Food Law Prof Blog

Salad season, E. coli lettuce, and salmonella tomatoes

It's hardly news by now (even if I haven't blogged it), but bagged romaine lettuce is being blamed for an E. coli outbreak in Washington state, and several fast food chains and Wal-mart are pulling raw tomatoes from the menu because of salmonella contamination (and you thought salmonella only came from raw eggs?)

Here's a piece on the E. coli lettuce from newsinferno.com:

Another E. coli outbreak, which has sickened 10 people in Washington state, may be  linked to tainted lettuce.  However, while tainted romaine lettuce is the suspected culprit in the Washington E. coli outbreak, no lettuce has been tested.  And now, health officials in the state have conceded that the source of the E. coli outbreak might never be known.

Washington health officials began receiving reports of E. coli in mid May, and the last case that health officials are aware of was reported May 29.  According to seattlepi.com, five of the 10 E. coli victims had to be hospitalized and four of those five were released from the hospital by Thursday. About half of the victims were teenagers. Health officials said the lettuce may have been eaten at a restaurant or school. The fact E. coli was linked to a couple of locations leads officials to believe the lettuce  was already contaminated when it was delivered,  as opposed to being contaminated in the foodservice setting.

more on lettuce

And more about tomatoes from yahoo.com:

Burger King, Outback Steakhouse and Taco Bell were among other restaurants voluntarily withdrawing tomatoes from their menus, following federal recommendations that consumers avoid red plum, red Roma or round red tomatoes unless they were grown in certain states and countries.

McDonald's Corp., the world's largest hamburger chain, stopped serving sliced tomatoes on its sandwiches as a precaution until the source of the bacterial infection is known, according to a statement Monday from spokeswoman Danya Proud. The Oak Brook, Ill.-based company will continue serving grape tomatoes in its salads because no problems have been linked to that variety, she said.

more on tomatoes

FDA amicus on New York City menu board labeling

Ricardo Carvajal and Diane McColl of Hyman, Phelps and McNamara have posted a discussion of the FDA's recent amicus brief in the New York City menu board nutrition labeling case.  From FDA Law Blog:

FDA has filed an amicus curiae brief with the Second Circuit Court of Appeals that supports a New York City (“NYC”) law requiring all menu boards and menus in chain restaurants with 15 or more establishments nationally to bear calorie content information for each menu item.  The case is New York State Restaurant Association v. New York City Board of Health, Docket No. 08-1892-cv.  Oral argument in the case is scheduled for mid-June.  The NYC law is one of several similar local laws or proposals in various stages of consideration across the country.  FDA’s support for the NYC law could lend a boost to similar measures elsewhere.

Read the rest of the post on FDA Law Blog

Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety

FDA Press Release:

HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA.

Today’s action supports the fundamental change in strategy currently underway at FDA to adapt to the demands of the rapidly growing and changing global economy.  These funds will expedite implementation of the strategy outlined in the Action Plan for Import Safety and the complementary Food Protection Plan, both released in November 2007.

“Last year we outlined important changes in how this nation deals with imports.  We are moving from an intervention strategy – where we stand at the border and try to catch things that are unsafe – to an integrated strategy of prevention with verification.  We are rolling the borders back and seeking to build safety and quality into products at every step of the way before they reach American consumers,” Secretary Leavitt said.

The Secretary continued, “Combined with crucial legislative proposals, this increase will allow FDA to continue to transform its regulatory strategies to meet the challenges of the evolving global marketplace.  I urge Congress to act quickly to give FDA the authority and funding it needs to enhance the safety of our food and medical products.”

Under the budget amendment, FDA will be able to expedite steps to improve import safety, including:

• FDA will significantly expand its reach beyond American borders by establishing a presence in five countries or regions and by implementing other measures that will help ensure greater foreign compliance with FDA standards.   
• Another initiative will offer expedited entry for goods bearing certification by trusted parties. 
• FDA will modernize its information technology infrastructure.
• Finally, FDA will conduct at least 1,000 more foreign inspections of food and medical product facilities and an additional 1,000 domestic inspections with funds in the budget amendment.

