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.

US Mustard Tariffs in Retaliation for EU limits on hormones with US Beef

Barry Levenson, Curator of the Mount Horeb Mustard Museum, wrote Habeas Codfish: Reflections on Food and the Law, which is an entertaining and recommended book.

Barry wrote guest posting which follows:

For the last nine years European mustards have been subject to a 100 percent tariff. Not only has this meant higher prices for our mustards from Dijon, from Ireland, from Germany, from Holland, etc., it has also resulted in fewer European mustards coming into the U.S.

You can do something to help get rid of this terrible tax on imported mustards.

First, some brief background. In 1999, the U.S. imposed 100 percent duties on a variety of goods in retaliation for Europe’s unwillingness to buy American beef from cattle that had been treated with growth hormones. Some of these goods were European beef products and that made sense. However, the office of the United States Trade Representative (USTR) went further and imposed duties on several randomly selected goods, including mustard.

Although the beef hormone dispute remains unsettled, we have a chance to get mustard off of the hit list. The USTR is soliciting public comments on the items on the current hit list with the possibility that some items will be removed. THAT’S WHERE YOU CAN MAKE A DIFFERENCE.

Comments are due by Monday, December 8. You can fax them or send them electronically. I have already sent in my comments and you can see them by following the URL address at the end of this paragraph and then double-clicking the PDF icon after the word ‘VIEWS.’ http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064807c1ecf

Now it’s your turn to participate in the process. You can fax your comments to Sandy McKinzy at (202)-395-3640 or by posting them electronically at the government web site, http://www.regulations.gov/.

When you open the site, you can get to the right docket by typing the following in the ‘SEARCH DOCUMENTS’ box: USTR-2008-0036 and then <<GO>>. This will take you to the page with all of the posted comments. On the left side of the page, you will see ‘DOCUMENT TYPE.’

Click on NOTICES. Then click on ‘Send a Comment or Submission’ (next to a yellow thought bubble).

Be sure to put at the top of your comment: “Re: Prepared Mustard, HTS21033040” Even something as simple as “Please, take mustard off the tariff list” will help.

I have met personally with representatives of the USTR. I do not advise trying to take sides in the beef-hormone dispute; they are firm in their position that hormone treated beef is safe.

Then voice your support for removing mustard from the tariff list.

Thanks.

Barry

Scientific Panel Rebukes FDA on BPA

“A scientific panel has issued a blistering report against the Food and Drug Administration, saying the agency ignored important evidence in reassuring consumers about the safety of the controversial chemical bisphenol-A,” wrote Tara Parker-Pope, “Panel Rebukes F.D.A. on Plastic Safety,” the New York Times. BPA is used to make plastic water and baby bottles and in the lining of soft drinks and canned food products.

“The panel . . . did not draw any conclusions about the safety of the chemical, known as BPA. But it criticized the F.D.A. for ignoring crucial studies and using what it said were flawed methods in reaching its conclusions.”

“In its statement, the F.D.A. said consumers should know that ‘based on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.’”

For a PDF of the scientific group’s full report, click here.

Philadelphia to Require Nutrition Labeling on Chain Restaurant Menus

Philadelphia has become the latest U.S. city to require restaurants to list calories on their menus. In a 12 to 5 vote, the city council approved an ordinance requiring food service establishments with 15 or more outlets to provide the total number of calories, saturated fat, trans fat, carbohydrates and sodium for all foods and beverages offered for sale on menus. For items not on menus but on menu boards or with food tags, the nutrition information may be limited to the total number of calories per item provided that the additional information is made available to customers upon request. Restaurants that fall under the ordinance must comply by January 1, 2010.

For a copy of the ordinance click here. For a copy of an article in Philly.com click here.

UK Food Standards Agency Advises Pregnant Women to Limit Caffeine

The United Kingdom’s Food Standards Agency (FSA) is advising pregnant women to limit caffeine intake to 200 mg a day. The FSA had previously advised a maximum daily intake of 300 mg. The new guidelines follows research carried out on behalf of the FSA by the Universities of Leeds and Leicester.

“Too much caffeine might result in a baby having a lower birth weight than it should, which can increase the risk of some health conditions for the baby in later life, or could possibly result in spontaneous miscarriage.” FSA Press Release. “Professor Justin Konje, Chair of the Project Steering Group from the University of Leicester, said: ‘This was a large study involving about 2,500 pregnant women, designed to overcome the limitations of previous research in this area.’”

“This new advice doesn’t mean that pregnant women have to cut out caffeine completely, simply that they should be careful and make sure they don't have too much,” said Andrew Wadge, FSA chief scientist. “We would emphasize that the risks are likely to be very small and believe our new advice, which is based on new research and has been considered by leading independent scientists, is sensible and proportionate.”

