Food & Drug Law Prof Blog

Baby raccoons saved from pop machine

Soda pop isn't good for raccoons either.  Cute video alert:

http://video.yahoo.com/network/100000086?v=5289218&l=100000085

More on the Beef Recall from Marler Blog

USDA had been Warned of E. coli Risk of Mechanically Tenderized Steak

. . . However, over the weekend I learned that USDA Secretary Vilsack was warned in June 2009 (FSIS was well aware of the risk before as well) of the exact risk of “non-intact steaks (mechanically tenderized prior to further processing),” by a coalition of Food Safety Advocates. . . .

Click here to read this article on Marler Blog

Beef recall in six states

USDA Recall Release:

WASHINGTON, December 24, 2009 - National Steak and Poultry, an Owasso, Okla., establishment, is recalling approximately 248,000 pounds of beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

FSIS became aware of the problem during the course of an investigation of a cluster of E. coli O157:H7 illnesses. Working with the Centers for Disease Control and Prevention (CDC) and state health and agriculture departments, FSIS determined that there is an association between non-intact steaks (blade tenderized prior to further processing) and illnesses in Colorado, Iowa, Kansas, Michigan, South Dakota and Washington. FSIS is continuing to work with the CDC and affected state public health partners on the investigation. Anyone with signs or symptoms of foodborne illness should consult a physician. . . .

Click here to go to the full news release including a list of recalled products.

Raw milk lawsuit in Wisconsin

I know people who go to great lengths to obtain raw milk.  And I know people who think all sales of raw milk should be strictly illegal.  Most states fall somewhere in between, allowing consumption of milk from one's own cows,  sometimes allowing on-farm sales to consumers who come with their own containers, and more rarely, allowing certified producers to sell in stores.  I find the legal tightrope intriguiging.  When I first became interested in food, I wondered whether there was anything that was illegal to eat. 

A lawsuit filed this week in Wisconsin seeks declaratory judgment and construction of Wisconsin's raw milk statute, particularly as it applies to "cow shares." According to the complaint, the Wisconsin Department of Agriculture Trade and Consumer Protection has interpreted sec. 97.24 Wis. Stats. to permit :

"agreements sharing ownership in [a] milk producer license under applicable law that may include allowing actual owners to take a share of the ungraded raw milk produced under the license.”

The issue in the case is whether this sort of "cow share" agreement can extend to a members-only farm store.  Here's the Farm-to-Consumer-Legal-Defense-Fund news announcement:

The Farm-to-Consumer Legal Defense Fund (FTCLDF) has filed a complaint for declaratory judgment on behalf of Wisconsin farmers Kay and Wayne Craig and related entities against the Wisconsin Department of Agriculture, Trade and Consumer Protection (DATCP).  The complaint seeks declarations that the Craigs,  the farm store they operate (GrassWay Organics Farm Store LLC) , and GrassWay Organics Association and its members who have invested in the LLC are not engaging in the illegal sale of raw milk in violation of Wisconsin laws, and that the farm store does not need to obtain a “retail food establishment” license in order to operate.  “Kay and Wayne Craig, their LLC and their Association members have been harassed long enough by DATCP.  We are asking the court to declare that the Craigs, the LLC, and the Association are operating within the law,” said Pete Kennedy, President of the Fund.  “We hope the Court issues an injunction that will prevent DATCP from taking enforcement action against what we believe to be lawful activity, “  Kennedy continued.

The complaint alleges that DATCP, over a period of several years, has been changing its interpretation of what constitutes an “incidental” sale of raw milk, which are legal under Wisconsin law.  The complaint also alleges that the LLC operated by the Craigs (the farm store) is not a “retail food establishment” because it does not sell to the general public.  The farm store is open only to members of the Association that has purchased an interest in the LLC.  “In Wisconsin, it is legal for an entity that holds a Grade A  permit to sell interests or shares in the entity.  This is a legal arrangement that is lawful in all respects, yet it is being threatened by DATCP,” said the Fund’s General Counsel, Gary Cox.  “We hope the court agrees that DATCP cannot be arbitrary and capricious in their interpretation and enforcement of the law against law-abiding citizens, and try to force them out of business,” said Cox.

