I Was Dooped by the Loops of Froot

What a shock to find out that Froot is not fruit. What next, no good luck from Lucky Charms? However, I am (pretty) sure Fruity Pebbles do not contain real pebbles.

Kevin Underhill at Lowering the Bar (legal humor, seriously) shares some humor at the expense of yet another consumer alleging being duped into thinking Froot Loops contained real fruit.

“[Plaintiff] was misled by the packaging and marketing, which by design and intent convey the message that the Product contains real, nutritious fruit," alleges Werbel about a product named "Froot Loops."  The complaint continues, "[h]ad he known that 'Froot Loops' contained no fruit, he would not have purchased it."  This, of course, is pleaded as a class action, and Werbel alleges that the manufacturer's practices with regard to Froot Loops "present a threat to members of the general public . . . ."  Oh, the humanity.

By my count, these are the sixth and seventh lawsuits in California against the manufacturers of these two fictitiously named cereals.  But hey - just because you are 0-5 and your arguments have been openly mocked by judges as well as a large percentage of the nation's bloggers does not mean you shouldn't give it one or two more tries. It does mean that, presumably, PepsiCo and Kellogg's are highly unlikely to settle, and that in two or three months plaintiffs should be 0-7.

Kevin Underhill swiped at earlier plaintiffs, who alleged they were led to believe that "Crunch Berries" and/or "Froot Loops" are made with real fruit, “I still think this is like claiming emotional distress because you just learned "The Hobbit" isn't a true story.”

In light of this case, SF Weekly has issued a “corporate caveat noting that, while our offices are located at 185 Berry Street, our publication should in no way be considered a nutritious source of fruit.”

Defect Action Levels (The Maggots in Your Mushrooms)

It is economically impractical to produce food that is completely free of all naturally occurring defects. Non-hazardous defects that are unavoidable by good manufacturing practices are subject to tolerances, which the Food and Drug Administration (FDA) lists as “Defect Action Levels.” 

E. J. Levy had an interesting op-ed piece recently on this topic: 

You may be grossed out, but insects and mold in our food are not new. The F.D.A. actually condones a certain percentage of “natural contaminants” in our food supply — meaning, among other things, bugs, mold, rodent hairs and maggots.

In its (falsely) reassuringly subtitled booklet “The Food Defect Action Levels: Levels of Natural or Unavoidable Defects in Foods That Present No Health Hazards for Humans,” the F.D.A.’s Center for Food Safety and Applied Nutrition establishes acceptable levels of such “defects” for a range of foods products, from allspice to peanut butter.

Among the booklet’s list of allowable defects are “insect filth,” “rodent filth” (both hair and excreta pellets), “mold,” “insects,” “mammalian excreta,” “rot,” “insects and larvae” (which is to say, maggots), “insects and mites,” “insects and insect eggs,” “drosophila fly,” “sand and grit,” “parasites,” “mildew” and “foreign matter” (which includes “objectionable” items like “sticks, stones, burlap bagging, cigarette butts, etc.”).

Tomato juice, for example, may average “10 or more fly eggs per 100 grams [the equivalent of a small juice glass] or five or more fly eggs and one or more maggots.” Tomato paste and other pizza sauces are allowed a denser infestation — 30 or more fly eggs per 100 grams or 15 or more fly eggs and one or more maggots per 100 grams. . . .

E. J. Levy, The Maggots in Your Mushrooms, New York Times (Feb. 12, 2009).

For more fun and to amaze and gross out your friends:  FDA’s  Defect Levels Handbook: The Food Defect Action Levels — Levels of natural or unavoidable defects in foods that present no health hazards for humans.

Bon appétit!

Greg Jaffe Seminar on Genetically Engineered Food Oct 20 at Michigan State University

Larry King Blows It On Unsafe Meat

Marion Nestle’s comments about Larry King’s show on meat safety, Larry Kings Blows It On Unsafe Meat, is available in TheAlantic.com.  A clip from the show, of Bill Marler’s reaction to Larry King butchering the term, “E. coli” appeared on David Letterman Show right near the end of the monologue (three minutes in).

