Category: Crisis Management

Subscribe to Crisis Management RSS Feed

FDA’s Right To Photograph In Your Plant

The FDA asserts in its inspection manual its right to photograph in your plant. Yet the FDA does not have statutory authority to photograph. The manual cites the following cases as authority for its right to photograph the inside of a plant: Dow Chem. Co. v. United States, 476 U.S. 227 (1986), and United States … Continue Reading

3 New Ways FDA Will Access Your Records and 5 Things You Can Do About It

The Food Safety Modernization Act ("FSMA") significantly expands the FDA’s ability to access a food company’s records. The expanded authority is found in three places in the statute: FSMA § 101 amends 31 USC § 350c(a) and allows the FDA to obtain records related not only to a product that the FDA believes "will cause … Continue Reading

Food Companies Should Revisit Insurance Program and Other Risk Management in Light of Emerging Massive European Union E. coli Outbreak

The E. coli outbreak unraveling now in the European Union, centered primarily in Germany, is setting new records for both the number of affected persons and the number of persons diagnosed with Hemolytic Uremic Syndrome (HUS), a serious complication from E. coli infection (HUS can lead to kidney failure, brain damage and death). As of … Continue Reading

More on FSMA and Food Safety Risk Avoidance

Thank you to Parker Smith & Feek for inviting me to speak to about FSMA and how it’s changing the status quo. My slide-deck can be viewed here. Following my talk, Marty Bask from Parker Smith & Feek led a very interesting discussion about the pros and cons of product recall and contamination coverage. A link … Continue Reading

The FDA’s Reportable Food Registry: Four Burning Questions

I authored the following article that appeared in the April 29, 2011 issue of Food Chemical News: As the clock ticks on the FDA’s 24-hour deadline to report to the FDA’s Reportable Food Registry, a food retailer, manufacturer or supplier is forced to make snap decisions that can profoundly impact business and litigation. Once a … Continue Reading

How Regulatory Changes Affect Litigation Risks

On February 24, 2011, Lee Smith and I presented "How Regulatory Changes Affect Litigation Risks" to the Grocery Manufacturers Association’s food litigation conference. A link to the slide-deck can be found here. We discussed ways that the Reportable Food Registry (RFR) and the Food Safety Modernization Act (FSMA) are affecting litigation now and can be … Continue Reading

Beyond Statistics: What the FDA’s RFR Report Means for Food Manufacturers

Last week, the FDA issued its first annual report on the Reportable Food Registry (RFR). The report provides statistics on the first year of the RFR (2240 entries, 229 "primary reports," a breakdown of the report by hazards, etc.). Beyond the statistics, the FDA report should be noted by food companies for two reasons: Food … Continue Reading

It’s Official: The Food Safety Modernization Act Is Law. What Food Companies Need to Do Right Now

President Obama signed into law today the Food Safety Modernization Act (FSMA). Companies with facilities subject to FDA jurisdiction should  take immediate steps to review and, where necessary, modify SOPs, policies and procedures. For example, given the FDA’s expanded access to business records, companies should set SOPs that anticipate (before a crisis occurs) what records they may … Continue Reading

Unintended Consequences of FDA Mandatory Recall Authority?

For years, a debate has raged on the merits of vesting the FDA with mandatory recall powers. Mandatory recall is part of the food safety legislation that may or may not pass in this Congress, so it’s worth discussing. At present, the FDA lacks any power to order a recall. Its only legal authority is … Continue Reading

Arm Me with Knowledge: A Response to Ken Odza

Ken posted an entry with the title: “Can Business Lawyers Afford to Practice ‘Defensively.’” I’ve been a business lawyer for almost 30 years, so I think I have at least some perspective on that issue and I thought I’d contribute to the discussion with some historical observations. I apologize in advance if I sound like I’m suggesting that … Continue Reading

FDA Issues Warning on Alcoholic Energy Drinks; States Move to Ban “Blackout in a Can”

Note: The following is authored by guest blogger Jake Storms, from the Alcoholic Beverages Law Blog. Amidst rising incidences of hospitalizations in college and teenage drinkers linked to consumption of alcoholic energy drinks, the Washington State Liquor Control Board banned their sale effective tomorrow, November 18, 2010. The move came on the heels of a … Continue Reading

Food Safety Tools and Defenses for Cheesemakers

Cheesemakers have endured a string of bad publicity recently over food safety. Cheesemakers, especially raw milk cheesemakers, are in the cross hairs of the FDA, the media, retailers and plaintiffs’ lawyers such as Bill Marler. I was interviewed last week on FDA seizure issues by the Pacific Northwest Cheese Project. Click here for the PowerPoint … Continue Reading

Listeria Recall Toolkit

The FDA recently took the relatively unusual step of obtaining a court-issued warrant to seize all cheese products at Estrella Family Creamery, a small, family-owned artisan cheese maker in Washington State. According to the United States Attorney’s Office for the Western District of Washington, "the FDA asked Estrella to recall all cheese products. The company … Continue Reading

The OchocincO’s Misprint: This Wouldn’t Happen with Flutie Flakes

There is a niche market out there for celebrity-endorsed food products that benefit charities. PLB Sports out of Pittsburgh appears to be a market leader in this niche, labeling products ranging from beef jerky to salsa to mustard with images and slogans relating to both individual sports figures and teams. Probably the most famous of these were … Continue Reading

A Reportable Food Registry Toolkit

This article was first published on August 27, 2010 in Food Chemical News as part of its "On the Front Burner" series. In its first year, the FDA’s Reportable Food Registry has proven itself to be a high-stakes game changer. The ticking of the RFR’s 24-hour reporting deadline forces a company to make snap decisions … Continue Reading

Preserving the Brand and Avoiding Media Backlash During a Crisis

I’ll be moderating and speaking on a panel at the upcoming ACI’s Advanced Summit on Food Safety Regulatory Compliance in Chicago, June 28-29. Scott Rickman from Del Monte, public relations professionals and I will be presenting on  "Effectively Responding to Negative Media Coverage: How to Avoid the Backlash" (If you plan to attend, register soon and contact … Continue Reading

Cleaning Up the Docket – Northern District of California Dismisses Lanham Act Claim Alleging Mislabeling of Personal Care Products

As we have blogged about, litigation regarding product labeling has been a hot topic within the food and beverage industry. A recent decision from the Northern District of California could hold interesting implications for Lanham Act claims centering on the labeling of products as “organic.” While the case, One God Faith, Inc. v. Hain Celestial … Continue Reading

Take-Aways from November 3 Webinar: Making Good Marketing Claims: Product Labeling Pitfalls, Third-Party Certification and “Green Washing”

Tuesday, November 3, we held our second webinar in a three-part series on bringing sustainable food products to market. Thanks again to our presenters and attendees. The recorded webcast was archived and is accessible at this link. Click here to access a PDF copy of the presentation slides. Take-aways from the second webinar include: • … Continue Reading

From Onions to Chicken Soup: The Wall Street Journal Weighs in On Home Flu Remedies

Melinda Beck has a terrific article in today’s Wall Street Journal about home remedies for the H1N1 virus and (as we have previously blogged) the FDA’s efforts to reign in those making unsupported marketing claims for their remedies.  One remedy sweeping the blogosphere like wildfire is the use of onions to soak up flu bugs.  … Continue Reading
LexBlog