October 10, 2008
This letter is intended to ensure that members of the United States food manufacturing industry are aware of the Food and Drug Administration's (FDA's) serious concern about the possibility that foods or food ingredients produced in China and exported to the United States may be contaminated with melamine or its analogues. FDA has information indicating that melamine and its analogues have been added to milk produced in China and that milk contaminated in such a fashion has been used to manufacture infant formulas and other dairy-based products. As of this writing, Chinese authorities are reporting that in China approximately 53,000 infants have suffered illnesses, with 13,000 hospitalizations and four deaths. Approximately 158 of the victims thus far have suffered acute kidney failure. Chinese authorities have disclosed that, in addition to discovering contaminated infant formulas, melamine has been discovered in 24 of 1202 samples of milk and yogurt. There is little information at this stage to determine when the contamination might have begun or how widespread the contamination might be. However, Chinese authorities report that melamine was found in infant formula, milk, yogurt, and ice cream manufactured by 22 companies in China. The Chinese investigation into this matter is ongoing.
There are currently two recalls for products in the United States related to this situation. Tristar Food Wholesale Co., Inc. has issued a recall of Blue Cat Flavor Drink (Lanmao), manufactured in China, due to possible contamination with melamine. Also, seven Mr. Brown brand instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co., Ltd. due to possible contamination with melamine. In addition, California and Connecticut report that their testing of White Rabbit Creamy Candies manufactured in China has shown melamine contamination. Further, other countries (South Korea, Singapore, Hong Kong, Japan, Taiwan, Australia, Indonesia, Canada and New Zealand) have all identified products containing melamine including flavored milks, cakes, candies, crackers, rice snacks, coffee creamer, lactoferrin, and cereal.
Milk and milk products that could originate from China include condensed, dried, and non-fat milk, condensed and dried whey, lactose powder, permeate powder, demineralized and partially demineralized whey powders, caseins, yogurt, ice cream, cheese, whey protein concentrate, and milk protein concentrate.
In light of current circumstances, there are several useful steps to help protect the public health available to manufacturers of products containing milk-derived ingredients, including the following:
- Know the precise origin of each milk-derived ingredient. For example, milk-derived ingredients that are sourced from countries other than China could actually originate from China.
- Determine that milk-derived ingredients originating from China are free of melamine and its analogues prior to usage.
- For food manufactured in the last twelve months which might still be on the shelf at retail or in stock elsewhere, determine whether the food might contain any milk-derived ingredients from China. If any such foods exist, verify that they do not contain melamine or its analogues.
In addition, it would be useful for manufacturers to be alert to the possibility that non-milk-derived ingredients from China that are or may be sold on the basis of protein content, such as soy protein, also could be contaminated with melamine.
Should firms decide to recall any of their products because of the presence of melamine, please follow FDA's guidelines in 21 CFR Part 7 Subpart C. We encourage you to communicate any concerns to your local FDA district office.
A gas chromatography-mass spectrometry (GC-MS) as well as a liquid chromatograph-tandem mass spectrometry (LC-MS/MS) method for determining melamine and its analogues is available at the following link to the FDA website: http://www.fda.gov/oc/opacom/hottopics/melamine.html#testing.
In addition to sending this letter, FDA has taken, and will continue to take, proactive measures to help ensure the safety of the American food supply. In conjunction with state and local officials, FDA will continue to check retail stores for food items imported from China that could contain a significant amount of milk or milk-derived ingredients. At the same time that FDA began working with the States on this matter, it began sampling and testing milk and milk-derived ingredients and finished food products that could contain these milk-derived ingredients from Chinese sources. The sampling is being done either when products are offered for entry into the United States or at the retail level. In addition to working with state and local governments, FDA is working in close cooperation with Customs and Border Protection within the U.S. Department of Homeland Security, the U.S. Department of Agriculture, other federal agencies, and foreign governments.
FDA recognizes and appreciates the extraordinary collaborative efforts to protect consumers by all of the aforementioned government authorities and industry in response to this matter. We are confident that you will continue to work to provide safe food products to the U.S. customer.
If you have any questions regarding this letter, you may contact John F. Sheehan, J.D. at (301)436-2367 or Benson M. Silverman, M.D. (301)436-1459.
Nega Beru, Ph.D.
Office of Food Safety
Center for Food Safety And Applied Nutrition