More Soda Tax News

The Food Law Prof Blog, Soda Tax in the News, has a compilation of articles on proposed taxes on sugar sodas:

• Food Law Prof Blog on President Obama's thoughts. 

• "A recent study by a star-studded cast of nutrition and obesity experts published in the New England Journal of Medicine this week is stirring things up. :The Public Health and Economic Benefits of Taxing Sugar-Sweetened Beverages, (by Kelly D. Brownell, Ph.D., Thomas Farley, M.D., M.P.H., Walter C. Willett, M.D., Dr.P.H., Barry M. Popkin, Ph.D., Frank J. Chaloupka, Ph.D., Joseph W. Thompson, M.D., M.P.H., and David S. Ludwig, M.D., Ph.D.)"

• New York Times, Sept. 16, 2009: Proposed Tax on Sugary Beverages Debated

• ABCNews.go.com, Sept. 16, 2009: Public Health Leaders Propose Soda Tax 

The Precautionary Principle Is Not The Answer

“Better safe than sorry,” is a well known aphorism because it contains a lot of sense. The precautionary principle allures us with words that sound similar to common-sense precaution. 

Unfortunately, the principle is a both a shape shifter and a chameleon. The term can shift in meaning to support whatever side one wishes to take on an issue. Worse, the principle appears to—but does not—provide us guidance in dealing with uncertain risk. The principle appears effective only because it compares uncertain risk against implicit zero risk for the status quo. 

In the real world, difficult questions of uncertain risk are problems of benefits versus risks, risks versus risks, and benefits and risks versus alternative benefits and risks. The principle is at its worst in guiding us with risk versus risk situations. The precautionary principle advises us to avoid both risks—but how do both take action and inaction at the same time? Or as Michael Crichton said, “The precautionary principle properly applied forbids the precautionary principle. It is self-contradictory.”

Ronald L. Doering has written a pithy essay, “The Precautionary Principle Is Not The Answer,” that uses excellent examples to illustrate the fundamental flaw with the using the precautionary principle as an approach to deal with risk versus risk:

If the hazard of DDT, for example, were a possible threat to the environment, then the application of the precautionary principle would be to ban the product until the science is clearer. If the hazard is malaria causing mosquitoes and the million persons killed (and the 300 million made seriously ill) by malaria each year then wouldn’t the principle support taking action to continue to use the product until the science is more certain? A principle that is this malleable cannot be a reliable guide to decision making, but it is still often used as a justification for a decision taken for other reasons.

Or consider the fortification of enriched flour with folic acid. The risk of neural tube defects (major birth defects of the brain and spine, such as spina bifida) can be reduced by 50-70 percent if women receive folic acid supplementation starting three months before becoming pregnant. An estimated 1,000 more babies are born healthy each year because of mandatory fortification of foods with folic acid in the US. 
On the other hand, there are unknown risks of folate fortification for the majority of consumers who receive no benefit from increased folate. A recent study showed there might be a link between high intakes of folic acid and possible increased risk for colon cancer.
The precautionary principle supports mandatory fortification with folate. Rather than take the risk of inaction while the science is uncertain about the risks of fortification, it is better to be safe and prevent a thousand newborns a year from major birth defects. Accordingly, the US in 1994 and Canada in 1998 mandated fortification of certain flours and breads. “Applying the same principle, Britain and Ireland declined to require mandatory fortification.”

FTC's Revised Guides Governing Endorsements, Testimonials

The Federal Trade Commission (FTC) revised its guidance to advertisers on how to keep their endorsement and testimonial ads in line with the FTC Act.  Changes to the FTC’s Guides Concerning the Use of Endorsements and Testimonials in Advertising address endorsements that feature a consumer and convey his or her experience with a product or service as typical when that is not the case will be required to clearly disclose the results that consumers can generally expect.  Advertisers no longer can consider a disclaimer, such as “results not typical,” to be a safe harbor.

More information is available here.  The text of the Federal Register Notice is here.

