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The FDA's Reportable Food Registry ("RFR") first went online in September 2009.

Since its inception, numerous questions have been asked regarding the specific circumstances under which a food company is required to inform the FDA about a potentially dangerous food product.

Generally speaking, under the RFR, any food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if the company learns that it has manufactured, received or distributed a potentially implicated food product.

Because the FDA reporting requirements are only triggered under certain defined circumstances, however, a food company uncertain about its reporting obligations under the registry should consider contacting legal counsel to determine the extent and scope of any potential reporting requirements triggered by the FDA rules.

In their current form, the FDA rules extend to any company that is required to submit registration information to the FDA as a manufacturer, processor, packer, or distributor of food. In turn, the rules apply to any food product regulated by the FDA, with the exception of infant formula and dietary supplements which are covered by other regulatory requirements.

Under existing FDA rules, a food company is required to alert the FDA – through the RFR Portal – within 24 hours of becoming aware it has sold and shipped a "reportable food." In turn, a reportable food is defined generally as any food product that has a “reasonable probability” of causing health problems or death in humans or animals. As explained by the FDA, some examples of reasons a food may become reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

In turn, once a food company discovers a problem with a product it has received, manufactured or shipped, and submits a report through the RFR, it will be required to cooperate with the FDA to help determine the cause and contain any potentially affected products. In addition, responsible parties will be required to notify their relevant suppliers, distributors and customers of any potential food safety issues, be ready to submit further data and analysis to the FDA, and initiate their own investigation if the problem is thought to have originated internally.

Notably, however, in addition to other exceptions, the FDA’s reporting requirements apply only to products that have been shipped into commerce. For this reason, a food company is not required to report a problem to the FDA if it was the sole manufacturer of the food product, it discovered the problem internally before the food product was distributed, and it then corrected the problem or destroyed the implicated food.

For additional information on the registry and reporting requirements, please visit www.fda.gov/ReportableFoodRegistry.

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Our food safety lawyers work with food companies nationwide, helping them avoid risk, prevent litigation, manage recalls and defend high profile foodborne illness outbreaks and claims. 

Over the last decade, the firm has assisted food companies throughout the country on a wide-range of food safety matters involving regulatory compliance, crisis planning and management, and outbreak litigation.

During this period, the firm has defended food industry clients against high-profile foodborne illness outbreak claims in more than 2o states throughout the country (including Arizona, Arkansas, Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Maine, Massachusetts, Michigan, Minnesota, Nebraska, New Jersey, New Hampshire, New York, North Carolina, Ohio, Pennsylvania, Tennessee and Wisconsin). These have included outbreaks and claims involving a wide-range of foodborne pathogens, including E. coli O157:H7, Campylobacter, Clostridium Perfringens, Norovirus, Salmonella and Staphylococcus.  The firm's food safety team also assists clients with crisis management and other issues in advance of and following major food product recalls.

Shawn K. Stevens, a member of the firm's food safety team, is one of the only lawyers in America who dedicates his practice entirely to representing the food industry. 

Mr. Stevens counsels food industry clients throughout the country (including some of the nation’s largest food producers, national restaurant chains, and several food distributors and grocers) on a wide-range of food safety regulatory and liability issues.  Mr. Stevens works closely with clients to identify and appropriately manage risk, plan and prepare for possible crises, and also respond to governmental enforcement actions and recalls.  Mr. Stevens also defends industry clients against high-profile foodborne illness outbreaks and claims. Mr. Stevens has additional, wide ranging experience counseling clients in commercial, insurance and medical malpractice disputes.

In addition to his legal practice, Mr. Stevens also speaks regularly to national and international audiences on issues relating to food safety, regulatory compliance, crisis management, and foodborne illness outbreaks, recalls and lawsuits.  Mr. Stevens also serves as a weekly contributor to Meatingplace (as the author of its newest “Legally Speaking” Blog), writes a dedicated monthly food safety column for the National Provisioner, and is a regular contributor to Food Quality Magazine.

Mr. Stevens has also been recognized by his peers as a Wisconsin Super Lawyer Rising Star, and was recently selected as one of Milwaukee's 2011 "Forty Under 40." 

Ralph A. Weber, Ralph A. Weber has represented clients in several of Wisconsin’s highest profile lawsuits over the past several decades, and currently litigates for one of the world’s largest companies in food safety cases throughout the United States. His trial experience includes many lengthy jury and court trials. His appellate experience includes multiple oral arguments before the Wisconsin Supreme Court and intermediate appellate courts.

The prestigious international lawyer reference, Chambers Guide-USA, identifies Mr. Weber as a top commercial litigator. He also has been recognized by his peers through selection to Best Lawyers in America, Wisconsin Super Lawyers, and has been selected one of the Best of The U. S.’s list of “Best of Class” service providers in the United States.

An Adjunct Professor at Marquette University Law School, he taught Trial Advocacy for 15 years, and created a jury research and courtroom facility, the Trial Science Institute. In addition to speaking about litigation subjects, Mr. Weber co-edited a best selling book, Dear Americans: Letters from the Desk of Ronald Reagan (Doubleday, 2003).

