Dave Theno had it right - Bill Marler Guest Blog

Secretaries Vilsack and Sebelius should pay attention

Lauren Beth Rudolph died on December 28, 1992 in her mother’s arms due to complications of an E. coli O157:H7 infection - Hemolytic Uremic Syndrome. She was only 6 years, 10 months, and 10 days old when she died. Her death, the deaths of three other children, and the sicknesses of 600 others, were eventually linked to E. coli O157:H7 tainted hamburger produced by Von’s and served at Jack in the Box restaurants on the West Coast during late 1992 and January 1993. Roni Rudolph, Lauren’s mom, I have known for 16 years.

Dave Theno became head of Jack in the Box’s food safety shortly after the outbreak. I too have known Dave for 16 years. However, I only learned recently a significant fact about Dave – one that made me admire him even more – one that I think, not only that all leaders in corporate food safety should emulate, but one that both Secretaries Vilsack and Sebelius should pay attention too.

Dave and I shared the stage at the Nation Meat Association annual convention a few months ago. The NMA is an association representing meat processors, suppliers, and exporters. Dave, spoke just before I did and was rightly lauded as someone who takes food safety to heart. However, it was his story about Lauren Rudolph and his relationship with Roni that struck me. Dave told the quiet audience about Lauren’s death. Dave also told us that the death of Lauren and his friendship with Roni had changed him. He told us all that he had carried a picture of Lauren in his brief case everyday since he had taken the job at Jack in the Box. He told us that every time he needed to make a food safety decision – who to pick as a supplier, what certain specifications should be – he took out Lauren’s picture and asked, “What would Lauren want me to do?”

I thought how powerful that image was. The thought of a senior executive holding the picture of a dead child seeking guidance to avoid the next possible illness or death is stunning, but completely appropriate. I wonder if Secretaries Vilsack and Sebelius do anything similar when they do their work on President Obama’s Food Safety Working Group? If they do not, perhaps they should?

Secretaries Vilsack and Sebelius right now there are hundreds of families struggling right now due to illnesses and death related to food that you oversee that has been tainted with E. coli O157:H7.

Yesterday, I spent time with a family in South Carolina whose 4 year old ate cookie dough and suffered months of hospitalizations, weeks of dialysis and seizures. She faces a lifetime of complications. And, there is a woman in Nevada who is still hospitalized, who has lost a portion of her large intestine, was on dialysis until a few days ago. She faces months if not years of rehabilitation. Both ate cookie dough that was watch over by Secretary Sebelius’s FDA.

Today I sat across the kitchen table with a family who lost their only daughter because she died from an E. coli O157:H7 infection from meat inspected by Secretary Vilsack’s USDA/FSIS. I then visited families in a Cleveland hospital whose children are struggling in their battle against Hemolytic Uremic Syndrome – again E. coli O157:H7 tainted hamburger is to blame.

Secretaries Vilsack and Sebelius you should be like Dave Theno. Run your departments like Dave ran food safety at Jack in the Box. Go meet these families. Sit across their kitchen tables. Go to their child’s hospital room and see more tubes and wires than you can count. Understand what these people have lived though. Take their stories into your heart. It is hard, very hard, but it will give you a real reason to do your jobs.

William D. Marler, Esq.
Marler Clark LLP PS
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Team Diarrhea to the Rescue!

Minnesota Senator Amy Klobuchar introduced the Food Safety Rapid Response Act of 2009, S 1269. The bill is intended to enhance foodborne illness surveillance and improve food safety by through more rapid and coordinated response to foodborne disease outbreaks. The bill would direct the Centers for Disease Control (CDC) to promote best practices for foodborne illness surveillance and improve the surveillance capacities of the states.

Like the Emperor’s New Clothes, no one wants to talk about the lack of capacity at many state and local health departments. However, this is not just a state and local issue. Our federal food safety system stands (or falls) on the shoulders of the ability and capacity of the states.

Contrast a few states, like Minnesota, known for fine foodborne disease surveillance. Minnesota has a group of investigators, known as Team Diarrhea, that race into action when there is a suspected foodborne disease outbreak. Minnesota was the first to trace the source of the recent Salmonella disease outbreak to peanut butter from Georgia. Essentially, our federal food safety system depended on people in Minnesota getting sick or dying to detect a national food safety problem that started in Georgia?

S 1269 would help create a more rapid and coordinated response to foodborne illness outbreaks. The bill could possibly lead to the institution of Team Diarrhea nationally.

Senator Klobuchar’s press release.

Hat tip to Cynthia Dizikes in MinnPost.com.

Public Workshops on the FDA Reportable Food Registry

FDA announced three public workshops on the Reportable Food Registry. The public workshops are to explain the purpose of the Registry, how it will work, and the responsibilities of persons required to submit a report regarding instances of reportable food to FDA through the Reportable Food electronic portal. In addition, the role of federal, state and local public health officials in voluntarily reporting instances of reportable food to FDA will be discussed.

Electronic registration is encouraged. Please go to Reportable Food Registry Public Workshops for more information.

On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by creating a new section referred to as 417, Reportable Food Registry. Section 417 requires the Secretary of Health and Human Services to establish within the Food and Drug Administration (FDA) a Reportable Food Registry. The congressionally-identified purpose of the Reportable Food Registry is to provide a "reliable mechanism to track patterns of adulteration in food [which] would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health" (Pub. L. 110-085, § 1005(a)(4)).