GMA's 2010 Food Claims and Litigation Conference - Feb. 23-25 - Austin, TX

The Grocery Manufacturers Association's 2010 Food Claims and Litigation Conference is scheduled to take place February 23-25, and will be held at Barton Creek in Austin, Texas.  Nationally recognized authorities from the food, legal, and scientific communities will present up-to-the-minute information on:

-Recent Developments in Product Liability

-Emerging Trends in Foodborne Illness Litigation

-Micro-Contaminants in Food: Emerging Legislative, Regulatory and Litigation Trends

-A Thirty-Year Retrospective on Trial Sciences

-Food Allergens: Understanding the Science and Avoiding the Pitfalls

-Mass Tort 911: The Company's Been Sued! Now What?

-What Every Food Industry Defense Lawyer Needs to Know About Bankruptcy

-Recent Preemption Rulings May Be Opening the Floodgates of State Law Consumer Fraud in Labeling Class Litigation

-The Recall Playbook: Offense and Defense

-Flavoring Litigation: Current Status and Latest Regulations And Their Effect on Future Litigation

-Trends in Global Food Litigation:  Class Actions and Collective Redress

More information is available here.

It is Time for the Food Safety Enhancement Act

H.R. 2749 passed in the House of Representatives. Now is the time for the Senate to vote.

Bill Marler predicted that food safety legislation would pass Congress by Thanksgiving and be signed by the President before Christmas. Predicting the movement of Congress is difficult. Sometimes only a shocking event can prod Congress to action. Tainted cookie dough may have been the last straw for the House passage of H.R. 2749.

Senators, what are you waiting for?

The Congressional Research Service (CRS) a nonpartisan arm of the Library of Congress prepared the following summary of H.R. 2749:

As of 6/8/2009--Introduced. Food Safety Enhancement Act of 2009 - 

 ·    Amends the Federal Food, Drug, and Cosmetic Act to set forth provisions governing food safety.

 ·    Requires each food facility to: (1) conduct a hazard analysis; (2) implement preventive controls; and (3) implement a food safety plan.

 ·    Requires the Secretary of Health and Human Services to: (1) issue science-based performance standards to minimize the hazards from foodborne contaminants; (2) establish science-based standards for raw agricultural commodities; (3) inspect facilities at a frequency determined pursuant to a risk-based schedule; (4) establish a food tracing system; (5) assess fees relating to food facility reinspection and food recall; and (6) establish a program for accreditation of laboratories that perform analytical testing of food for import or export.

 ·    Authorizes the Secretary to: (1) order an immediate cessation of distribution, or a recall, of food; (2) establish an importer verification program; and (3) quarantine food in any geographic area within the United States.

 ·    Defines the term "color additive" to include carbon monoxide that may affect the color of fresh meat, poultry products, or seafood.

 ·    Requires country of origin labeling on food and annual registration of importers.

 ·    Provides for unique identifiers for food facilities and food importers.

 ·    Deems a food to be adulterated if an inspection is delayed or refused.

 ·    Requires the Secretary to establish a corps of inspectors dedicated to inspections of foreign food facilities.

 ·    Sets forth provisions governing the reorganization of Food and Drug Administration (FDA) field laboratories and district offices.

 ·    Gives the Commissioner of Food and Drugs subpoena authority with respect to a food proceeding.

 ·    Establishes whistleblower protections.

For further thoughts:

•      Bill Marler’s summary
•      New York Times Editorial, Vote for Safer Food 
•            Hearings of the Subcommittee on Health

Dannon Settles False Ad Suit for $35 Million

Noreen O'Leary reports that the law firm, Coughlin, Stoia, Geller, Rudman & Robbins, secured a $35 million settlement with Dannon over allegedly misleading ads and labeling of  Activia and DanActive yogurt products. Under the stipulation of settlement, Dannon also agreed to change the way it markets and labels these products.

Now CSGR&R is pursuing a similar complaint against General Mills and its Yoplait Yo-Plus yogurt. The complaint against Yo-Plus alleges, "General Mills has no support for these claims, even though it states that it does, going so far as to claim it has clinical proof. General Mills' representations are false, misleading and reasonably likely to deceive the public."

A rep for General Mills, which began to market Yo-Plus in August 2007, said: "As a standing practice, we don't comment on pending litigation."

