Saturday, January 31, 2009

Troubled peanut firm's chief also an industry quality adviser

BOB KEEFE/Cox Washington Bureau, The Atlanta Journal-Constitution (Jan. 31, 2009):

 The president of the peanut company linked to a nationwide salmonella outbreak serves on an industry advisory board that helps the U.S. Department of Agriculture set quality standards for peanuts.

 Stewart Parnell, president of Peanut Corp. of America, based in Lynchburg, Va., was first appointed to the USDA’s Peanut Standards Board in July 2005 and was reappointed in October for a second term that runs until June 2011, according to the USDA.

 The outbreak of salmonella linked to peanut butter made at the Peanut Corp. of America plant in Blakely, Ga., has sickened more than 500 people in 43 states and may have caused the deaths of eight.

 On Friday, the U.S. Food and Drug Administration said it is working with the Department of Justice on a criminal investigation of the Peanut Corp. of America.

 The Georgia Bureau of Investigation also is looking into whether the company may have broken any state laws. . . .

The full story is available here.

Playing Hard Ball With FDA Might Lead to Criminal Prosecution

An FDLI Update article by RiĆ«tte van Laack and John R. Fleder highlights the risk of aggressively defending your position against the FDA at any time. A recent court ruling, United States v. Kaminski, shows the potential perils faced. Ovimmune, Inc., and its owners may have found themselves with enhanced criminal sentences after they allegedly obstructed justice by complaining about FDA’s allegedly poor treatment of them during an investigation of defendants’ hyperimmunized eggs product.

According to the article, “Ovimmune was a small corporation and the sale of the hyperimmunized eggs, although found to be adulterated and misbranded, did not apparently cause any physical harm. Nevertheless, the hostilities that developed during the government’s investigation may well have caused the prosecution to be initiated, and surely increased the sentences that were imposed after conviction.”

On a related now, the first months of the new administration are a poor time to test the limits of the law. New FDA administrators who want to signal a change are likely to look for cases that send the message, Theres a new sheriff in town!

Hat tip to the FDA Law Blog.

GMA's 2009 Food Claims and Litigation Conference - Feb. 24-26 - Rancho Mirage, CA

It is 10 degrees F (-12° C) in East Lansing as I write this. The GMA Food Claims and Litigation Conference in Rancho Mirage, California, is looking better and better.

Conference registration information and agenda are available at: http://www.gmalitigationconference.com/.

Draft Risk Assessment for Avian Influenza in Food

The Draft Interagency Risk Assessment for the Public Health Impact of Highly Pathogenic Avian Influenza Virus (HPAIV) in Poultry, Shell Eggs, and Egg Products is available here. The Food Safety and Inspection Service (FSIS) is requesting public comment on the draft quantitative food safety risk assessment.

The purpose of this risk assessment is to: (1) Estimate the public health impact from human exposure to HPAI virus through the consumption of

contaminated poultry products, shell eggs, and egg products, and (2) evaluate the relative effectiveness of strategies to reduce or prevent exposure to HPAI virus from the consumption of poultry meat, shell eggs, and egg products. Submit written comments by February 2, 2009. More information is available in Federal Register Notice (Dec 2008) Docket No. FSIS-2007-0001.

Information on the Risk Assessments for Avian Influenza, BSE, E. coli O157:H7, Poultry Slaughter Inspection, Ready-to-Eat Meat & Poultry Products, Risk-Based Sampling Algorithms, and Shell Eggs & Egg Products are available here.

Additional risk assessment links are available at FoodRisk.ORG, which is a clearinghouse for risk analysis professionals. The site provides data, tutorials, tools and links to numerous resources, including a list of future research needs identified by FSIS and FDA food safety risk assessments.

Snake oil, science and the FDA

From “Snake oil, science and the FDA,” by Paul W. Jackson, Michigan Farm News (Jan. 30, 2009) :

There's something about snake oil that captures American imaginations.