The Secretary has delegated to the Commissioner of FDA the responsibility for administering FD&C Act section 417. To further the development of the Reportable Food Registry, section 417 requires FDA to establish an electronic portal by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. A "reportable food" is an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.

(FD&C Act § 417(a)(2)). "Responsible party" is defined as the person who submits the registration information to FDA for a food facility that manufactures, processes, packs, or holds food/feed for human or animal consumption in the U.S.

The Registry is scheduled for implementation on September 8, 2009, and applies to all FDA-regulated categories of foods except dietary supplements and infant formula. FDA has published draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (June 2009). This guidance contains questions and answers relating to the requirements under section 417 of the FD&C Act, including (1) how, when and where to submit reports to FDA; (2) who is required to submit reports to FDA; (3) what is required to be submitted to FDA; and (4) what may be required when providing notifications to other persons in the supply chain of an article of food.

Comical Case Names

Drunkenness image via Wikipedia

From Lowering the Bar. Legal Humor. Seriously, by Kevin Underhill:

United States v. 11 1/4 Dozen Packages of Articles Labeled in Part Mrs. Moffat’s Shoo-Fly Powders for Drunkenness, 40 F. Supp. 208 (W D.N.Y. 1941) (holding product was misbranded because it was not in fact a cure or treatment for drunkenness).

Julius Goldman's Egg City v. United States, 464 U.S. 814 (1983).

United States v. Approximately 64,695 Pounds of Shark Fins, No. 05-56274 (9th Cir. Mar. 17, 2008).

A Scary Reminder that Restaurant Allergen Negligence Can be Fatal

I sat up half the night with an Epi-pen watching my wife to see if she was still breathing. The restaurant we ate at that night contaminated my wife’s meal with tree nuts. Although we had told the server that my wife was allergic to nuts -- and the server assured us there would be no nuts -- someone or some system failed at the restaurant.

The restaurant, Gulfstream, an upscale eatery in Orange Country, California, looked beautiful. Everyone at the restaurant presented a polite façade, but ultimately seemed unconcerned about their negligence, which could have killed one of their patrons. The restaurant management has not answered or returned my phone calls.

The Orange Country HCA Environmental Health agency was perhaps worse. The agency would not take my complaint on food contaminated with hidden allergens. The HCA person acknowledged the agency inspected the restaurant, but she thought allergens were solely the consumers’ responsibility. Moreover, the health agency employee seemed unaware that allergic reactions could be serious or even fatal. She dismissed my complaint as not their concern.

Someone ought to instruct Orange County government about the contents of the FDA Food Code, which is adopted by the state of California. We clearly have a ways to go on educating food service managers and health inspectors about food safety.

FSIS and FDA to Host a Public Meeting on Listeria Risk Assessment

FSIS and FDA to host a public meeting to discuss the interagency retail Listeria monocytogenes risk assessment on June 23 in Washington, DC, to discuss the background, approach and scope of a new interagency risk assessment.

Today's Hearing on the Draft Food Safety Enhancement Act of 2009

Documents and video from today's Energy & Commerce Subcommittee on Health hearing on “Food Safety Enhancement Act of 2009” are available here.

Stalemate at the USDA

Tom Laskawy at the Beyond Green blog has an interest post on the reasons why Vilsack “can't find anyone to run the USDA's Food Safety and Inspection Service. You wouldn't think it would be that hard. There must be dozens of scientists and food safety experts who fit the bill.”  . . . “The three candidates mentioned for the post so far, Michael Osterholm, Michael Taylor (though it's unclear if he was really up for the job) and Mike Doyle (so many Mikes!) are all champions of what Marion Nestle likes to call "late-stage techno-fixes." Or, as Obamafoodorama puts it, ‘Zap the crap!’" . . .

The President's Food Safety Working Group has a “spanking new website, [but] the administration hasn't released the names of anyone who's serving on it. The administration's food safety stalemate applies over there as well.”

Read the whole article here.

Search Warrants-What Happens When the FDA Storm Arrives

FDA’s use of criminal search warrants is increasing according to John R. Fleder in his recent article in Update, “Search Warrants—What Happens When the FDA Storm Arrives.” The article offers precautionary steps to ensure a business is prepared to deal with the possibility of a FDA search.

Summary of Discussion Draft of the Food Safety Enhancement Act of 2009

Representatives John D. Dingell, Henry A. Waxman, Frank Pallone, Bart Stupak, Diana DeGette, and Betty Sutton released a discussion draft of the Food Safety Enhancement Act of 2009. The draft is largely based on the food provisions of H.R. 759, the Food and Drug Administration Globalization Act of 2009, introduced in January by Reps. Dingell, Stupak, and Pallone. The Food Safety Enhancement Act of 2009 incorporates technical assistance from the new Administration as well as other stakeholders. The legislation grants the Food and Drug Administration (FDA) the authorities and resources it needs to better ensure the safety of the nation's food supply. The Committee has scheduled a legislative hearing for June 3, 2009.

From the Summary of Discussion Draft of the Food Safety Enhancement Act of 2009:

Food Safety

1. Creates an up-to-date registry of all food facilities serving American consumers: Requires all facilities operating within the U.S. or importing food to the U.S. to register with the FDA annually.

2. Generates resources to support FDA oversight of food safety: Requires registered facilities to pay an annual registration fee of $1,000 in order to generate revenue for food safety activities at the FDA; requires registered facilities to pay for FDA’s costs associated with reinspections and food recalls; allows FDA to charge a fee to domestic firms requesting export certificates for exported food.

