The Phone Call that Comes Too Late

At least once a month, our USDA or FDA practice group receives that phone call…the phone call that comes from an existing or prospective food client at that point in time (and no sooner) when the proverbial “slop is about to hit the fan.” I… Read More
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It Is “That” Time of Year

No, it is not time to face the Christmas shopping crowds, the kids have their back to school supplies, and we have made our fantasy football selections.  So what is it I am supposed to be dreading?  Oh yes, final days for government budgets, contin… Read More
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Livestock & Meat Groups Want COOL Relief Pending WTO Review

On Monday, a group of trade associations representing the spectrum of America’s beef and pork production system issued an urgent plea to USDA Secretary Tom Vilsack and the Office of the U.S. Trade Representative Ambassador Froman. The coalition w… Read More
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FDA’s GRAS Review Process for Foods May Be Tested by Litigious Public Interest Group

By Bruce Silverglade and Mark L. Itzkoff As reported in Politico this week, there has been a shake-up of sorts within the public interest advocacy community regarding the tactics used to pressure the Food and Drug Administration (FDA) into changin… Read More
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MDR Reporting of Foreign Adverse Events -- What is Your Obligation?

Under the U.S. Food and Drug Administration’s (FDA) Medical Device Reporting (MDR) Regulation, 21 C.F.R. Part 803, medical device manufacturers must report adverse events involving their devices to FDA when information reasonably suggests that: Th… Read More
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HITECH First Amendment Challenge Delayed – HHS Promises Guidance and Agrees to Limited Enforcement Delay

The Department of Health and Human Services (HHS) revealed in court filings yesterday that it expects to issue guidance regarding prescription refill reminder programs before September 23, 2013.  It also stated that it will not enforce the restricti… Read More
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Judge Denies Attempt to Stop New COOL Rule

Opponents of USDA’s new mandatory Country-of-Origin-Labeling (mCOOL) rule received a setback this morning.  A federal judge denied the mCOOL opponents request for a preliminary injunction, which would have halted implementation of the new lab… Read More
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The FTC and Keeping Privacy Promises

In 2012, identity theft was the number one complaint reported to the Consumer Sentinel Network.  Protection of private consumer information continues to be a high priority for law enforcement and any business dealing with consumer information – th… Read More
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FDA Proposed Reg will be “Game Changer” for Auditing and Certification Organizations

Get ready, set, go!  After years of delay, FDA is now on a fast-track to finalize its proposed regulation on accreditation of third-party auditors in accordance with the Food Safety Modernization Act (FSMA), 78 Fed. Reg. 45,781 (July 29, 2013) Accre… Read More
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