Food & Drug Law Prof Blog

Timothy D. Lytton: Guest Blog Series on Front-of-Package labeling on Fooducate

Timothy D. Lytton (Albany Law School) has published a series of three articles on Fooducate Blog.

Regulating Front-of-Package Nutrition Labels, Part 3 of 3: Objections to the Imposition of a Single FDA Scheme

In my previous posts I have proposed that the FDA regulate front-of-package nutrition labels by better enforcement of existing regulations and by setting minimum standards for labels that rate the overall nutritional value of foods. By contrast, the Center for Science and the Public Interest as well as the Fooducate Blog have advocated that the FDA develop and impose on the food industry “a simple, uniform science-based system [that] would bring consistent and reliable information to the marketplace and help consumers choose more healthful diets.”

However, the high level of complexity involved in designing nutritional rating systems gives rise to two reasons to prefer a regulatory approach that merely sets minimum-standards. . . .

Here are links to Professor Lytton's earlier two posts on Fooducate Blog:

Regulating Front-of-Package Nutrition Labels, Part 1 of 3: Better Enforcement of Existing Standards

Regulating Front-of-Package Nutrition Labels, Part 2 of 3: Developing New Minimum Standards for Complex Rating Schemes

Recipe Secrets -- Bimbo Bakeries litigation

From the National Law Journal, via Law.com:

Bimbo Bakeries Seeks Limits on Its Departing Muffin Man: Bimbo is suing former executive not because he has actually stolen any secrets, but because he might

The secret recipe for Thomas' English Muffins is putting to the test an unsettled legal doctrine: that you can sue someone out of fear that he might steal your trade secrets.

In a highly watched trade secrets case in Pennsylvania, Bimbo Bakeries USA is going after former executive Chris Botticella, a 20-year employee who allegedly told the company he was retiring when he was really taking a job with rival Hostess Brands Inc. . . .

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Hat tip: Steve Sholk. 

Bill Marler: FSIS Should Require Labeling for Tenderized Steaks

From Food Safety News:

On Christmas Eve 2009, the U.S. Department of Agriculture's (USDA's) Food Safety and Inspection Service (FSIS) announced that National Steak and Poultry was recalling 248,000 pounds of mechanically tenderized beef products contaminated with E. coli O157:H7.

Within days of the recall announcement, the Centers for Disease Control and Prevention confirmed that 21 people from 16 states had become infected with the outbreak strain of E. coli O157:H7 after eating the mechanically tenderized steaks. . . .

more here

Timothy D. Lytton publishes Signs of Change or Clash of Symbols? FDA Regulation of Nutrient Profile Labeling

Timothy D. Lytton (Albany Law School) has  published Signs of Change or Clash of Symbols? FDA Regulation of Nutrient Profile Labeling, Health Matrix, Vol. 19, No. 2, 2010.  The article is available for download on SSRN.

Abstract:
A new generation of food labels uses symbols and ratings on the front of packages and on supermarket shelves to indicate a product’s nutritional value. Proponents of these new labels assert that they help consumers make healthier dietary choices. Critics contend that the new labels are confusing and misleading. This article argues that, with some minor reforms, the FDA’s existing regulatory framework governing nutrient content claims on food labels is well suited to balance these competing considerations. With regard to the most novel and complex labels - those that rate the overall nutritional value of food products - based on detailed algorithms the article proposes that the FDA provide minimum standards that would prevent fraudulent or misleading claims while allowing for genuine experimentation and competition within the private sector that is likely to advance knowledge in the areas of nutrition and food labeling as a public health strategy.

Black Pepper and Salmonella

From Food Safety News:

Black pepper supplied by New York's Wholesome Spice to Daniele Inc. to coat its salami products was found by Rhode Island public health officials to contain the Salmonella Montevideo outbreak strain responsible for making at least 189 people sick in 40 states. . . 

more here:  http://www.foodsafetynews.com/2010/01/black-pepper-positive-for-outbreak-strain/

FDA Law Blog: Animal Feed Safety Agenda "Ambitious"

From FDA Law Blog:

FDA Lays Out Ambitious Agenda in the Latest Draft of its Framework of the Animal Feed Safety System

By Ricardo Carvajal & Diane B. McColl – In the fourth and most recent draft of the framework of its Animal Feed Safety System (“AFSS”), FDA provides a comprehensive overview of the system and of the significant gaps in that system that FDA intends to address (the AFSS is “FDA’s program for animal feed aimed at protecting human and animal health by ensuring production and distribution of safe feed,” and it covers both feed for food-producing animals and pet food). . . .