Wyeth v. Levine – Supreme Court Oral Argument

The U.S. Supreme recently heard oral arguments on Wyeth v. Levine. The case is being watched closely by those interested in FDA preemption law. CNBC called it the “business case of the century.”

Diana Levine brought a common-law negligence claim against Wyeth, claiming that Wyeth should have revised a drug’s FDA-approved label to bar IV push administration. Wyeth argued that Ms. Levine’s state tort suit was preempted by federal law. The jury returned a verdict in favor of Ms. Levine, and the court opinion held that the jury’s state law based judgment presented no obstacle to FDA’s regulatory objectives. Wyeth appealed to the state supreme court.

In a divided opinion, the Vermont Supreme Court upheld the trial court’s ruling. The Court found that FDA approval is not required to strengthen label warnings, so Wyeth could have complied with both state and federal law. The court also held that FDA labeling regulations create minimum requirements, and that state tort liability for FDA-approved labels would not frustrate the objective of promoting the public health that led Congress to enact the FD&C Act. The Vermont Supreme Court did not afford any deference to recent FDA statements claiming that “FDA approval of labeling under the [FD&C Act] . . . preempts conflicting or contrary State law,” and that “FDA interprets the [FD&C Act] to establish both a ‘floor’ and a ‘ceiling,’ such that additional disclosures of risk information can expose a manufacturer to liability under the act if the additional statement is unsubstantiated or otherwise false or misleading.” Wyeth appealed the Vermont Supreme Court decision to the U.S. Supreme Court.

For additional information on this case and the issues:
· An excellent overview of the case is provided by Kurt R. Karst in the FDA Law Blog.
· Additional background on the case is available at the Drug & Device Law Blog.
· The briefs filed in the case and other background materials are available via the SCOTUS Wiki.
· A transcript of the oral argument is available here.
· Ed Silverman has predicted that the new President and a Democratic Congress will erase any preemption protection won in the last eight years.
· The American Association for Justice, the trial lawyers’ group, issued a preemption report last week, “Get Out Of Jail Free: How the Bush Administration Helps Corporations Escape Accountability.”
· A report prepared for Rep. Henry Waxman as Chair of the House Committee on Oversight and Government Reform found that some FDA career officials objected to Bush Administration drug labeling preemption policy. The senior officials viewed justifications for labeling preemption as “false and misleading,” based on “false assumption,” “naïve to what actually occurs in practice,” and relied on “gross overstatement.”

WSJ: Restaurants Prep For Rules On Menu Data

“While federal menu-labeling standards would unify a hodgepodge of local and state ordinances, restaurant operators will confront issues including costs associated with redesign and installation, overcrowded menu listings and customers coming face-to-face with their caloric intake before ordering.

Congressional leaders recently introduced the Labeling Education and Nutrition, or Lean, Act that would create a uniform standard requiring restaurants and grocery chains with more than 20 locations that serve prepared food to post calories on menus and menu boards.

Several national chains and the industry's largest trade group have thrown their weight behind the bill. Yum Brands Inc. has said it would voluntarily post calories on menu boards at company-owned restaurants by 2011.

The federal legislation follows similar menu-labeling laws passed in California, New York City and other places in recent months.

While some restaurant operators oppose additional regulation, having one standard for their menus and menu boards would solve a major concern: having different variations of laws aimed at providing nutritional information to customers.

"Imagine running a national chain and having 30 or 50 different menu-disclosure requirements," said Dennis Lombardi, a restaurant consultant with WD Partners. "Having to create space and produce these variations would become a nightmare." . . .

In New York, which passed a law requiring calorie counts to be displayed more prominently, consumers have changed their consumption habits. According to a survey by restaurant research firm Technomic Inc., most customers are either buying lower-calorie alternatives or cutting out certain items altogether.

Calorie-disclosure laws could have the most negative impact on casual-dining chains. Diners may be more aware that fast-food chains have a bevy of high-calorie meal options, but may be surprised to learn how many calories are in some casual-dining offerings, according to Buckingham Research Group analyst Mitchell J. Speiser.

http://www.cattlenetwork.com/Beef_Content.asp?contentid=258645

FDA Amending Health Claim for Calcium and Osteoporosis

The Food and Drug Administration (FDA) is amending its labeling regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to:

1) Include vitamin D so that, in addition to the claim for calcium and osteoporosis, an additional claim can be made for calcium and vitamin D and osteoporosis;
2) Eliminate the requirement that the claim list sex, race, and age as specific risk factors for the development of osteoporosis;
3) Eliminate the requirement that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population, and that the claim identify the populations at particular risk for the development of osteoporosis;
4) Eliminate the requirement that the claim identify the mechanism by which calcium reduces the risk of osteoporosis and instead make it optional;
5) Eliminate the requirement that the claim include a statement that a total dietary intake greater than 200 percent of the recommended daily intake (2,000 milligrams (mg) of calcium) has no further benefit to bone health when the food contains 400 mg or more of calcium per reference amount customarily consumed or per total daily recommended supplement intake; and
6) Allow reference for the need of physical activity in either of the health claims to be optional rather than required.

