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.

Troubled peanut firm's chief also an industry quality adviser

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

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

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

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

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

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

The full story is available here.

Playing Hard Ball With FDA Might Lead to Criminal Prosecution

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

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

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

Hat tip to the FDA Law Blog.

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

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

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

Draft Risk Assessment for Avian Influenza in Food

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

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

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

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

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

Snake oil, science and the FDA

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

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

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

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

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

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

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

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

. . . .

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

Final Rule on Mandatory Country of Origin Labeling

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

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

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

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

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

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

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

Photograph adapted from the Marler Blog.

Food Regulation: Law, Science, Policy, and Practice

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

If you would like more information:

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

Dietary Guidelines Advisory Committee Meeting Announced

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

The Meeting will:

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

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

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

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

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

Hot Topics in Food Law

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

Program Description

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

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

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

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

Registration Options click here

FDA's Final Guidance on GE animals

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

From Bill Marler on Peanut Butter

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

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

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

The families of five dead people are waiting.

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

Frank Torti to be Acting FDA Director

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

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

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

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

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

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

The Wall Street Journal (subscription required).

Smaller sizes, same prices at the market

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

Visit msnbc.com for Breaking News, World News, and News about the Economy

Sanjay Gupta Picked for U.S. Surgeon General

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

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

FDA Requires Specific Label Declaration of Cochineal Extract and Carmine

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

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

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

Hat tip to Ricardo Carvajal.

Food poisoning can sometimes lead to chronic illness

The St. Petersburg Times Tampabay.com ran today’s article by Annys Shin’s (of the Washington Post) on the long-term health consequences of foodborne illnesses.

Campylobacter, a bacterium associated with raw chicken, a leading cause of Guillain-Barre syndrome. Certain strains of Salmonella can cause arthritis. And E. coli O157:H7 can release toxins that cause hemolytic uremic syndrome, or “HUS, a kidney disorder that in 25 to 50 percent of cases leads to kidney failure, high blood pressure and other problems as much as 10 years later, including the risk of birth defects.”

“Until recently, doctors were focused on the acute phase of food-borne infections, but since the 1990s, there has been "a more gradual recognition that some of the pathogens do have long-term (effects)," said Marguerite Neill, an infectious-disease specialist who teaches at Brown University.

“The impact of HUS, however, is great. .  . According to a long-term study of 157 HUS victims co-written in 1994 by Andrew Pavia, an infectious-disease expert at the University of Utah, more than half developed kidney problems seven or more years after the initial illness.

“These people face a lifetime of medical treatment. ‘Anyone with HUS will be monitored for the rest of their lives. If the acute course was severe enough, the risk of long-term kidney complications, including end-stage renal disease and kidney transplant, is quite high. The future medical cost alone can then be in the millions,’ said William Marler, a Seattle lawyer who sues retailers and food companies on behalf of food poisoning victims. . . .”

My wish for Santa is that everyone will focus more on food safety during the holidays and in the new year.

Hat tip to the Marler Blog by marler@marlerclark.com (Food Poisoning Lawyer) for the lead.

FDA Commissioner Eschenbach to Resign

Alicia Mundy, Wall St. Journal (Dec. 15, 2008).

“Food and Drug Administration Commissioner Andrew von Eschenbach has told his staff that he plans to resign effective Jan. 20, 2009. “In an internal message sent Monday to FDA officials, Dr. von Eschenbach said he would work closely with President-elect Barack Obama's transition team "to ensure a seamless change in political leadership at the agency. As with any transition, there will likely be changes for other senior managers as well, although all current Deputy Commissioners and the Chief of Staff are career civil servants who have served me and FDA well." . . .

For “The Onion” style humor at the Pharma Marketing Blog: Eschenbach Announces Resignation, FDA Staffer Throws Shoes in "Farewell Kiss".

Proposed Serving Facts Labeling for Alcoholic Beverages

TTB proposes to require Serving Facts labeling on alcoholic beverages which would be similar to this Nutrition Facts labeling. The new rules would requires a statement of alcohol content as well. You can read more at Bevlog, where you can also seen an image of what the new alcohol beverage labels might look like.