USDA details COOL interim final rules

The U.S. Department of Agriculture yesterday issued an interim final rule for the mandatory country of origin labeling (COOL) program that will become effective on Sept. 30. The rule covers muscle cuts and ground beef (including veal), lamb, chicken, goat, and pork; perishable agricultural commodities (fresh and frozen fruits and vegetables); macadamia nuts; pecans; ginseng; and peanuts -- as required by the 2002 and 2008 Farm Bills. USDA implemented the COOL program for fish and shellfish covered commodities in October 2004.

Commodities covered under COOL must be labeled at retail to indicate their country of origin. However, they are excluded from mandatory COOL if they are an ingredient in a processed food item. USDA has also revised the definition of a processed food item so that items derived from a covered commodity that has undergone a physical or chemical change (e.g., cooking, curing, smoking) or that has been combined with other covered commodities or other substantive food components (e.g., chocolate, breading, tomato sauce) are excluded from COOL labeling.

Food service establishments, such as restaurants, lunchrooms, cafeterias, food stands, bars, lounges, and similar enterprises are exempt from the mandatory country of origin labeling requirements.

The rule outlines the requirements for labeling covered commodities. It reduces the recordkeeping retention requirements for suppliers and centrally-located retail records to one year and removes the requirement to maintain records at the retail store. The law provides for penalties for both suppliers and retailers found in violation of the law of up to $1,000 per violation.

The rule prescribes specific criteria that must be met for a covered commodity to bear a "United States country of origin" declaration. In addition, the rule also contains provisions for labeling covered commodities of foreign origin, meat products from multiple origins, ground meat products, as well as commingled covered commodities.

USDA plans to conduct education and outreach activities during the six months following the rule's effective date to help the industry comply with the law.

The full text of the interim final rule will be published in the Aug. 1, 2007, Federal Register.

Copies of the interim final rule and additional information can be found at: http://www.ams.usda.gov/COOL.

Warning: May Contain Guff

Warning: May Contain Guff, Conor Pope, Irish Times (Jul. 28, 2008)

There was a time when the only the makers of certain shampoos and moisturisers could get away making absolutely ridiculous claims about their products. In recent years, however, more and more manufacturers have climbed on board the crazy train and now if you take a walk through your local supermarket, you will quickly lose count of the number of foods that promise to keep you alive and gorgeous looking for longer.

There are sugary cereal bars which use extra nutrients and calcium to distract from their calorific content, vegetable spreads that promise to lower your cholesterol in a heart beat and yoghurt drinks with unpronounceable additives which, the ads say, will improve you digestion and immunity. And because these products are even better than real food — as the manufacturers will have you believe — they can justify charging a premium for them. It's a win win situation, for them at any rate.

Last year the increasingly outlandish claims being made on some food labels finally prompted the EU to take action, and legislation was introduced prohibiting manufacturers from making unverifiable health claims about their products. In the future, all nutritional or health claims will have to be backed by proper scientific evidence, although certain products are hanging in there after getting a two-year derogation so they can get their houses in order.

Functional foods, which claim to have beneficial nutrients added, are not entirely without merit, however. Earlier this month Enterprise Ireland announced €20 million in funding for the establishment of a National Functional Foods Research Centre. The new centre will bring together four of the biggest food groups in the country - Dairygold Food Ingredients, Glanbia Nutritionals, Carbery and Kerry Ingredients Ireland - to maximise the commercial value of milk.

The companies will work in conjunction with researchers from UCD, UCC, UL and Teagasc to enhance foods (including infant formula, dairy spreads, yogurts and cheese) with extra nutrients. Speaking at the launch, the Tánaiste and Minister for Enterprise, Trade and Employment Mary Coughlan said the investment would "lead to the delivery of new high-value, innovative food products for the health conscious consumer".

Gov. Schwarzenegger signs law banning trans fats in restaurants

Gov. Schwarzenegger signs law banning trans fats in restaurants, Patrick McGreevy, Los Angeles Times (Jul. 25, 2008).

“California became the first state to require restaurants to cook without artery-clogging trans fats, such as those in many oils and margarines, under restrictions signed into law Friday by the health-conscious governor. Gov. Arnold Schwarzenegger, a physical-fitness advocate and crusader against obesity, sided with legislators who said the measure would help get the fat out of Californians who are too dependent on fast food.”

"California is a leader in promoting health and nutrition, and I am pleased to continue that tradition by being the first state in the nation to phase out trans fats," Schwarzenegger said. "Consuming trans fat is linked to coronary heart disease, and today we are taking a strong step toward creating a healthier future for California. . . .”

Under the new law, most California eateries must stop cooking with all but small amounts of trans fat by 2010. The California Restaurant Association opposed the legislation, but voiced confidence that members will meet the deadline. A copy of the law is available here.

California is seen as a leader in this matter, and it they are successful, we may seen the law copied by other states. However, I wonder if some form of restaurant nutrition labeling, particularly saturated fat, trans fat, cholesterol, sodium, and calories, might have been more effective in promoting better health. “Trans fat free” does not mean healthy.

Critical Report on Claims of Organic Food's Nutritional Superiority

A report by Dr. Joseph Rosen from Rutgers University, US, was published this week by the American Council on Science and Health (ACSH) entitled "Claims of Organic Food's Nutritional Superiority: a Critical Review." Dr. Rosen analyzed a pro-organic report by Charles Benbrook and colleagues at the Organic Trade Association's Organic Center and found the data had been selectively chosen and presented to "prove" the desired point. When Dr. Rosen recalculated some of the organic data, correcting inaccuracies, he concluded that the conventional products were actually 2% more nutritious than the organic varieties. The complete report is available at: http://www.acsh.org/docLib/20080721_claims_of_organic_foods.pdf.

Improving Food Safety: Insights from Intensive Care

Paraphrasing Tom Sawyer, a person who takes a bull by the tail once, learns sixty or seventy times more than a person who hasn’t. Perhaps no one has seen the inside of as many intensive care units for foodborne illness as Bill Marler.

Gain some of Marler’s insight on improving food safety by reading his latest commentary, E. coli O157:H7 is a powerful and deadly bacterium. “You cannot see it, taste it, or smell it. 250,000 E. coli O157:H7 (E. coli) bacteria will fit on the head of a pin. Ten to 50 will kill your child or your grandmother.”

Make sure you read to through to the end of the “Might I suggest” section.

GAO Report: Selected Countries' Systems Can Offer Insights

The Government Accountability Office (GAO) released a new report on July 14, "Food Safety: Selected Countries' Systems Can Offer Insights into Ensuring Import Safety and Responding to Foodborne Illness." (GAO-08-794, June 10.)