The complaint was filed on December 16 in Dane County Circuit Court, Wisconsin and names the Secretary of DATCP as a Defendant, Rod Nilsestuen.

Food Insecurity? or Hunger?

From Food Safety News

 Isn't It Hunger?
by Olivia Marler | Dec 11, 2009

The New York Times headline shouts:  "Hunger in U.S. at a 14-Year High."  
President Obama says:  "hunger rose significantly last year."  But, researchers for a Department of Agriculture report will only say that people are experiencing "food insecurity" or even "very low food security."  This latter terminology is politically motivated doublespeak.  

So why is the Department of Agriculture using the term "food insecurity" and not "hunger?"

Petri Dish Pork?

My only question is who will regulate this product? USDA? or FDA?  From singularityhub.com:

Artificial Meat Could Be On Your Table in 5 Years

". . . Researchers in the Netherlands may be able to sidestep ethics and solve some of the environmental issues [of meat production] with their latest creation – pork cells cultured in a petri dish. This artificial meat is grown from myoblasts (special muscle cells which repair damage) incubated in a solution derived from the blood products of animal fetuses."

USDA and HHS Continue Food Safety Working Group Efforts

FDA News Release(12/9/09):

Agriculture Secretary Tom Vilsack and Health and Human Services (HHS) Secretary Kathleen Sebelius today commended the Department of Homeland Security for opening a center devoted to ensuring the safety of foods imported to the United States.  The Commercial Targeting and Analysis Center (CTAC) for Import Safety is operating under the direction of Customs and Border Protection (CBP).  It was created on the recommendation of President Obama’s Food Safety Working Group, which is charged with advising the President on how to upgrade the U.S. food safety system for the 21st century. 

“As co-chairs of the Food Safety Working Group, we are committed to improving the safety of food produced in the United States, and also improving the safety of all the food that makes it to the American consumers’ dinner tables,” said Secretary Sebelius.  “With so much food coming from abroad, we must do all we can to ensure that it conforms to the same safety standards as our own food safety systems.”

“As part of the Food Safety Working Group’s efforts to strengthen the food safety system in this country, we identified close cooperation between federal agencies as a key to achieving real progress,” said Secretary Vilsack. “The new CTAC announced today is an important step toward the type of collaboration necessary to ensure that Americans have access to a safe and healthy food supply.”

“In addition to guarding against terrorism and crime, securing our borders and facilitating legitimate trade involve ensuring the safety of imported products,” said Department of Homeland Security Secretary Janet Napolitano. “This new targeting center will enhance the inspection of goods entering our country by centralizing and strengthening federal efforts to protect U.S. consumers.”

The import safety CTAC, located in Washington, D.C., is one of CBP’s six commercial targeting centers in the U.S.   It will specifically target shipments of imported cargo, including food, for possible safety violations.  The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) and other partnering government agencies, including the U.S. Food and Drug Administration (FDA), the Environmental Protection Agency, and the Consumer Product Safety Commission, will provide on-site expertise at the Center.   

“The expertise FSIS, FDA, and our other partners bring to the table is invaluable to ensuring that America’s imported food supply is safe,” said CBP Acting Commissioner Jayson P. Ahern.  “We look forward to continued cooperation with the Food Safety Working Group and its future recommendations.”

As part of its collaboration with CBP, FSIS will extend its enforcement efforts to target ineligible imports investigate suspicious shipments based on manifest information filed prior to the arrival of goods at U.S. ports.

For more information of the Food Safety Working Group, please visit www.foodsafetyworkinggroup.gov.

The most important information on a food label?