3. Prevents food safety problems before they occur: Requires all facilities operating within the U.S. or importing food to the U.S. to implement safety plans that identify and protect against food hazards. FDA would have the authority to specify minimum food safety plan requirements and to audit food safety plans.

4. Requires safety plans for fresh produce: Directs FDA to issue regulations for ensuring the safe production and harvesting of fruits and vegetables.

5. Increases inspections of food facilities: Sets a minimum inspection frequency for all registered facilities. High-risk facilities would be inspected at least once every six to 18 months; low risk facilities would be inspected at least once every 18 months to three years; and warehouses that store food would be inspected at least once every three to four years. Refusing, impeding, or delaying an inspection is prohibited.

6. Improves traceability of food: Enhances FDA’s ability to trace the origin of tainted food in the event of an outbreak of foodborne illness. FDA would be required to issue regulations that require food producers, manufacturers, processors, transporters, or holders to maintain the full pedigree of the origin and previous distribution history of the food and to link that history with the subsequent distribution history of the food; and to establish an interoperable record to ensure fast and efficient traceback (current law permits facilities to hold a record in any format — paper or electronic — making efficient tracing of foods difficult for FDA). Prior to issuing such regulations, FDA would be required to conduct a feasibility study, public meetings, and a pilot project.

7. Enhances the safety of imported food: As an additional layer of protection, FDA can require food to be certified as meeting all U.S. food safety requirements by the government of the country from which the article originated or by certain qualified third parties. Third party certifying entities must meet strict requirements to protect against conflicts of interest with the firm seeking certification.

8. Expands laboratory testing capacity: Requires FDA to establish a program to recognize laboratory accreditation bodies and to accept test results only from duly accredited laboratories. Gives FDA the ability to require laboratories to send test results to FDA.

9. Provides strong, flexible enforcement tools: Provides FDA new authority to issue mandatory recalls of tainted foods. Strengthens criminal penalties and establishes civil monetary penalties that FDA may impose on food facilities that fail to comply with safety requirements.

10. Creates fast-track import process for food meeting security standards: Permits FDA to develop voluntary security guidelines for imported foods. Importers meeting the guidelines would receive expedited processing.

11. Enhances the safety of infant formula: Enhances FDA’s ability to assure the safety of new infant formulas before they go on the market.

12. Advances the science of food safety: Directs the Secretary to include food in an active surveillance system to assess more accurately the frequency and sources of human illness. The Secretary is also directed to identify industry and regulatory approaches to minimize hazards in the food supply.

13. Enhances FDA’s ability to block unsafe food from entering the food supply: Strengthens FDA’s authority to administratively detain unsafe food products. Grants FDA “quarantine” authority under which the agency may restrict or prohibit the movement of unsafe food products from a particular geographic area.

14. Directs FDA to assess the use of carbon monoxide in certain foods: Requires FDA to conduct a safety review of the use of carbon monoxide in meat, poultry, and seafood products.

15. Enhances transparency of GRAS program: Requires posting on FDA’s website of documentation submitted to FDA in support of a “generally recognized as safe” (GRAS) notification.

16. Requires country-of-origin labeling and disclosure: Requires all processed food labels to indicate the country in which final processing occurred. Requires food manufacturers to identify the country of origin for all ingredients on their websites. Requires country-of-origin labeling for all produce.

 

General Provisions

1. Creates an up-to-date registry of importers: Requires all importers of drugs, devices, and foods to register with the FDA annually and to pay a registration fee.

2. Requires unique identification numbers for facilities and importers: To enhance information about FDA-regulated entities, creates unique identification numbers for all drug, device, and food facilities and importers.

3. Creates a dedicated foreign inspectorate: Requires FDA to establish and maintain a corps of inspectors to monitor foreign facilities producing food, drugs, devices, and cosmetics for American consumers.

4. Grants FDA new authority to subpoena records related to possible violations.

5. Provides protection for whistleblowers that bring attention to important safety information: Prohibits entities regulated by the FDA from discriminating against an employee in retaliation for assisting in any investigation regarding any conduct which the employee reasonably believes constitutes a violation of federal law.

IFT Annual Meeting & Food Expo

The Institute for Food Laws & Regulations (IFLR) will be at the IFT Annual Meeting & Food Expo June 6-9. Stop by and see us at booth #602.

Thousands of food industry professionals from around the globe convene at IFT to learn about the latest developments in scientific research, technologies, new products, food law, and consumer trends. The IFT Annual Meeting & Food Expo brings together decision-makers from all of the many disciplines involved in food science, technology, law, and more. The meeting packs in tremendous educational sessions as well as offering great networking for professionals in R&D and other scientific/technical positions, as well as in corporate management, purchasing, consulting, academia, government/regulatory, and technical sales and marketing.

Hope to see you in Anaheim!

Seminar on Food Import Safety May 26-27

Neal Fortin will be speaking on food import law on May 27 in Madison, Wisconsin. The seminar titled, Food Import Safety: Systems, Infrastructure, and Governance, is sponsored by the Center for World Affairs and the Global Economy at University of Wisconsin – Madison. More information and the agenda are available here, here, and here.

To register, send an email to chpra@engr.wisc.edu with the following information: Name, Title, Affiliation, Mailing Address, Telephone Number, Fax Number, and E-mail. The conference is free-of-charge but space is limited. For a map of the UW campus, see http://www.map.wisc.edu/.