For the full report, click here.

For highlights, click here.

FDA: Synthetic Ingredients May be "Natural"?

In a recent letter to the Corn Refiners Association, the Food and Drug Administration (FDA) stated that synthetically produced high fructose corn syrup (HFCS) may be labeled as “natural” under certain circumstances.

FDA longstanding policy on “natural” claims was, “not to restrict the use of the term ‘natural’ except for added color, synthetic substances, and flavors as provided in §101.22. Additionally, the agency will maintain its policy regarding the use of ‘natural,’ as meaning that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food. Further, at this time the agency will continue to distinguish between natural and artificial flavors as outlined in §101.22.” 58 Fed. Reg. 2407 (Jan 6, 1993).

The July 3 FDA letter states that the agency would object to calling HFCS “natural,” if synthetic enzymes or synthetic processing aids remained in the final product. However, FDA does not object to synthetic HFCS being labeled as “natural” if no synthetic enzymes or processing aids end up in the final product.

Frankly, this is a tortuous interpretation. Unless you like dancing on a pin, I urge caution in applying this “clarification.”

Hat tip to Lynn Kuntz of Food Product Design for bringing this to my attention.

Dingell, Stupak Announce Hearing on FDA's Struggle with Salmonella Outbreak

Reps. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak, Chairman of the Subcommittee on Oversight and Investigations, today announced plans to hold a hearing related to the Salmonella Saintpaul outbreak.

Salmonella Saintpaul Outbreak: Concerns About FDA/CDC Lack of Trace Back The Control Group

Interesting comments from Jim Prevor, the Perishable Pundit at http://www.perishablepundit.com/index.php?date=7/03/08:

. . . It was good news to learn that CDC was basically starting anew and doing new survey work with people who became ill after June 1, 2008. This survey work would involve additional questions and presumably build on learning from inadequacies in the initial investigation of those who fell ill in April and May. . . .

What was shocking — and very disappointing for the produce industry — was word that even in this new investigation, CDC is not doing any traceback of the control group. This group consists of people similar in demographics to the ill people but who did not fall ill.

Our interview with Michael T. Osterholm PhD, M.P.H., focused on the necessity for doing traceback with the control group. Here is what Dr. Osterholm said:

…it is not biologically plausible to have Mexico and Florida both at the source of this outbreak. It epitomizes the ineptitude of the investigation. FDA and CDC should have obtained tomato product consumption information from both outbreak cases and controls. They needed to conduct full fledged tracebacks all the way back to the source not only of the sick cases but of the control group as well.

The epidemiology conducted to learn what product is associated with this outbreak by interviewing those sick and those not sick on what they were eating is a prerequisite but the epidemiology needed to go further. It was critical for the investigators to learn the locations of where both the cases and controls ate tomatoes and trace back from there.

When doing the traceback, you may come up with a few possibilities of where the tomatoes came from. If you collect data over time of the cases and controls, using the same methods to make the product association, you may find 85 percent of outbreak cases trace back to a certain field or grower, or re-packer versus the control product. Then you begin to get a much better handle on where product came from.

Q: Why did the government forego this strategy?

A: FDA and CDC have not made this a priority. They will never find a silver bullet by just tracing back a product. They’re looking for a cluster that matches up exactly with the one gun barrel. They’re under the false impression that they’re going to get a clean, clear-cut answer by finding the magic cluster. They need to do this case/control approach.

Now whatever happened with the initial investigation, whatever judgments or considerations were made, this much is beyond dispute: It didn’t work.

A quote attributed to Albert Einstein defined insanity as doing the same thing over and over again yet expecting different results. So surely CDC should be open to enhancing its methodology. Certainly there is no way that doing a traceback on the control group could hurt.

We have Dr. Osterholm, a highly credible person with extensive experience, saying this is a necessity. This is from a man who was doing traceback in Salmonella investigations on tomatoes a decade ago.

So, we have a methodology that has not been working, a highly credible source suggesting a specific improvement in that methodology, yet when asked, CDC gave a simple response of no, it is not tracing back the control group. . . .

This CDC also needs to consider its dismissive manner. An issue such as this merits an explanation. In light of the failure of the last traceback and the input from Dr. Osterholm, if CDC doesn’t want to do a traceback on the control group, it should have the decency to explain why to the general public.

Does CDC lack the resources required? Does it have a substantive disagreement with Dr. Osterholm?

The people at CDC are hired by the citizens of America to handle this portion of their affairs. A decent respect for the people who pay the bills requires CDC to be more transparent in its decision-making process..

IDFA Files Lawsuit to Stop Ohio's No-rBST Labeling Law

The International Dairy Foods Association (IDFA) filed a lawsuit against the State of Ohio challenging the state's new regulations regarding the labeling of dairy products from cows that have not been treated with artificial growth hormones. In the lawsuit, IDFA says the Ohio rule interferes with the First Amendment right of its members to communicate truthful information to Ohioans and with interstate commerce. “The practical effect of the Ohio rule silences manufacturers of dairy products and prevents Ohioans from knowing whether artificial growth hormones have been used in dairy products,” said Peggy Armstrong, IDFA communications director. To read the news release, click here. To view IDFA's complaint, motion and brief, click here.

Lou Dobbs: Bush Should Be Impeached for Salmonella Outbreak

An angry Lou Dobbs of CNN assailed the ineptitude of the Food and Drug Administration (FDA) and place the blame squarely on President George W. Bush, calling for his impeachment (reported by Jeff Poor, Business & Media Institute).

“You know, I have heard a lot of reasons over the years as to why George W. Bush should be impeached,” Dobbs said. “For them to leave the Food and Drug Administration (FDA) in this state, its leadership in this sorry condition and to have no capacity apparently or will to protect the American consumer – that is alone to me sufficient reason to impeach a president who has made this agency possible and has ripped its guts out in its ability to protect the American consumer.”

On June 18, Dobbs called the FDA “excessively intellectually challenged.” The night before he called the FDA “moronic.”

“The FDA, led by complete moronic, unengaged incompetents,” Dobbs said on his June 17 broadcast. “The idea that they would sit there and say that they’re not going to reveal where a cluster of this outbreak occurred, this is arrogant beyond belief. Who in the world do these idiots think they are? Who do they think they’re working for?”

CSPI Proposes ban on Some Artificial Food Dyes

The Center for Science in the Public Interest (CSPI) has petitioned the FDA to ban the artificial food dyes Yellow 5, Yellow 6, Red 3, Red 40, Blue 1, Blue 2, Green 3, and Orange B because they may cause hyperactivity and other behavioral problems in some children. You can see a CBS Evening News segment on this topic here.