The increase brings the Administration’s total proposed increase in the FDA's budget for FY 2009 to $404.7 million – a 17.8% boost in funding from FY 2008.

Some new authorities requested for federal agencies in the Action Plan for Import Safety that Congress has not yet granted include:

• Authorizing FDA to accredit highly qualified third parties to evaluate compliance with FDA requirements.
• Authorizing FDA to require certification of designated high-risk products as an additional condition of importation.
• Authority to refuse admission of imports from a firm who delayed, limited, or denied FDA access to its facilities.
• Empowering FDA to issue a mandatory recall of food products when voluntary recalls are not effective.

“FDA’s mission to protect and promote the health of the America public will be greatly aided by these additional funds to implement our strategic plan,” said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs.  “FDA has already embarked on an ambitious program to transform the Agency. This added funding will ensure that FDA can move ahead with these proposals more rapidly.”

Consistent with the Administration’s emphasis on fiscal discipline, the budget amendment is fully paid for within budgetary totals.

The budget amendment proposes the following increases for core FDA programs:

Protecting America’s Food Supply (+$125 million)

The increase allows FDA to intensify actions to implement FDA’s Food Protection Plan. Announced on November 6, 2007, the Food Protection Plan is an integrated, risk-based strategy to help ensure the safety of domestic and imported food and feed. The $125 million increase adds to the $42.2 million increase proposed for food protection in the budget announced in February 2008.

The increase in food protection activities will allow FDA to reduce threats to the food supply, expand FDA’s international presence, and increase technical assistance to help ensure that foreign and domestic food facilities comply with food safety standards. FDA will also be able to improve the risk-based approach it uses to conduct more targeted import exams and foreign and domestic inspections of food manufacturing, processing, and packaging facilities. FDA will pursue additional research on ways to prevent intentional and unintentional contamination, deploy screening technologies to identify microbial and chemical contamination, and respond more quickly to contain outbreaks of food-borne illness. 

Safer Drugs, Devices, and Biologics (+$100 million)

The increase of $100 million for the FDA’s medical product programs will strengthen FDA’s ability to ensure the safety and effectiveness of medical products, from product development and pre-approval testing, through approval, and post-approval safety surveillance. FDA faces growing challenges from the globalization of medical product development and manufacturing. The increase for medical product programs will allow the FDA to respond to this trend.

FDA will more aggressively conduct active safety surveillance to identify early signs of adverse events linked to medical products. FDA will also implement new requirements under the FDA Amendments Act of 2007 related to clinical trials, pediatric drugs and devices, postmarket study commitments, and the labeling and safe use of drugs. FDA will also establish unique device identifiers to track devices, facilitate device recalls, and support inventory management during disasters and the response to terrorism events. Finally, FDA will conduct more import exams and foreign and domestic inspections of medical product manufacturers.

Modernizing FDA Science and Workforce (+$50 million)

The budget amendment also proposes increases to strengthen FDA’s capacity to support product safety and development in areas of emerging science such as nanotechnology, cell and gene therapies, robotics, genomics, advanced manufacturing, and the critical path initiative. FDA will also improve laboratories and other facilities that are essential to carrying out FDA’s mission and invest in science training, professional development, and fellowship programs to strengthen and modernize the FDA workforce.

The program increases listed above include $65 million to modernize FDA’s information technology infrastructure.

Additional information is available online at:

www.importsafety.gov

www.fda.gov

http://www.fda.gov/oc/initiatives/advance/food.html

IFT International Food Nanoscience Conference

Friday, June 27, 5:30 – 7:30 p.m.
Saturday, June 28, 8:00 a.m. – 5:00 p.m.
Hilton New Orleans Riverside Hotel 

Leading authorities from around the world will convene to examine the latest research and information in the emerging arena of the application of nanoscale science and technology in food science and the food industry. Potential implications associated with food-related uses will be examined, as this annual event continues to build the understanding of one of the most promising, innovative, and controversial research areas to impact food science and technology in decades. View the agenda and register at ift.org/IFT08.