Food counterfeiting, John Spink Video Presentation

Food counterfeiting, contamination outpace international regulatory systems

John Spink discusses food counterfeiting and contamination. Watch>>

PDF of Spink's presentation

From MSU News, Special Report available at: http://special.news.msu.edu/aaas2009/food_release.php

CHICAGO — Intentionally contaminated Chinese milk killed several children and sickened 300,000 more, causing concern around an increasingly connected world economy. Demand for inexpensive products virtually guarantees future repeats of food adulteration and counterfeiting from overseas, Michigan State University researchers said, as trade volumes overwhelm regulatory oversight.

Nobody can guarantee safe food, said Ewen Todd, but governments need to improve controls by promoting increased corporate responsibility, identifying vulnerabilities and assessing risks. Todd, a professor of advertising, public relations and retailing, conducted a symposium on the safety of imported food today at the American Association for the Advancement of Science annual meeting held in Chicago.

Increasing risk-based inspections and sampling; improving the detection of food system signals that indicate contamination; improving immediate response to contamination events; and improving risk communication all should be part of a more stringent regimen, Todd said.

The U.S. Food and Drug Administration inspects less than 2 percent of the food coming into the country, while 13 percent of America’s food is imported, Todd said.

“It’s a worldwide trend. First of all, transportation is easier, trade is easier,” he said, while consumers are increasingly well traveled and have higher expectations. “We want stuff in the winter when we can’t grow it.”

Between the extremes of accidentally contaminated food and terrorism via intentional contamination lies the counterfeiter, seeking not to harm but to hide the act for profit. The melamine incidents are such examples. As an industrial chemical that mimics protein content in tests was added to milk and subsequently created kidney problems for children.

Product counterfeiting is the focus of a presentation by John Spink, an instructor at the National Food Safety and Toxicology Center and director of the Packaging for Food and Product Protection (P-FAPP) initiative, both at MSU. He is developing a criminal justice program focused on food counterfeiting.

“We take a risk-based approach to analyze where the gaps are and look closer at where there is a higher reward for fraud,” he said.

“Counterfeiting goes back to Roman times, when French wine had a seal of Roman origin,” he said. “Products are moving around the world so fast now that there’s more opportunity for fraud. When food was distributed more regionally, there was less potential for large-scale fraud, or outbreaks of any kind.”

Recent instances of counterfeiting or contamination include conventionally grown vegetables sold as organic; fish sold as a more premium species; milk and pet food adulterated with melamine; catfish containing banned antibiotics; toothpaste contaminated with diethylene glycol (a base chemical in antifreeze); and canned energy drinks of unknown origin labeled with brand names.

Pharmaceutical counterfeiting has attracted most of regulators’ attention until recently, he said, but those companies are required to report adverse affects or similar problems, while food companies and other manufacturers are not.

“At MSU, our approach to anti-counterfeiting strategy is extremely interdisciplinary to address the many aspects of the risk,” Spink said, including public health communication, supply chain and packaging security. “Overall, we take a holistic, strategic perspective on the human element that led an individual to perceive an opportunity and then act — this perspective is led by criminal justice, social anthropology and basic business economics. Of course other important disciplines are intellectual property rights law, food law, medicine, nursing, public health, international trade, psychology, consumer behavior, retailing, management, economics and business.”

MSU’s international experience also gives it a valuable perspective by understanding source country economies and cultures, Spink said.

FDA Comments on Nutrition Symbols Public Hearing

FDA developed a memorandum discussing the agency’s September 2007 Public Hearing, Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria. The memorandum responds to the comments submitted and presented by participants of the public hearing.

The document also explains the FDA still lacks sufficient data to answer all the questions surrounding the use of front-of-pack nutrition symbols. In particular, FDA received little information on consumer understanding and use of nutrition symbols or the economic impacts of nutrition symbols on food labels.

The full document is available here.

What Do Bill Marler and Ashton Kutcher Have in Common?

In a Twitter challenge to reach one million followers, Ashton Kutcher donated 10,000 bed nets to fight malaria in Africa.  Now the Bill Marler set out a challenge to reach just 25,000 followers by the end of the month. If he does, he will donate $25,000 to the best charity suggested by the Twitter folks.

You can get to Bill on Twitter at @bmarler.  Read more about the challenge here.

Stronger Partnerships for Safer Food

George Washington University Professor Michael R. Taylor and the Association of Food and Drug Officials (AFDO), the Association of State and Territorial Health Officials (ASTHO), and the National Association of County and City Health Officials (NACCHO) today released a new report, Stronger Partnerships for Safer Food: An Agenda for Strengthening State and Local Roles in the Nation’s Food Safety System.

With attention direction toward federal food safety reform, the vital contributions of state and local agencies are often forgotten. Food safety reform will be incomplete and insufficient unless an integrated national food safety system takes full advantage of and enhances the contribution state and local agencies.

The report outlines the current roles of federal, state, and local agencies in protecting Americans against foodborne illness.  It contains 27 findings on the strengths and weaknesses in illness surveillance, outbreak response, regulation, and inspection. The report makes 19 specific recommendations for strengthening state and local roles and for building an integrated national food safety system that works effectively to prevent foodborne illness. It is the product of a collaborative project involving the GW School of Public Health and Health Services, AFDO, ASTHO, and NACCHO and funded by the Robert Wood Johnson Foundation.

