AG/FDA Blog

FDA Nixes “Evaporated Cane Juice” as Ingredient Name

Pursuant to consideration of public comments submitted on its October 2009 draft guidance document (see our prior article here), FDA today announced (81 Fed. Reg. 33,538) the availability of its finalized guidance document, Guidance for Industry: Ing… 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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FDA Extends Compliance Date on Menu Labeling

FDA announced today it will give restaurants and “similar retail food establishments” an additional year – until December 1, 2016 — to comply with its menu labeling rule.  The final rule originally required compliance by December 1, 2015… Read More
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Doom and Gloom: FSIS Provides Recommendations to Retailers on Listeria Control

The Food Safety and Inspection Service (FSIS) has authority under the Federal Meat and Poultry Products Inspection Acts to ensure that products are not adulterated at retail and at all steps in the distribution chain. Retail operations are generally… Read More
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FDA Issues Final Compliance Policy Guide on Food Facility Registration

The Food and Drug Administration (FDA) has issued a final Compliance Policy Guide (CPG) on food facility registration.  Compliance Policy Guide Sec. 100.250; Food Facility Registration – Human and Animal Food.  The CPG provides guidance to FDA st… Read More
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FDA/CDRH Revamps Structure of its Office of Compliance

This past Monday (November 18), the FDA Center for Devices and Radiological Health (CDRH) launched a new webpage describing the revamped structure of its Office of Compliance (OC).  One of the stated goals of the reorganization is to better align OC… Read More
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FDA Margin Call On Off-Label Promotion

FDA’s Office of Prescription Drug Promotion (OPDP) just issued a warning letter to the CEO of Aegerion Pharmaceuticals Inc. (Aegerion) for making unapproved drug claims during two television interviews on CNBC.  FDA says Aegerion CEO, Marc Beer, o… Read More
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My Mobile Medical Application Will be Regulated by FDA…What Do I Do Now?

Recently, FDA finalized its guidance on Mobile Medical Applications (MMA), which is available here. The release of this guidance document lifted much of the regulatory uncertainty regarding which types of mobile apps FDA would and would not be active… Read More
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“Gluten-Free” Now Has an Official FDA Definition

FDA has published a final rule defining the term “gluten-free” for voluntary use in food labeling.  Food labels will have to comply with the new regulatory definition starting August 5, 2014, roughly ten years after Congress directed FDA to defi… Read More
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FDA Tells Food Importers How It Wants Them To Verify the Safety of the Foods They Import

FDA has published two proposed rules to implement to provisions of the Food Safety Modernization Act (FSMA) related to the safety of imported foods. Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Accredita… Read More
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