The EU is considering uniform nutritional labeling, and a recent study showed that Irish consumers are paying attention.  The traffic light system is fine, merely color coding the nutrient amounts, not so much.

A summary article on Food Navigator.com describes the survey. This is the bit that really caught my attention:

“The main reasons consumers now read food labelling is to look for nutritional and calorific information, whereas in 2002 the key reason to read a label was to check the best before date. This indicates that people are concerned about healthy eating and want to know more about the nutritional aspects of the food they are buying.”

That said, the respondents still cited the use by or best before date as the single most important piece of information on food labels, followed by the list of ingredients and the name of the food.

I'm not even sure why I read food labels these days.  I can't stop myself.  DMB

Liquid Dietary Supplement vs. Beverage -- FDA Guidance

What is a beverage?  Beverages are conventional foods that should not be marketed as dietary supplements. And dietary supplements are not supposed to be represented as conventional foods.  It's a matter of getting the product, the label, and the marketing plans to line up on the same side of the line.  The line is blurry.  FDA released draft industry guidance yesterday to help make it clearer:

Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods

. . . The Food and Drug Administration (FDA) has observed and become concerned about two trends in the marketing of beverages.  First, we have seen an increase in the marketing of beverages as dietary supplements, in spite of the fact that the packaging and labeling of many liquid products represent the products as conventional foods.  Products that are represented as conventional foods do not meet the statutory definition of a dietary supplement in section 201(ff) of the FFDCA (21 U.S.C. 321(ff)) and must meet the regulatory requirements that apply to conventional foods. 

Second, FDA has seen a growth in the marketplace of beverages and other conventional foods that contain novel ingredients, such as added botanical ingredients or their extracts.  Some of these ingredients have not previously been used in conventional foods and may be unapproved food additives. In addition, ingredients that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels or in new beverages or other conventional foods.  This trend raises questions regarding whether these ingredients are unapproved food additives when used at higher levels or under other new conditions of use.  Some foods with novel ingredients also bear claims that misbrand the product or otherwise violate the FFDCA.

read the whole thing

 

$100 million lawsuit filed in E coli case

Yesterday (Friday, 12/4/09) Bill Marler filed a lawsuit seeking $100 million in damages for Stephanie Smith, the 22 year old dancer left paralyzed after eating a burger tainted with E. coli 0157:H7.

Read about the lawsuit in the St. Paul Pioneer Press (my home town newspaper).

Read about it on Marler Blog, Bill Marler's own food poisoning law blog:

This morning’s papers across the United States are covered with paralyzed, former dancer, Stephanie Smith’s battle against food giant, Cargill. Cargill’s hamburger, sold at Wal-Mart, nearly killed Stephanie with Hemolytic Uremic Syndrome, and has left her, with brain damage, with failing kidneys, with no bowel or bladder control, and facing a life confined to a bed or a wheel chair. Despite her hard work, Stephanie will not dance again. As I type this in my kitchen, my three daughters are helping my wife decorate the Christmas tree. Like you, I cannot imagine seeing one of them in Stephanie’s condition – from eating a hamburger.

Iowa County providing incentives for organic production -- goal is all organic

Using tax breaks and other incentives, Woodbury County, Iowa is encouraging organic farming.  From the New York Times (the original source is Greenwire):

SIOUX CITY, Iowa -- In the midst of sprawling corn and soybean fields, industrial animal-processing plants and ethanol refineries, Woodbury County is . . . trying to go whole-hog into organic agriculture.

"This is a totally new direction for us," said Debi Durham, president and CEO of the Siouxland Chamber of Commerce. . . . "Within the next 10 years, we will be known as the organic capital -- of the world."

