(Updated: January 5, 2009)
Topics on this Page
* Introduction
* Update on FDA’s Investigation
* FDA's Warnings/Advisories
* News Updates
* List of Company Recalls
* Information for Industry
* FDA's Testing Methods
* Other Resources
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 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
-
National
Brands Inc. Issues a Nationwide
Recall of Topaz brand Wafer Rolls
Because of Possible Health Risks
New!
-
Dorsey
Marketing Inc. Voluntarily Recalls
Three G&J Gourmet Market Cocoa
Products: 120126, 120129, 120144
(Dec.
19, 2008)
-
Interfood
Shareholding Company Issues a Nationwide
recall of Wonderfarm Brand Biscuits
Because of Possible Health Risk
(Dec.
9, 2008)
-
Walgreens
Recalls 173 Teddy Bears With Chocolate
Bars Sold Since Late September
2008
(Dec. 5, 2008)
-
Everlasting
Distributors Inc. Issues a Nationwide
Recall of Fresh and Crispy Jacobina
Biscuits Because of Possible Health
Risks
(Oct. 29, 2008)
-
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 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
