Category: FDA
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FDA Not Required to Hold Hearings on Antibiotics Bans, Second Circuit Says
The Second Circuit has reversed a district court’s decision that ordered the U.S. Food and Drug Administration (FDA) to initiate hearings responding to a livestock antibiotics challenge from the Natural Resources Defense Council (NRDC) based on a 1977 agency finding that the use of growth antibiotics for healthy animals was unsafe. NRDC v. FDA, No.…
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FDA Warns Against Use of Powdered Pure Caffeine Products
Following the recent death of an Ohio teenager whose autopsy reportedly revealed blood levels of more than 70 micrograms of caffeine per milliliter, the Food and Drug Administration (FDA) this week issued “consumer advice” warning parents that powdered pure caffeine is a “powerful stimulant and very small amounts may cause accidental overdose.” Such products are…
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FDA to Present 4-MEI Survey Findings at ACS National Meeting
Food and Drug Administration (FDA) representatives are slated to present findings of the agency’s analysis of more than 200 foods containing Class III and Class IV caramels for 4-methylimidazole (4-MEI), a chemical byproduct of manufacturing processes, during the American Chemical Society National Meeting & Exposition, August 10-14, 2014, in San Francisco, California. According to the…
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FDA Finalizes Guidance on Nanotech Use in Food
The U.S. Food and Drug Administration (FDA) has released its final guidance on the use of nanotechnology in food as well as draft guidance on use of the technology in animal food. Rather than categorically judging nanotech as either safe or harmful, the agency indicated that it will consider specific characteristics of products with nanotech…
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FDA Issues Draft Guidance on Fish and Mercury Intake for Children and Pregnant Women
The U.S. Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) have joined to issue draft guidance on mercury levels and fish consumption, directed at pregnant women and guardians of young children. Recommendations include eating 8 to 12 ounces (two to three servings) of low-mercury fish like tilapia, catfish, cod, salmon, and shrimp…
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FDA Clarifies Position on Use of Wood Shelving in Artisanal Cheesemaking
The U.S. Food and Drug Administration (FDA) has issued a clarification of its position on artisanal cheesemakers’ use of wood shelving, which can aid in aging cheese by controlling moisture to form rinds and hosting microbes that add character and flavor. FDA’s Constituent Update called reports that the agency established a new rule banning wood…
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FDA Finalizes Manufacturing Practices for Infant Formula
The U.S. Food and Drug Administration (FDA) has announced a final rule setting standards for manufacturers of infant formula. With a compliance date of September 8, 2014, the final rule includes (i) “current good manufacturing practices specifically designed for infant formula, including required testing for the harmful pathogens (disease-causing bacteria) Salmonella and Cronobacter”; (ii) “a…
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Federal Court Reverses ECJ Decision, Citing Primary Jurisdiction
In a putative class action alleging that a food company misled its customers by using the term “evaporated cane juice” (ECJ) instead of “sugar” on its labels, a California federal court has followed the lead of several other courts in recent decisions by dismissing the case without prejudice under the primary jurisdiction doctrine—this time, reversing…