Noreen O’Leary also wrote, “Junk Science: 'Functional' foods promise good health -- but can they deliver?"

That Model of Poor Legal Drafting

My morning distraction was reading the Hatch-Waxman 25^th Anniversary Trivia by Kurt Karst. My favorite part is the exchange between Judge Roger W. Titus, U.S. District Court for the District of Maryland, and Gerald C. Kell from the Department of Justice (December 21, 2006) in Biovail Corporation. v. FDA:

THE COURT:  [After asking detailed questions about the Federal Food, Drug, and Cosmetic Act.]  All right.  There’s a special place in Hell where they torture people who write things like this.  For 14 years I was on the Rules Committee of Maryland’s Court of Appeals that didn’t have as many subsections as this, so I would flunk the person who gave me this as a draft rule.  I would say this is 50 rules.

Anyway, I wanted to wander into the right place of this endless section.  When I first went to Westlaw and said, just give me section 355, it had to tell me it was going to be 85 pages.  I said, no, no, no, no.  Let’s try (j), and I get this huge thing here.

ATTORNEY:  Well I hope that our brief lays out the precise subsections, Your Honor.  I believe it does.  But that is the sum of my argument, unless the court has any further questions.

THE COURT:  No.  You’ve been very helpful.  I’m glad to have somebody here who knows what they’re talking about.

ATTORNEY:  So am I, Your Honor.  It’s just not me.  Thank you.

THE COURT:  Thank you.  

To protect the public and to put a trial lawyer out of business

A clever blog post by Bill Marler, "New Food Safety Legislation is needed - to protect the public and to put a trial lawyer out of business."

USDA Reopens Comments on Use of "Natural"

The U.S. Dept. of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) has issued an Advance Notice of Proposed Rulemaking (ANPRM) to seek additional comments from the public on the conditions under which FSIS should permit the claim “natural” in the labeling of meat and poultry products. After considering the more than 12,000 comments on “natural” submitted in response to a Federal Register notice that the Agency issued on Dec. 5, 2006, and the comments presented at a public meeting held by the FSIS on Dec. 12, 2006, FSIS has decided to solicit additional public input.

FSIS is soliciting further comments on numerous issues. More information is available in 74 Federal Register 46951-46957 (Sept. 14, 2009). Comments are due by Nov. 13, 2009.

Additional reading: Ricardo Carvajal, FSIS Has Second Thoughts On Issuing a Proposed Rule to Define “Natural”.

Fish Detective Busts Restaurant Switcharoos

The NPR Health Blog’s Scott Hensley has an interesting short piece concerning economic adulteration. Restaurants sometimes substitute cheaper fish for more expensive species, like grouper and red snapper. You can read the blog post here. Particularly interesting are the precocious New York high school students who used genetic testing to detect adulteration in the Big Apple’s restaurants and markets. Half the restaurants and six of ten grocery stores had mislabeled fish.

Hungry for Change

Kristin Choo, wrote a nice article, “Hungry for Change: The feds consider a steady diet of stronger regulation to help fix the U.S. food safety network, for the September 2009 Issue of ABA Journal. She did a fine job summarizing a complex subject. You can read the article here.

FDA USDA Letter to the Smart Choices Program

Advising the Smart Choice program that the agencies will be scrutinizing their front-of-the-pack nutrition label, the August 19 letter noted that consumer research indicates people are less likely to check the Nutrition Facts label on the back or side panel of foods with front-of-pack labeling. Therefore, “it is essential that both the criteria and symbols used in front of package and shelf-labeling systems help consumers make healthy food choices.”

These labels and symbols have proliferated in recent years. FDA and USDA noted that they will, “monitor and evaluate the products as they appear and their effect on consumers' food choices and perceptions.FDA and FSIS would be concerned if any FOP labeling systems used criteria that were not stringent enough to protect consumers against misleading claims; were inconsistent with the Dietary Guidelines for Americans; or had the effect of encouraging consumers to choose highly processed foods and refined grains instead of fruits, vegetables, and whole grains.”

