FDA Revises Food Product Categories for Food Facility Registrations

FDA has issued a revised guidance that explains the necessity of having food product categories in food facility registrations submitted to FDA under section 415 of the FD&C Act (21 U.S.C. 350d), and that updates the food product categories to be… Read More
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2015 In Retrospect

Happy New Year, readers! Yet another year has come and gone. I hope that 2015 was a good year for you, professionally and personally. As I look back on 2015, here are a few developments that caught my attention. In January, the House Energy and Comme… Read More
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FDA Final Rule: CGMPs and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

On September 17, 2015, the federal Food and Drug Administration (“FDA”) released a major final rule to implement the Food Safety Modernization Act (“FSMA”): Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Contr… Read More
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FDA DRAFT Guidance: “Ensuring Safety of Animal Feed Maintained and Fed On-Farm”

In earlier blogs, I have mentioned having horses and other animals while growing up on a small farm. Even now, to my husband’s dismay, I have never outgrown being “horse crazy.” But during all this time, I never remember being concerned about t… Read More
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Regulatory Round-Up Newsletter, Spring 2015

On behalf of the Agriculture practice group at OFW Law, here is a copy of our Spring newsletter. We hope you find it useful. To receive this periodic newsletter by e-mail, please contact Carrie Morgan at Read More
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FDA Issues Guidance Documents on the Use of Nanotechnology in FDA-Regulated Materials

By Mark L. Itzkoff On June 24, 2014, the Food and Drug Administration (FDA) released three final and one draft guidance document regarding the use of nanotechnology in the manufacture of FDA-regulated products. Specifically, the agency issued the fol… Read More
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