October 26, 2008
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From 9/28/09 Has the FDA failed again? No the FDA failed again? Which Fool did the report about the FDA and no guidence for the amount of melamene in the system. I can't remember who did it.
FOR IMMEDIATE RELEASEOctober 3, 2008
Media Inquiries: Stephanie Kwisnek, 301-827-0955Consumer Inquiries: 888-INFO-FDA
The U.S. Food and Drug Administration (FDA) today issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula.
A safety/risk assessment is a scientifically based methodology used to estimate the risk to human health from exposure to specified compounds. It is based on available data and certain scientific assumptions in the absence of data. 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. The interim safety/risk assessment evaluated the melamine exposure in infant formula and in other foods.
The safety/risk assessment, prompted by reports of melamine contamination of milk-derived ingredients and finished food products containing milk manufactured in China, was conducted by scientists from FDA's Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. The FDA reviewed scientific literature on melamine toxicity. The FDA is in the process of identifying a group of experts that would be charged with the task of reviewing the risk assessment and providing guidance regarding the current gaps in scientific knowledge relating to the toxicity of melamine and its analogues.
FDA is currently 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 about the toxicity of melamine and its analogues in infants, including:
There is too much uncertainty to set a level in infant formula and rule out any public health concern. However, it is important to understand that this does not mean that any exposure to any detectable level of melamine and melamine–related compounds in formula will result in harm to infants.
In food products other than infant formula, the FDA concludes that levels of melamine and melamine-related compounds below 2.5 parts per million (ppm) do not raise 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 any uncertainties. The TDI is an estimate of the maximum amount of an agent to which an individual could be exposed on a daily basis over the course of a lifetime without an appreciable health risk.
Devoish asks why it is ok to add any amount of any product with no nutritional value, intended to improve the results of protein tests without actually improving the protein content?
FDA continues to screen products, collaborate with foreign governments and their regulatory agencies, and monitor reports of contamination from international sources to help ensure that potentially contaminated products from foreign sources are examined if imported into the United States. If products are adulterated because they contain melamine and/or a melamine-related compound, the agency will take appropriate actions to prevent the products from entering commerce.
Devoish asks, with what funding and how many people, considering we are already able to screen less than 1% of imported food.
This is from the Center for Disease Control website malamine FAQ's wherein they are assuring us that the FDA does not allow melamine in food products, despite the fact that there were no melamine guidlines until the FDA decided small amounts are ok, as opposed to my understanding of the term "not allowed".
The United States does not allow melamine to be used as a food ingredient. Most reports of melamine in food products and of health problems related to melamine in food products have centered in China. The US Food and Drug Administration (FDA) is working together with local, state, federal, and international agencies to ensure the safety of the American food supply including broadening its domestic and import sampling and testing of milk-derived ingredients and finished food products containing milk, such as candies, desserts, and beverages that could contain these ingredients from Chinese sources.
Devoish reminds us that it is important to know that the USDA does not require Country of Origin Labeling on processed foods and therefore does not set COOL labeling standards, so a voluntary "made in USA" COOL label might refer to 10% of ingredients were sourced from the USA.