Synthetic food dyes have been controversial for decades, but not until recently had any studies shown adverse effects. Information on three recent studies on food dyes and behavior are at available here on CSPI’s website.

Enhancing State and Local Roles in Food Safety - Public Symposium June 17, 2008

The symposium kicks off a new project in which three national organizations representing state and local food safety and health officials – The Association of Food and Drug Officials (AFDO), the Association of State and Territorial Health Officials (ASTHO), and the National Association of County and City Health Officials (NACCHO) – will collaborate with The George Washington University (GWU) School of Public Health and Health Services to forge an updated agenda for enhancing the contribution state and local agencies make to the nation’s food safety system. The project is funded by the Robert Wood Johnson Foundation and is being coordinated by GWU research professor Michael R. Taylor.

Confirmed speakers at the June 17 symposium include USDA Under Secretary for Food Safety Richard Raymond, FDA Associate Commissioner for Regulatory Affairs Margaret Glavin, state and local food safety regulators (Joe Corby of New York and David Ludwig of Maricopa County, Arizona), state and local health officials (David Bergmire-Sweat of North Carolina and Joseph Russell of Flathead County, Montana), David Gombas of United Fresh Produce Association, Bob Brackett of the Grocery Manufacturers Association, and Caroline Smith DeWaal of the Center for Science in the Public Interest.

Two additional workshops will be hosted by ASTHO, NACCHO, and AFDO over the summer to develop specific proposals for enhancing state and local roles in foodborne illness surveillance, outbreak response, food safety regulation and inspection at state and local levels.

In October 2008, the proposals developed at the workshops, which could include changes in law, policy, programs and resources, as well as other ideas for building a more effective, nationally integrated food safety system, will be discussed at a second public symposium in Washington for all interested stakeholders.

The June 17 symposium will be held from 8:30 am-12:30 pm in the Media and Public Affairs Building on the GWU campus in Washington, D.C., at 21st and H St., NW. The MPA building is located three blocks from the Foggy Bottom Metro Station on the Orange/Blue lines.

Please RSVP to foodsafety@gwumc.edu by June 10 if you would like to attend. If you have any questions, please contact Stephanie David at Stephanie.David@gwumc.edu.

Harnessing Knowledge to Ensure Food Safety

The Food Safety Research Consortium (FSRC) released a new report that calls for sweeping changes in the way food safety information is collected and shared. The report, “Harnessing Knowledge to Ensure Food Safety: Opportunities to Improve the Nation’s Food Safety Information Infrastructure,” was written by Michael Taylor (George Washington University) and Michael Batz (University of Florida) with funding from the Robert Wood Johnson Foundation.

Some key findings include:

· System-wide improvement in how food safety information is collected and shared is essential to achieving the vision of a risk-based, preventive system in the Food and Drug Administration’s Food Protection Plan and in most of the food safety bills being developed in Congress.

· This lack of coordination is a consequence of the highly decentralized nature of the food safety system, built-in obstacles to data sharing in many government and private organizations and the lack of incentives and means for organizations and individuals to help meet the information needs of the system as a whole.

To address these problems, the authors recommend the following:

· Establish a national policy making it the duty of all federal agencies to better coordinate information collection, consider the information needs of the system as a whole, and maximize information sharing among all levels of government and with the private sector.

· Establish a forum to foster communication and collaboration among government, industry, consumers and academia to solve food safety information problems.

· Give high priority to enhancing the nation’s investment in food safety epidemiology and making the collection and sharing of epidemiological data more responsive to the needs of regulators, the food industry and consumers.

· Use the Web to connect dispersed databases and electronic networks in order to make it easier for those seeking food safety information to find it.

· Do a better job of prioritizing information collection and making valuable data generated by academic researchers and private firms more readily available to others in the food safety system.

· Provide adequate public resources to implement the new food safety information policy and program.

The full report and executive summary are available from the FSRC Web site at: http://www.thefsrc.org/FSII/events.htm.

Bisphenol A Report

The Congressional Research Service released Bisphenol A (BPA) in Plastics and Possible Human Health Effects, available at http://assets.opencrs.com/rpts/RS22869_20080505.pdf.

Who's Minding the Store: The Current State of Food Safety and How It Can be Improved

A number of people have asked for more information on the conference, Who's Minding the Store: The Current State of Food Safety and How It Can be Improved. Marler Clark has put the PowerPoint presentations from the conference on their website here.

I have attended a great many conferences, and this one was a stand out. Hats off to William Marler, Marler Clark LLP PS, Kenneth M. Odza, Stoel Rives LLP, and the Seattle University School of Law!

Is the Green Fairy a Myth?

David Bradley posted an interesting piece, Arty with a Capital F and the Myth of Absinthe, concerning absinthe’s legendary psychotropic effects. Sometimes called the “Green Fairy” or the “Green Muse,” in part because of its typical green color, absinthe has become associated with artists, writers, and Bohemian culture of late 19th- and early 20th-century Paris.

A recent article in the Journal of Agricultural and Food Chemistry compares modern day absinthe with pre-ban (before 1915) absinthe. “The authors conclude that the thujone concentration of preban absinthe was generally overestimated in the past. The analysis of postban (1915–1988) and modern commercial absinthes (2003–2006) showed that the encompassed thujone ranges of all absinthes are quite similar, disproving the supposition that a fundamental difference exists between preban and modern absinthes manufactured according to historical recipes. Analyses of pinocamphone, fenchone, base spirits, copper, and antimony were inconspicuous. All things considered, nothing besides ethanol was found in the absinthes that was able to explain the syndrome ‘absinthism’.”

I have to take issue with the wording of the final conclusion, however, as it seems overbroad. The legend of absinthe’s psychotropic properties may exceed reality. However, the authors of this recent study only tested for a limited number of chemicals. Absinthe contains essences from a number of herbs that have long been recognized for medicinal properties, such as common wormwood (Artemisia absinthium L.), anise (Pimpinella anisum L.), hyssop (Hyssopus officinalis L.), and Florence fennel (Foeniculum Vulgare Mill.). The pharmacological properties of the mix remains a scientific mystery.

GlaxoSmithKline Petitions FDA to Prohibit Weight Loss Structure/Function Claims

GlaxoSmithKline Consumer Healthcare (GSK) and others submitted a citizen petition to the Food and Drug Administration (FDA) asking the agency to prohibit weight-loss structure/function claims for dietary supplements. In addition to prohibiting weight loss claims, the petition asks FDA to prohibit claims for energy expenditure, modulation of carbohydrate metabolism, increased satiety or suppression of appetite, increased fat oxidation or reduced fat synthesis, and blockage of fat absorption.

