AG/FDA Blog

FDA Begins to Move on CBD Policy and Enforcement

Earlier this week, the FDA made significant movement on issues and policy involving cannabis and its components, including cannabidiol (CBD).  The agency issued a notice in the Federal Register announcing a hearing and requesting comments on “scie… Read More
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FDA Drug Promotion Enforcement Update

It has been an interesting week from the perspective of an FDA drug promotion attorney. On the one hand, we have a federal district court expanding how drug companies can promote drugs; on the other, we have FDA’s Office of Prescription Drug Promot… Read More
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FDA Releases Draft Guidance on Compounding Animal Drugs

Yesterday, FDA released a Draft Guidance for Industry on Compounding Animal Drugs from Bulk Drug Substances (Draft Guidance).  The Federal Register notice accompanying the Draft Guidance can be found here.  The agency also withdrew its previous Com… Read More
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Warning Letters Update

This past week FDA made a number of Warning Letters available on its website, with issues ranging from Juice HACCP to cGMPs for finished pharmaceuticals. A Warning Letter is informal and advisory, with the aim to achieve voluntary compliance and to e… Read More
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FDA’s “Gluten-Free” Labeling Rule Takes Effect

On August 5th, FDA’s regulation defining the claim “gluten-free” for voluntary use in food labeling became effective.  FDA cautions consumers that there may still be some products on store shelves labeled “gluten-free” that do not comply w… Read More
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NRDC Issues Report Critical of GRAS Self-Determinations and CSPI Joins in Criticism

By Mark L. Itzkoff On April 7, 2014, the Natural Resources Defense Council (NRDC) issued its latest report on GRAS self-determinations, entitled Generally Recognized as Secret: Chemicals Added to Food in the United States.  We previously reported o… Read More
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FDA Declines To Define “Natural” for Foods Formally, Leaving Its Informal Policy in Place

FDA once again has “respectfully declined” to define the term “natural” when used in food labeling.  In a January 6, 2014, letter from Leslie Kux, Assistant Commissioner for Policy, to three federal judges handling civil litigation brought… Read More
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Adverse Event Reporting for Medical Devices and the Law: Where Has FDA Gone Wrong?

On September 27, 2007, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007 (“FDAAA”).  FDAAA both enhances and curtails FDA’s authority in many respects.  Specifically, FDAAA removes a r… Read More
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Dealing With FDA Warning Letters

By Casper E. Uldriks The FDA issues Warning Letters to provide firms notice that unless they achieve voluntary correction of the violations noted in the letter, the agency is prepared to initiate an enforcement action without further notice.  Enfor… Read More
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DMAA Dietary Ingredient Withdrawn from Market

FDA’s publication last week, on April 11th, of a warning to consumers about dietary supplements containing dimethylamylamine (DMAA) (a/k/a 1,3-dimethylamylamine, methylhexanamine or geranium extract) followed up on Warning Letters issued on Apr… Read More
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