Donate Food Generously and With Immunity

By Guest Blogger Matti Neustadt Storie

It’s that time of year again – time to be thankful for all that we have and to reflect on those who don’t have as much. Many people consider working at soup kitchens and donating to local food banks as a way to help. But what liability attaches to those who donate food? Can you get rid of that can of smoked oysters that’s been in the back of the pantry for four years? What if the food you donate is bad? Or people get sick after eating it?

The federal government and most states have considered this and do not want fear of litigation to prevent people from donating to food banks. “Good Samaritan” food donation laws that immunize good-faith donors of food from both criminal penalty and civil liability exist at both the state and federal level. The Bill Emerson Good Samaritan Food Donation Act (the “Act”) is the federal law, and most states (such as Washington) model their acts after it. The Act limits the liability of food donors absent gross negligence or willful misconduct. Except in cases where a donor donates food that does not meet state or federal regulations regarding quality or labeling, it is unlikely that a contractual release or waiver would be effective in overriding these limitations because of public policy concerns. Other states (such as Oregon) have similar laws, but with slightly different language.

The Act states that a person is not subject to civil or criminal liability arising from the nature, age, packaging, or condition of “apparently wholesome food” that the person donates in good faith to a nonprofit organization for ultimate distribution to needy individuals (e.g., a food bank). “Apparently wholesome food” is defined as “food that meets all quality and labeling standards imposed by federal, state, and local laws and regulations even though the food may not be readily marketable due to appearance, age, freshness, grade, size, surplus, or other conditions.” So that four-year-old can of smoked oysters may still be a valid donation!

The Act is drafted very broadly, and the immunity from civil or criminal liability is regardless of who is making the claim – neither the food bank nor the ultimate consumer of the food will be able to sue to donor. Furthermore, the Act indicates that it cannot be construed to create liability due to noncompliance with any aspect of the law. This makes it unlikely that a court will find liability based on mere negligence, for example, if a food product was negligently mislabeled such that it would not technically be “apparently wholesome food.” Absent gross negligence or willful misconduct, no liability will attach.

That said, don’t go digging up your recalled spinach and beef from the past year. Liability may still be imposed when the donor acts in bad faith, with gross negligence, recklessness, or intentionally. And no, that doesn’t mean you can draft a waiver to have the food bank accept the recalled food – in most states a pre-injury release or waiver will not prevent a defendant from being held liable for damages due to gross negligence under public policy arguments. Throw out food that is known to be spoiled, contaminated, or otherwise unfit for human consumption. One would hope this common sense advice is so obvious that it need not be said, but you never know ….

So pack up your excess pantry food – or go out and get some fresh stuff – for your local food bank. Nonperishable foods such as dried beans, peanut butter, canned soups, canned vegetables, and dried pastas are always welcomed. Many food banks will also take perishable foods such as hot dogs, ground beef, butter, eggs, and even (in some states) processed game. If you were lucky enough to bag wild game this season but can’t fit it all in your freezer, contact your local food bank to see if they can accept it. And if you live in southern Illinois or the St. Louis metro area, contact the Food Pantry at St. Mark in Belleville. Tell them Pastor Ron’s daughter blogged about them – Merry Christmas, Dad!

New York Times on the Rise in Unfair Competition Claims: Challenging Competitors' Advertising Is Increasingly an Important Part of an Overall Marketing Strategy

Stephanie Clifford wrote over the weekend in the New York Times about what’s behind the increase in unfair competition claims. Ms. Clifford reports:

The number of complaints over ads from competitors filed with the National Advertising Division of the Council of Better Business Bureaus, the industry’s main self-regulatory program for national ads, is on track to set a record this year. There have been 82 formal complaints so far in 2009, after last year’s record of 84 challenges, a sharp increase from 62 in 2007 and 52 in 2006.