Perhaps it's the invocation of the Wild West's pioneering spirit, or perhaps it makes us think we're smarter than our ancestors who bought bottles of colored grain alcohol because the salesman said it would cure dropsy and gout at the same time.

The spirit of snake oil continues today, but it's taken a new twist. Today's snake oil salesmen would have Americans think food is chronically toxic. They ignore the fact that people are living longer, growing taller and remaining healthier than any time in history.

Having tolerated the idea of food toxicity promoted by snake oil-peddling extremists, the message of how far we've come from an age when winter rural diets consisted of salt pork and stored turnips gets lost. That's where Michigan's farmers come in.

More specifically, Michigan's blueberry, cherry, grape, bean and cranberry growers - to name just a few - have invested a great deal of time and money into research to prove just how beneficial eating certain foods can be. Scientific studies have revealed antioxidant properties and other benefits, and anecdotal evidence continues to mount.

Still, in the back of the mind, the old snake oil image makes some folks cautious.

The Food and Drug Administration (FDA), in particular, is constantly on the lookout for what it thinks is snake oil, and that zeal to find unsubstantiated claims led to warning letters to 29 Michigan agricultural businesses in 2005.

. . . .

Read the entire article at: http://www.michiganfarmbureau.com/farmnews/transform.php?xml=20090130/cover.xml.

Final Rule on Mandatory Country of Origin Labeling

On January 12, 2009, the United States Department of Agriculture announced details of the final regulation for the mandatory country of origin labeling (COOL) program required by the 2002 and 2008 farm bills. The full text of the final Rule was published in the January 15, 2009, "Federal Register." The Rule becomes effective on March 16, 2009, 60 days after the date of publication. To read this news release, visit: http://www.usda.gov/2009/01/0006.xml

Copies of the final Rule and additional information are on display on line at: http://www.ams.usda.gov/COOL.

Friday, January 30, 2009

"Change is coming to America" Well, at Least to the Peanut Butter Industry

"I'm Mike Wallace, and I'd like talk with you," used to be the scariest words a company official could hear. Once upon a time, the words, "The FDA has filed a complaint with the DA," could send shudders through food company officials.

Today it seems like too often the first scary words heard are, "Someone died from eating our product." Maybe it is just my perception.

I think that today the scariest words that a food company official can hear are, "You've received a complaint and summons from William Marler.

Perhaps this poster should be put up in the board rooms of the Peanut Corporation of America:








Photograph adapted from the Marler Blog.

Food Regulation: Law, Science, Policy, and Practice


Neal Fortin’s new book, Food Regulation: Law, Science, Policy, and Practice, is now available.

If you would like more information:

  • The Summary of Contents (HTML) is available here.
  • The full Table of Contents (PDF) is available here.
  • Chapter 1 is available here.
  • The index is available here.

Friday, January 23, 2009

Dietary Guidelines Advisory Committee Meeting Announced

The U.S. Department of Agriculture (USDA) and the U.S. Department of Health and Human Services (HHS) have announced the Second Dietary Guidelines Advisory Committee Meeting. The Meeting will be held January 29 - 30, 2009, from 8:30 a.m. to 4:00 p.m. at the USDA, 1400 Independence Avenue, SW, Jefferson Auditorium, Washington, DC. 20250. Jointly updated and issued every five years by UDSA and HHS, the Guidelines provide authoritative advice for persons two years and older about how good dietary habits can promote health and reduce risk for major chronic diseases.

The Meeting will:

a. Provide an opportunity for the public to give oral testimony (morning of Jan. 29);

b. Include presentations on the descriptive statistics on usual nutrient and food-group intakes in the U.S. population and MyPyramid research updates; and

c. Allow for the continued formulation of plans for future work of the Committee.

Information regarding Registration can be viewed at: www.dietaryguidelines.gov. (Scroll down to Meeting Registration). Additional meeting details, including the minutes and transcripts of the first meeting and a public comments database, are also available at this website.