FDA announces comment period on Internet survey on barriers to food label use

In 74 Fed. Reg. 42676 (Aug. 24, 2009), the Food and Drug Administration (FDA) has announced an opportunity for public comment on a proposed voluntary Internet survey to assess barriers to food label use by consumers. Analyses or previous surveys have shown a sharp decline in food label use between 1994 and 2002, especially among consumers younger than 35 years old. The purpose of this survey is to learn the reasons for this decline in label usage. “The study goals are to: (1) identify attitudes and beliefs among consumers toward health, diet and label usage; (2) determine relationships between those attitudes and beliefs, as well as demographics, with food label use and non-use; and (3) evaluate the relative importance of these attitudes between consumers of various age groups to determine whether barriers to label use differ between younger consumers and older consumers.” Comments on the proposed information collection should be submitted by October 23, 2009.

Don't Eat That! Legal Issues in Food Safety

On Wednesday, September 16, 2009, a 60-Minute ABA Teleconference will held from 1:00 to 2:00 PM (eastern time), “Don't Eat That! Legal Issues in Food Safety.” The program description reads:

It seems that hardly a month goes by without a story about American food shoppers falling prey to another nasty pathogen lurking in the local supermarket. Several well-publicized outbreaks of food-related illness have created a rare political alignment. Angry consumers and a food industry haunted by the double specter of bad publicity and lawsuits both appear ready to embrace actions by the federal government to make the U.S. food supply safer, and the federal government has begun to take some of those steps.

In March, President Barack Obama announced the formation of a Food Safety Working Group to develop proposals for upgrading federal food safety laws and improving coordination among at least a dozen federal entities that share responsibility for the safety of the nation’s food supply. Some of the working group’s recommendations already are being put into effect.

Meanwhile, legislation has been introduced in Congress that would dramatically increase the oversight power of the Food and Drug Administration over much of the food sold in the United States, including imports. It appears certain that the legal framework for regulating food safety in the United States is going to change, and lawyers—especially those who represent companies in the food industry—are going to have to hustle to keep up.

What sorts of changes are likely and how effective they will be is currently being debated. While some see a consensus around the need for sweeping reform, others are concerned that proposals in the works are over-broad and will be detrimental to organic farmers and small producers among others.

Join our distinguished group of experts as they discuss the current situation of food safety law changes.

The Panelists are:

Neal D. Fortin, Director, Institute for Food Laws and Regulation, Michigan State University, East Lansing, MI

James T. O'Reilly, Professor, University of Cincinnati, Chair, FDA Committee, American Bar Association Section of Administrative Law and Regulatory Practice, Cincinnati, OH

Stuart M. Pape, Managing Partner, Patton Boggs LLP, Washington, DC

Register by phone at: 800.285.2221 or online at: http://www.abanet.org/cle/connection.html.

FDA Guidance on Labeling of Certain Beer Products

The Food and Drug Administration (FDA) issued draft guidance on the labeling of non-malt This blog discussed some of the issues involved in When Beer is not Beer. Beer-like products without malted barley or that are made without hops, fall under FDA rather than the Alcohol and Tobacco Tax and Trade Bureau (TTB). The guidance advises the industry on how to label "beers" that are subject to the FDA's labeling requirements under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.

FDA's new draft guidance, "Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration," specifies the mandatory information required on the labels of these non-malt beers. Manufacturers of non-malt beers are expected to comply with the FDA's labeling requirements by Jan. 1, 2012. The Federal Register notice (74 FR 41438) can be viewed on the GPO Access web site and the guidance can be viewed on the FDA website.

Weasel Words (AKA Disclaimer)

One humorous disclaimer I saw on a legal blog:

“this is not legal advice, this is a general information blog post on the internet. (And if it's on the internet, it's gotta be true, right? Uh ... no.) If you haven't paid me a retainer, you are not (yet) my client and should not rely on any of this information to make any decisions. The law is complicated. The facts even more so. If I could have learned the law by reading blogs, I'd ask for money back from those three plus years of hell I paid for in law school.”

You can catch F. Bennett Callicoat’s blog and disclaimers at the Tulsa Bankruptcy and Consumer Law blog.