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.

Practice Pointer: Don't Insult the Judge

In a recent case in Florida, a lawyer actually told a judge she was "a few French Fries short of a Happy Meal." Check out the transcript: http://www.abovethelaw.com/2007/05/atl_practice_pointers_dont_ins.php

We Are All the Mitten State - FDA Preemption and the Lipstick Problem

Professor Henry Greenspan (Psychologist, U Mich) has posted an article on the TortDeform Blog focusing on efforts to make FDA standards preemptive. He presents reasons why FDA regulations should not pre-emption state tort actions (as Michigan law does with drug injury cases—Michigan is the Mitten state). The lipstick problem is the focus on reforming FDA as the means to resolve criticism of FDA preemption of states.

[M]ore central to the issue of FDA preemption, there remains a wide range of potential delinquencies relevant in civil litigation but over which the FDA – even in its most "revitalized" incarnation – has no authority whatsoever. Staying with Vioxx, for example, we learned that there was an orchestrated campaign to threaten and intimidate academic researchers who did not see things the company's way. Tactics like those may profoundly influence what does and does not become known about a drug's safety, but they have nothing to do with whether a company is "in compliance" with FDA regulations. They are not within the FDA's jurisdiction at all.

We have also learned that data may be skewed, even excised, in ways that impact what is published in major medical journals. These are the sources of information upon which physicians rely. Again, however, the FDA has no authority whatsoever over the editorial policies of those journals. Indeed, in a now well known article about Celebrex published in the Journal of the American Medical Association – in which, it turned out, half the data was simply left out – the most seasoned medical reviewer at the FDA, Dr. Robert Temple, noted "when the JAMA article comes out and confirms the hype, that probably has more impact than our labeling does." Unfortunately, even if we had the most "revitalized" FDA imaginable, there would remain very large arenas for potential intimidation, misinformation, and hype.

That is why there is no FDA reform conceivable – and even less what was just passed by the Senate – that would substitute for the accountability that civil liability makes possible. The two systems complement each other; they do not cover the same ground. And that is why, when the FDA preemption gang starts to invoke that bill to suggest that FDA's problems are now solved, we should not be distracted. We should not confuse the pig, when there is one, with the lipstick.

You can read the whole article at: http://www.tortdeform.com/movabletype/mt-tb.cgi/873.

Gluten factory had a toxic history

By Don Lee and Abigail Goldman
May 9, 2007

XUZHOU, CHINA — Before Mao Lijun's business exported tainted wheat products that may have killed American pets, his factory sickened people and plants around here for years.

Farmers in this poor rural area about 400 miles northwest of Shanghai had complained to local government officials since 2004 that Mao's factory was spewing noxious fumes that made their eyes tear up and the poplar trees nearby shed their leaves prematurely. Yet no one stopped Mao's company from churning out bags of food powders and belching smoke — until one day last month when, in the middle of the night, bulldozers arrived and tore down the facility.

It wasn't authorities that finally acted: Mao himself razed the brick factory — days before the investigators from the U.S. Food and Drug Administration arrived in China on a mission to track down the source of the tainted pet food ingredients.

In the end, Chinese authorities caught up with Mao and arrested him. And Tuesday, after weeks of denials, China acknowledged that Mao's company and another Chinese business had illegally exported wheat and rice products spiked with melamine, a chemical used in making plastics and fertilizers. That chemical is banned in foods in the U.S.

For the rest of the story: http://www.latimes.com/business/la-fi-petfood9may09,1,5484365.story?ctrack=1&cset=true (requires free membership).

Food Safety Hearing

The U.S. House Committee on Agriculture will hold a hearing to review the impact of imported contaminated food and recent food safety emergencies on food safety and animal health systems, at 11:00 a.m. ET on May 9, 2007. The hearing will be held in Room 1300 of the Longworth House Office Building. For more information, visit http://agriculture.house.gov/hearings/schedule.html.

"Panel urges schools to replace junk foods"

Washington Post (04/26/07) Sally Squires

The Institute of Medicine (IOM) has released a report proposing bans on soft drinks, sugary snacks, and other junk foods sold in schools to combat obesity in children. The recommendations, drafted at the request of Congress, were the first to address the issue of “competitive foods,” snacks and drinks often sold to raise money for schools, and which compete with healthier cafeteria offerings. IOM said less-nutritious offerings should be replaced with fruits, vegetables, low-fat dairy products, and whole-grains. The recommendations also suggest that the calorie content of snacks and drinks be limited to no more than 200 per portion, and that schools switch to items that contain no trans fat, lower levels of sugar and sodium, and no more than 35 percent of calories from fat. IOM also suggests a ban on sports drinks, soft drinks, and caffeinated drinks, calling for schools to provide free, safe drinking water or allow students to buy nonfat or low-fat milk or 100 percent juice. J. Justin Wilson, of the Center for Consumer Freedom, called the recommendations “misguided,” warning that the report jeopardizes the classroom birthday party. But “Children eat 30 to 50 percent of their calories at schools on school days,” said Margo Wootan of the Center for Science in the Public Interest. “When parents send their kids to school with lunch money, they don’t want to worry that it will be spent on Cheetos and Gatorade.”

To read the text of the IOM report, Nutrition Standards for Foods in Schools: Leading the Way toward Healthier Youth, visit http://www.iom.edu/CMS/3788/30181/42502.aspx.]

Food Labeling Workshop

Food Labeling Workshop

The Henry Center · July 19-20, 2007 · Lansing, Michigan

This workshop presents the FDA requirements for 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.
Register Online

Registration Form (PDF)

or call IFLR at (517) 355-8295

"The Federal food safety system: A primer"

"The Federal food safety system: A primer"

Congressional Research Service (CRS) (Feb. 14, 2007).

Numerous federal, state, and local agencies share responsibilities for regulating the safety of the U.S. food supply, which many experts say is among the safest in the world. Nevertheless, critics view this system as lacking the organization and resources to adequately combat foodborne illness, which sickens an estimated 76 million people and kills an estimated 5,000 each year in this country. The 110th Congress may face calls for a review of federal food safety agencies and authorities, and proposals for reorganizing them. Among the issues likely to arise are whether reform can improve oversight, and the cost to industry, consumers, and taxpayers. This report provides a brief introduction to the system and the debate on whether reorganization is needed.  The report is available at http://opencrs.cdt.org/rpts/RS22600_20070207.pdf