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.

Truthful Statements Cannot Always Cure a False or Misleading One

In Williams v. Gerber, the Ninth Circuit recently reinstated a law suit against Gerber that alleged labeling on “fruit juice snacks” constituted misrepresentation and breach of warranty under California law. Gerber’s “Graduates for Toddlers Fruit Juice Snacks,” juxtaposed the product name with images of fruit (such as oranges, peaches, strawberries, and cherries) on the front of the package. However, the product contained none of those fruit juices, but only white grape juice from concentrate.

The product also stated that the Fruit Juice Snacks were made with “fruit juice and other all natural ingredients.” The court found that a reasonable consumer could interpret that to mean that all the ingredients were natural, which appeared to be false. The court also found that the label “claim that Snacks is ‘just one of a variety of nutritious Gerber Graduates foods and juices that have been specifically designed to help toddlers grow up strong and healthy’ adds to the potential deception.”

An important part of the defense in this case was that the product offered a full ingredient listing on the side panel, which cured any potentially misleading representations on the package। In abstract, this may seem reasonable. But here are the ingredients: “corn syrup, sugar, white grape juice from concentrate, contains less than 2% of the following: carrageenan, ascorbic acid (vitamin C), corn starch, natural flavors, citric acid, hydrogenated coconut oil, carnauba wax, red cabbage extract color, paprika color, beeswax, annatto color and elderberry juice concentrate color.” What do you think? Are these “Fruit Juice Snacks” or Fruit-flavored Candy”?

Basically, the court held that reasonable consumers should not be expected to look beyond misleading representations on the front of the box to discover the truth from the ingredient list in small print on the side of the box:

We do not think that the FDA requires an ingredient list so that manufacturers can mislead consumers and then rely on the ingredient list to correct those misinterpretations and provide a shield for liability for the deception. Instead, reasonable consumers expect that the ingredient list contains more detailed information about the product that confirms other representations on the packaging.

This decision follows the line of the classic “lollipop” case, “However, even though the actual ingredients are stated on the outside of a carton, false or misleading statements inside the carton may lead to the conclusion that the labeling is misleading, since a true statement will not necessarily cure or neutralize a false one contained in the label.” United States v. 432 Cartons Individually Wrapped Candy Lollipops, 292 F. Supp. 839 (1968). (Shameless plug: In chapter three of my book, Food Regulation: Law, Science, Policy, and Practice.)

Ken Odza in Food Liability Law Blog, When Is Labeling Misleading and Actionable Under State Law? Is There Any Clearly Understood Standard? found the Williams decision troubling:

As a practical matter, the only way manufacturers can mitigate against these types of putative class actions is to involve lawyers directly in the marketing and labeling process. Under the world imagined in the Williams case, legal training seems to be a prerequisite to understanding which labels may give rise to litigation and which may not.

Good advice, Ken, because lawyers should be on the product development team early on—before the marketing gurus get too far out. Labeling can be simple, but it can also enter some tangled swamps. The marketing people need to know when they are entering a swamp and seek a competent guide.

Frankly, I don’t have much sympathy for those who wring their hands over the expense of hiring an experienced guide for the swamp. If you cannot bear the expense, it is simple to stay out of the swamp. The Williams court quoted another classic labeling law case, “It is not difficult to choose statements, designs, and devices which will not deceive.” United States v. Ninety-Five Barrels More or Less of Alleged Apple Cider Vinegar, 265 U.S. 438, 443 (1924). (Also in chapter three of my book, Food Regulation: Law, Science, Policy, and Practice.)

Gerber also offered compliance with FDA’s requirements as a defense. Surprisingly, the district court bought into this, noting that it believed that “the FDA authorizes the way in which Gerber labels snacks.” The lower court should have known better. Food Law 101: FDA does not authorize or approve labels.

This is one of the inherent tradeoffs involved in the policy decision regarding pre-market approval. If you want federal pre-emption of states, you have to be willing to grant more authority to the federal government. You can’t have your fruit juice snacks and eat them too.

Pharming Goats for Antithrombin

The Food and Drug Administration (FDA) approved for the first time the sale of a drug made by genetically engineered animals. The goats are genetically engineered to secrete antithrombin in their milk. The drug is needed by patients with a hereditary deficiency of antithrombin in their blood.

