Tag: FDA
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FDA Releases Guidance on Initiating Voluntary Recalls
The U.S. Food and Drug Administration (FDA) has issued draft guidance on initiating voluntary recalls of food and other agency-regulated products. The guidance discusses (i) “what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures”; (ii) “preparations firm in the distribution channel should consider making to…
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FDA Announces Start Date for Intentional Adulteration Inspections
The U.S. Food and Drug Administration has announced that inspections for compliance with a rule aiming to mitigate the risk of intentional adulteration (IA) will begin in March 2020. The rule, which “is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread…
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FDA Announces Next Steps in Cannabis Regulation
The U.S. Food and Drug Administration (FDA) has announced that it will take a number of steps to advance its consideration for the potential regulatory framework for cannabis and cannabidiol (CBD) products. Specifically, this includes a public hearing, an agency working group, question-and-answer updates and the possibility of enforcement actions. A public hearing on May…
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FDA Announces Webinar on Genome Editing in Animals
The U.S. Food and Drug Administration has announced an April 25, 2019, public webinar about “genome editing in animals, an innovative and rapidly evolving technology that offers significant public health benefits.” The webinar will focus on “current scientific evidence, promising uses of this technology in animals, and the potential risks.” FDA intends the webinar to…
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FDA Lifts Import Alert on GE Salmon
The U.S. Food and Drug Administration (FDA) has deactivated an import alert that prevented the introduction of genetically engineered (GE) salmon into interstate commerce. The agency’s statement indicates that it placed the ban in 2016 with the intention of lifting it when standards for labeling GE food were finalized. With the implementation of the National…
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Kind Petitions FDA to Revise Nutrient Content Claims
Kind LLC has submitted a citizen petition urging the U.S. Food and Drug Administration (FDA) to require disclosure of added sugar and trans fat on food packaging and remove the required disclosures for total fat and cholesterol. In addition, the petition recommends that FDA “[r]evise its nutrient content claim regulations to only allow a food…
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FDA Commissioner Scott Gottlieb To Resign
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has indicated that he will resign by the end of March 2019. Gottlieb reportedly said that he no longer wanted to commute between Washington, D.C., and Westport, Connecticut, where his family lives. Commentators have speculated that Gottlieb’s departure may affect FDA initiatives, such as its planned…
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USDA, FDA to Jointly Oversee Cell-Based Meats
The U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) have announced “a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry.” The agreement “describes the oversight roles and responsibilities for both agencies and how the agencies will collaborate to regulate the development…