Highlights will include:

• Keynote address, Prospects and Tools for Nanoscience: Applications, Characterization, and User Facilities, Altaf H. Carim, PhD., Co-chair, NSET Subcommittee of NSTC and Program Manager, Nanoscale Science and Electron Scattering Centers, U.S. Department of Energy
• Technical presentations including research data and examples of innovations already in commerce in areas of applications such as food safety and defense, food processing and ingredient technologies, and food packaging
• Exploration of ethical and societal considerations associated with the application of nanoscale science and technology in food, including issues ranging from nanomaterials characterization methodologies, to regulatory issues, risk assessment, and consumer acceptance
• Luncheon address: Application of Nanoemulsion Technology for the Delivery of Nutraceuticals, Pharmaceuticals and Cosmeceuticals  Robert J. Nicolosi, Ph.D, Professor of Nutritional Sciences and Director, Center for Health & Disease Research, Division of NanoMedicine, University of Massachusetts, Lowell 

FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes

FDA news release:

The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes.

FDA recommends that consumers not eat raw red Roma, raw red plum, raw red round tomatoes, or products that contain these types of raw red tomatoes unless the tomatoes are from the sources listed below. If unsure of where tomatoes are grown or harvested, consumers are encouraged to contact the store where the tomato purchase was made. Consumers should continue to eat cherry tomatoes, grape tomatoes, and tomatoes sold with the vine still attached, or tomatoes grown at home.

On June 5, using traceback and other distribution pattern information, FDA published a list of states, territories, and countries where tomatoes are grown and harvested which have not been associated with this outbreak. This updated list includes: Arkansas, California, Georgia, Hawaii, North Carolina, South Carolina, Tennessee, Texas, Belgium, Canada, Dominican Republic, Guatemala, Israel, Netherlands, and Puerto Rico. The list is available at www.fda.gov/oc/opacom/hottopics/tomatoes.html#retailers. This list will be updated as more information becomes available.

FDA’s recommendation does not apply to the following tomatoes from any source: cherry, grape, and tomatoes sold with the vine still attached.

FDA recommends that retailers, restaurateurs, and food service operators not offer for sale and service raw red Roma, raw red plum, and raw red round tomatoes unless they are from the sources listed above. Cherry tomatoes, grape tomatoes, and tomatoes sold with the vine still attached, may continue to be offered from any source.

Since mid April, there have been 145 reported cases of salmonellosis caused by Salmonella Saintpaul nationwide, including at least 23 hospitalizations. States reporting illnesses linked to the outbreak include: Arizona, California, Colorado, Connecticut, Idaho, Illinois, Indiana, Kansas, New Mexico, Oklahoma, Oregon, Texas, Utah, Virginia, Washington, and Wisconsin. Salmonella Saintpaul is an uncommon type of Salmonella.

Salmonella can cause serious and sometimes fatal infections particularly in young children, frail or elderly people, and those with weakened immune systems. Healthy persons often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, the organism can get into the bloodstream and produce more severe illnesses. Consumers who have recently eaten raw tomatoes or foods containing raw tomatoes and are experiencing any of these symptoms should contact their health care provider. All Salmonella infections should be reported to state or local health authorities.

FDA recognizes that the source of the contaminated tomatoes may be limited to a single grower or packer or tomatoes from a specific geographic area. FDA also recognizes that there are many tomato crops across the country and in foreign countries that will be ready for harvest or will become ready in the coming months. In order to ensure that consumers can continue to enjoy tomatoes that are safe to eat, FDA is working diligently with the states, the Centers for Disease Control and Prevention, the Indian Health Service, and various food industry trade associations to quickly determine the source of the tomatoes associated with the outbreak.

FDA is taking these actions while the agency continues to investigate this outbreak with state and federal partners. Such actions are a key component of FDA’s Food Protection Plan, a scientific and risk-based approach to strengthen and protect the nation’s food supply.

FDA will continue to issue updates as more specific information becomes available.