ABA's Hot Topics in Food Law - One Hour Telconference - Tuesday Feb 10th - 1pm ET - 10am PT

Hot Topics in Food Law

The American Bar Association Section of Litigation and the ABA Center for Continuing Legal Education
Tuesday, Feb. 10th
1:00 PM-2:00 PM Eastern 12:00 PM-1:00 PM Central
11:00 AM-12:00 PM Mountain 10:00 AM-11:00 AM Pacific

Program Description

From melamine in infant formula, to BPA in food packaging, to false or misleading labeling of products, food safety and marketing have been in the news. How pervasive are these food safety problems? Will the federal government expand its regulation of product labeling? How can you help your clients manage risk even if they are not currently involved in litigation? Join our expert faculty as they explore the hot issues in this embroiling field of law.

After listening to the teleconference and reading the program materials, you will be able to:

    • Discuss the melamine issues: its pervasiveness, current cases and preventive measures to stay out of the fray
    • Describe how BPA became an issue and what the real public health risk is
    • Compare the differences between FDA’s regulation of contaminants and unsafe food additives
    • Explain the differences in how products labeled “natural,” “organic,” or “sustainable” are regulated, current cases, and the growing importance of this issue
    • List action steps to prioritize risk and provide suggestions for risk management strategies

Program Faculty
Jessalyn Zeigler (Moderator), Bass, Berry & Sims, PLC, Nashville, TN
Robert E. Brackett, Ph.D, Senior Vice President and Chief Science and Regulatory Affairs Officer, Grocery Manufacturers Association
Ricardo Carvajal, Of Counsel, Hyman, Phelps, & McNamara, PC, Washington, DC
Stephen Gardner, Director of Litigation, Center for Science in the Public Interest, Dallas, TX
Sherry A. Marcouiller, Chief Counsel, Food Law, Kraft Foods Global, Inc., Northfield, IL

Registration Options click here

Friday, January 16, 2009

FDA's Final Guidance on GE animals

The Food and Drug Administration (FDA) has issued final guidance on its approach to regulating genetically engineered (GE) animals. The guidance is aimed at industry, but consumers may also be interested in FDA regulation of GE animals. (FDA regulates GE animals under the "new animal drug" provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA), and FDA must approve them before they are allowed on the market.) FDA has also produced a consumer oriented document on its regulation of GE animals.

Thursday, January 15, 2009

Cass Sunstein to be Regulatory Czar

Cass Sunstein will be named the Obama administration's regulatory czar, according to the Wall Street Journal.

Mr. Sunstein, a friend of President-elect Barack Obama from their faculty days at the University of Chicago law school, will mark a sharp departure for the White House Office of Information and Regulatory Affairs. Although obscure, the post wields outsize power. It oversees regulations throughout the government, from the Environmental Protection Agency to the Occupational Safety and Health Administration.” . . .

Mr. Sunstein, a prolific academic with wide-ranging interests, may be best known for advancing a field known as "law and behavioral economics" that seeks to shape law and policy around the way research shows people actually behave. The theory builds on earlier approaches developed at the University of Chicago law school that sought to harmonize regulatory law with free-market economics. Although widely embraced by conservatives, critics said it failed to account for the sometimes less-than-rational aspects of human behavior. . . .

Mr. Obama believes in "doing law in a way that's realistically based on human behavior," Mr. Sunstein said. "He's a University of Chicago Democrat, so he's very attuned to the virtue of free markets and the risks of free-market regulation. He's not an old-style Democrat who's excited about regulations" for their own sake.

Mr. Sunstein has a stellar mind and is renowned for his legal scholarship. He is also one of the best thinkers on risk analysis and human behavior.

Cass Sunstein should send a healthy message that there will not be a wholesale housecleaning of Bush administration policies but, rather, new regulations or changed regulations will be based on reason and thoughtful decision.

From Bill Marler on Peanut Butter

People should not die from eating peanut butter. According to the Brainerd Dispatch and AP, health officials in Idaho and Minnesota are reporting two more deaths associated with a nationwide salmonella outbreak that has sickened more than 425 people in 43 states. That brings the total number of people who had salmonella when they died to five.