The European Union (EU)—although known for dragging their feet on the approval of genetically engineered (GE) products—approved this drug in 2006. 

Photo: GTC Biotherapeutics. For more information, see Shankar Vedantam, Washington Post, Drug Made In Milk of Altered Goats Is Approved, and MSNBC, FDA OKs drug from genetically altered animals.

DeLauro Reintroduces Food Safety Modernization Bill

Flanked by a mother whose son was sickened by Salmonella poisoning from peanut butter and a son whose mother died of Salmonella poisoning from peanut butter, U.S. Rep. Rosa DeLauro reintroduced a plan to restructure the Food and Drug Administration (FDA).

From the press release:

“This salmonella outbreak represents the full-scale breakdown of a patchwork food safety system. And it should act as the final wake up call,” said DeLauro. “That is why, today, I am introducing the Food Safety Modernization Act to separate food safety regulation from drug and device approvals and to restore the balance that has long been missing at Health and Human Service. . . .

In addition to the structural change, The Food Safety Modernization Act also updates food laws and would change the focus to preventing disease-causing contamination. The bill would utilize a modern approach to food safety by requiring food producers to: control health hazards in their operations; meet federal standards for preventing or removing contaminants and pathogens from food; and be subject to regular inspections by federal officials based on the risk profile of the products they produce. When prevention fails, the Food Safety Administrator would have sufficient enforcement authority, including authority to order recalls, seize unsafe food before it enters the market, and impose fines on companies that refuse to abide by the law.

More in available on this story here, and here. Copy of the bill (S.3385) is available here.

FDA Supplement Warning Letters: 2008 Year in Review

Ivan Wasserman and Svetlana Walker have published the useful FDA supplement warning letters: 2008 year in review in Foodnavigator.com (27-Jan-2009). Wasserman and Walker analyzed the 44 warning letters issued by the US Food and Drug Administration (FDA) to supplement marketers last year. This type of analysis can provide insight into the types of claims and other issues that are at the top of FDA’s list for enforcement.

FDA’s emphasis on cancer claims made on internet web sites is no surprise as this has long been a red flag to the agency. All 44 of the warning letters involved some type of concern regarding disease claims (36 mentioned cancer claims). Website claims were mentioned in 41 of the letters. By comparison, only three warning letters were sent following facility inspections.

The amount of letters triggered by website reviews highlights the importance of diligence when it comes to creating website content. FDA may consider any statement that appears on a company’s web pages to be a labeling claim. Consumer testimonials, even when truthful can still be misleading, and when used in a company’s marketing, FDA will consider these testimonials to be the same as direct claims.

In addition, FDA considers metatags (hidden tags used direct search engines) to also be part of a product’s claims. For instance, “gout” as a metatag for a dietary supplement webpage would drive customers seeking gout information to that website. Almost half of the 2008 FDA Warning Letters sent to dietary supplement marketers identified the use of disease terms in metatags.

Hearing to be held on Salmonella outbreak Feb. 11

The House of Representatives Energy and Commerce Committee has announced plans to hold a hearing on Feb. 11 to examine the recent Salmonella outbreak associated with peanut butter manufactured by the Peanut Corp. of America (PCA). “There are still far too many questions surrounding FDA’s role in allowing the PCA to distribute contaminated products,” said Rep. Bart Stupak, Chairman of the Oversight and Investigations Subcommittee. “We have already requested a number of documents from the company and I hope this hearing will bring to light not only what went wrong but also what the FDA and industry can do to prevent future outbreaks.” For more information, see the press release.

FDA Commissioner Update

From the In Vivo Blog, Announcement Timing Provides Clues:

“Comments out of the White House that an announcement is imminent on President Obama’s choice for FDA commissioner indicate the pick is someone who has already been thoroughly vetted.

“Duke cardiologist Robert Califf and Baltimore Health Commissioner Joshua Sharfstein have been formally interviewed for the job by HHS Secretary-designate Tom Daschle and would appear to be the two most serious names to make the final cut (“The Pink Sheet,” January 19, 2009, p. 3). . . .”

