U.S. Food and Drug Administration
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Melamine Contamination in China
(Updated: January 5, 2009)

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On September 12, 2008, in light of reports from China of infant formula contaminated with melamine, the FDA issued a Health Information Advisory to proactively reassure 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. That advisory also warned members of Asian communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants. No Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States.

The FDA contacted the companies that manufacture infant formula for distribution in the United States and received information from the companies that they are not importing formula and do not source milk-based ingredients from China.

In addition, the FDA -– in conjunction with state and local officials – continues to check Asian markets for food items that are imported from China and that could contain a significant amount of milk or milk proteins.

The FDA has broadened its domestic and import sampling and testing of milk-derived ingredients and finished food products containing milk or milk-derived ingredients from Chinese sources. FDA has recommended that consumers not consume certain products because of possible contamination with melamine. A list of those products is below.

Update on FDA’s Investigation

November 28, 2008: FDA’s ongoing investigation continues to show that the domestic supply of infant formula is safe and that consumers can continue using U.S. manufactured infant formulas. FDA has concluded that levels of melamine alone or cyanuric acid alone, at or below 1 part per million (ppm) in infant formula do not raise public health concerns. FDA has updated its interim risk assessment, issued in early October, with this information: http://www.cfsan.fda.gov/~dms/melamra4.html.

The FDA has been collecting and analyzing samples of domestically manufactured infant formula for the presence of melamine and melamine-related compounds. To date, FDA tests have found extremely low levels of melamine in one infant formula sample and extremely low levels of cyanuric acid in another. The levels were so low (well below 1 ppm) that they do not pose a health risk to infants: http://www.fda.gov/oc/opacom/hottopics/melamine/testresults.html.

Melamine is not naturally occurring and is not approved to be directly added to food in the United States. However, melamine is approved for use as part of certain food contact substances. Low levels of melamine are present in the environment and trace amounts may occur in certain food commodities as a result of approved uses.
Parents using infant formula should continue using U.S. manufactured infant formula. Switching away from using one of these infant formulas to alternate diets or home-made formulas could result in infants not receiving the complete nutrition required for proper growth and development.

Transcript for FDA’s Media Briefing: FDA’s Updated Interim Safety and Risk Assessment of Melamine and its Analogues in Food for Humans
November 28, 2008

FDA’s Warnings/Advisories

The FDA is advising consumers not to consume the following products because of possible melamine contamination:

  • Topaz Wafer Rolls with Chocolate Flavored Cream Filling New!
  • Topaz Wafer Rolls with Hazelnut Chocolate Flavored Cream Filling New!
  • Topaz Wafer Rolls with Vanilla Flavored Cream Filling New!
  • Topaz Wafer Rolls with Mocha Cappuccino Flavored Cream Filling New!
  • G&J Hot Cocoa Stuffer Item 120144
  • G&J His and Hers Hot Cocoa Set Item 120129
  • G&J Cocoa item 120126, sold in 2 flavors: French Vanilla Cocoa and Double Chocolate Cocoa
  • Wonderfarm "Successful" Assorted Biscuits
  • Wonderfarm "Royal Flavour" Assorted Biscuits
  • Wonderfarm "Lovely Melody" Assorted Biscuits
  • Wonderfarm "Daily Life" Assorted Biscuits
  • Topaz Hazelnut Wafer Rolls with Hazelnut Chocolate Flavored Creme Filling (photo page)
  • Sweet Time Christmas Dressy Bear with Chocolate Bar
  • Fresh and Crispy Jacobina Biscuits
  • Koala’s March Crème filled Cookies
  • YILI Brand Sour Milk Drink
  • YILI Brand Pure Milk Drink
  • Blue Cat Flavored Drinks
  • White Rabbit Candies
  • Mr. Brown Mandehling Blend Instant Coffee (3-in-1)
  • Mr. Brown Arabica Instant Coffee (3-in-1)
  • Mr. Brown Blue Mountain Blend Instant Coffee (3-in-1)
  • Mr. Brown Caramel Macchiato Instant Coffee (3-in-1)
  • Mr. Brown French Vanilla Instant Coffee (3-in-1)
  • Mr. Brown Mandheling Blend instant Coffee (2-in-1)
  • Mr. Brown Milk Tea (3-in-1)
  • Infant formula manufactured in China

News Updates

November 13, 2008: As part of its ongoing strategy to address the present problem with melamine contamination of consumer products exported from the People’s Republic of China, FDA has expanded its import controls on Chinese dairy products, and food and feed products manufactured in China that contain dairy ingredients. Since Oct. 10, 2008, FDA has had an import alert in place for specific products found contaminated with melamine and melamine-related compounds. FDA has collected additional information on the scope of the melamine contamination problem in China, and determined a countrywide import alert is warranted.

This action will help ensure that only Chinese dairy products and food and feed products manufactured in China that contain dairy ingredients are not contaminated with melamine and melamine-related compounds reach U.S. consumers. No adverse health effects have been reported in the United States from contamination with melamine of dairy products or dairy containing products. But melamine is not approved for direct addition to human or animal foods and no manufacturer is allowed to deliberately add it to any food for U.S. consumers.

As part of ongoing activities, FDA will also examine a range of protein-containing products beyond just dairy and dairy-containing products for contamination with melamine and melamine-related compounds. FDA will continue to take appropriate regulatory action if these efforts uncover additional contamination.

Company Recalls

Information for Industry

FDA's Testing Methods

The FDA Field laboratories are using LC-MS/MS methods that are capable of determining melamine and cyanuric acid at levels of 0.25 ppm in powdered infant formula and other dairy-containing food products or ingredients. These and a GC/MS method for melamine and its analogues are:

Other Resources

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