Among a discussion of what it means to file an NAD complaint versus court action and why both seem to be increasing is this salient quote from Linda A. Goldstein at Manatt, Phelps & Phillips, LLP: “How brands will deal with their competitors’ advertisements is an increasingly important component of the overall marketing strategy.”

Take-Aways from November 17 Webinar: Sustainable Foods Increase Litigation Risks: Developing Strategies to Minimize Exposure

On November 17, we held our final webinar in a three-part series on bringing sustainable food products to market. Take-aways from the third webinar include:

• Be aware that "natural" is a hot button when advertising and labeling sustainable food products.

• "Sustainable" is not addressed in FTC Green Guides so it is imperative to be specific with your claim and/or use third-party certification.

• Truitt Brothers packaging/labels depict the source of their ingredients.

• Food-borne illness issues affect all food producers. Large producers have made significant investments in prevention in recent years; small producers of sustainable products without capital to improve farming or manufacturing practices are at a competitive disadvantage and possibly more susceptible to legal exposure from food borne illness claims.

• Food sellers should identify a crisis management team, review supplier agreements and understand insurance coverage to mitigate risk.

• Food sellers should understand that product recall coverage is excluded on most Commercial General Liability coverage forms.

Thanks again to our presenters and attendees. The recorded webcast was archived and is accessible here. Click here to access a PDF copy of the presentation slides.

Stay tuned for a possible new webinar series on food traceability. We're tracking the latest regulatory and legislative developments.

Oil and Water Meet Caffeine and Alcohol: FDA to Look into Safety of Caffeinated Alcoholic Beverages

By Guest Bloggers Tyler Anderson and Stephanie Meier

On November 13, the FDA notified nearly 30 manufacturers of caffeinated alcoholic beverages that the agency intends to look into the safety and legality of their products. As the FDA explained in a news release announcing this action, under the Federal Food, Drug, and Cosmetic Act any substance intentionally added to food, in this case caffeine in alcoholic beverages, is deemed unsafe and is unlawful unless its specific use has been approved by an FDA regulation, the substance is subject to a prior sanction, or the substance is Generally Recognized as Safe (GRAS). To date, the FDA has only listed caffeine as GRAS as an ingredient for use in cola-type beverages in concentrations specified by the agency.

The FDA noted in its release that it is not aware of any basis on which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS sanctioned. Consequently, in its letters to notified companies, including City Brewing, Gaamm Imports, Inc., and United Brands Company, Inc., the agency asked that within 30 days the notified companies “produce evidence of their rationale, with supporting data and information” for their conclusion that the use of caffeine in their products is GRAS or prior sanctioned. If the FDA determines that the use of caffeine in the alcoholic beverages is not GRAS or prior sanctioned, the agency stated it would take “appropriate action to ensure that the products are removed from the marketplace.”

This issue has been fermenting (pun intended) for some time. In the past year, alcoholic beverage industry leaders Anheuser-Busch and MillerCoors agreed to discontinue their popular caffeinated alcoholic beverages Tilt, Bud Extra, and Sparks, and further agreed not to produce any caffeinated alcoholic beverages in the future. In late September 2009, the FDA received letters from eighteen attorneys general and one city attorney and five scientists expressing concerns about caffeinated alcoholic beverages. Among the chief policy concerns cited by these stakeholders was the increasing popularity and consumption of caffeinated alcoholic beverages by college students, coupled with general health risks associated with excess consumption of both alcohol and caffeine.

Manufacturers of alcoholic beverages had been operating under the TTB guideline that caffeine was a permitted but restricted ingredient, and had been warned by TTB and FTC about prohibited and/or deceptive advertising practices related to the effects of combining caffeine and alcohol. If the FDA takes the strong position that caffeine is an illegal additive, these advertising concerns related to caffeine and alcohol will disappear. The TTB and FTC will likely continue to focus scrutiny on other less common alcoholic beverage additives that have been treated like caffeine, such as ginseng, guarana and taurine.

