Joi Jackson

John Block: Bird Flu

There is no industry more volatile or more uncertain than agriculture. The drought came and Texas and Oklahoma ranchers had to sell their cattle – not enough feed. Beef prices shot up. We still don’t have enough beef. The pork industry was hit with a swine disease. Thousands of baby pigs died. That resulted in

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Device Firms: What You Should Know About The 21st Century Cures Act

Last month, legislation that would affect, among other things, FDA’s regulation of medical devices and the manufacturers of such devices took a considerable step forward when it was introduced and then unanimously approved by the House Energy and Commerce Committee by a vote of 51-0 on May 21.  Known as the 21st Century Cures Act (“Act”),

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Former Consumer Products Safety Commissioner Nancy Nord Joins OFW Law

We are pleased to announce that Nancy Nord, former Acting Chair of the United States Consumer Product Safety Commission, has joined OFW Law as Of Counsel.  Nord is a nationally recognized expert on safety regulation and corporate compliance with a wealth of experience in both the public and private sectors. Please click the announcement, below,

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CPSC Enforcement Action Against Michaels Highlights Importance of Proper Reporting

By Elliot Belilos The U.S. Consumer Product Safety Commission (CPSC) recently filed an action in federal court against Michaels Stores, Inc., seeking civil penalties for allegedly untimely reporting injuries from a vase sold in the stores and, notably, for allegedly falsely reporting the incidents as a retailer rather than as the manufacturer of the product.  According

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FDA Releases Draft Guidance on Compounding Animal Drugs

Yesterday, FDA released a Draft Guidance for Industry on Compounding Animal Drugs from Bulk Drug Substances (Draft Guidance).  The Federal Register notice accompanying the Draft Guidance can be found here.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 Compliance Policy Guide (CPG) 608.400, Compounding of Drugs for Use in Animals. Though FDA has been actively implementing Title

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Mike’s Legacy

By Marshall L. Matz, as published in Agri-Pulse Michael B. Jandreau, the visionary leader of the Lower Brule Sioux Tribe in South Dakota for almost 40 years, passed away last month at the age of 71.  Known to all as “Mike” he believed that Indian Tribes had to establish a private sector economy on the Reservations if

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May 19 Webinar on the Drug Supply Chain Security Act

Tish Eggleston Pahl will be speaking on May 19 at a webinar on dispenser obligations under the Drug Supply Chain Security Act (DSCSA).  The webinar is sponsored by the Healthcare Distribution Management Association (HDMA).  This “DSCSA Overview for Dispensers” continues HDMA’s education and outreach on the pharmacy and hospital–related implementation requirements under the DSCSA.  Particular focus

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Spotlight on Compliance of Wood Products

By Elliot Belilos In the wake of the recent 60 Minutes piece that highlighted alleged elevated formaldehyde in the Chinese-made wood flooring imported by Lumber Liquidators, all manufacturers and importers of consumer products containing compressed wood need to ensure that their products comply with the California Air Resources Board (CARB) limits regarding formaldehyde emissions.  And while

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John Block: Raisins

By John R. Block The U.S. Supreme Court decides a lot of very serious, high-profile cases – gay marriage for example. However, recently, they heard one about raisins. Yes – raisins. The Raisin Program dates back to the Great Depression of the 1930s. President Roosevelt cut the production of many farm products to reduce surplus and

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Clearing Up Confusion: The Net Quantity of Contents Declaration on Food Labels

By Robert A. Hahn The FDA’s food labeling regulations include some traps for the unwary.  A few of those traps have to do with the net quantity of contents declaration. Here are a couple of points to keep in mind when declaring a food product’s net contents: When the net contents declaration is expressed in terms

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Food Defense Plans

By Barbara J. Masters, D.V.M. One of the goals of the Food Safety and Inspection Service’s Strategic Plan is to “ensure that facilities implement safeguards and systems to protect food from contamination by people who might try to intentionally and maliciously harm consumers.”  The Agency has a FY 2015 target of 90% of all establishments having a

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FDA Provides Another Guidance Concerning FDA’s Use of Foreign Study Data

By Mason Weeda FDA’s Center for Devices and Radiological Health (“CDRH”) and Center Biologics Evaluation and Research (“CBER”) recently published a new draft guidance entitled “Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States [(“OUS”)] (“Draft Guidance”) (available here). With this Draft Guidance, FDA aims to minimize the possibility for additional

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