Food Labeling Workshop at MSU July 28-29

Institute for Food Laws & Regulations
	» Hurry, registration is limited Food Labeling Workshop   July 28-29, 2010   ·   Lansing, Michigan This workshop presents the FDA requirements for US food labeling.  The workshop format and materials are designed to provide a user-friendly approach for those new to food labeling and also provide a thorough system and reference for those experienced with food label design and review.  The workshop format allows time for questions. The focus is practical, and students are encouraged to bring problem labels for hands-on review.     For more information, click here. Early bird discount (by May 14, 2008):  $895 Register Online or Download a Registration Form (PDF)    Free Bonus Workshop participants will receive the Guide to U.S. Food Labeling Law (Vol. I) by Peter Barton Hutt, Esq. The Guide provides practical guidance and expert advice on FDA, FTC, and USDA labeling requirements in plain English. The Guide is an invaluable resource for regulatory officials, industry personnel, and anyone reviewing food labels.  The Instructors Neal Fortin, is Professor and Director of the Institute for Food Laws & Regulations, Michigan State University.  His law practice experience concentrated on food law, labeling, ingredient evaluation, advertising, legislation, and administrative law. Professor Fortin also has 20 years experience in food regulatory work with the state of Michigan, including being the primary drafter of Michigan Food Law of 2000.  He has trained more than 1,500 people on the labeling law.  Constance Henry, U.S. Food and Drug Administration (FDA).  James E. Hoadley is a senior consultant with EAS Consultant Group. In Dr. Hoadley's 20-year FDA career he served ten years a Senior Regulatory Scientist in the Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) with primary responsibilities in food label claim regulations. Dr. Hoadley has been directly involved in the scientific review and drafting of authorizing regulation, or denials, of nearly all health claim petitions received by CFSAN over the last decade. Dr. Hoadley has received the CFSAN Distinguished Career Service Award.  John Spink is the Director of the Packaging for Food and Product Protection Initiative at Michigan State University (MSU) and a faculty at the MSU School of Packaging. John developed and teaches the graduate classes “Packaging for Food Safety” and “Food Protection & Defense – Packaging Module”, and the “Future of Sustainability.” IFLR Internet Courses International Food Laws and Regulations Food Regulation in the United States Food Regulation in the European Union Food Regulation in Latin America Food Regulation in Canada Codex Alimentarius (The Food Code) IPPC (International Plant Protection Convention) Food Regulation in Asia New Summer Course Offering:  Animal Health, World Trade, and Food Safety (OIE)  Learn more about IFLR at: www.IFLR.msu.edu or call (517) 355-8295       Email: IFLR@msu.edu                       Telephone: (517) 355-8295 Fax: (517) 432-1492                        web: www.IFLR.msu.edu    Institute for Food Laws and Regulation Michigan State University, 140 G.M. Trout Building, East Lansing, MI 48824

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More Frooty Claims

A class action lawsuit was refilled against Kellogg USA alleging that “Froot Loops”—here’s the shock—contain no actual fruit!  The plaintiff said he was duped by the “brightly colored cereal made to resemble fruit” depicted on the package, the use of the word “Froot,” and depictions of real fruit on the label.“ He finds these practices likely to mislead and deceive a ‘reasonable consumer’ such as himself . . .”  The plaintiff, Roy Werbel, claims he was deceived over a four year period when he bought the cereal.

I sympathized with Mr. Werbel’s plight. I really do. Really. Assuming he honestly ate Froot Loops for four years believing they were made from real fruit. Nonetheless, I am finding it hard to believe enough similarly situated consumers are out there for a class action.  Can there really be a whole class of reasonable consumers that eat neon-colored, candy flavored loops of froot for the real fruit content?

You can read more here: Froot Loops’  complaint. I wrote about an earlier complaint here: “I Was Duped by the Loops of Fruit.” The case, Roy Werbel v. Kellogg USA, Case. No. CV 10-1660 EMC, was filed in the U.S. District Court for the Northern District of California on April 19, 2010.

If you had any doubts about globalization of food

With Flights Grounded, Kenya's Produce Wilts by Jeffrey Gettleman of the New York Times discusses how the volcanic eruption in Iceland has devastated the horticulture businesses in Kenya. Horticulture is Kenya's top foreign exchange producer and a critical piece of the national economy.

