Better late than never:

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.

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.

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.