FDA’s longstanding position has been that weight loss claims are permissible structure/function claims. However, the petition urges FDA to change its position on the ground that: (1) recent evidence establishes that overweight is a risk factor for disease; (2) consumers believe that there is a relationship between weight loss and a reduction of risk of disease; (3) claims that a product will reduce a risk factor for disease are disease claims; (4) the use of ineffective therapies can divert consumers from safe and effective therapies such as GSK’s weight loss drug Alli; and (5) manufacturers of weight loss supplements should be forced to substantiate their claims through health claim petitions before going to market.

Hat tip to Ricardo Carvajal for this information.

Fixing Food Safety: Protecting America's Food Supply from Farm-to-Fork

The Trust for America's Health (TFAH) released a new report that identifies major gaps in the nation's food safety system, including obsolete laws, misallocation of resources, and inconsistencies among major food safety agencies.

"Our goal should be reducing the number of Americans who get sick from foodborne illness. But we can't adequately protect people from contaminated foods if we continue to use 100 year-old practices," said Jeff Levi, PhD, Executive Director of TFAH. "We need to bring food safety into the 21st century. We have the technology. We're way past due for a smart and strategic upgrade."

The complete report, Fixing Food Safety: Protecting America's Food Supply from Farm-to-Fork is available at: http://healthyamericans.org/reports/foodsafety08/FoodSafety08.pdf

Tyson Foods Enjoined from Claiming "Raised Without Antibiotics"

Sanderson Farms and Perdue Farms v. Tyson Foods
U.S. District Court for the District of Maryland
Civil Case No. RDB-08-210 (April 22, 2008)
Opinion by U.S. District Judge Richard D. Bennett
http://www.mdd.uscourts.gov/Opinions/Opinions/SandersonMemoOp.pdf

The U.S. District Court for the District of Maryland issued a preliminary injunction against Tyson Foods from continuing advertising claiming that the company’s chicken is “Raised Without Antibiotics.” The Court found that Tyson uses ionophores (types of antibiotics that are not used in human medicines and therefore present “only a miniscule threat to antibiotic resistance in humans”) in its chicken feed. The Court also found that the U.S. Department of Agriculture (USDA) erroneously approved Tyson’s “Raised Without Antibiotics” label application in May, 2007. The company was informed of the error in September 2007 and told USDA would revoke the prior approval for the label. In December, USDA approved Tyson’s application for a new label with qualifying language: “Raised Without Antibiotics that impact antibiotic resistance in humans.” But Tyson continued its advertising campaign with the unqualified “Raised Without Antibiotics” claim and un-approved variations of the qualified claim, leading Sanderson and Perdue to file suit. The Court concluded that Tyson’s advertising labels were misleading to consumers, including the qualifying language regarding antibiotic resistance in humans. The Court noted that the phrase, ‘that impact antibiotic resistance in humans,’ is not understood by a substantial portion of the consumer public…[and] may even reinforce consumer misconception. … The public interest compels that this advertising stop and that a preliminary injunction be issued in this case.”

Food Labeling Workshop July 23-24, 2008

This workshop presents the FDA requirements for US food labeling. The workshop format and materials are designed to provide a user-friendly approach for those new to food labeling and also provide a thorough system and reference for those experienced with food label design and review. The workshop format allows time for questions. The focus is practical, and students are encouraged to bring problem labels for hands-on review. For more information, click here.

Early bird discount (before May 15, 2008): $795

In Lean Times, Biotech Grains Are Less Taboo

       People tend to magnify their concerns over risks when there is no practical cost to doing so. Similarly, when there is no direct burden to them, people tend to take “better safe than sorry” as their overarching principle.

       This approach makes sense in many situations. Unfortunately, this shorthand approach creates the illusion that real risk assessment has been applied. When there is no personal stake in the costs, for example, benefits are overlooked and risks and benefits are not balanced.

       With rising food prices and grain shortages looming, perhaps we will see more balanced assessments of genetic modifications.

     Andrew Pollack of the NY Times wrote recently,

Soaring food prices and global grain shortages are bringing new pressures on governments, food companies and consumers to relax their longstanding resistance to genetically engineered crops.

In Japan and South Korea, some manufacturers for the first time have begun buying genetically engineered corn for use in soft drinks, snacks and other foods. Until now, to avoid consumer backlash, the companies have paid extra to buy conventionally grown corn. But with prices having tripled in two years, it has become too expensive to be so finicky. . . .

And Everyone is Above Average

Patrick McGee writes, “But we do need to remind our industry, the media, and the public that we have the safest food manufacturing and distribution system in the world.” Mr. McGee’s editorial is titled, “The Good News” and appears in the current issue of Food Quality magazine.

Mr. McGee hasn’t been keeping up with Doug Powell of the International Food Safety Network, who has been a ubiquitous stickler for accuracy on this point. You can read his comments on barfblog.com, where he has a special safest-food-in-the-world section.

Another reality check comes from Phil Brasher of the Des Moines Register, who wrote:

America has the safest food supply in the world. True or False?

It's impossible to say. The statistics don't exist to make such a claim. But that doesn't stop meatpackers, lobbyists, lawmakers and even government regulators who should know better, from repeating the claim every time there's a food-borne illness outbreak or major food recall.

It's not just Americans who make the claim.

"I've lived in many countries that have the safest food in the world," says Canice Nolan, a food-safety official with the European Commission in Washington.

FDA Globalization Act of 2008

The U.S. House of Representatives Committee on Energy and Commerce released a Discussion Draft of the "Food and Drug Administration Globalization Act of 2008." The “Discussion Draft is meant to stimulate discussion about how to provide adequate funding and authority for FDA to ensure safety of . . . food, drug, medical device, and cosmetic” products, according to a memorandum accompanying the draft legislation.

The Discussion Draft is likely to undergo significant changes during hearings and markup. Among the interesting proposals:

• an annual registration fee of $2,000 for food facilities operating in the U.S. or exporting food to the U.S.
• provide a voluntary FDA-certification program
• require 2-year inspection intervals of foreign and domestic food establishments if not certified
• require country-of-origin labeling of foods
• require labeling whether certain foods have been treated with carbon monoxide
  provide FDA with mandatory recall authority
• a registration fee to cover the cost of drug and device inspections
• drug and device country-of-origin labeling
• cosmetic facilities registration with the FDA at a cost of $2,000 per facility
  adverse-event reporting for cosmetics
• increase the capacity of FDA to monitor foreign facilities
• Fees registration, reinspection, certification, certifying agent accreditation, laboratory accreditation, export certification, and importer registration.