Consumer Representatives Needed for FDA Advisory Committees

Do you want to make a difference in FDA’s decision-making? Do you have ties to consumer groups or community-based organizations? Can you analyze scientific data? If so, plan to attend FDA’s public meeting on April 30, 2010, in Rockville, Md., to learn what it takes to become a consumer representative on FDA’s advisory committees and panels. More information is available here.

Proposed Free Speech About Science A...

Peter M. Jaensch, in his blog post Proposed Food Labeling Changes May be Hard for Pharmaceuticals to Swallow, provides a snapshot introduced H.R. 4913–-the Free Speech About Science Act of 2010, which would amend the Food, Drug, and Cosmetic Act (FD&C Act) to expand disease and health-related claims in the labeling of some foods and dietary supplements. The bill would also add a new subsection to FD&C Act to permit certain claims "to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases" in labeling for dietary supplements. These changes, Jaensch notes, "would permit food and dietary supplement manufacturers to make claims similar to those typically made for drug products, without subjecting them to the same degree of oversight or requiring the same depth of scientific analysis."

More efficient methods of food-recall notices needed

MSU professor Ewen Todd discussed food recalls at the American Association for the Advancement of Science (AAAS) meeting. "As our food supply becomes increasingly global and interconnected, food recalls that were largely regional in the past have the potential of injuring vast numbers of consumers across the United States in relatively short periods of time," Todd said. "For this reason, time is of the essence in delivering targeted recall messages to consumers through various means to reduce the risk of illness. Direct phone calls, e-mail messages and even Facebook are now being explored for a more targeted approach, as opposed to the more traditional media and word of mouth."

Menu Nutrition Labeling and Consumer Choices

Information is beginning to come in on the effect of providing nutrition information on menus in chain restaurants. The result is consumers make lower calorie selections.  Here are some of the studies and commentaries:

The Stanford Graduate School of Business study, Calorie Posting in Chain Restaurants, looked at the effect of mandatory calorie posting on Starbucks stores in New York City. Customers averaged six percent less calories per transaction.

An Atlantic article, Calorie Labeling Works, II, which also references New York City health department's Preliminary  Data from New York City , and a Yale study, Evaluating the Impact of Menu Labeling on Food Choices.

Nutrition Menu Labeling May Lead to Lower-Calorie Restaurant Meal Choices for Children in Pediatrics, which found that when nutritional information is available on menus, on average pick lower-calorie foods for their children. In BusinessWeek, Listing Calories on Fast-Food Menus Cuts Kids' Intake, quotes Dr. Pooja Tandon: "When parents are provided with calorie information they chose about 100 calories less [per meal] for their 3- to 6-year-old child compared to parents who didn't have that information."

The Wall Street Journal, Restaurants Begin to Count Calories, notes, "Restaurants from Applebee's to Starbucks are pushing new low-calorie menu items in an effort to attract customers who say they want healthier options.  Chain restaurants, traditionally known for peddling fatty food and sugary drinks, hope that offering healthier fare will give them a competitive advantage, especially with the prospect of a federal nutrition labeling law looming."

How Great is the Burden of Foodborne Illness?

Susan Jones, “Counting the global burden of foodborne disease,” Speaking of Medicine (Nov. 2, 2009):

[Y]ou may be surprised to find that the global burden of disease attributable to foodborne illness, which is perhaps the most basic information needed to push forward research and action on foodborne illness, is not known. Why is there such an apparent lack of interest in documenting the scope of illnesses that affect people from all countries? One reason may be a common misconception that foodborne diseases are mild and self-limiting. A second and very important reason is that it’s often incredibly difficult to attribute foodborne illnesses and deaths to a specific foodstuff. And a third reason is that there is no well-heeled funder providing the impetus and cash to tackle foodborne illness, unlike other global problems such as HIV, malaria and TB.

In 2007, the WHO launched an international initiative to tackle foodborne disease. The WHO Initiative to Estimate the Global Burden of Foodborne Diseases aims to quantify how many people die from, or are affected by, all major foodborne causes each year. The FERG (Foodborne Disease Burden Epidemiology Reference Group) initiative, led by Claudia Stein and Jorgen Schlundt from the WHO, aims to set the problem of foodborne illness incontext. . .