Peanut scare a new crisis of deregulation

CYNTHIA TUCKER wrote an editorial on the peanut scare in  the Atlanta Journal Constitution (Sunday, Feb. 1, 2009):

The good people of Blakely, Ga. — a town that calls itself the “Peanut Capital of the World” — are relearning long-lost lessons about the perils of unfettered capitalism. Along with former Wall Street secretaries and unemployed bank clerks, they have become collateral damage in an age of deregulation and an ideology that defined government as always the problem, never the solution.

Virginia-based Peanut Corp. of America shut down its processing plant outside Blakely, in southwest Georgia . . .  the locals wonder about the future of the plant, which has laid off most of its 50 or so employees. . . .

Food and Drug Administration inspectors say plant managers found evidence of salmonella in its peanut butter products but still sold them, in violation of the law. Plant executives had a very simple reason for hesitating to destroy the products — it would have cost the company money.

Instead, they bought the services of an outside lab, which declared the peanut butter safe. (That sounds suspiciously like Wall Street, which paid ratings agencies that declared exotic financial instruments to be nearly risk-free. Those financial instruments have since wrecked the world banking system.)

Since then, salmonella traced to the facility has sickened more than 500 people in 43 states and may be linked to the deaths of several others.

Did plant executives violate the rules? Apparently. Should they be prosecuted? Absolutely.

But wouldn’t consumers and — in the long run — even the plant, its executives and employees have been better off with a tightly regulated system that would have prevented those violations? With more federal and state scrutiny, plant managers would have been less likely to break the rules because they would have feared getting caught.

It’s simple human nature. Any system of rules and regulations is only as good as its enforcement. And lately, the nation’s food-safety enforcement has been lax. . . .

Those were the years of cutting taxes and minimizing government, which was routinely denounced as wasteful, inept and overbearing. Businesses were allowed to police themselves, a laughable concept that suggests that business executives are exempt from the human foibles that plague the rest of us, including greed. . . .

Now, however, Georgia legislators, including Republicans, are suddenly clamoring for stiffer laws and more oversight. Indeed, the entire country is in the midst of a cultural shift as Americans rediscover the many reasons that smart government oversight of commerce and industry makes good sense.

In the decades he has been involved in food safety, Doyle [director of the Center for Food Safety at the University of Georgia] said, he has encountered many companies where executives are “highly committed” to ensuring the safety of food. But other companies “just don’t want to get caught,” he said.

Of course, it’s hard for consumers to tell the difference, which is why strict government oversight in necessary.

• Cynthia Tucker is editorial page editor. Her column appears Sundays.

Caution: Eggs contain Egg

“Beware: The daft egg-box warning that contents 'may contain eggs'” reports Helen Dowd in the Mail online (Jan. 24, 2009):

In these health-conscious times food companies are increasingly keen to warn consumers if ingredients may cause allergic reactions.

 But one firm has gone a step further by advising shoppers that its boxes of eggs contain...egg.

 The Happy Egg Company’s six-pack of eggs – which features the company’s name and is decorated with a picture of an egg and a cartoon chicken – contains the message ‘allergy advice: contains egg’ inside the lid of the boxes. . . .

 The firm initially claimed that supermarkets’ strict labelling criteria were to blame for the overzealous warning.

 A spokesman said: ‘Some retailers insist on this information within their packs as part of a due diligence procedure. Any products deemed as potentially allergenic are included in this. A crazy world, but occasionally we have to do silly things to cover ourselves.’

Later The Happy Egg Company  admitted it had chosen to print the advice of its own volition – after the supermarkets involved said they only demand producers comply with the law – adding: ‘We have to state the obvious to cover all eventualities.’

But bizarrely, the company has not printed the warning in its boxes of ten eggs. . . .

The Happy Egg Company is sticking to its story that this labeling was to be precautionary.  However, this “Allergy Advice” is so ridiculously overzealous, I  am guessing that the label reflects its designer's wit. Moreover, this is from the United Kingdom, not the US. So you cannot blame this one on Bill Marler and US tort law. I can almost see this as a Monty Python skit. 

Thanks to Katherine Teodosic for alerting me to this one.