Drake Forum on America's New Farmers

The Drake Forum on America's New Farmers: Policy Innovations and Opportunities will be held March 4 and 5, 2010, at the L'Enfant Plaza Hotel in Washington DC.

This two day national policy conference will identify innovative policies and projects at the federal, state, and local levels to support new and beginning farmers. The conference will feature national keynote speakers and regional voices on panel discussions. To learn more about the Forum and to register please visit the Agricultural Law Center site at http://www.law.drake.edu/centers/agLaw/ or write to americasnewfarmer@drake.edu

If you would like to request a scholarship to attend please let us know by Feb. 10th. To take advantage of the group rate for rooms we have reserved at the L'Enfant Plaza Hotel contact them no later than February 10th.

5th Circuit Upholds Texas' Wine Sales Method

The Associated Press via Law.com

A federal appeals court has sided with Texas in a dispute over buying wine and efforts to control its quality.

The Dallas Morning News reported Thursday that the recent ruling by the New Orleans-based 5th U.S. Circuit Court of Appeals allows Texas to continue regulating alcohol sales under its current system. The California-based Specialty Wine Retailers Association had challenged the Texas law.

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Hat tip: Steve Sholk

Article: Biotech Crop Litigation Update

ABA Environmental Litigation and Toxic Torts Committee Newsletter, August 2009, by Guy T. Knudsen. 11 NO. 2 ABA Envtl. Litig. & Toxic Torts Committee Newsl. 5

Genetically modified ("transgenic" or "biotech") crops have transformed U.S. agriculture, but almost 15 years after the first commercial introduction of transgenic corn, the release and production of biotech crops remains controversial and litigious. In the past couple of years, some significant cases have continued to alter the playing field for companies producing, marketing, or seeking federal regulatory approval for transgenic crops. Some of these cases reflect an increasingly sophisticated legal and public relations approach by anti-biotech plaintiffs. Claims based on environmental laws and regulations have the potential to be bolstered with common law tort theories of liability (i.e., negligence, trespass, or nuisance). . . .

 

US Supreme Court grants Cert in Geertson Seed Farms case (genetically engineered alfalfa)

The Supreme Court has granted cert in Monsanto v. Geertson Seed Farms.  The case arose when APHIS decided to deregulated Roundup Ready Alfalfa (genetically engineered to be resistant to glyphosate) without preparing an environmental impact study.  A California District Court ordered a preliminary injunction against further planting of GE alfalfa until an environmental impact statement could be prepared. The Ninth Circuit upheld the injunction on appeal.

SCOTUS Blog has links to the briefs and other documents in the case.

Geertson Seed Farms is represented by Center for Food Safety lawyer, George Kimbrell.  The link is to the CFS press release on the Cert decision.

FDLI Food Hot Topics, Jan 27-28, 2010, Washington DC

From the Food and Drug Law Institute website:

Program Description
Not your typical food program, these four, half-day workshops are designed for intermediate level professionals in the food and dietary supplement industries. This is your opportunity to interact with the experts in a small setting focused on critical issues affecting food and dietary supplement law and regulation. Register for one or all four programs!

January 27, 2010

• FDA Enforcement of the New Dietary Supplement GMP’s and What it May
  Portend to the Conventional Food Industry if Congress Passes Food Safety
  Reform Legislation
• Food Advertising and the National Advertising Division

January 28, 2010

• The Future of Food and Dietary Supplement Recalls
• Claims Substantiation and Fraud Issues

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"Digestiv" and alcohol labels

From Bevlog (a really fun blog about alcohol beverage labels!):

Remove the Word “Digestif”

. . .  TTB does not allow any reference to digestif, digestiv or similar. Here is an example of a recent rejection, wherein TTB explains that the term is not allowed, and why. TTB regards it as a therapeutic claim. . . .