The Energy and Commerce Committee predicts that the food registration fees will generate approximately $600 million for food safety activities at FDA. In addition, the bill provides for the levying of substantial fines for violations of the new requirements.

A hat tip to FDA Law Blog for writing of this.

FDA: HFCS is Not "Natural"

"A Food and Drug Administration (FDA) official sent the corn refiners lobby into a tizzy today, by stating that high-fructose corn syrup (HFCS), whatever merits or demerits it may have, should not be marketed as ‘natural,’” wrote Parke Wilde at U.S. Food Policy.

Lorraine Heller at FoodNavigator-USA.com reports that she wrote FDA to ask whether high-fructose corn syrup could be labeled "natural." Geraldine June at the FDA responded:

"The use of synthetic fixing agents in the enzyme preparation, which is then used to produce HFCS, would not be consistent with our (…) policy regarding the use of the term 'natural'.
"Moreover, the corn starch hydrolysate, which is the substrate used in the production of HFCS, may be obtained through the use of safe and suitable acids or enzymes. Depending on the type of acid(s) used to obtain the corn starch hydrolysate, this substrate itself may not fit within the description of 'natural' and, therefore, HCFS produced from such corn starch hydrolysate would not qualify for a 'natural' labeling term."

The corn refiners association released a press statement:

A comment today by a single Food & Drug Administration employee regarding whether High Fructose Corn Syrup (HFCS) is “natural” was mistakenly portrayed by an online news outlet as the official position of the agency, but actually reflects only the personal view of that one employee who was responding to a reporter’s question.

Last year, under pressure from possible consumer group lawsuits, Cadbury Schweppes agreed not to use the term "all natural" in advertising 7-UP, a carbonated beverage made with HFCS.

Funding for Food and Agricultural Research

Congress is now in the final stages of writing a new Farm Bill (H.R. 2419), which should be a critical source of food and agricultural research funding through 2012. However, funding for land-grant universities conducting vital food science and technology research is in jeopardy.

Food and agricultural research, extension, and education are already chronically underfunded. The most recent proposed cut in funding for research is in excess of 75%. Federal funding for land-grant universities supports research on key problems of global, national, and regional importance in biological, environmental, physical, and social sciences relevant to agriculture, food, and the environment on a competitive, peer-reviewed basis.

We face a world with many new and emerging challenges in food and agriculture. A lack of funding will stifle scientific discovery and the spirit of innovation that will help us meet these challenges. If we are to advance the science of food and achieve our long-range vision of “a safe and abundant food supply for healthier people everywhere,” we must increase research funding, not decrease it. Food and agriculture research is an affordable program with priceless results.

This research is vital. Therefore, I urge you to help land-grant universities retain the modest level of funding for food and agricultural research, extension and education.

Please contact your Representative and Senators and ask them to maintain the overall funding level for food and agriculture research. You may find the contact information for your senators and representatives at www.house.gov and www.senate.gov.

Here is the letter I sent:

Dear (Senator/Representative):

I am writing to express my strong concern with regard to the House-Senate conference on H.R. 2419, the Farm Bill.

I am distressed by indications that existing mandatory "Research Title" funding for land-grant research, extension, and teaching will be devastated.

We need for more research funding, not less. Additional university funding is necessary to combat the growing problem of obesity; to find new conservation techniques for preserving soil and water; to develop methods to provide agricultural production at less cost (to the farmer, the consumer, and the environment); to establish key links between food and human disease; to make our food supply safer; and to find ways to feed our citizens and people in the rest of the world.

The most recent conference documents indicate a reduction of $1.244 billion from the Research Title - a cut of over 75%! This would appear to be the largest percentage cut from the baseline of any title in the Farm Bill. Food and agricultural research and education is already chronically underfunded,

We recognize that difficult decisions lie before the conferees. But these massive cuts to the Research Title are inconsistent with the increase in overall Farm Bill spending and are disproportionate to that being contemplated in other titles of the bill (such as trade and crop insurance).

The challenges facing rural America and the nation's nutrition-challenged populations have never been greater - and neither have the opportunities to meet these challenges. We cannot address these and other problems without an enhanced investment in land-grant research, extension, and teaching.

The best opportunity to do that is in this Farm Bill.

Please do not let the outcome of this Farm Bill be the destruction of existing Research Title funding. If you cannot find ways to enhance funding, I urge you to at least protect the current land-grant funding baseline.

Sincerely,

Neal Fortin

NY Calorie Posting Law Upheld

In a decision released today, the United States District Court for the Southern District of New York upheld the constitutionality of New York City’s calorie-posting requirement for certain restaurants. The Court ruled that the federal Nutrition Labeling and Education Act of 1990 does not pre-empt the city’s regulation, and it held that the posting requirement does not violate the free speech rights of New York State Restaurant Association members. For the complete ruling: http://www2a.cdc.gov/phlp/docs/Calorie%20decision.pdf.

Mitigating Liability

I had the pleasure to meet Kenneth Odza last week at the “Who’s Minding the Store?” seminar at Seattle University. Mr. Odza’s specialty is food liability defense law. He publishes a useful blog on this subject, the Food Liability Law Blog. You can subscribe via RSS feeder or email.

A recent blog entry talked about how meat grinding logs can mitigate supermarket liability. In one case, an salmonellosis outbreak was tied to ground beef from a supermarket chain. The meat producer could not be identified largely because the supermarket chain did not keep clear grinding logs. “For no reason other than poor record keeping, the supermarket chain, not the meat producer, bore responsibility for the outbreak (and any resulting liability). . . . Meat grinding logs can be vital tools in defending against and mitigating liability claims attributed to ground beef (especially those related to E. coli, BSE, Salmonella, etc.).”

To Mr. Odza’s advice, I would also add that keeping cooking temperature logs can similarly be vital. I once cleared a grocery store of a salmonellosis case because it had clear cooking temperature logs. Logs also can and should be an important tool for management to ensure that delegated tasks are be carried out by employees.

New FDA Food Labeling Guide

FDA’s Center for Food Safety and Applied Nutrition has published a new version of “A Food Labeling Guide.” This is an excellent basic guide to food labeling. Most frequently raised questions have been answered in easy to read, question-and-answer format.

The document note: “FDA receives many questions from manufacturers, distributors and importers about the proper labeling of their food products. This guidance is a summary of the required statements that must appear on food labels under these laws and their regulations. To help minimize legal action and delays, it is recommended that manufacturers and importers become fully informed about the applicable laws and regulations before offering foods for distribution in the United States.”