Such a prediction is almost mind-boggling, considering that the county had not one registered acre of organic farmland in the 2007 U.S. Department of Agriculture census -- and this in a county with a total 450,000 acres of farmland.

more

Large organic farm decertified for four years

It all boils down to keeping and producing records.  From a Cornucopia Institute press release:

In an investigation and legal case that dragged on for almost four years, one of the largest organic cattle producers in the United States, Promiseland Livestock, LLC, was suspended from organic commerce, along with its owner and key employees, for four years. The penalty was part of an order issued by administrative law judge Peter Davenport in Washington, DC on November 25.

Promiseland, a multimillion dollar operation with facilities in Missouri and Nebraska, including over 13,000 acres of crop land, and managing 22,000 head of beef and dairy cattle, had been accused of multiple improprieties in formal legal complaints, including not feeding organic grain to cattle, selling fraudulent organic feed and "laundering" conventional cattle as organic.

"We are pleased that justice has been served in the Promiseland matter," said Mark A. Kastel, Senior Farm Policy Analyst for the Wisconsin-based Cornucopia Institute. Scrutiny from Cornucopia, one of the industry's most aggressive independent watchdogs, was part of the genesis for the comprehensive USDA investigation and subsequent legal proceedings.

more of the press release

USDA Findings of Fact and Order -- (contains a good description of how the organic certification process works.  I may use this document in my Food Law Class. -- DMB)

the Complaint dated June 4, 2008

Poultry Purity

First Consumer Reports reported that most store-bought broilers are contaminated with Campylobacter or Salmonella, the two most common sources of food poisoning:

Campylobacter was in 62 percent of the chickens, salmonella was in 14 percent, and both bacteria were in 9 percent. Only 34 percent of the birds were clear of both pathogens. That's double the percentage of clean birds we found in our 2007 report but far less than the 51 percent in our 2003 report.

The National Chicken Council says the findings are overblown:

Chicken is safe. Like all fresh foods, raw chicken may have some microorganisms present, but these are destroyed by the heat of normal cooking. Consumers are encouraged to follow the safe handling and cooking instructions printed on every package of fresh meat and poultry sold in this country.

According to Reuters, USDA reports lower levels of contamination, but Consumers Union tested products further along in the retail chain.

Food Blogs in the ABA Top 100 blogs -- Marlerblog and FDA Law Blog

Two of my favorite blogs have made the Third Annual ABA Journal Blawg 100.  The ABA (American Bar Association) invites online readers to vote for their favorites.

Bill Marler's MarlerBlog has been my favorite source of food safety information.  Bill posts often, uses humor and graphics, and is right on top of every foodborne pathogen outbreak.  Here's what the ABA says:

Marler Blog is the flagship of Seattle lawyer Bill Marler’s fleet of 10 blogs devoted to food-borne illness. It covers reports of outbreaks and adds commentary on how governments and corporations should respond to them.

Twitter: @bmarler

Quick Take: Marler took his show on the road, appearing on Larry King Live in October as an expert on food-borne illness.

FDA Law Blog covers everything to do with the FDA, which means a lot of drug and medical device news that mostly goes over my head, but when there is Food News from FDA, this blog is really helpful in clarifying the legal issues and providing context. 

At FDA Law Blog, lawyers from Hyman, Phelps & McNamara in Washington, D.C., cover conferences, court rulings and Federal Trade Commission actions related to the Food and Drug Administration, as well as FDA an­nouncements and draft guidance documents. It also tracks legislation and citizen petitions related to the Food, Drug and Cosmetic Act.

Twitter: @fdalawblog

Quick Take: Reader Cheryl Graham works at the FDA but says she de­pends on the blog for up-to-date regulatory information. “There is no one within the agency that does what this blog provides.”

A Just and Sustainable Recovery: Bread for the World Institute’s 2010 Hunger Report

A Just and Sustainable Recovery: Bread for the World Institute’s 2010 Hunger Report  is now available online. This year’s report focuses on green jobs and domestic economy, but still includes international statistics on food security, poverty, and development. The 2010 report includes new data on economic mobility, housing, health and climate change." [Christine Matthews, Librarian - Bread for the World Institute]