FERG has commissioned research seeking to quantify burdens of different foodborne diseases. Early reports were presented at the meeting and revealed the shocking level of the problem. A systematic review by Christa Fischer-Walker and Robert Black from Johns Hopkins School of Public Health in the US revealed that there are a whopping 5 billion episodes of diarrhea in children aged >5 annually, with 3.2 billion cases in South-East Asia. Specific inspection of papers reporting deaths revealed that there were more than 1.15 million estimated deaths from diarrhea in South East Asia and Africa each year in children >5; this is almost a million more deaths than was previously estimated. The paucity of data was laid bare by these preliminary results, with no data for China, Latin America, the Middle East. Pathogens in the spotlight in these systematic reviews were the usual suspects, including E. coli, Shigella, Vibrio cholerae, Campylobacter and Salmonella. This is not a burden solely borne by those living in poverty—455 million episodes of diarrhea each year in the Americas and 419 million episodes each year in Europe. The data are so limited that these global estimates are virtually bound to underreport the problem. . . .

Food in Bloom: Cross Pollination and Cultivation of Food Systems, Cultures and Methods

The Twelfth Annual Joint Annual Meeting of the
Association for the Study of Food and Society (ASFS)
Agriculture, Food and Human Values Society (AFHVS)
with the Society for the Anthropology of Food and Nutrition (SAFN) June 2 to June 6, 2010.
Hosted by Indiana University, Bloomington, IN

For more information click here.

Time to Put Aside Biotech Biases

The World Summit on Food Security in Rome just finished a few days ago. A few words of Peter Brabeck-Letmathe, the chairman of Nestlé, talking about how hostility to new food technologies exacerbated the global food crisis by holding back agricultural productivity, “It is disheartening to see how easily a group of well-intentioned and well-fed activists can decide about new technologies at the expense of those who are starving.”

Some have dismissed these remarks. Harder to dismiss are the thoughts of Paul Collier, a professor of economics at Oxford University and author of “The Bottom Billion: Why the Poorest Countries Are Failing and What Can Be Done About It,” in the New York Times,

The debate over genetically modified crops and food has been contaminated by political and aesthetic prejudices: hostility to U.S. corporations, fear of big science and romanticism about local, organic production.

Food supply is too important to be the plaything of these prejudices. If there is not enough food we know who will go hungry.

Genetic modification is analogous to nuclear power: nobody loves it, but climate change has made its adoption imperative. As Africa’s climate deteriorates, it will need to accelerate crop adaptation. As population grows it will need to raise yields. Genetic modification offers both faster crop adaptation and a biological, rather than chemical, approach to yield increases.

Opponents talk darkly of risks but provide no scientific basis for their amorphous expressions of concern. Meanwhile the true risks are mounting. Over the past decade global food demand has risen more rapidly than expected. Supply may not keep pace with demand, inducing rising prices and periodic spikes. If this happens there is a risk that the children of the urban poor will suffer prolonged bouts of malnutrition.

African governments are now recognizing that by imitating the European ban on genetic modification they have not reduced the risks facing their societies but increased them. Thirteen years, during which there could have been research on African crops, have been wasted. Africa has been in thrall to Europe, and Europe has been in thrall to populism.

Genetic modification alone will not solve the food problem: like climate change, there is no single solution. But continuing refusal to use it is making a difficult problem yet more daunting.

I have written on a related aspect of this issue, In Lean Times, Biotech Grains Are Less Taboo. When there is no direct burden to people, they tend to take “better safe than sorry” as their overarching risk-management principle. Sometimes this approach works, but it also can magnify risk grossly out of proportion to reality.

Google legal research is free!

Google launched a free online case law search system available through Google Scholar (select scholar as search option, then legal cases). Of course, it's not LEXIS or Westlaw, but it is surprisingly comprehensive and robust. Every citation is hyperlinked to the full text of the opinion cited. It looks like a great tool for preliminary research. One announcement is here.

Ensuring Global Food Safety

Ensuring Global Food Safety: Exploring Global Harmonization, edited by Christine E. Boisrobert et al., is now published. I wrote a very small part of this large book. You can find out more here.

FDA To Look Into Safety of Caffeinated Alcoholic Beverages

The Food and Drug Administration (FDA) notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.

“The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible,” said Dr. Joshua Sharfstein, principal deputy commissioner of food and drugs.

Under the Federal Food, Drug, and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed “unsafe” and is unlawful unless its particular use has been approved by FDA regulation, the substance is subject to a prior sanction, or the substance is Generally Recognized As Safe (GRAS). FDA has not approved the use of caffeine in alcoholic beverages and thus such beverages can be lawfully marketed only if their use is subject to a prior sanction or is GRAS.  For a substance to be GRAS, there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts.

