Defending Food Safety : Food Safety Defense Lawyer & Attorney : National Food Industry Counsel : National Food Regulatory Lawyer and Attorney, FDA Lawyer and Attorney. USDA Lawyer and Attorney : Gass Weber Mullins Law Firm

Food manufacturers are constantly reminded about the nearly 76 million people in the United States each year who are affected by some type of food-borne illness.

In turn, many in the media – and elsewhere – often site these statistics to support misguided arguments that the safety of consumer food products is trending downward.

While improvements in national food-borne illness surveillance and reporting explain the recent increase in food product recalls and outbreaks, the reality is that with increased corporate and industry awareness, new interventions and emerging food safety technologies, the food we buy is the safest it has ever been.

What, then, explains the large number of annual food-borne illnesses?

People – not products.

Indeed, less cited statistics confirm that approximately 70 percent of food-borne illnesses (or, over 50 million cases annually) have nothing to do with the underlying safety of food. Rather, the majority of illnesses are caused by contamination where food products are prepared. As a result, if consumers and those who handle foods simply wash their hands, and prepare foods appropriately, most illnesses can be eradicated.

In turn, Dr. Peter Snyder, President of the Hospitality Institute of Technology and Management, advocates a simple solution. In a recent presentation, Dr. Snyder explains quite effectively how food handlers can exponentially reduce the risk of food-borne illness by following some very basic and simple hand washing techniques:

While we should never relent in our efforts to produce food that is as safe as possible, those who actually prepare and consume food also need to understand that the risks of food-borne illness can, in most instances, be virtually eliminated in the kitchen.

Thus, enjoy the presentation, and join us in giving Dr. Snyder a hand.

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It's no secret that virtually all foods are safe if handled properly.

Indeed, according to FDA, most food-borne illnesses are avoidable if consumers follow proper food handling techniques. This is true whether consumers are shopping for products, transporting them home or preparing them in their kitchen.

While proper handling and cooking is key, food safety starts at the grocery store. By following safe food handling practices while shopping, consumers can significantly reduce the potential for food-borne illness at home. In this Consumer Update video, FDA Consumer Safety Officer Doriliz De León guides consumers through a local grocery store while explaining how they can – and should – do their part to keep both their foods and families safe.

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Despite a national food safety system that has defined our food supply as one of the safest in the world, food-borne illness continues to impact many Americans. The CDC estimates that, each year, nearly 76 million people are affected by some type of food-borne illness.

In turn, given recent improvements in outbreak surveillance, more illnesses are being identified and more outbreaks are being reported. By extension, many outbreaks are being associated with an increasing number of variable sources, and more companies are – either directly or indirectly – being affected.

So, where can you turn when hungry plaintiffs’ lawyers or voracious government regulators come knocking? Reserve a spot at the table, and be sure join us at this year’s Food Law Specialized Law Group Session (“SLG”) during the DRI Product Liability Conference April 7-9, 2010 in Las Vegas.

The Food Law SLG is scheduled for the afternoon of Thursday, April 8, 2010, and will feature presentations on product warnings, packaging and claims defense. This year, I’ll be speaking about emerging food safety regulations now on the horizon. With an exceptional faculty, and smorgasbord of, well, delectable insight, we are truly looking forward to satisfying any appetite.

And, in case you were wondering, food isn’t the only thing on the menu at this year’s annual convention. In addition to presentations on food safety, the annual meeting also offers premier educational and networking opportunities, along with numerous general sessions and additional workshops designed to provide helpful insight across the entire product liability spectrum. Click on the following link to view the full DRI 2010 Product Liability Conference Brochure.

Thus, whether you’re in the mood for the latest in food safety, or product liability generally, the conference won’t disappoint. We are truly looking forward, along with all of our colleagues at DRI, to seeing you in Vegas!

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The recent hydrolyzed vegetable protein (“HVP”) recalls may force certain food processors to refine their product formulations which, by extension, could implicate current product labels.

To the extent that any ingredient revisions would force existing labels out of compliance, the FSIS has announced that an establishment should seek “temporary approval” for the continued use of existing labels. According to FSIS, the temporary approval will extend to any products in which HVP ingredients are removed or replaced with a non-allergenic substitute. Ultimately, the purpose behind the announcement is to permit establishments to exhaust their existing label inventory, despite the reformulation of potentially affected products.

To obtain temporary approval (which can be granted for a period of up to 180 days), food companies should submit their request to the FSIS Labeling and Program Delivery Division. According to the agency, any requests which clearly indicate they are a result of the HVP recalls will receive expedited review. Although establishments will still be required to submit information that demonstrates they meet the conditions for temporary approval set forth in 9 C.F.R. 317.4(f) and 381.132(f), the agency’s stated goal is to grant any such applications within 24 hours. Click on the following link to view the FSIS’ Labeling Guidance.

In the event food companies have any additional or specific questions regarding the FSIS labeling guidance, or to the extent they need any additional assistance, they are invited to call the FSIS Labeling and Program Delivery Division at (301) 504-0878 or (301) 504-0879.

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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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According to the FDA, Basic Food Flavors (of Las Vegas, Nevada) has announced a recall of hydrolyzed vegetable protein (HVP) paste and powder. HVP is a common ingredient used most frequently as a flavor enhancer in many processed foods, including soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips and dressings.

The recall of HVP was announced following the discovery of Salmonella Tennessee in certain product samples, along with other samples reportedly collected at the company’s processing facility. In turn, Basic Food Flavors announced a recall all HVP in powder and paste produced and distributed by the company since Sept. 17, 2009. Click on the following links to view a copy of the FDA News Release and FDA Recall Information.

Although, to date, there have been no reported illnesses associated with the consumption of any food products affected by the recall, the FDA and CDC report that they are currently assessing and closely monitoring the potential risks of illness from affected products.

The FDA is also advising industry that any recalled bulk HVP product should be destroyed or reconditioned according to FDA-approved procedures. Click on the following link for Product Handling And Reconditioning Information. Under the guidelines, FDA is allowing companies to recondition potentially affected HVP if thier processing contains protocols validated to inactivate Salmonella. 

Additionally, according to FDA, companies will not be required to recall any food products containing HVP if the products have validated cooking instructions which are sufficient to inactive Salmonella, FDA is recommending that any down-stream food companies that used HVP as an ingredient in food products which might be eaten by consumers without any further processing or cooking to address the potential risk, however, consider recalling such products. Under new FDA guidelines, certian companies may also have reporting obligations under the Reportable Food Registry.

In any event, additional information relating to potentially affected products can be found at www.foodsafety.gov.

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

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services to establish a mandatory reporting registry for potentially dangerous foods. The stated purpose of the amendment was to provide FDA with “a reliable mechanism to track patterns of adulteration in food.” Implementation of the new law, however, was delayed while the FDA worked on developing an effective electronic reporting system.

Now that the Reportable Food Registry (“RFR”) is up and running, a food company may be required to alert the FDA (through the RFR Portal) within 24 hours of becoming aware it has received, sold or shipped a "reportable food." According to the FDA, a reportable food is defined as any food product that has a “reasonable probability” of causing health problems or death in humans or animals. 

Because reporting is only required under specific circumstances, however, any company uncertian about its reporting duties should seek legal advice to determine the extent and scope of any reporting requirements under the RFR.

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

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