Category: FDA
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FDA Proposes Fees to Finance FSMA Implementation
The U.S. Food and Drug Administration (USDA) has proposed two new fees—a food import user fee and a food facility and inspection fee that the agency says will “enhance the safety protections for imported food and feed” as well as support “new and improved activities required by the Food Safety Modernization Act (FSMA) to modernize…
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FDA Issues Draft Compliance Policy Guide on Food Facility Registration
The Food and Drug Administration (FDA) has announced the availability of “Draft Compliance Policy Guide Sec.100.250 Food Facility Registration— Human and Animal Food” (draft CPG), which aims to “provide guidance for FDA staff regarding enforcement of the food facility registration provisions under a section [415] of the Federal Food, Drug, and Cosmetic Act .” To…
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Animal Rights Groups Sue Federal Agencies over Egg Labeling
The Animal Legal Defense Fund (ALDF) and Compassion Over Killing have reportedly filed a complaint in a California federal court against the Food and Drug Administration, U.S. Department of Agriculture and Federal Trade Commission claiming that the agencies have failed to regulate animal-welfare labeling on egg cartons. According to ALDF, rulemaking petitions were filed in…
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OMB Makes Cuts to FSMA Regulatory Package
According to news sources, the White House Office of Management and Budget (OMB) removed some provisions from the regulatory implementation package that the Food and Drug Administration (FDA) proposed under the Food Safety Modernization Act (FSMA). Analysis of documents submitted to the rulemaking docket apparently reveals that the following requirements were removed from the draft…
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FDA Secures Consent Decree from New Jersey Bakery over Labeling Issues
According to the Food and Drug Administration (FDA), a federal court has approved a consent decree with Clifton, New Jersey-based Butterfly Bakery, Inc. over claims that it distributed misbranded food products, such as muffins and snack cakes. United States v. Butterfly Bakery Inc., No. 13-669 (D.N.J., order entered March 5, 2013). Under the agreement, the…
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Petitioners Ask FDA to Regulate Use of Antibiotics in Distillers Grains
Two agricultural organizations have filed a citizen petition with the Food and Drug Administration (FDA) seeking to ban the use of antibiotics in ethanol production so that the leftover mash, known as “distillers grains with solubles (DGS),” which is fed to livestock, does not add to the levels of antibiotics used in the production of…
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FDA Declines to Change Mercury Action Levels for Fish
The Food and Drug Administration (FDA) recently denied a citizen petition seeking to replace “the FDA action level of 1.0 parts per million (ppm) mercury in fish with an action level, regulatory limit or tolerance no greater than 0.5 ppm mercury in fish in order ‘to protect women of childbearing age, pregnant and nursing women,…