Letter to Andrew C. von Eschenbach, MD, Acting Commissioner Food and Drug Administration

Letter

DURBIN, DELAURO PRESS FDA ON CONTAMINATED MILK INVESTIGATION

Contact: Max Gleischman (Durbin)

Adriana Surfas (DeLauro)

United States Senator Dick Durbin (D-IL) and Representative Rosa DeLauro (D-CT) sent a letter to the Food and Drug Administration (FDA) yesterday, asking for assurances that the FDA is proactively doing all it can to protect consumers from contaminated milk products from China.

"We are writing in response to the recent reports of milk products from China contaminated with melamine, the same industrial chemical involved in a series of pet food recalls in 2007. A number of safety issues have emerged in recent years with respect to Chinese imports, such as pet food, seafood, and toothpaste. This latest incident not only demonstrates that significant work remains for China to reform its food safety system, but raises serious questions about the FDA's ability to protect consumers and our food supply from hazardous products that originate overseas," Durbin and DeLauro wrote.

More than 54,000 have been sickened and 13,000 hospitalized in China in recent weeks as a result of melamine-tainted infant formula produced by Chinese dairy companies. The World Health Organization has said that a delay in reporting the contamination contributed to the magnitude of the incident. Authorities in both China and the US are investigating if other milk-based products are at risk of contamination.

On September 12, the FDA issued an advisory stating there was no known threat of contamination in infant formula being sold in the U.S. On September 26, the FDA updated its advisory to alert customers to a possible contamination Mr. Brown instant coffee and milk tea products. FDA is currently testing other milk-based products imported from China to ensure that the melamine contamination has not spread to the US. No contaminated products or illnesses resulting from these products have been confirmed in the US.

Durbin and DeLauro are seeking information on the status of ongoing investigations and future plans for banning or recalling certain Chinese imports due to contamination.

A copy of the letter can be found below.

September 29, 2008

Andrew C. von Eschenbach, M.D.

Commissioner

U.S. Food and Drug Administration

U.S. Department of Health and Human Services

5600 Fishers Lane

Rockville, MD 20857

Dear Dr. von Eschenbach:

We are writing in response to the recent reports of milk products from China contaminated with melamine, the same industrial chemical involved in a series of pet food recalls in 2007. A number of safety issues have emerged in recent years with respect to Chinese imports, such as pet food, seafood, and toothpaste. This latest incident not only demonstrates that significant work remains for China to reform its food safety system, but raises serious questions about the FDA's ability to protect consumers and our food supply from hazardous products that originate overseas.

To date, infant formula tainted with melamine has sickened 54,000, hospitalized 13,000, and caused the deaths of four infants in China. Concerns over contamination have spread beyond infant formula to include processed foods that may contain milk-based ingredients produced in China. In response, dozens of countries across Europe, Asia, and Africa have begun testing or banning Chinese imports containing dairy ingredients or recalling such products from off the shelves.

According to the World Health Organization, delays in reporting, including a deliberate failure to report, contributed to the magnitude of the incident. News agencies report that Sanlu Group, one of 22 Chinese dairy companies producing tainted milk, received complaints as early as last December and became aware of a contamination in June. But the company failed to notify the government until early August, and more than a month passed before an official investigation was launched.

On September 12, the FDA issued a Health Information Advisory to inform the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. On September 26, the FDA updated its advisory to alert customers to a possible contamination in Mr. Brown instant coffee and milk tea products. It is our understanding that the FDA is also testing milk-based products imported from China for melamine contamination, including dairy-based candies and desserts.

We appreciate the steps the FDA has taken to respond to this latest incident. Yet, we are seeking assurances that the FDA is proactively doing everything in its power to protect the public health now, before contaminated products put consumers at risk. As such, we ask that you answer the following questions:

1. What is the status of the current investigation?

2. Please provide a detailed timeline from when the FDA first learned about a potential contamination through the present that also details the actions taken in response.

3. How many dairy products, or products containing dairy ingredients, were received by the U.S. from China in 2006, 2007, and 2008?

4. How many of these imports were inspected by the FDA?

5. Were any of these refused import? For what reasons? Did these concerns suggest a systemic risk?

6. Does the FDA plan on banning certain Chinese imports or issuing recalls in response to the contamination?

7. What changes in current law or funding levels are needed so that the FDA can best protect the public and the food supply from tainted imports?

8. Please provide a status update on the implementation of the December 11, 2007 memorandum of agreement (MOA) between the United States and China with respect to food safety.

Thank you for your attention to this matter. We ask that you provide a response within 20 days.

Sincerely,

Richard J. Durbin

United States Senator

Rosa L. DeLauro United States Representative

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