And consumers will turn back to the original Red Bull and vodka for their caffeinated alcoholic beverage.

Tomorrow's (11/17) Webinar on Mitigating the Legal Risks of Sustainable Food Products

Please join me, Steve Marinkovich from Propel Insurance, my colleague at Stoel Rives, Anne Glazer, and Peter Truitt, CEO of Truitt Bros., Inc. tomorrow, November 17, at 9 am PST, noon EST, (live Twitter feed at #sustainlaw) for the last webinar in our 3-part series on Bringing Sustainable Food Products To MarketRegister here.

We will discuss (and respond to your questions):

• Preventing and Dealing with Consumer Fraud, Unfair Trade and False Advertising Claims from Consumers and Competitors

• Real-Life Businesses Approaches to Sustainability, Product Labeling and Marketing

• Coping with Increased Risks of Food-Borne Illness from Local or Small Farm Products

• Insurance Coverage You Need, Think You May Have but Don’t Have or Think You May Want but Shouldn’t Get

Delio v. McDonald's Corp.: The Connecticut Grilled Chicken Case

It took our intrepid docket clerk a few weeks of digging, and finally contacting the plaintiffs' counsel directly, to get a copy of the complaint in Delio v. McDonald's Corp., a case filed in Superior Court in Hartford County, Connecticut on October 6.  Plaintiff's counsel is Robert Solomon, a clinical professor at a small New Haven law school called Yale, along with Daniel Kinburn of The Cancer Project. 

Unlike the Denny's suit on which both Ken and I have blogged previously, the Conneciticut Grilled Chicken case is remarkably streamlined in its allegations and the remedies sought.  The named plaintiffs in the class action suit are two Connecticut residents who consumed grilled chicken products at McDonald's, Burger King and Friendly's stores in Connecticut between October 21, 2006, the date on which the complaint claims McDonald's and Burger King were warned their grilled chicken products were tested to show they contained PhIP, or 2-Amino-1-methyl-6-phenylimidazo[4,5-b]pyridine, a carcinogen, and October 17, 2008, when the plaintiffs allegedly became aware of the cancer-causing effects of grilled chicken.  The remedy claimed, beyond what would be nominal damages for the named plaintffis' purchase of grilled chicken products, is an injunction under the Connecticut Unfair Trade Practices Act which would require warning labels to sell these defendants' grilled chicken products.   They also seek punitive damages and attorneys' fees, although the complaint's allegations on those points appear thin.

The complaint is quite readable.  Missing are claims of violations of a warranty of merchantibility, or similar claims.  The plainitffs appear more willing, instead, to focus solely on their judicial attempt to require a warning label, and then only in Connecticut.  Without getting into the validity of their claims, or their motives (which have been questioned by others), this is at least a style of litigation that focuses solely on the issue of food safety and an appropriate remedy. 

There are some interesting questions in the case, however.  One is why Friendly's was added as a defendant.  It is not for the usual reason, an attempt to keep the case from being removed to federal court, because Friendly's is incorporated and headquartered in Massachusetts.  But the allegations about testing of products relate only to McDonald's and Burger King; there is just an allegation that Friendly's "is assumed to be aware of health issues pertinent to restaurants anywhere in the United States" and and even more conclusory, "Upon information and belief, Defendants' grilled chicken products are prepared in the same manner throughout the United States."  What is missing, though, is any direct allegation that anyone has tested Friendly's grilled chicken products and found they contain PhIP. 

The broader question is why this claim is appropriate for judicial resolution, as opposed to legislative or agency action.  If the plaintiffs are right, one presumes the issue is not limited to McDonald's, Burger King and Friendly's, yet the relief requested, if granted, would apply only to them, and only in Connecticut.  One assumes the plaintiffs desire that if granted their relief, at least every restaurant grilling chicken in Connecticut would follow suit in putting their desired warnings in place, but enforcement would only be by additional separate suits that would require proof in each instance.  That is cumbersome and inefficient and does not protect the public if the public needs to be protected. 