For the complete guide: http://www.cfsan.fda.gov/~dms/2lg-toc.html. For a complete list of all of FDA’s Food and Cosmetic Guidance Documents: http://www.cfsan.fda.gov/~dms/guidance.html.

Food Safety Conference at Seattle University Draws Experts from the US and Abroad

Posted on April 7, 2008 by Bill Marler

Seattle University School of Law hosts an in-depth conference titled “Who’s Minding the Store: The Current State of Food Safety and How It Can Be Improved” on April 11th and 12th, 2008. Participants include international, national and local representatives of government, the food industry, consumer organizations, scientists, and the media.

Recent years have seen a plethora of food warnings and recalls, raising new questions about the quality and integrity of our existing system for assuring food safety. Seattle was the epicenter of the Jack in the Box E. coli outbreak that sickened 600 and killed four 15 years ago. In addition to explaining how the present system works, this program is intended to discuss how changing consumer preferences are affecting the development and distribution of food, examine whether federal, state and industry oversight roles are changing, and discuss how the regulatory and judicial processes can be most efficiently balanced.

Washington Governor Christine Gregoire will present the keynote address. Featured speakers include Dr. Richard Raymond, Under Secretary for Food Safety, United States Department of Agriculture, and Dr. Patricia Griffin, Chief; Enteric Diseases Epidemiology Branch, Centers for Disease Control & Prevention.

In addition, the conference brings together international experts, including Jorgen Schlundt of the World Health Organization, Qiu Yueming of the China National Institute of Standardization, Deon Mahoney of Food Standards Australia New Zealand, Chris Griffith of University of Cardiff Wales, and Dr. Canice Nolan, of the EU.

For a detailed agenda and registration, visit:
http://www.law.seattleu.edu/cle/archive/2008/foodsafety.

2007-2008 H. Thomas Austern Memorial Writing Competitions -- Deadline is June 13

The FDLI H. Thomas Austern Memorial Writing Competitions encourage law students interested in the areas of law that affect foods, drugs, devices, cosmetics and biologics. Additionally, winning papers will be considered for publication in the Food and Drug Law Journal. Entrants must be currently enrolled in a J.D. program at any of the nation's law schools. To learn more about the 2007-2008 Writing Competitions, download the brochure.

FARM BILL ACTION ALERT -- IMMEDIATE ATTENTION NEEDED

The following Action Alert was sent to National Association of State Universities and Land-Grant Colleges (NASULGC)Board of Agriculture Assembly and the Councils on Agricultural Research, Extension and Teaching and Governmental Affairs. I encourage you to consider adding your voice in concern over funding for the "Research, Teaching, and Extension" Title of the Farm Bill.

Below the Action Alert is a plea to the Farm Bill Conferees that provides additional information that you can may find useful.

ACTION ALERT – HOUSE and SENATE CALLS/EMAILS NEEDED - IMMEDIATELY!

TO: Board on Agriculture Assembly
Council on Agricultural Research, Extension, and Teaching
Council on Governmental Affairs

As you know, (see: www.create-21.org/alerts/02-13-2008.htm) the top Farm Bill priority for the land-grant system is mandatory funding for research, extension, and teaching.

Current documents from the House-Senate Farm Bill conference show a $1.244 billion reduction in such funding -- a 75% reduction in the "Research, Teaching, and Extension" Title. No other title in the Farm Bill received such a large percentage reduction.

We need you -- and your researchers, extension personnel, graduate students, and any other parties willing to help -- to immediately call and/or email your senators and representatives. Please urge them to communicate with the Agriculture Committee leadership in their respective chamber. (Senators Harkin and Chambliss or Representatives Peterson and Goodlatte)

WE NEED TO INUNDATE CAPITOL HILL WITH OUR CALLS AND EMAILS!

The message follows:

++++++++++++++++++++++++++++++++++++++++++++

Dear (Senator/Representative):

I am calling/writing to express my strong concern with regard to the House-Senate conference on H.R. 2419, the Farm Bill.

While it is encouraging to hear of progress being made which would bring the conference to a conclusion, I am distressed by indications that existing mandatory "Research Title" funding for land-grant research, extension, and teaching will be all but wiped out.

Over the past many years, I have heard senators and representatives from both sides of the aisle talk about the need for more funding, not less.

Additional university funding is absolutely necessary to combat the growing problem of obesity; to find new conservation techniques for preserving soil and water; to develop methods to provide more plant and animal production at less cost (to the farmer, the consumer, and the environment); and to find ways to feed our citizens and people in the rest of the world.

The most recent conference documents indicate a reduction of $1.244 billion from the Research Title — a cut of over 75%!

This would appear to be the largest percentage cut from the baseline of any title in the Farm Bill. And, it would be far below what either House or Senate Bills contained when originally passed.

We recognize that difficult decisions lie before the conferees. But these massive cuts to the Research Title are inconsistent with the increase in overall Farm Bill spending and are disproportionate to that being contemplated in other titles of the bill (such as trade and crop insurance).
The challenges facing rural America and the nation’s nutrition-challenged populations have never been greater — and neither have the opportunities to meet these challenges. We cannot address these and other problems without an enhanced investment in land-grant research, extension, and teaching.

The best opportunity to do that is in this Farm Bill.

Please do not let the outcome of this Farm Bill be the destruction of existing Research Title funding. If you cannot find ways to enhance funding, I urge you to at least protect the current land-grant funding baseline.

++++++++++++++++++++++++++++++++++++++++++++

There is a tremendous stake for the land-grant system in a positive outcome. We need you and all of your faculty, staff, graduate students, and outside supporters to make these calls and emails!

Thanks, as always, for your assistance.

PLEA TO FARM BILL CONFEREES:

DO NOT KILL THE AGRICULTURAL RESEARCH BASELINE

Based on limited available information, we are of the understanding that the tentative agreements reached by House and Senate Agriculture Committee staff on the Research Title of the Farm Bill will, if ratified by the Conferees, result in three significant fiscal impacts regarding agricultural research:

1. It eliminates current law Initiative for Future Agriculture and Food Systems (IFAFS) funding – a net loss in the Farm Bill of $1.6 billion in budget authority ($1.244 billion in budget outlays)
2. It creates two or three new targeted mandatory research programs for specialty crops, organics, and energy. No figures are available but the total is approximately $200 million over five years.
3. It terminates these targeted programs in 2012. This will result in ZERO dollars in the Committee baseline for agricultural research in FY 2012 and the future.

This course of action would be a huge step backwards for the federal commitment to agriculture, nutrition, energy and related research – with permanent negative repercussions far beyond the five year life of the Farm Bill.