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Food Law at AALS today

The Food, Law & Values program takes place this afternoon at AALS (Association of American Law Schools) in New Orleans.  It's cold here, but the food is good! 

Food Law at AALS, Friday, Jan. 8

The Association of Americal Law Schools (AALS) meets in New Orleans later this week.  The Open Source Program this year is Food, Law and Values. It takes place Friday, January 8, 4:00 to 6:00 p.m. Here's the program:

AALS Open Source Program – Food, Law, & Values Friday, January 8, 4:00 – 6:00 p.m.

4:00 – 4:50 Food Production beyond Technology: Risks, fears, environment, and labor
Moderator: Bret C. Birdsong, University of Nevada, Las Vegas, William S. Boyd School of Law

A program on food law would naturally begin with food production. Increasingly, consumers are interested in how food was produced, demonstrating that food production is more than agricultural and scientific techniques. Food production raises value-laden questions of identity, personal autonomy, and concern for culture. In addition, advancing technology implicates uncertainty and risk. This panel presents several points of focus on values in food production, approaches to risk and uncertainty in food production, and the appropriate roles for governmental intervention.
Format: Traditional – each panelist speaks for 7 to 10 minutes, followed by about 10 minutes of panel discussion and audience participation.

Panelists: Stephanie Tai, University of Wisconsin Law School – Food safety regulation development and confined animal feeding operation (CAFO) siting management may seem to be widely disparate subjects, but Professor Tai will bring these together by focusing on the tensions between public participation and scientific expertise in these two different contexts. Rather than providing normative recommendations regarding these issues, however, the focus is on recognizing the implications of public participation structures for the epistemic nature of the scientific information used by agencies in reaching their regulatory decisions.

Guadalupe T. Luna, Northern Illinois University College of Law – Agricultural laws affect more than food. Professor Luna will discuss globalization of the agricultural workforce and its impact on domestic Indians and the Purepecha Indians from Mexico. The Purepecha are farmworkers residing on the Cahualla Indian Reservation in California and in difficult housing conditions. The immediate intent is not to lay blame on the tribe housing the farmworkers; but to illustrate how agricultural laws are directly harming both groups with further attendant harm on the environment of an Indian nation.

James Ming Chen, University of Louisville, Louis D. Brandeis School of Law -- The mass marketing of foods derived from organisms modified through recombinant DNA technology has put extreme pressure on the interpretation and implementation of the United States' basic food safety law, the venerable Food, Drug & Cosmetic Act. In its classic form, the FD&CA reflects its Progressive and New Deal roots. It vests enormous trust in a specialized agency, the Food and Drug Administration, which is presumed to have nonpareil expertise over food safety. The political reality of GM foods, however, has placed the FD&CA and its implementation by the FDA in severe tension with the Organic Foods Production Act and with commercial speech doctrine.

Fear about food is one of the most deeply seated forms of behavioral protection against the natural world. It is precisely here, where food comes into contact with notions of good and evil, that the classic regulatory state must take its stand. The FDA's regulation of foods using rDNA technology upholds the best of the Progressive regulatory tradition and deserves to survive the challenge posed by the OFPA, the revived commercial speech doctrine, and contemporary consumer distrust of governmentally supervised review of science and safety.

Marne Coit, Coit Consulting, Fayetteville, Arkansas – Local food systems and sustainability. For people who work in agriculture, there is often a tendency to view one’s work as either helping farmers or as helping consumers. A dichotomous viewpoint such as this is not necessarily productive. In particular, when thinking about sustainability, it is more productive to use a systems approach, and to think about these issues in a way that takes farmers, consumers, the environment, culture, and ethics into consideration. One model that seeks to accomplish this is local food systems, which works to meet the needs of both farmers and consumers in a sustainable manner and has become increasingly popular in recent years. Ms. Coit will examine the role of law, policy, and values in local food systems.

4:55 to 5:25 The Role of Governments – Labels, Regulation, Economy, and Safety Moderator: Donna M. Byrne, William Mitchell College of Law

The Obama administration seems to be taking a more aggressive approach with respect to controlling the food industry through increased regulation. States and local governments are also taking a more pro-active approach. One area where regulation has an obvious role is labeling. Food labeling should be a way to provide consumers with the opportunity to make decisions about what they eat - decisions that may be based not only on safety or nutrition but on other factors such as social or economic issues. But, how can the law better assure that food labels serve these larger purposes? How do other countries address these issues?