KFC just came out with a huge ad campaign for Grilled Chicken; they are not defendants.  TV chefs promote grilled chicken all over television; they are not defendants.  Barbecue manufacturers encourage their customers to use their grills to grill chicken; they are not defendants.  Chicken producers encourage their customers to grill their chicken products; they are not defendants.  I have no idea whether any of these products contain PhIP, but if there is to be a conversation about the health impacts of grilled chicken, I would think they should all be at the table.  And with all due respect to the Hartford County Superior Court, I'm not sure one of its judges is the right person to have at the head of the table. 

Hurdles Faced By Plaintiffs In Class Action Lawsuit for Sale and Marketing of Cold and Flu Medications Containing Vitamin C

By Guest Blogger Tyler Anderson

On November 2, we blogged about the FDA warning letter issued to Procter and Gamble for its unlawful marketing of Vicks cold and flu medications containing Vitamin C. On November 4, 2009, a putative class action lawsuit was filed against Procter and Gamble in the U.S. District Court for the Southern District of Ohio (Sixth Circuit) alleging Procter and Gamble violated federal and state consumer protection laws through false and misleading advertising practices regarding the two Vicks products mentioned in the FDA warning letter.

Regardless of the merits of their case, the plaintiffs in this action may have a hard time obtaining their desired relief. In Count 1 of the complaint, the plaintiffs allege Proctor and Gamble violated the consumer protection laws of 43 separate states. The Seventh Circuit’s holding in its Bridgestone/Firestone decision (J. Easterbrook) and its progeny, suggests that under FRCP 23(b)(3), such a class action is unmanageable. Courts point to the impracticability of one court applying the divergent laws of differing jurisdictions in circumstances such as those at bar.

“Plausibility” pleading standards (see recent discussion of Wright v. General Mills) present additional hurdles. Applying Twombly as the court did in the Wright case, to survive a motion to dismiss the plaintiffs would need to make plausible, non-conclusory allegations that the plaintiffs purchased the Vicks products because they contained Vitamin C and the cost of the product with the Vitamin C was greater than it would have been without. No such allegations exist here, so applying the holdings of Twombly and Wright to this claim indicates that it may be subject to dismissal.

“Reliance” may be yet another avenue to dismiss the action (at least in part). Many state consumer fraud statutes require reliance. This means that the plaintiffs would be required to show that each plaintiff in the action bought the product in reliance on the purported fraudulent statement. Because purchasing decisions are individual decisions, proving reliance on a class-wide basis would be an individual inquiry that would predominate over issues of fact common to the class, which would negate class treatment.

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:

• With the exception of the FDA’s policy on “natural” claims, it has been silent on “green claims.”

• “Natural” could be hottest claim on the market but is becoming controversial. Food companies should continually monitor the marketplace to see which claims are drawing challenges.

• Food companies should pay attention to consumers union findings regarding eco-label credibility.

• While third-party certification may not help every food business, certification is a tool that supports your brand and your marketing/sales strategy.

• Retail leaders in sustainability, such as Burgerville, aspire for continuity of sustainability in each link in its supply chain.

• To understand the FTC green guidelines companies need to appreciate three key points: substantiation, specificity and qualification.

• To avoid “green washing” issues, food companies need to understand the complex matrix of federal, state, local and foreign statutes, regulations and guidelines governing “green” advertising.

I hope you can join me, Steve Marinkovich from Propel Insurance, my colleague at Stoel Rives, Anne Glazer, and Peter Truitt from Truitt Bros., Inc. on November 17, at 9 am PST, noon EST, (live Twitter feed at #sustainlaw) for the last webinar in the series as we discuss the following:

• Preventing and Dealing with Consumer Fraud, Unfair Trade and False Advertising Claims from Consumers and Competitors

• Real-Life Businesses Approaches to Sustainability, Product Labeling and Marketing

• Coping with Increased Risks of Food-Borne Illness from Local or Small Farm Products

• Insurance Coverage You Need, Think You May Have but Don’t Have or Think You May Want but Shouldn’t Get

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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.  I did a Google search on the topic "onion flu remedy" and while a couple of articles came up debunking the idea (including Ms. Beck's), far more were articles claiming that the home remedy was in fact effective. 

