By David Acheson, Leavitt Partners
As many in the food industry continue to ponder exactly what will be required of them from the new preventive control regulations due out in 2012 the FDA is giving us a glimpse of where they are heading. In its ongoing efforts to be transparent and involve stakeholders in the creation and implementation of the mandates of the Food Safety Modernization Act, FDA published a new presentation, “Focus on Prevention/FDA Food Safety Modernization Act” in November. Focused on its current thinking on preventive controls and relevance within the wording and standards of FSMA, the presentation discussed the four main themes of FSMA as: Prevention; Partnerships; Import Safety; and Inspections, Compliance and Response. Read more.
As food safety management and consumer claims continue to be of high interest throughout the food industry, Sarah Brew will be presenting on a panel ”Assessing the Food Safety Modernization Act’s Impact on Your Litigation Paper Trail: Knowing What to Document, When and How” at the American Conference Institute’s 5th National Forum on Food-Borne Illness Litigation, on November 30, in Chicago. Her co-panelists will be John Batz, director of regulatory affairs at Malt-O-Meal, and Nick White, general counsel at JBS USA Holdings, Inc.
Kristin Eads will also be a speaker the following day, December 1, at the related American Conference Institute’s Advanced Summit on Defending Food & Beverage Consumer Fraud Litigation, also in Chicago. She will be joined by panelists Lori Marco, vice president of external affairs and general counsel at Hormel Foods Corporation, and John Min, counsel at Kellogg Company, to address the topic of “Effective Defenses to Deceptive Packaging and Labeling-Based Claims.”
Please watch our blog for key takeaways and insights from these conferences.
Faegre & Benson recently assisted its client, a dietary supplement manufacturer, and the client’s California counsel in obtaining dismissal of a punitive class action complaint, which alleged the manufacturer had made unsubstantiated claims on the labels of one of its dietary supplements. The manufacturer client moved to dismiss the claim against it for failure to state a claim based upon there being no private right of action for unsubstantiated advertising under California law. The Court agreed, dismissing all of the Plaintiff’s claims without prejudice. A copy of the Order is available here.
Law360 reports on a dismissal in a nationwide class action suit, alleging that certain national food companies used unfair, deceptive, and misleading claims on the labels of their sandwich deli meats. Defense counsel filed a motion to dismiss based upon preemption and other grounds. The court agreed the claims were both preempted and not misleading, dismissing all the claims but allowing the plaintiff to re-file on a very limited ground. Read more
The Centers for Disease Control and Prevention (“CDC”) yesterday released its surveillance data on foodborne illness outbreaks for 2008. The report tends to show that salmonella is increasingly becoming the most important of the various foodborne pathogens, causing almost a third of the overall illnesses and more than half the deaths. More information can be found on the CDC’s website.
We have defended numerous cases arising from foodborne illness outbreaks, including many involving salmonella, over the past few years. This data is consistent with the trend we have seen as of late: fewer outbreaks involving E. coli but a significant uptick in the number of outbreaks involving salmonella.
Under the Food Safety Modernization Act (“FSMA”), the U.S. Food and Drug Administration (“FDA”) was directed to establish at least two pilot programs to relating to product traceability – one for the fresh produce industry and the other for the processed food industry. FDA announced today that it has contracted with the non-profit group the Institute of Food Technologists (“IFT”) to carry out the required pilot projects. The purpose of the pilots is to “evaluate methods technologies for rapid and effective tracing of foods” with the ultimate goal of providing FDA with the information it needs to draft its regulations regarding recordkeeping for high risk foods (as mandated in FSMA). We will continue to monitor these pilot projects and FDA’s implementation of FSMA and provide updates.
For more information on these pilot projects, please see FDA’s press release. For more information on how these pilot projects fit with the rest of the requirements of FSMA, please see Faegre & Benson’s webcast on FSMA.
FDA recently made the Food Related Emergency Exercise Boxed Set (FREE-B) publicly available. Developed in coordination with the CDC and APHIS, this is a tool designed to allow companies and other stakeholders to review responses in case of a food emergency. Taking a “whole community” approach to developing responses, a series of five scenarios will allow stakeholders to ensure they are prepared across a number of areas. More information on the program and how to download it is available on FDA’s website.
The FDA announced that it continues to make progress on implementing the Food Safety Modernization Act (FSMA), recently completing two tasks that were required to be completed within 180 days of the law’s enactment: issuing an anti-smuggling strategy and issuing draft guidance to clarify FDA’s expectations regarding new dietary ingredients. A link to the press release can be found here .
The anti-smuggling strategy was developed in coordination with the Department of Homeland Security and is designed to help prevent smuggled foods from entering the U.S. The concern is that these foods pose a threat to both consumer safety and health, as well as national security. Smuggling target criteria will be developed in conjunction with U.S. Customs and Border Protection, and increased information sharing and joint examinations (between DHS and FDA) will occur as well when appropriate.
The second task included the release of draft guidance regarding a new preventative control from new dietary ingredients. In FDA’s words, this will “ensure that consumers are not exposed to unnecessary public health risks from new ingredients with unknown safety profiles.” Manufacturers of dietary supplements are now required to provide advance notice to FDA if a new dietary ingredient is intended for use in their products. Not only must the new ingredient be identified, but the company must also provide evidence of the ingredient’s safety. There is an exception made for ingredients that have already been part of the food supply and have not been chemically altered. You can access the complete Draft Guidance document on the FDA website.
While these two tasks were required to be completed by July 3, 2011, that date was also the effective date for FDA’s authority to suspend the registration of food facilities (in accordance with the previously released rules) and FDA’s enhanced ability to administratively detail food items.
In an interesting quote, Deputy Commissioner for Foods, Michael Taylor, stated that “The Food Safety Modernization Act requires the agency to build a new food safety system.” This quote highlights FDA’s view that FSMA does more than just update certain programs, but instead is going to result in broad changes across the entire food regulatory and manufacturing industry. We can expect to see many more of these types of announcements over the next year, as many of FSMA’s requirements require FDA action within 18 months. With six months under their belts, FDA still has a lot of work to do to meet FSMA’s mandates.
The U.S. Food and Drug Administration held a hearing on June 6, 2011, which focused on implementing the inspection and compliance provisions of the Food Safety Modernization Act. Faegre & Benson attorneys attended a webcast of the session and provided a summary of the proceedings.
Summaries of the two previous hearings are also available:
- March 29, 2011 Hearing (Import Provisions)
- April 20, 2011 Hearing (Preventive Control Provisions)
The new Agriculture Retailers Association (ARA) Model Fertilizer Contract is 
now available in an electronic format that will provide a clearer, more easy to use product. Faegre & Benson lawyers Ross Johnson, Jacob Bylund and Adam Hertzke were part of the task force that developed the contract for use in the industry. This tool is designed to help companies balance risk and establish common terms and conditions. Click here to access the new fertilizer contract, which is now available to download on the ARA website. If you have any questions regarding the new version of the contract, please contact Richard Gupton in the ARA office at (202) 457-0825 or richard@aradc.org.