"Cheat Death" Fruit Juice Ad Banned

An advertisement for POM Wonderful read, “Cheat Death. The antioxidant power of pomegranate juice.” POM Wonderful offered the “no one would take it serious” defense. While consumers are unlikely to believe the juice would make them immortal, some may believe the product somehow contributed to a longer life, concluded the UK Advertising Standards Authority. The claim for longer life was not substantiated and was banned. The article in the UK Telegraph is here.

Would Dietary Supplements and Cosmetics Find a Home in a New Food Safety Administration?

This blog summarized the Trust for America’s Health report, “Keeping America’s Food Safe: A Blueprint for Fixing the Food Safety System at the U.S. Department of Health and Human Services?” earlier.

More recently, Ricardo Carvajal published some insightful questions on the Blueprint and other proposals for a single Food Safety Administration (FSA).  These proposal raise the “question of whether FDA’s dietary supplements and cosmetics programs should be housed in a new FSA or in the medical products agency that would remain once FDA’s food safety functions have been split off.”

Dietary supplements are defined as foods under the Food, Drug, and Cosmetic Act.  Yet, the Blueprint appears to suggest that dietary supplements should be regulated by the medical products agency because they often are marketed for drug-like effects.

Ironically, the fear that FDA would regulate dietary supplement as drugs was a significant force behind passage of the Dietary Supplement and Health Education Act of 1994 (DSHEA). DSHEA was a significant rebuke to idea of treating dietary supplements like drugs.

Passing an statute to create a new Food Safety Administration is a monumental task. Hardly the time to exhume issues that Congress has already settled. This issue could kill the Blueprint’s chance of passage.

Mr. Carvajal  notes,

It strikes us as curious that the decision of where to house the dietary supplement and cosmetics programs would be based to any degree on the fact that unlawful marketing claims might be made for those products (a problem that needs to be addressed through enforcement), or that some consumers might seek those products out for their “drug-like” effects (what is to become of coffee?).  In any case, we thought that Congress had definitively settled the question as to how dietary supplements should be regulated – as food – and that nothing about the recent or current food safety crises suggests otherwise.  As for cosmetics, their regulatory paradigm has long resembled the one for foods much more strongly than the one for drugs.

Read all of  Ricardo Carvajal, “Would Dietary Supplements and Cosmetics Find a Home in a New Food Safety Administration?” here.

FDA Seeking Comments on Retail HACCP Manual

FDA is seeking comments on its Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments. The Operator's Manual contains information and recommendations for operators of retail and foodservice establishments who wish to develop and implement a voluntary food safety management system based on Hazard Analysis and Critical Control Point (HACCP) principles. The Regulator's Manual contains recommendations for state, local, and tribal regulators on conducting risk-based inspections of retail and foodservice establishments, including recommendations about recordkeeping practices that can assist operators in preventing foodborne illness.  The full notice is available here.

GAO Report: Seafood Fraud

The Government Accountability Office (GAO) released a report, "Seafood Fraud: FDA Program Changes and Better Collaboration among Key Federal Agencies Could Improve Detection and Prevention." GAO-09-258 (Feb. 19, 2009).  Highlights are available at: http://www.gao.gov/highlights/d09258high.pdf.

People Will Make Healthier Choices If Restaurants Provide Nutritional Data, Study Finds

ScienceDaily reports on a new study showing potential benefits for nutrition labeling in restaurants. The study shows that nutritional information can help consumers moderate their eating over time. 

A field study, experiment, and consumer food diaries were used to explore how nutrition information disclosure on menus may influence consumers’ product evaluations and consumption behaviors.  Howlett et al., Coming to a Restaurant Near You? Potential Consumer Responses to Nutrition Information Disclosure on Menus. Journal of Consumer Research, 2009; 090325111256050 DOI: 10.1086/598799.

Save 20% on Food Regulation Text

Food Regulation: Law, Science, Policy, and Practice, provides an in-depth discussion of the federal statutes, regulations, and agencies involved in food regulation.  After an introduction to U.S. food and drug regulation, it covers current food regulations, inspection and enforcement, international law, the Internet, and ethics.  With detailed discussion of policies and case studies, the book remains accessible to students and professionals alike.  

If you would like more information, a summary is available here. The full Table of Contents is available here.  A free copy of Chapter One is available here. 

Save 20% until June 30, 2009! [click here]  Web orders, use promotion code WX9W5EE.  For other orders, use X3E9AEE.

Health Canada Guidance on Food-like Natural Health Products

In Canada, natural health products and foods are regulated under the Food and Drugs Act (FDA) and its regulations. Products that meet the definition of a “natural health product” under the Natural Health Product Regulations (NHPR) are subject to the FDA. Products that are “food” as defined by the FDA are subject to regulation under the food requirements of the FDA and to Parts A, B and D of the Food and Drug Regulations (FDR).

Since implementing the Natural Health Product Regulations (NHPR) in 2004, Health Canada has received several hundred product license applications for products in food format (e.g., energy drinks, vitamin or mineral supplements in candy, and water with added vitamins or minerals). These products have characteristics of both natural health products (NHPs) and foods. There have been regulatory challenges in classifying these products. Are they food-like NHPs or NHPs in food form?

Health Canada provides a new guidance document that outlines the principles and consideration to be applied in determining if a product in a food format is a natural health product.

