Kenneth Odza

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Moving In-House

As you might have heard, I’m leaving Stoel Rives LLP this month, my professional home for almost 14 years (and parts of three decades). I am honored and humbled to have been asked by The Kellogg Company to join them as their in-house food safety and quality lawyer. My departure from Stoel Rives is bittersweet. … Continue Reading

Are FDA Reinspection Fees An Opportunity?

Fred Degnan, from King & Spalding, led a very insightful presentation on "Responding to Government Investigations and Warning Letters" at the recent ACI food regulatory summit. His presentation led to an interesting discussion about FDA’s close out of investigations. It was generally agreed that the FDA, in essence, is not notifying parties when it has decided to … Continue Reading

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

Learn How to Prepare for an FDA Inspection

Next Wednesday at the ACI Food Regulatory Summit in Chicago I’ll be presenting a talk entitled "Curtailing Downstream Liability Arising Out of On-Site Inspections: How to Prepare and What to Do Should Government Come Knocking." My slide-deck can be linked here. Topics that I plan to cover include: FDA’s plan to increase frequency of inspections … 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

What to Ask About Recall or Product Contamination Insurance Coverage

If they don’t already have it, I advise my clients to talk with their insurance broker about purchasing recall insurance (otherwise known as product contamination insurance) . For clients who have recall insurance, I advise them to make sure the policy provides the coverage they expect. Recall insurance is a different animal than other policies … Continue Reading

Listen on Demand to April 29, 2011 AON Webinar on the FSMA

A 60-minute webinar broadcast on April 29 on the Food Safety Modernization Act (and a short discussion of implications of the Japanese earthquake, tsunami and resulting nuclear disaster on food safety) is available for replay at this link. The webinar was sponsored by AON. My gratitude to AON for inviting me to participate. As always, I’m interested in your feedback and questions.… Continue Reading

FDA’s Reportable Food Registry Makes a Profound Impact

Here is a link to my article, "FDA’s Reportable Food Registry Profoundly Impacts Litigation and the Food Industry," posted this week by the American Bar Association‘s Litigation Section (Products Liability). The article is a follow-on to lively discussions over the litigation impacts of the federal Reportable Food Registry ("RFR") at the ABA’s recent Food & … Continue Reading

Health Claims Class Actions Set to Explode

Stoel Rives food liability attorney Ken Odza discussed with NutraIngredients-USA.com the significance of a rise in activism from consumer lobby groups combined with food manufacturers pushing the envelope with more aggressive health claims. General Mills recently lost its bid to invalidate class action certification at the Eleventh Circuit of Appeals in a Florida lawsuit involving … Continue Reading

Defeating a Consumer Fraud Putative Class Case Early

Last week at the DRI products liability conference in New Orleans, Lara White from Adams and Reese and I presented "Regulatory Compliance Alone Is Not Enough: Understanding and Mitigating Consumer Fraud Claims." Our presentation dealt with putative class claims aimed at the marketing and labeling of food products. A link to the slide-deck can be … Continue Reading

Looking for Information and Presentations on FSMA, Recalls and The RFR? Look No Further.

I’ll be speaking at several events over the next two months on the Food Safety Modernization Act (FSMA) and how this comprehensive and far reaching legislation affects the status quo for food companies. Two of these events are free, and all promise to address relevant and critical issues for those involved in the food industry. a. May … Continue Reading

RAISED RIGHT Trademark Blocks BRASSTOWN BEEF Logo

Note: The following post is authored by guest blogger Anne Glazer. The Trademark Trial and Appeal Board (“TTAB”) recently affirmed a USPTO refusal to register the following mark for use with beef: The TTAB said the BRASSTOWN BEEF logo is likely to cause confusion in relation to the word mark RAISED RIGHT, which was already … Continue Reading

Prop 65 Targets Cooked Food, Coffee and Vitamin Supplements

This blog entry was originally written by Lee Smith from the California Environmental Law Blog. The Industry Acrylamide Coalition (Coalition) filed suit against the State of California Office of Environmental Health  Hazard Assessment (OEHHA), the agency that manages and revised the Prop 65 list to include 4-metheylimidazole (4-MEI), as a carcinogen.  4-MEI is often found … Continue Reading

More on the FSMA and the “Tester Amendment”

Earlier this week, I presented a webinar to the American Cheese Society entitled the "Food Safety Modernization Act and Product Liability." A link to the presentation is here. The presentation covered a number of topics and included a discussion of the so-called "Tester Amendment" to FSMA. The "Tester Amendment" in section 103 of FSMA "exempts" … 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

Preparing for FSMA Produce Safety Rules: What “Ag-in-the Middle” Needs to Do

Many who track FDA’s implementation of the Food Safety Modernization Act (FSMA) believe that a priority for FDA is Section 105, “Standards for Produce Safety” (FDCA section 419), in particular, the leafy greens regulations. Farms are exempt under FSMA’s produce safety rules if: (A) during the previous 3-year period, the average annual monetary value of … Continue Reading

Why CSPI’s Loyalty Card Suit Has No Merit and Does Not Promote Food Safety

Following the playbook it has followed in the past with sodium and other issues, the Center for Science in the Public Interest (CSPI) has filed yet another complaint of very questionable legal merit to promote a policy agenda. This time CSPI seeks to compel all retailers to use loyalty cards as a recall alert system. … Continue Reading

Proposed Bill Would Eliminate the Corporate and LLC Shield for Many Washington Contracts

Note: This blog entry was  authored by Douglas Batey and originally published on the LLC Law Monitor blog. The Washington legislature is currently considering a bill that would apparently require any contract that calls for the payment of money by an LLC or corporation, to include an extra signature by an authorized representative that would render the … 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
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