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FDA Explains its Regulation of Bottled Water

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Recently, the U.S. Food and Drug Administration (“FDA”) published “Food Facts”, a document providing the public with information concerning the Agency’s regulation of bottled water. Found here, the document details how the Agency works in conjunction with the Environmental Protection Agency (“EPA”) to ensure that drinking water is safe. While the EPA is primarily responsible for the nation’s tap water, the FDA is the regulatory body responsible for overseeing bottled water. The regulation of bottled water may be broken into two main areas: CGMPs and labeling. Current Good Manufacturing Practices (“CGMPs”) are the particular guidelines that producers of most FDA-regulated…
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FDA Approves Drug for Treatment of Plague Through Animal Efficacy Rule

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On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) approved Levaquin (levofloxacin), a drug used to treat those afflicted with plague. In addition to treating those with the deadly infection, Levaquin is also approved to reduce the risk of contracting plague after exposure to Yersinia pestis, the bacteria responsible for causing the disease. Although the FDA estimates that only 1,000 to 2,000 people worldwide contract the infection each year, the Agency is interested in expanding available treatment options for the disease based on its belief that it could potentially be used as a bioterrorism agent in the future.…
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FDA Warns Consumers of Dangers Associated with Crackers Lacking Proper Allergy Warnings

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On April 5, 2012, the U.S. Food and Drug Administration (“FDA”) issued a press release warning consumers not to eat certain crackers because of the potential dangers for those with milk or nut allergies. TWI Foods Inc., the crackers’ manufacturer (called “Rusk” brand Crispy crackers), initiated a voluntary recall of its crackers and toast, because of the undeclared allergens in product labeling. Under the Food Allergen Labeling and Consumer Protection Act of 2004 and FDA regulations, manufacturers and/or distributers of finished food products are required to declare the presence of major food allergens in labeling. “Major food allergens” include the…
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