A Blueprint for Fixing the Food Safety System

The Trust for America's Health and the Robert Wood Johnson Foundation released a report, Keeping America's Food Safe: A Blueprint for Fixing the Food Safety System at the U.S. Department of Health and Human Services, which examines problems with the current system and proposes ways to improve the food safety functions at the U.S. Department of Health and Human Services (HHS) to better protect the nation's food supply.

The report calls for the immediate consolidation of food safety leadership within the Food and Drug Administration (FDA) and ultimately the creation of a separate Food Safety Administration within HHS. Currently, no FDA official whose full-time job is food safety has line authority over all food safety functions.

"FDA certainly needs a modern food safety law and more resources, but to make good use of these tools, HHS needs a unified and elevated management structure for food safety that can implement a science- and risk-based food safety program dedicated to preventing foodborne illness," said Michael R. Taylor, JD, Research Professor of Health Policy at the School of Public Health at The George Washington University and Former Deputy Commissioner for Policy at FDA and Former Administrator of the Food Safety and Inspection Service at the U.S. Department of Agriculture. "Major organizational change requires careful planning and implementation and should not be rushed, but the time is ripe for building sustainable solutions to the problems in our nation's food safety system," he added.

Investigators Find Source of Many Foods Untraceable

From a NY Times story:

Most food manufacturers and distributors cannot identify the suppliers or recipients of their products despite federal rules that require them to do so, federal health investigators have found.

A quarter of the food facilities contacted by investigators as part of the study were not even aware that they were supposed to be able to trace their suppliers, according to a report by Daniel R. Levinson, the inspector general of the Department of Health and Human Services. . . .

Do Fewer Inspections Make Food Safer?

Doug Powell has written a number of blog posts pointing out that inspection don’t make food safety (see the fallacy of food safety inspections.)

Increasing the number of poor inspections will  never improve food safety. However, let’s be careful not to over generalize.  Just ask yourself, “Do fewer inspections make food safer?” 

The past decade has been an American experiment with federal food safety deregulation. The experiment has left Americans with a growing sense of the failure of their government, left the public feeling vulnerable, and intensified calls for reform of our food safety system. Less government oversight and fewer inspections is not working.

I had a great trainer once who challenged me, “Practice does NOT make perfect!  Proper practice makes perfect!”

Inspections do not make food safer.  Proper inspections make food safer.

Posner Dresses Down Prosecutor in Salad Dressing Dispute

Judge Richard Posner blasted a federal prosecutor in an appellate opinion for her repeated “false and misleading” characterization of salad dressing “best when purchased date” as the expiration date, the ABAJournal.com reports. Open criticism of a prosecutor by a judge is rare. Such criticism of a U.S. Department of Justice Attorney is exceedingly rare. Therefore, Judge Posner’s candor is surprising.

The defendant in the case had bought 1.6 million of bottles of Henri's salad dressing and attached new labels that extended "best when purchased by" dates. He was convicted of violating food-labeling laws and wire fraud and was sentenced to five years' probation. However, at trial the prosecutor repeated characterized the “best when purchase date” as an expiration date. The prosecutor also represented the salad dressing as “foul, rancid food,” when the acidic salad dressing apparently had no expiration date and was shelf stable.

The appellate review involved mostly what was not in the record. Posner noted, “the omissions are more interesting than the scanty contents of the government’s threadbare case.” The prosecutor produced no evidence of a health concern, not a single consumer complaint about the taste, and no evidence of product deterioration.

Judge Posner also criticized the testimony of the Food and Drug Administration (FDA) expert witness, as "not just improper and inadmissible but incoherent." The FDA expert apparently testified as to unpublished agency interpretation or guideline. Posner said, “It is a denial of due process of law to convict a person of a crime because he violated some bureaucrat’s secret understanding of the law. ‘The idea of secret laws is repugnant. People cannot comply with laws the existence of which is concealed.’” (Quoting Torres v. INS, 144 F.3d 472, 474 (7th Cir. 1998).

“Misbranded” food under the Federal Food, Drug, and Cosmetic Act (FD&C Act) is an expansive definition. In fact, the definition is so breathtakingly broad I have to work hard to find limitations to talk about in my food law class. However, the FD&C Act definition of misbranded is silent on dates, and unlike some states, FDA has no regulations on “best by” dates. FDA has given me something new to add to my curriculum, United States v. Charles Farinella.

To read more:

Ameet Sachdev, Posner tosses out salad-dressing verdict with unusually stern words for prosecutor, ChicagoTribune.com (Mar. 16, 2009).

Above the Law, Judge Posner Says Expired Salad Dressing is Fine... But Federal Prosecutor Isn't.

California Court of Appeal Affirms that Methylmercury in Tuna is "Naturally Occurring"

Canned tuna is exempt from California’s Proposition 65 for methylmercury, a chemical listed by the state of California as a reproductive toxin and carcinogen, because the methylmercury in tuna is naturally occurring for purposes of Proposition 65.  So confirmed the California Court of Appeals in an opinion by Associate Justice Timothy A. Reardon in The People ex rel. Edmund Brown Jr. v. Tri-Union Seafoods (A116792, filed Mar. 11, 2009)

The tuna company defendants had also argued that federal law preempts Proposition 65 and that the level of methylmercury is below the threshold at which a warning is required; however, the appellate decision did not consider these other grounds. The decision was based solely on the whether the toxin was naturally occurring for purposes of Proposition 65.