This final rule is effective January 1, 2010. For more information, visit 73 Federal Register 56477–56487 (Sept. 29, 20008), which is available here: [TEXT] [PDF]

Creekstone Farms v. USDA

In a split decision the U.S. Court of Appeals for the D.C. Circuit in Creekstone Farms Premium Beef v. USDA, the majority found that the Virus-Serum-Toxin Act (VSTA) authorizes USDA to prohibit use of a test kit for bovine spongiform encephalopathy (BSE). VSTA authorizes USDA to enact regulations “as may be necessary to prevent the preparation, sale, barter, exchange, or shipment as aforesaid of any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the treatment of domestic animals, or otherwise to carry out this chapter.”

The court accepted USDA’s interpretation of “analogous products” to include test kits that are used in the diagnosis of disease. Diagnosis of disease is integral to the treatment of disease, so this is not too far of a stretch to include diagnosis as part of treatment. But Creekstone Farms never intended to use the test for the treatment of disease. Creekstone would have tested only already dead animals. Further, BSE is invariably fatal and untreatable. USDA’s argument that Creekstone’s testing would be a form of treatment stretches plausibility. Nonetheless, a diagnostic test that helps control of the spread of a disease might be squeezed into “treatment.”

But the stretching must continue because VSTA applies to products that are used in treatment of domestic animals and are a “worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product.” The agency appears to lacks authority to restrict useful, non-contaminated, non-dangerous, non-harmful products. USDA finds this BSE test kit worthwhile enough to use in its own testing, so it is not clear how this BSE test kit is worthless, contaminated, dangerous, or harmful.

USDA argues, not that the test kits are worthless, but only Creekstone’s proposed use is worthless. Given the young age of most cattle at slaughter and the long incubation period for BSE, USDA argues the test would produce meaningless results. This authority to regulate the use of otherwise acceptable test needs to be pulled from VSTA general empowerment of USDA to enact regulations to, “otherwise carry out” the Act. What if Creekstone wanted to use home pregnancy test kits on its cattle? Would USDA have the authority to ban this use?

In his dissent, Judge Sentelle remained unpersuaded that VSTA grants this “use” authority. Sentelle found USDA “exceeded the bounds of reasonableness” in aggregating power to itself. Sentelle explained, "congressional provision of an expressed authority mandate to accomplish statutory goals does not create for the agency ‘a roving commission’ to achieve those or ‘any other laudable goal,' by means beyond the authority granted in the statute." [Citations omitted.]

This matter has not ended. One count remains to be decided by the district court. Creekstone argues that USDA's refusal to allow Creekstone to purchase BSE test kits to test its own cattle is arbitrary and capricious. USDA offered two reasons for the denial. The agency asserts that this use would not be scientifically sound, and USDA has a mandate to “maintain domestic international confidence in U.S. cattle and beef products.”

However, Creekstone did not want to test to ensure the safety of its beef but, rather, to allow the company export its meat to Japan and Korea. From Judge Sentelle’s dissent, “It seems that the Department’s fear is that Creekstone’s use of the test kits would enable it to provide buyers with a false assurance that the cattle from which its beef is obtained are free of Bovine Spongiform Encephalopathy. However, as I read the record, all Creekstone hopes to do is assure foreign buyers that the beef is as well-tested as would be the case with beef produced in the home countries of those buyers.” The purpose of VSTA is not to prevent false claims, and USDA has other authorities to prevent false claims, as does the Federal Trade Commission.

Granted, USDA has a mandate to maintain domestic international confidence in U.S. cattle and beef products. How USDA finds these reasons within its authority under VSTA is unclear. It will be interesting to see whether either of these reasons can survive the arbitrary and capricious test on the district court’s review.

Hat tip to Jonathan Adler and The Volokh Conspiracy for his insight on this decision.

