acid? If so, why didn't your testing detect this chemical?

We have conducted our own testing, using a third party laboratory and published U.S. FDA testing methodology, and have not detected the presence of melamine or of cyanuric acid above the safety level established by numerous regulatory agencies around the world.

However, it is important to understand that ultra trace levels of many substances have always been present in natural foods or processed foods that you consume every day. New and more sensitive testing methods are being developed to detect increasingly lower and lower levels of these substances-as low as parts per billion. Based on statements issued by the U.S. FDA and Health Canada, our products are safe for your baby.

We continue to work closely with regulatory agencies to ensure that we are using the most reliable and validated testing technology.

Does the presence of cyanuric acid mean that melamine is also present?

No. While melamine and cyanuric acid are compounds in the same chemical family, the FDA-approved uses of cyanuric acid can result in trace amounts of cyanuric acid in food products. That does not indicate that melamine is present.

Mead Johnson's Commitment to Quality and Safety

Our products are manufactured under the most sanitary conditions possible and are subjected to numerous quality control checks before, during and after production.

We carefully inspect and test raw materials, make in-process checks and thoroughly evaluate and test each finished batch to ensure that it meets our high standards for quality and safety. For example, our products undergo over 2,300 quality control checks throughout the manufacturing process. Additionally, our liquid products are commercially sterilized during processing. We do not release a batch if it does not meet our stringent specifications for quality and safety.

Mead Johnson operates in full compliance with numerous federal and state regulations in our manufacturing facilities. These requirements include (among others) the FDA's Good Manufacturing Practices for Foods (GMPs), Consumer Product Safety Commission (CPSC) Regulations, and all applicable Occupational Health and Safety Administration (OSHA) requirements. In addition, our manufacturing facilities are subjected to periodic inspection by both state and federal agencies.

Recent News & Events FDA TESTING

In late November, the Associated Press incorrectly reported that testing by the U.S. Food and Drug Administration (FDA) had found Enfamil LIPIL® contained a trace of melamine. The FDA has since confirmed that no melamine has been detected by its tests in Enfamil LIPIL infant formula products and that media reports indicating that a trace level had been detected were inaccurate.

The U.S. FDA posted its findings on its website confirming that no melamine has been detected in Enfamil® infant formula products and that consumers can continue using U.S. manufactured infant formulas.

The U.S. FDA also reported that very low levels of cyanuric acid were detected in Enfamil® products. These trace levels are well below the 1 part per million standard set by the U.S. FDA and do not pose a health risk to infants. We have conducted our own testing, using a third party laboratory and published U.S. FDA testing methodology, and have not detected the presence of melamine or of cyanuric acid above the safety level established by FDA, Health Canada and numerous regulatory agencies around the world.

HEALTH CANADA TESTING

Health Canada recently conducted a survey of infant formulas sold in Canada to differentiate between the presence of very low levels of melamine common in food and the problem of intentional tainting of infant formula, like the recent events in China. The results of the survey led Health Canada to reiterate the safety of infant formula products in its December 10, 2008, statement.

On December 10, 2008, Health Canada reported extremely low levels of melamine in brands of infant formulas sold in Canada, including Mead Johnson formulas. Health Canada's unpublished testing methodology allows the detection of melamine at increasingly lower and lower levels - in this case over 60 times lower than the level able to be detected by FDA's fully validated published method for infant formula.

These findings confirm that melamine is present at unavoidable background levels and do not pose a health risk to consumers. The levels detected are extremely low and, even at maximum daily consumption of formula, the total exposure would fall below the levels deemed to be safe by the World Health Organization, FDA, Health Canada and numerous regulatory agencies around the world.

Additional Resources

More information on the U.S. FDA's findings can be found here:

12/12/2008