• REPEALS MORE THAN $1.2 BILLION (OUTLAYS) IN MANDATORY AG RESEARCH FUNDING: The tentative agreement would abandon funding for the IFAFS program provided in current law in the amount of $200 million per year for eight fiscal years (2010 through 2017). This would repeal $1.6 BILLION in mandatory research budget authority (and $1.244 Billion in outlays) over the 10 year budget baseline of the bill.


• TARGETED RESEARCH FUNDS ARE NOT A SUBSTITUTE: While the tentative agreement reportedly includes some mandatory funding targeted to specialty crops, organics, and renewable energy, the total amount of new mandatory research funds made available are more than ONE BILLION DOLLARS LESS THAN CURRENT LAW.
  
  


• KILLS LONG TERM COMMITMENT TO AG RESEARCH BY REPEALING PERMANENT LAW BUDGET BASELINE: Not only does the tentative agreement specifically terminate IFAFS funds beginning immediately, it would eliminate the new, targeted funds in FY 2012. This means that the budget baseline for all of these agriculture research priorities will be ZERO when the next Farm Bill is written in 2012. Specialty crops research baseline = ZERO. Renewable energy research baseline = ZERO. Organics research baseline = ZERO. IFAFS research baseline = ZERO. This would reverse more than 10 years of effort in building the budget baseline for agricultural, nutrition, renewable energy, and related research.

HOW YOU CAN HELP!

PRESERVE THE BUDGET BASELINE FOR MANDATORY AGRICULTURE RESEARCH FUNDING BY:

1. PROVIDING MANDATORY FUNDS THROUGH FY 2012. DO NOT MAKE BASE FUNDING “SUBJECT TO APPROPRIATIONS” IN THE FARM BILL.

2. MAINTAINING FUNDING FOR IFAFS AT THE HIGHEST AMOUNT POSSIBLE—ESPECIALLY IN FY 2012.

Aspartame safety study

Direct and indirect cellular effects of aspartame on the brain

European Journal of Clinical Nutrition (2008) 62, 451–462; doi:10.1038/sj.ejcn.1602866; published online 8 August 2007 http://www.nature.com/ejcn/journal/v62/n4/abs/1602866a.html

This study explored the direct and indirect cellular effects of aspartame on the brain.  Aspartame and its breakdown compounds may disturb the brain concentrations of catecholamines.

 

Lapses in FDA's inspections for fresh spinach safety

The U.S. House of Representatives’ Oversight and Government Reform Committee has released a report from finding significant lapses in the FDA’s current inspection regime for packaged fresh spinach: http://oversight.house.gov/documents/20080312103036.pdf.

"Humane Society Sues USDA over mad-cow safety rules"

“Humane Society Sues USDA over mad-cow safety rules”

Ilan Brat et al., Wall Street Journal (Feb. 28, 2008) http://online.wsj.com/article/SB120416641582098803.html?mod=googlenews_wsj (subscription required)

The Humane Society filed suit last week against the U.S. Department of Agriculture (USDA) over a purported loophole in regulations meant to prevent bovine spongiform encephalopathy (BSE). Under USDA regulations, “downer cattle” that cannot stand or walk on their own are generally prohibited from entering the human food supply because inability to walk is a symptom of BSE. But in July 2007, USDA issued a regulatory exception to that rule, allowing federal veterinarians to determine case-by-case whether to permit non-ambulatory cattle that become injured following an initial inspection.

“It’s an inconsistent policy in the sense that the timing of the animal going down is irrelevant in terms of the food-safety or animal-health issues,” said Wayne Pacelle, president of the Humane Society. USDA declined comment on the pending litigation. According to Ron DeHaven, chief executive of the American Veterinary Medical Association and former administrator of animal testing at USDA, three main safeguards protect humans from eating BSE-infected meat, which can lead to a fatal brain affliction. First, hundreds of thousands of high risk cattle have been tested by USDA since 2003 (with only one in a million diagnosed with BSE); second, USDA generally prohibits downer cattle; third, USDA prohibits feed containing brain, spinal-cord tissue and other parts that could contain BSE. Immediately prior to filing suit, the Humane Society released a video showing workers at a meat plant in California processing downer cattle for human consumption; the video prompted the recall of 143 million pounds of beef.

[The complaint by the Humane Society filed in the U.S. District Court for the District of Columbia is available at: http://www.hsus.org/web-files/PDF/farm/hsus-v-schafer-usda-complaint.pdf.]

Cloned Food - Son of Frankenfood?

From an interesting article in The Economist, Son of Frankenfood?:

“IT IS beyond our imagination to even find a theory that would cause the food to be unsafe.” With that ringing endorsement, Stephen Sundlof, the chief food-safety expert at America's Food and Drug Administration (FDA), this week declared food derived from the offspring of cloned cows, pigs and goats to be safe for human consumption. The decision came just days after the European Food Safety Authority (EFSA) publicly reached the same conclusion. . . . [Emphasis added.]

Nonetheless, there seem to be lingering innuendo that cloned food may be unsafe. For example, take the untrue statement from the (inappropriately named) Center for Food Safety, “In January 2008, the FDA essentially told the public that the meat and milk from cloned livestock are safe for human consumption. FDA's action flies in the face of widespread scientific concern about the risks of food from clones . . .” http://www.centerforfoodsafety.org/cloned_animals.cfm.

Can anyone think of a remotely plausible theory or scenario that would cause the food to be unsafe?

Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables

Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables Federal Register: February 25, 2008 (Volume 73, Number 37) [Page 10037-10038]

SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a final guidance document entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables'' (the fresh-cut guidance or guidance). Previously, FDA announced the availability of the fresh-cut guidance as a ``draft final'' document, pending approval by the Office of Management and Budget (OMB) of the information collection provisions in the guidance. FDA is publishing this notice to announce that the fresh-cut guidance is now final. The text of the guidance has not changed from the previously published draft final version. The fresh-cut guidance complements FDA's current good manufacturing practice (CGMP) requirements for foods by providing specific guidance on the processing of fresh-cut produce. The fresh-cut guidance and the CGMP regulations are intended to assist processors in minimizing microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers and retail establishments in a ready-to-eat form.

Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease

Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease Federal Register: February 25, 2008 (Volume 73, Number 37) [Page 9938-9947]

[Docket No. FDA-2008-P-0090] (formerly Docket No. 2006P-0393)

ACTION: Interim final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending the health claim regulation entitled ``Soluble fiber from certain foods and risk of coronary heart disease (CHD)'' to add barley betafiber as an additional eligible source of beta-glucan soluble fiber. Barley betafiber is the ethanol precipitated soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain barley flour. FDA is taking this action in response to a health claim petition submitted by Cargill, Inc. FDA previously concluded that there was significant scientific agreement that a claim characterizing the relationship between beta-glucan soluble fiber of certain whole oat and whole grain barley products and CHD risk is supported by the totality of publicly available scientific evidence. Based on the totality of publicly available scientific evidence, FDA now has concluded that in addition to certain whole oat and whole grain barley products, barley betafiber is also an appropriate source of beta-glucan soluble fiber. Therefore, FDA is amending the health claim regulation entitled ``Soluble fiber from certain foods and risk of CHD'' to include barley betafiber as another eligible source of beta-glucan soluble fiber.