FDA Public Meetings on Produce Traceability

The Food and Drug Administration (FDA) announced two public meetings regarding product tracing systems for fresh produce. The purpose of the meetings is to stimulate and focus a discussion about mechanisms to enhance product tracing systems for fresh produce and to improve FDA's ability to use the information in such systems to identify the source of contamination associated with fresh produce-related outbreaks of foodbome illness.

This discussion will help FDA determine what short and long term steps we should take to enhance the current tracing system. FDA hopes to address concerns on specific issues ranging from the scope of traceability and the costs, benefits and logistics of standardization, to FDA's role in enhancing produce traceability.

If you would like to attend one or both of the produce traceability meetings, you are requested to register in advance. For further information, contact: Deborah Harris, EDJ Associates, Inc., 11300 Rockville Pike, suite 1001, Rockville, NID 20852,240-221-4326, FAX: 301-945-4295, e-mail: dharris@edjassociates.com.

Food Claims and Litigation Conference

The Grocery Manufacturers Association's Annual 2009 Food Claims and Litigation Conference is scheduled to take place February 24-26, 2009 and will be held at Rancho Las Palmas in Rancho Mirage, CA. Nationally recognized authorities from the food, legal, and scientific communities will present these issues in a thought-provoking environment:

· Recent Developments in Food Product Liability
· Country-of-Origin-Labeling
· Utilizing Internal Company Resources to Help Defend a Food Product Liability Lawsuit
· Food Safety McCarthyism
· Confronting Criminal Allegations When Contamination Hits
· Pre-Litigation Risk Management for Consumer Products Companies
· CA Prop 65 and Food, The Current Landscape of Food
· Litigation from a Plaintiff’s Perspective
· Utilizing Non-Traditional Discovery Methods to Investigate and Defeat the Plaintiff’s Case
· Flavoring Litigation
· Current Issues with the Insurance Industry Current Issues with the Insurance Industry

For more information, click here. <http://www.gmalitigationconference.com/>

Barbie Takes on Menu Labeling

The Center for Science in the Public Interest (CSPI) has clever video of Barbie looking for menu labeling at fast food restaurants.

Student Writing Competitions in Legal Medicine

The American College of Legal Medicine (ACLM) has announced their 2009 Student Writing Competitions in Legal Medicine.

Legal Medicine Writing Competition

ACLM will award $1,000 each winner in three categories: medical student, law student, and health care professional student. Papers must be submitted by January 9, 2009. For more information, click here.

Bioethics Student Writing Competition

ACLM will present awards for three outstanding original papers written by law or health professions students on topics in bioethics. 1st Prize – $1,000 2nd Prize – $500 3rd Prize – $250. In addition, the ACLM will pay the costs of travel and lodging for the winner of the 1st prize to present his or her paper at the ACLM Annual Meeting, February 27- March 1, 2009 in Las Vegas, NV Travel and lodging arrangements will be made by the ACLM. The deadline for submission is January 9, 2009. For more information, click here.

ERS "Food Safety and Import"

The USDA’s Economic Research Service (ERS) has published, Food Safety and Imports: An Analysis of FDA Import Refusal Report. The report examines the Food and Drug Administration (FDA) data on refusals of food offered for importation into the United States from 1998 to 2004. The report does not necessarily show the distribution of risks because FDA has focused its import efforts on problems that appear to recur. The data show some food industries and types of violations may be consistent sources of problems both over time. The three food industry groups with the most violations were vegetables (20.6 percent of total violations), fishery and seafood (20.1 percent), and fruits (11.7 percent).

The full report is available here.

Irradiation as a Food Processing Aid for Beef

The Food Safety and Inspection Service (FSIS) announced that it has received a petition from the American Meat Institute (AMI) to recognize the use of low penetration and low dose electron beam irradiation on the surface of chilled beef carcasses as a processing aid. FSIS will hold a public meeting on September 18, 2008, to review the information contained in the petition and to receive public comments on what action it should take with respect to the petition. FSIS is also receiving comments until October 18, 2008.
The announcement of the meeting and direction for submitting comments is available here: [TEXT] [PDF].

US Mandates Irradiation

To read a clever spoof, visit US Mandates Irradiation by Phyllis Entis on efoodalert.com.

Hat tip to Bill Marler for pointing this out.

Illinois Food Safety Symposium Sept. 24-25

Regional food professional conferences often are underappreciated bargains for continuing education and professional development. These regional venues provide an ideal forum for professional growth and networking. One such conference is the Illinois Food Safety Symposium, which will be held September 24-25, in Champaign, Illinois.

I am speaking on “Why Food Laws Matter” on September 24. The conference is sponsored by The Illinois Department of Public Health, the Illinois Department of Agriculture, and the Illinois Public Health Association.