The FDA alerted manufacturers to the fact that the agency is considering whether caffeine can lawfully be added to alcoholic beverages. The FDA noted that it is unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS or prior sanctioned.  To date, the FDA has only approved caffeine as an additive for use in soft drinks in concentrations of no greater than 200 parts per million.  It has not approved caffeine for use at any level in alcoholic beverages.

The FDA requested that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or prior sanctioned.  FDA's letter informed each company that if FDA determines that the use of caffeine in the firm's alcoholic beverages is not GRAS or prior sanctioned, FDA will take appropriate action to ensure that the products are removed from the marketplace. 

In the past year, Anheuser-Busch and Miller agreed to discontinue their popular caffeinated alcoholic beverages, Tilt and Bud Extra and Sparks, and agreed to not produce any caffeinated alcoholic beverages in the future.

The federal agency with primary responsibility for regulating alcoholic beverages, the Treasury Department's Alcohol and Tobacco Tax and Trade Bureau, requires that alcoholic beverages contain only ingredients that satisfy FDA's requirements for use. In late September, the FDA received a letter from 18 Attorneys General and one city attorney expressing concerns about caffeinated alcoholic beverages.

For more information visit: http://www.fda.gov/Food/FoodIngredientsPackaging/ucm190366.htm     

Courts force U.S. reckoning with dominance of GM crops

Paul Voosen, New York Times (Oct. 8, 2009), writes that 90% of U.S. soy and cotton crops are genetically engineered (GM crops).  In addition, 85% of the corn crop is also genetically engineered, and it is found throughout the food system. 

     “These crops are safe to eat. The science on that is unequivocal, even in Europe, where a moratorium on new GM crops has existed for a decade. And by most accounts, GM crops have been an economic benefit to farmers, simplifying field maintenance and reducing the number of hands needed for weeding.

     “But as these crops have come to dominate the agricultural landscape, farmers who eschew their growing -- for ethical, organic or trade reasons -- have found themselves at a loss, frustrated by regulators and the majority of fellow farmers who have accepted GM crops as the new normal. . . . For the past two decades, the government has argued "essentially that there's no difference between a GM crop and its nonmodified sibling," said Alison Peck, a law professor at West Virginia University.

     "’Their arguments all sort of flowed from this presumption -- that these two kinds of crops are fungible,’ Peck said.

     “Two recent decisions out of the Northern District of California are the first-time acknowledgement by any federal entity of a difference between GM and non-GM crops, Peck said. The latest ruling, on the GM sugar beets of Willamette Valley, came down late last month and will move into the remedy phase at the end of this month. Both rulings -- the first, upheld several times on appeal, came down in 2007 -- found the regulatory apparatus used by the Department of Agriculture severely lacking. USDA, along with the Food and Drug Administration and U.S. EPA, oversees GM crops, using jury-rigged laws written well before the invention of biotechnology. Unlike Japan, Europe or even Russia, the United States has never passed legislation on GM crops.”

     USDA came to view GE and non-GE crops as identical, fungible. If the farmer wanted to keep GE-genes out of their field, it was that farmer’s burden to provide for buffer zones and other measures to keep out pollen drift. This could have serious economic consequences for organic and other non-GE farmers.

     To make the point about keeping out pollen, Voosen makes a interesting comparison to cattle ranching. “In the eastern part of the United States, traditionally, farmers have been obliged to fence in cattle. In the West, meanwhile, landowners are required to fence out roaming herds. The same distinctions apply to crops. Europe has been busy erecting a complex regulatory apparatus requiring farmers to ‘fence in’ their GM crops with isolation distances and liability funds. With no regulations, the United States has in effect required non-GM farmers to ‘fence out’ GM crops, placing the economic burden on conventional farming.”

  A copy of Judge Jeffrey S. White order in Center for Food Safety, et al. v. Thomas J. Vilsack, et al., is available here.

High Fructose Corn Syrup - 'Natural' or Not?

Dave Babcock has written an excellent article on the debate over whether high fructose corn syrup is natural:

So, let's say I was making you dinner, and in preparing one of the ingredients was "fixed to a column by the use of a synthetic fixing agent, glutaraldehyde."  Even if I told you that I washed off all the "unreacted glutaraldehyde," would you be willing to call the dinner I made you "natural?"

If you wouldn't, don't eat with the decision makers from the FDA. 

Kudos to Marler Clark for presenting us with FoodSafetyNews.com.

More on natural claims is here: USDA Reopens Comments on Use of "Natural"  and here: Health Canada Guidance on Food-like Natural.

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.