Peanut inspection system filled with holes

Alan Ludd, The Atlanta Journal-Constitution (Sunday, March 08, 2009)

“Georgia’s food inspectors had rules for butchering alligators. They had procedures for the proper handling of ‘feral swine.’ But only since last month has the inspectors’ manual told them specifically how to ensure the safe processing of a more everyday fare: peanuts. .  .  .”   The full report is available here.

Trans Fat Ban in Boston

Effective March 12, Boston has banned the use of artificial trans fat in bakeries.  Earlier the Boston Public Health Commission had banned other food-service establishments from using trans fatty acids.  

“There are no health benefits and no level of consumption of artificial trans fat that is considered safe,” said Dr. Barbara Ferrer, executive director of the Public Health Commission. “In fact public health research over the past 20 years has shown that trans fatty acids significantly contribute to heart disease and other health problems.”  From the Boston Public Health Commission Media Release.

Maryland Bill Would Require Warning for Synthetic Food Colorings

Maryland S.B. 101 would require food manufacturers to place a warning label to foods that contain artificial color. This bill would require that, from January 1, 2010 to December 31, 2011, food products that contain specific color additives include the following warning label:

“Warning: The color additives in this food may cause hyperactivity and behavioral problems in some children.”

The labeling requirement also applies to all menus and food advertising notices. Beginning January 1, 2012, the bill prohibits the sale, purchase, use, or selling of food products containing the specified color additives. Violators would be subject to the same penalties as those that apply to adulterated and misbranded foods.

The eight coloring specified in the bill are: FD&C Blue No. 1; FD&C Blue No. 2; FD&C Green No. 3; FD&C Orange B; FD&C Red No. 3; FD&C Red No. 40; FD&C Yellow No. 5; and FD&C Yellow No. 6.

All synthetic food coloring must be approved by the Food and Drug Administration (FDA).  Seven of these colorings are fully approved by FDA as safe for use in foods.  FDA restricts the use of Orange B to casings or surfaces of frankfurters and sausages. (Citrus Red No. 2, which is not included in the bill, is restricted to being used on the skins of oranges not intended for processing.)

In its approval process, the FDA evaluates safety data to ensure that a color additive is safe for its intended purposes. Absolute safety of any substance can never be proven, therefore, FDA’s approval of  colorings and other food additives is made on the best scientific evidence available.  Recent studies (2) have suggested a relationship between artificial colors and hyperactivity in some sensitive children (but not all hyperactive children).  CSPI has petitioned FDA to ban these synthetic colorings.

USDA/APHIS Comment Period for Proposed Rule on Genetically Engineered Organisms

The USDA Animal and Plant Health Inspection Service (APHIS) has asked for comment on its proposal to revise APHIS regulations on the importation, interstate movement, and environmental release of genetically engineered organisms (74 Fed. Reg. 2907 (Jan. 16, 2009)).  APHIS requested comment on the following four issues:

(1) Scope of the regulation and which [Genetically Engineered (“GE”)]  organisms should be regulated;

(2) Incorporation into APHIS regulations of the Plant Protection Act’s noxious weed authority;

(3) Elimination of notification procedure and revision of the permit procedure;

(4) Environmental release permit categories and regulation of GE crops that produce pharmaceutical and industrial compounds.

APHIS is planning for April public meeting(s), but the dates of the meeting(s) are yet to be announced.  APHIS is also extending the comment period for the proposed rule until 60 days after the April meeting(s).

Comments may be sent postal or commercial delivery (two copies) to Docket No. APHIS-2008-0023, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238.  Comments may also be submitted on the Federal eRulemaking portal.

NYC Menu Calorie Labeling Requirement Upheld

New York City requires all menu boards and menus in chain restaurants with 15 or more establishments nationally to bear calorie content information for each menu item. The New York State Restaurant Association challenged this regulations, but the Second Circuit Court of Appeals has rejected the challenge both on federal preemption and First Amendment grounds.

The appellate court held that the Nutrition Labeling and Education Act of 1990 (NLEA), “does not regulate nutrition information labeling on restaurant food, and states and localities are free to adopt their own rules. The NLEA, however, does generally regulate nutrition content claims on restaurant foods, and states and localities may only adopt rules that are identical to those provided in the NLEA.”

The court also held the menu labeling requirement does not violate the First Amendment. In support of the purpose of the regulation the court cited in part on FDA’s amicus curiae brief and, “A 2006 FDA-commissioned report concluded that “obesity has become a public health crisis of epidemic proportions.”  The report is The Keystone Forum on Away-from-Home Foods: Opportunities for Preventing Weight Gain and Obesity (2006). The Keystone Report also associated obesity with the consumption of high-calorie meals fast-food meals, the apparent link between obesity and frequent dining out, and the potential benefits of providing diners with calorie information. The court concluded that the purpose and the means used to achieve that purpose were reasonable.

Hat tip to Ricardo Carvajal.

Indiana's Menu Labeling Bill

Indiana House Bill No. 1207 would require food  establishments having 20 or more locations in Indiana to post both calorie and carbohydrate information “in a manner that allows consumers to consider the information when selecting an item or unit of food.”  These establishments would also have to make available to customers the amount of calories, fat, saturated fat, trans fat, cholesterol, sodium, carbohydrates, fiber, sugars, and protein in each food item.  Violations would be punishable by a civil penalty up to $1,000 for each violation per day.

Hat tip to Cassandra A. Soltis.