Format: Each panelist speaks very briefly (5-7 minutes), followed by discussion among the panelists,

Panelists:

Margaret E. Sova McCabe, Franklin Pierce Law Center -- the relationship between scientific certainty, food label claims, and consumer information. Professor McCabe will use the gluten-free definition as an example of how Congress asked FDA for a definition in the FALCPA, but that FDA interprets this mandate to require comprehensive review of the status of science on celiac disease as well as product testing.

Neil D. Hamilton, Drake University Law School – A perspective from the Obama/Vilsack administration. Professor Hamilton chaired the Iowa Food Policy Council for six years under then Governor Vilsack and is now serving as an informal adviser to him and USDA on various issues - including the new Know Your Farmer Know Your Food effort as well as the People's Garden project.

Thomas Wilson, Alabama A&M University School of Agricultural & Environmental Sciences – A view from across the pond. Professor Wilson started the online Food Law Certificate Program at Michigan State and was chair of the Institute of Food Technologists food law committee for a year as well. But more recently Professor Wilson has lived in Europe working with the Food Directorates in the Netherlands.

5:30 – 6:00 Food Law, Food Law Scholarship and where we go from here. One of the driving notions behind the open-source program idea is to get folks together who often think about disparate things that bear some relation to food law. Although many scholars have been writing about food law for a long time, others of us are moving into the area from other disciplines. This panel will provide a chance for us to discuss, albeit briefly, where we, as legal scholars, see our particular niche (or niches) in the development/transformation of food policy.

Moderator: Stephanie Tai, University of Wisconsin Law School

Two Panelists will each briefly present a global perspective, followed by panel reactions:

Susan Schneider, University of Arkansas, School of Law, Fayetteville – From agriculture to food.The LL.M. program at the University of Arkansas School of Law now includes food law courses in its curriculum and recently changed its name to LL.M. in Agricultural & Food Law. When is agricultural law food law? Professor Schneider's recent scholarship calls for a reassessment of agricultural policy to reflect a closer connection to food policy goals and environmental sustainability. The shift in focus to consumer-driven issues with value-laden agricultural implications is bringing food law issues into the spotlight.

Bret C. Birdsong, University of Nevada, Las Vegas, William S. Boyd School of Law – Critical Rice Theory. What is the role of the academy? Are we asking the right questions? The food choices that are available to us as individuals and collectively are bound up with our system of food law. Law shapes and informs those choices, and the food system shapes and infomrs the law. The enterprise for legal scholars should be to explore the interlinking web of law and food, taking into account the wide array of values that food and food production systems implicate, and suggest improvements that can help to transform the system into one that is more balanced, just, and sane.

Large Panel -- Where do we go from here? Any or all can chime in.

Are we healthier after a decade? Not really

From the Associated Press:

Did Americans get any healthier over past decade?

By MIKE STOBBE, AP Medical Writer Mike Stobbe

ATLANTA – About 10 years ago the government set some lofty health goals for the nation to reach by 2010. So how did we do? By many measures, not so hot. There are more obese Americans than a decade ago, not fewer. We eat more salt and fat, not less. More of us have high blood pressure. More of our children have untreated tooth decay.

. . .

As we move into a new decade, the government is analyzing how well . . .

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Food Safety in 2010

From Andrew Schneider on Sphere.com:

After Scary Year, Will Food in 2010 Be Any Safer?

(Dec. 31) -- Here's a holiday menu that we'd all like to forget:

For the appetizer: San Antonio Bay oysters polluted with Noroviruses. For the main course: grilled beef infected with E. coli from contaminated tenderizing needles; chicken with Campylobacter or imported ham with Listeria monocytogenes. Then there's a side dish of stuffing loaded with salmonella-contaminated hazelnuts. And for those watching their weight: a popular nutritional drink fouled with the food poison Bacillus cereus.

All were recalled this month by the federal government or were the subjects of warnings by food safety experts. And 2010 . . .

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