So, when is FDA, CDC, King Nut and Peanut Corporation of America going to respond?

1. Make sure ALL product is promptly recalled;
2. Do not destroy any documents;
3. The companies should pay the medical bills and all related expenses of the innocent victims and their families;
4. The companies should pay the cost of all related Health Department, CDC and FDA investigations;
5. Provide all bacterial and viral testing of all recalled product and any other tested product (before and after recall);
6. Release all inspection reports on the plants by any Governmental Entity or Third-party Auditor;
7. Release all Salmonella safety precautions taken by either King Nut or Peanut Corporation of America - especially after the 2007 Salmonella Peanut Butter Outbreak;
8. Provide the public with the Epidemiological investigation (with names redacted), so it is clear who knew what and when about the likely source of the outbreak; and,
9. Show the public what is being done to prevent the next outbreak.

The families of five dead people are waiting.


William D. Marler, Esq.
Marler Clark LLP PS
W: www.marlerclark.com
www.marlerblog.com


Tuesday, January 13, 2009

Frank Torti to be Acting FDA Director

Dr. Frank Torti, the FDA's science chief, is to become its acting FDA Commissioner. William Gimson III, chief operating officer at the CDC, will serve as acting director after Dr. Julie Gerberding leaves January 20.

President-elect Barack Obama and his transition team look like they are hoping to make swift break with the Bush administration. Deliberations over the FDA are difficult because of competing interests, but they could announce a permanent appointee to lead the FDA in the next three weeks, sources said.

During a confirmation hearing last week, the nominee for secretary of the Department of Health and Human Services, former Sen. Tom Daschle, told a Senate panel, "I want to take ideology and politics as much as humanly possible out of the process and leave the scientists to do their job."

Dr. Torti, the FDA's present principal deputy commissioner, was named to the temporary slot heading the agency over the longtime director of the drug division, Janet Woodcock, who is under fire from Congress in relation to several drug-safety issues, including the importation of contaminated heparin from China.

Dr. Torti has been at the FDA since April, when he was brought in as chief scientist, a new position, from Wake Forest University, where he led its cancer center.

In a letter last month to the transition team, Rep. Bart Stupak, a Michigan Democrat who has held 16 hearings on issues at the FDA, asked Mr. Obama not to name any current high-level official of the agency to a post there because he said the drug division has been too closely aligned with the pharmaceutical industry's agenda. The FDA didn't respond to requests for comment.

The Wall Street Journal (subscription required).

Thursday, January 08, 2009

Smaller sizes, same prices at the market

NBC’s Today Show correspondent Janice Lieberman talks about smaller sizes and same prices in “Squeezed at the Supermarket.” Hat tip to Parke Wilde at the U.S. Food Policy blog.


Wednesday, January 07, 2009

Sanjay Gupta Picked for U.S. Surgeon General

From the Marler Blog: “In somewhat of a surprise, but brilliant appointment, Obama has tapped Sanjay Gupta as U.S. Surgeon General. When I was ‘hangin’ with Sajay’ during the filming of “Danger-Poisoned Food,” I was impressed with his smarts, savvy and good sense of humor . . .”

More about Dr. Gupta at is available here at CNN.

Tuesday, January 06, 2009

FDA Requires Specific Label Declaration of Cochineal Extract and Carmine

The Food and Drug Administration (FDA) has issued a final rule that requires food labels to specifically declare the presence of the color additives cochineal extract and carmine in the ingredient statement by their respective common or usual name, “cochineal extract” or “carmine.” Carmine must also be declared when contained in cosmetics.

The FDA is revising its requirements for cochineal extract and carmine in response to reports of severe allergic reactions, including anaphylaxis, to cochineal extract-containing food and carmine containing food and cosmetics. This action also responds to a citizen petition submitted by the Center for Science in the Public Interest (CSPI).

The final rule is effective on January 5, 2011, but FDA states that it “will not object to voluntary compliance immediately.”

Hat tip to Ricardo Carvajal.