Mr. Weber served on the Law Review at Columbia University Law School, graduating in 1982, and then served as a Law Clerk for the Hon. Richard D. Cudahy, United States Court of Appeals for the Seventh Circuit. He graduated summa cum laude from Marquette University in 1978.
 

Amelia L. McCarthy, a member of the firm, specializes in general commercial, health care, food and product liability litigation.

She also currently serves as a Municipal Prosecutor for a Wisconsin community and has served as a Public Service Special Prosecutor for the Dane County and Milwaukee County District Attorney's offices. 

Throughout the course of her career, Ms. McCarthy has tried over 50 court and jury trials. She also successfully defended four class action lawsuits, obtaining three dismissals with prejudice and one nuisance value settlement without having to proceed through class certification.

Ms. McCarthy has been recognized by her peers through selection to Wisconsin Super Lawyers and was recently named one of Milwaukee's Top "40 under 40" business leaders.

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In many food-borne illness cases, a winning defense begins long before a claim is actually filed.

Whether you are a food manufacturer, processor, distributor, grocer, restaurant or franchisor, there is a strong possibility you will become aware of illnesses potentially linked to your business or product soon after they are reported to state and federal investigators.

Thus, when faced with an alleged food-borne illness or outbreak, it is essential that you immediately understand the full nature of the investigation. Once an illness or outbreak is identified, you should immediately retain competent counsel who can work closely with state, local and federal agencies to, at the very least, accomplish the following goals:

• To directly assist investigators, where appropriate, during the course of the investigation;

• To determine, while assisting in any ongoing investigation, whether your product is (or is not) likely involved with the alleged illnesses or developing outbreak;

• To help quickly define (if your product will likely be implicated) the particular product involved along with the parameters of any potential voluntary recall;

• To prepare and refine appropriate responses (with an eye toward future litigation) to any formal requests from governmental agencies for production information, distribution records and/or proposed corrective actions;

• To track, in real time, the identification of existing and potential future illnesses and claims (this will likely pay significant dividends when such claims are later threatened or filed); and

• Based upon the information developed during the course of the ongoing investigation, to articulate appropriate responses to media inquiries.

Assuming that your company is well positioned at the outset of an investigation, you may be able (through your own internal efforts) to help establish that your product or business is not associated with the outbreak being investigated. Alternatively, if your product is likely implicated, aggressively tracking real time information will allow you to maintain a complete picture of the developing investigation, play an active role in the investigation itself, take immediate and productive corrective actions, if necessary, respond appropriately to media, and begin to develop a response to claims (whether meritorious or not) which will likely later result.

In this regard, focusing early on potential future claims will also pay huge dividends when litigation is later threatened. The information learned in the early stages of an investigation will in many cases allow you to understand, at the outset of an event, the true scope and nature of potential illnesses. In turn, once emerging cases can be pinpointed geographically, additional research can be performed to learn more about the circumstances surrounding each potential claimant. Using contacts established early on with governmental investigators, internet databases and other resources (such as media reports and hospital-facilitated patient websites), it may also be possible to track closely the progress and recovery of potential claimants as well.  Here too, if these potential claimants have already been identified and nature of their illness fully understood, false allegations when claims are later threatened or filed (i.e, the exaggeration of an injury or the understatement of an excellent recovery) can be quickly distinguished and separated from potentially meritorious or more serious claims.

Additionally, as noted, your company must also immediately consider how you wish to present yourself in the media.  A company spokesman should be selected, keeping in mind that this person will likely be deposed and/or his remarks used at trial. It may also be appropriate to have your lawyers respond to press inquiries, especially if you are responding to a statement by a plaintiff’s attorney. A press release that includes quotes on behalf of the company can also work, and may be the most prudent course in rapidly evolving circumstances where much remains unknown. In all events, it is necessary to have in mind what the company’s themes will be at trial, so that early statements will be consistent with arguments that may be made months and years later. Additionally, assuming your company has cooperated fully with governmental investigators throughout the course of an investigation, any statements issued by the government will likely be favorable to your company, and may also (at least implicitly) adopt some of these themes as well.

Once press releases are issued, expect to see significant press coverage and blog entries on the leading plaintiffs’ lawyers’ sites, including www.marlerblog.com. Because the FSIS provides email alerts about recalls, very little time passes between the press release itself and its appearance in the press and on the web. Claims and lawsuits, legitimate and not, of course follow promptly.

Alleged illnesses, outbreaks and recalls can be managed effectively, assuming that you and your company aggressively look for ways at the outset of an investigation to help governmental investigators solve the problem.  In the future, we will continue to offer advice from past experiences on how to best manage potential outbreaks and recalls.

While no two cases are the same, it is essential to remember that an effective defense begins the moment any potential illnesses and outbreaks are identified. 

Copyright 2009 by Shawn K. Stevens

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