FDA warns on China formula
This article was originally published in The Tan Sheet
Executive Summary
Milk-based infant formula manufactured in China may be contaminated with melamine, which raises the protein profile of dairy products and may have contributed to reports of kidney stones in Chinese infants, FDA says Sept. 12. The agency says companies approved for marketing milk-based formula in the U.S. are not importing materials from China, though officials are investigating whether Chinese infant formula is being sold in Asian specialty markets inside the U.S. In its same-day health information advisory, FDA requests the help of states in removing Chinese infant formula products from store shelves. In April 2007, melamine-tainted Chinese pet food caused FDA to issue an import alert on vegetable proteins from China (1"The Tan Sheet" May 21, 2007, p. 6)
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FDA melamine alert
On Nov. 12, FDA issued an import alert ordering all milk products, milk-derived ingredients and finished food products with milk from China be detained without physical examination due to the possible presence of melamine or melamine analogs. To secure release of shipments, importers must provide results of a third-party lab analysis verifying the absence of melamine and cyanuric acid, or documentation showing the product contains no milk or milk-derived ingredients. FDA also issued an interim safety and risk assessment of melamine in human food, saying in a Nov. 13 Federal Register notice it cannot establish a safe level of melamine and its analogues in infant formula. In foods for older children and adults, levels of melamine and melamine-related compounds below 2.4 ppm do not raise public health concerns, FDA says. The agency adds it does not approve melamine use in direct addition to food or as a fertilizer in the U.S. Comments on the paper, which was drafted after melamine-tainted infant formula caused 13,000 hospitalizations and three deaths. Comments are due Jan. 12 (1"The Tan Sheet" Sept. 15, 2008, In Brief)
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Following FDA's Sept. 12 health information advisory regarding melamine-contaminated infant formula from China, the agency says Sept. 23 "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." While state and local officials collaborating with the agency have not found Chinese formula on store shelves in large Asian enclaves in the U.S., FDA says it is taking "proactive measures" to sample and test other imported milk-derived ingredients and finished food products for Chinese milk proteins (2"The Tan Sheet" Sept. 15, 2008, In Brief)