I turned then to Snopes.com, the great arbiter of urban legends, and it's verdict was unequivocal:  false.  The article did a nice job of tracing the history of onion/flu fetishism well into the nineteenth century, though I suspect one can go further, perhaps to ancient Rome and Greece. 

Unlike most quack claims made for flu remedies, the onion cure at least has the advantage of being inexpensive and, particuiarly if you're using raw, unpeeled onion, completely benign. 

Ms. Beck was, however, quite positive on my own family's way of dealing with any form of illness, chicken soup.  Her article even includes a chicken soup recipe, which is not too far from the recipe my family has used for generations (although the key to ours is a kosher chicken).  Chicken soup may not cure anything (though the title of an abstract listed at the bottom of recipe suggests it might), but it sure feels good on a sore throat.

Marketing Missive: FDA Issues Warning Letter to Procter and Gamble for Unlawfully Marketing Cold and Flu Medications Containing Vitamin C

By Guest Blogger Tyler Anderson

On October 29, 2009, the FDA issued a warning letter to Procter and Gamble notifying the company that its “Vicks DayQuil Plus Vitamin C” and “Vicks NyQuil Plus Vitamin C” are illegally marketed combinations of drug ingredients and a dietary ingredient. Both of the over-the-counter (OTC) medicines, which contain Vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA issued the warning letter (1) to clarify that these single dosage form combinations of drug ingredients and dietary ingredients cannot legally be marketed because they have not been proven safe and effective, and (2) because the agency has previously determined that there is not sufficient data to show that Vitamin C is safe and effective in preventing or treating the common cold.

Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. The FDA found the two Vicks products did not comply with the applicable FDA monograph, and therefore the products must first be evaluated and approved under the agency’s new drug approval process before they can be legally marketed.

Some Take-Aways from ACI's 3rd National Forum on Food-Borne Illness Litigation

American Conference Institute (ACI) recently held its latest conference on food-borne illness litigation. The conference has been a fairly intimate gathering of the nation’s lawyers, insurers and experts involved with food-borne illness litigation.

This year, I had the privilege of moderating an in-house counsel “think tank.” The panel was composed of lawyers from a nice cross-section of food businesses: Yum Brands, Hormel, Fresh Express and SUPERVALU (though for each, food-borne illness litigation is a rare event)  A slide-deck from the panel can be found here.

Also among the presenters at this year’s conference were Center for Disease Control’s (CDC) Dr. Arthur Liang and USDA/FSIS representative Dr. Dan Engeljohn. Both presentations provided fascinating insight into changes afoot in food safety enforcement and policy at the federal level. Here are some of the take-aways:

“Outbreaks Waiting to Be Discovered” – Dr. Liang opined that, based on surveilled illnesses, most food-borne illness outbreaks are not presently discovered. He believes that recent data shows that there are perhaps 2-3 times more outbreaks nationally than what’s been uncovered over the last few years.

• Food Safety Progress Being Undone by Retail Deli Operations – FSIS says there has been a “steady increase in risky behavior at the retail level.” According to Dr. Engeljohn, budget authority is being sought to intervene with retailers, particularly smaller supermarket deli operations.

Negative Tested Product Can Be Considered Adulterated - FSIS will be issuing a policy soon that for the first time will consider a “negative tested product to be determined adulterated” under circumstances where an associated product tested positive for pathogens.

Non-0157 STECs - FSIS will be finalizing methodology to detect non-0157 Shiga Toxin-Producing Escherichia coli (STEC).