Food Traceability Bill Introduced in Senate

Sen. Sherrod Brown (D-OH) has introduced S. 425 to establish a national traceability system for all food under the Food and Drug Administration's (FDA) jurisdiction. The legislation is one of several major food safety bills that have been proposed in the new 111th Congress.

Brown's legislation would establish a nationwide tracking system through the FDA. The system would be developed by an advisory committee comprised of consumer advocates, industry leaders, and representatives from FDA and the USDA. The committee would determine which tracking mechanisms such as tracking numbers, electronic bar codes, and federal databases should be employed to protect consumers.

In addition, the bill would give FDA and USDA mandatory recall authority for contaminated meats, fruits, vegetables and other foods.  USDA has jurisdiction over meat and poultry while the FDA has jurisdiction over fruits and vegetables. (Hat tip to NASDA.)

GAO: FDA Needs to Do Better on Dietary Supplements

The Government Accountability Office (GAO) says the FDA should take actions to improve their regulation of dietary supplements.  Although FDA has taken limited steps to identify and act on safety concerns, a number of factors may allow potentially dangerous products on the market. FDA dedicates relatively few resources to dietary supplement oversight,  In addition, FDA ability to remove dietary supplements from the marketplace is hindered because the agency carries the burden proving significant or unreasonable risk.  (With food additives and drugs, the manufacturer has the burden of proving safety before marketing).

Anyone who has read my book will find this report to be old news.  However, the report offers a well written summary of the situation, and the appendices contain interesting information on FDA actions and a comparison chart on foreign country regulation of dietary supplements.

The  full GAO report is available here, and a summary is available here.  Here is the New York Times article.

It’s Organic, but Does That Mean It’s Safer?

By Kim Severson and Andrew Martin, New York Times (Mar. 3, 2009) http://www.nytimes.com/2009/03/04/dining/04cert.html.

Shoppers who think organic food is safer are often surprised to hear that organic certification has nothing to do with food safety. The recent case of peanut plants in Texas and Georgia sending out contaminated peanut butter and ground peanut products hammers this home. The plants held federal organic certification, but also had rat infestations, mold problems, and bird droppings.

Tainted Food Makes Bill Marler Madder than Any Cow

I couldn't resist this cover picture:

The article is available at:http://www.marlerblog.com/uploads/file/MarlerL&P.pdf.

Food Claims and Litigation conference next week - Rough Duty, but Someone Has to Do It

I will be at the GMA Food Claims and Litigation conference next week in Palm Springs. As Bill Marler, put it, "Rough duty, but someone has to do it."

Those of you who will attend, please say hi.

Neal Fortin

http://foodlawblog.foodlaw.org/2008/09/food-claims-and-litigation-conference.html  

http://foodlawblog.foodlaw.org/2009/01/gmas-2009-food-claims-and-litigation.html  

Senates Wants Criminal Prosecution in Peanut Case

“At a panel discussion at the U on the rash of salmonella cases, the senator urged action against a peanut company executive and changes in U.S. food safety laws.

” U.S. Sen. Amy Klobuchar said Monday that the owner of a peanut-processing company should be prosecuted for the salmonella poisoning of more than 600 people and federal laws should be changed in the hope of preventing future outbreaks of food-borne disease.

"’Based on my review of the evidence, there should be a criminal prosecution here,’ said Klobuchar, D-Minn., after hosting a two-hour panel discussion on food safety at the University of Minnesota's St. Paul campus. . . .”

David Shaffer, Klobuchar: Prosecute peanut case, StarTribune.com (Feb. 16, 2009) available at: http://www.startribune.com/politics/national/congress/39675512.html?page=1&c=y.

More for the Fructose Obesity Debate

In a paper in the Journal of Clinical Endocrinology and Metabolism, Karen L Teff and colleagues describe the outcome of an experiment in which they compared the effects of glucose-and fructose-sweetened beverages on hormones and metabolic substrates in 17 obese subjects (9 men and 8 women). Results indicated that, compared with the glucose-sweetened beverage, consumption of the fructose-sweetened beverage by the obese subjects, reduced insulin secretion, reduced the diurnal leptin profiles, and increased post-prandial triglyceride concentrations. Leptin is a hormone associated with reducing appetite. Compared with insulin-sensitive subjects, those with insulin resistance showed even greater increases in post-prandial triglycerides. Elevated blood triglycerides are risk markers not only for type 2 diabetes but also for cardiovascular disease. In summary the authors state that their results suggest “that fructose consumption may exacerbate an already adverse metabolic profile present in many obese subjects.”

Karen L. Teff et al., Endocrine and metabolic effects of consuming fructose- and glucose-sweetened beverages with meals in obese men and women: influence of insulin resistance on plasma triglyceride responses, Journal of Clinical Endocrinology & Metabolism (online Feb. 2, 2009) abstract available at: doi:10.1210/jc.2008-2192.

Jorgen Schlundt on Food Safety Regulation

Jorgen Schlundt, the director of food safety, zoonoses and food-borne diseases at the World Health Organization, recently talked with NPR on what is needed in food safety inspection systems. Click here to listen to the 5 minute interview.

MMWR on the Outbreak Associated with Peanut Butter

The MMWR report, Multistate Outbreak of Salmonella Infections Associated with Peanut Butter and Peanut Butter--Containing Products --- United States, 2008—2009 is now available.  Interesting reading if you are interested in how the outbreak investigation proceeded.