AG/FDA Blog

“Milk” Comes from Breasts/Udders

According to the Wall Street Journal: “Organic milk sales have cooled as the very shoppers who drove demand for the specialty product not long ago move on to newer alternatives, leaving dairy sellers and producers grappling with oversupply….Now,… Read More
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NYC Menu Labeling Law – Enforceable?

NYC just announced that its revised calorie labeling rule for food service establishments will take effect on May 22, 2017, and will begin being enforced with notices of violation subject to fines on August 21, 2017.  This pre-dates the recently re-… Read More
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2016 – Gone But Not Forgotten

Happy 2017, everyone!  2016 has come and gone.  Looking at 2016 in my rear-view mirror, here are a few matters that caught my personal attention. As food and drug lawyers and corporate execs in regulated companies know (or definitely should know!),… Read More
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CDRH Proposes Submission Requirements of Labeling for Certain Home-Use Devices

Today, FDA’s Center for Devices and Radiological Health published a proposed rule that would require manufacturers to electronically submit the device label and package insert for Class II and Class III devices labeled for “home-use.” The propo… Read More
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OSHA and FSMA (No, Not FDA This Time)

You thought FDA was the only agency implementing the Food Safety Modernization Act (FSMA), well think again.  The Occupational Safety and Health Administration (OSHA) promulgated a final rule that defines whistleblower protections for employees that… Read More
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FDA Finalizes GRAS Rule

FDA has published a final rule (81 Fed. Reg. 54,959 (Aug. 17, 2016)), based on its 1997 proposed rule (62 Fed. Reg. 18,937 (Apr. 17, 1997); see also 75 Fed. Reg. 81,536 (Dec. 28, 2010) (reopening comment period)), which: Clarifies the criteria for w… Read More
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FSMA Final Food Safety Rule: Mitigation Strategies to Protect Food against Intentional Adulteration

FDA has finalized a new food safety rule under the Food Safety Modernization Act (FSMA) that is intended to help prevent wide-scale public health harm by requiring companies in the U.S. and abroad to take steps to prevent intentional adulteration of… Read More
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FDA Seeks Input on the Meaning of “Natural” for Foods -- First Impact of FDA Action Will Be on Class Action Cases

For over two decades, when assessing the propriety of a “natural”-type claim (e.g., “natural,” “all natural,” “100% natural,” “from nature,” “naturally grown,” or “naturally sourced”) made in food labeling, FDA has applied… Read More
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FDA Notice Provides a “Backdoor” for Commenting on GRAS Notification Program

The U.S. Food and Drug Administration (FDA) today published a Federal Register Notice soliciting comments on its GRAS Notification (GRASN) Program.  “GRAS” is an acronym for the phrase “generally recognized as safe.” Under sections 201(s) an… Read More
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FDA Releases Two FSMA Final Rules: Preventive Controls for Human Food and Preventive Controls for Animal Food

The Food and Drug Administration (FDA) has released two major, final rules to implement the FDA Food Safety Modernization Act (FSMA). The final rules are: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for… Read More
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