Topics on this Page
Introduction
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 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.
FDA’s
Warnings/Advisories
The FDA is advising consumers not to consume the following products because of possible melamine contamination:
- Fresh and Crispy Jacobina Biscuits New!
- 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
Company
Recalls
- Everlasting
Distributors Inc. Issues a Nationwide
Recall of Fresh and Crispy Jacobina
Biscuits Because of Possible Health
Risks (Oct. 29, 2008) New!
- Lotte
USA, Inc. Initiates Nationwide
Recall of Koala's March Crème
filled Cookies (Oct. 17,
2008)
- HUA
XIA Food Trade USA, Inc. Recalls
YILI Brand Sour Milk Drink and
YILI Brand Pure Milk Drink, Because
of Possible Health Risk (Oct. 10,
2008)
- Tristar
Food Wholesale, Inc. Issues a Nationwide
Recall of Blue Cat Flavored Drink
Because of Possible Health Risk (Oct.
3, 2008)
- Mr.
Brown 3-In-1 & and 2-In-1
Powdered Packets in Bag Coffee Mixes
Due To Health Risk (Oct.
1, 2008)
- QFCO,
Inc. Recalls White Rabbit Candy
Because of Possible Health Risk (Sept.
26, 2008)
Information for Consumers
Information
for Industry
FDA’s Interim Safety and Risk Assessment of Melamine and Melamine-Related Compounds in Food
 The FDA issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula. The purpose of the FDA interim safety/risk assessment was to identify the level of melamine and melamine-related compounds in food which would not raise public health concerns.
For infant formula, the safety/risk assessment concludes that at this time FDA is unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns. In large part, this is because of gaps in our scientific knowledge.
In food products other than infant formula, the safety/risk assessment concludes that levels of melamine and melamine-related compounds below 2.5 ppm do not raise public health concerns. This conclusion assumes a worst case exposure scenario in which 50% of the diet is contaminated at this level, and applies a 10-fold safety factor to the Tolerable Daily Intake (TDI) to account for uncertainties.
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
|
Recalls & Alerts