Naturally Confused

Naturally Confused By Neal D. Fortin, Food Product Design (02/12/2008)

Merriam-Webster defines “natural food” in 13 words. New federal rules can be expected to add a few more.

Since 1982, USDA policy has defined "natural" as a product that contains no artificial flavoring or coloring, chemical preservative, or any other artificial or synthetic ingredient. FDA has been urged to define "natural" by regulation, but has declined. Recently, USDA initiated a rulemaking on "natural" to resolve growing controversy. . . .

http://www.foodproductdesign.com/hotnews/naturally-confused.html

Who's Minding the Store? - The Current State of Food Safety and How it Can be Improved

Who's Minding the Store? - The Current State of Food Safety and How it Can be Improved - Friday and Saturday, April 11 & 12, 2008
Food Safety conference at Seattle University, Organized and Co-Sponsored by: William D. Marler, Marler Clark LLP PS, and Kenneth M. Odza, Stoel Rives LLP
Marlerblog:
"Few subjects draw more immediate attention or concern than the safety of the food we eat. Recent years have included a plethora of food warnings and recalls, raising new questions about the quality and integrity of our existing system for assuring food safety. Seattle was the epicenter of the Jack in the Box E. coli outbreak that sickened 600 and killed four 15 years ago. In addition to explaining how our present system works, this program is intended to discuss how changing consumer preferences are affecting the development and distribution of food, examine whether Federal, state and industry oversight roles are changing, and discuss how the regulatory and judicial processes can be most efficiently balanced. Participants include international, national and local representatives of government, the food industry, consumer organizations and scientists."
For more information and registration:
Seattle University School of Law

Recall. Food &Toy Safety: An American Crisis

Recall. Food &Toy Safety: An American Crisis by Susie Hoeller

From a reader's review: "A much needed contribution to a critical discussion. Susie Hoeller has a written a timely and important book about an issue as fresh as today's headlines. Clear, urgent and articulate, she lays out in detail what producers and consumers need to know about food and consumer product safety in the age of globalization.

"Readable and well-reasoned, the book is useful not only to those seeking bottom-line information, but to students of modern commercial and trade practices. This book belongs on the shelf of anyone who buys, makes or sells food or anything else, for that matter. Well worth the investment both of time and money."

New Dietary Supplement Adverse Event Reporting

New dietary supplement requirements went into effect December 22, 2007, requiring new reporting and recordkeeping for adverse events associated with dietary supplements. You may read more about the requirements in the FDA draft publication:

Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act Draft Guidance (Oct. 2007) available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0388-gdl0001.pdf.

Law and Self-Regulation: Sugar-Sweetened Beverage Sales in Schools

Michelle M. Mello et al., American Journal of Public Health (free abstract) http://www.ajph.org/cgi/content/abstract/AJPH.2006.107680v1 (as of 10/10/07)

Study examines laws and industry self-regulation of sugary drinks in schools.

"Hot Topics in Food Law"

On October 17th, the American Bar Association will host a CLE teleconference on "Hot Topics in Food Law". The program is terrific, is just 90 minutes and your CLE credits can be completed from the comfort of your own desk.
The program hits a number of Hot Topic issues in the emerging area of Food Law, including litigating food contamination cases, class actions regarding labeling, allergens in food, and new food technologies, including cloning and genetic engineering.
If you are new to this emerging area and want an introduction to hot topics in Food Law, this is a great program. Even if you are a season veteran in Food Law and Litigation, this program will quickly update you on the newest and hottest issues.
Don’t let your Food Law knowledge go stale! The registration link is below, and a PDF detailing the program is attached.
http://meetings.abanet.org/aba_timssnet/Meetings/tnt_meetings.cfm?action=long&primary_id=CET7HTI&webtextid=31300&Subsystem=MTG&related_prod_flag=0

Prof. Roberts on Role of Regulation in Minimizing Terrorist Threats

Michael T. Roberts (Venable LLP, Professor at IFLR, teaching Food Regulation in Asia) has published The Role of Regulation in Minimizing Terrorist Threats Against the Food Supply: Information, Incentives, and Penalties, 8(1) Minn. J. L. Sci. & Tech. 199-223 (2007). The article is posted on the Agricultural Law Center website at http://www.nationalaglawcenter.org/assets/articles/roberts_regulation.pdf. The article begins:

Ringing alarm bells as he announced his resignation as Secretary of the Department of Health and Human Services, Tommy Thompson posited: “I, for the life of me, cannot understand why the terrorists have not . . . attacked our food supply because it is so easy to do.” The seeming ease of a terrorist attack on the United States food supply evokes the obvious question of what steps should be taken to minimize the threat. Determining what steps should be taken and implementing those steps naturally turns our attention to the government’s important role in protecting the safety of the nation’s food supply from terrorist attacks.

FDA Announces Final Rule Establishing cGMPs for Dietary Supplements

June 22, 2007

The Food and Drug Administration (FDA) today announced its final rule establishing current good manufacturing practices (cGMPs) for dietary supplements.

In the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress gave the Secretary of Health and Human Services and, by delegation, FDA authority to issue regulations establishing cGMPs for dietary supplements. The cGMPs will require that dietary supplements are produced in a quality manner, are not adulterated with contaminants or impurities, and are accurately labeled to reflect the ingredients in the product. The cGMPs apply to all domestic and foreign companies that manufacture, package, or hold dietary supplements intended for sale in U.S. commerce, including those involved with the activities of testing, quality control, packaging, labeling, and distributing.

In a companion document, FDA is also announcing today an interim final rule

(IFR) that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing of specific dietary ingredients. If the manufacturer can provide sufficient documentation that the supplier maintains appropriate in-process manufacturing controls and has consistently produced the dietary ingredient over a period of time, the manufacturer may be exempted from the testing requirement. FDA is soliciting comment from the public on the IFR. There will be a 90-day comment period.

Written comments may be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 or on line at:

http://www.fda.gov/dockets/ecomments

Additional information regarding the cGMPs is available through the CFSAN website at http://www.cfsan.fda.gov/~dms/supplmnt.html.