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

Spinach in the Hot Spot: Should We Irradiate Our Food?

Food Irradiation Meeting (3/7). The National Academies of Science will host “Spinach in the Hot Spot: Should We Irradiate Our Food?” on March 7, 2007, in Washington, DC. For more details, visit http://www8.nationalacademies.org/publicmeeting/meetingview.aspx?meetingid=209.

Clones overdue on the menu

Clones overdue on the menu
by Henry I. Miller (fellow at the Hoover Institution)

The FDA’s preliminary decision last week to permit the consumption of food from cloned animals is a good one. If anything, it’s long overdue, because scientists have known for years that the clones are indistinguishable genetically, biochemically and nutritionally from the parent. As one farmer who owns a pair of clones of a prize¯winning Holstein cow observed, they are essentially twins of “a cow that was already in production.”

http://www.iflr.msu.edu/

European Union Food Law Update By Nicole Coutrelis (June 2006)

European Union Food Law Update By Nicole Coutrelis (June 2006). Originally published in the Journal of Food Law & Policy 2 J. FOOD L. & POL�Y 493 (2006)

Are the States Preempted from Banning Trans Fat?

Are the States Preempted from Banning Trans Fat?

The states are clearly preempted on the labeling requirements for trans fat. The Federal Food, Drug, and Cosmetic Act (FDCA) expressly preempts state requirements on labeling that are not the same as the federal requirements.

The states are also preempted from banning trans fat from ALL foods because that would interfere with interstate commerce. That is, a state cannot be the Crisco Cop and stop the shipment of trans fat into the state, when FDA has approved trans fat. In addition, a ban on trans fat from all food would be a direct conflict with federal law, which approves foods that contain trans fat. Basically, a state cannot stop the manufacturing, transportation, or distribution of foods containing trans fat.

In the case of New York City, however, the city was clever enough to claim that they are not regulating commerce, but only regulating food preparation at the point of consumption. This is an area that the FDCA never mentions. The NYC trans-fat ban may be preempted, but NYC has raised a colorable argument. In addition, the courts have traditionally been sympathetic to any law that protects the health or safety of the citizens—which, after all, is a traditional power left to the states. FDA authority to regulate food is based on the Commerce Clause, not the power to regulate food safety.

By the way, the National Restaurant Association (NRA) has threatened legal action to overturn trans fat bans, but so far nothing has come of it. The NRA probably don't want the bad publicity of being the identified as the supporter of killer fat. Here is NRA's site for trans fat legislation around the United States http://www.restaurant.org/government/state/nutrition/bills_trans_fat.cfm.

www.iflr.msu.edu

What is Natural?

Some links on "natural" claims:

Kraft Florida lawsuit information re: Capri Sun "natural" claim
http://www.cspinet.org/new/200701081.html
http://cspinet.org/new/pdf/complaint.pdf

Wikipedia article (High Fructose Corn Syrup):
http://en.wikipedia.org/wiki/High_fructose_corn_syrup

USDA Public Meeting Notice - Product Labeling: Definition of the term "Natural" (Dec. 12, 2006):
http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2006-0040.pdf

USDA/FSIS Public Meeting on the Definition of the term "Natural" summary information:
http://www.americanbakers.org/documents/FSIS_Natural.pdf

http://www.iflr.msu.edu/

FDA Proposes Osteoporosis Health Claim for Calcium, Vitamin D

FDA Proposes Osteoporosis Health Claim for Calcium, Vitamin D

FDA is proposing a rule that would allow new health claims indicating the potential for foods and dietary supplements containing calcium and vitamin D to reduce the risk of osteoporosis. Adding vitamin D to the proposed claim updates an existing approved health claim showing the relationship between calcium intake and osteoporosis.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01543.html

Your Ignorance, Their Bliss

The Gourmet holiday issue, overwhelmingly dominated by cookie recipes and seasonal food, also contains an surprising piece, Your Ignorance, Their Bliss,”by Michele Kayal. “If Congress passes the National Uniformity for Food Act, many state-required food regulations will be replaced with less stringent ones set by the FDA. Can this really be a good idea?” See: http://www.epicurious.com/gourmet/toc.

The article’s point: The Food and Drug Administration, already facing added duties in protecting the national food supply against acts of terrorism, could have to take over the duties of food labeling and standards from individual states. The National Uniformity for Food Act would replace stronger state food labeling and safety standards with weaker, federally mandated rules. Moreover, the rules would need to be researched and imposed by an agency whose resources have been increasingly cut back, even as its duties have expanded.

A chart with the piece tells the story of the incredible shrinking FDA:

BUDGET

2003: $47.6 million

2006: $30 million

2007: $25 million

FULL-TIME EMPLOYEES

2003: 950

2006: 881

2007: 817

Thanks to James Norton and the “The Grinder” for the lead on this story.

Neal D. Fortin

www.iflr.msu.edu

Pasteurized milk: Built Ford Tough

Pasteurized milk: Built Ford Tough
Brae Surgeoner, Commentary from the Food Safety Network (Nov. 22, 06) www.foodsafetynetwork.ca.

In May 1943, Edsel Bryant Ford, son of auto magnate Henry Ford, died at the age of 49 in Detroit, of what some claimed was a broken heart.
Biology, however, decreed that Ford died of undulant fever, apparently brought on by drinking unpasteurized milk from the Ford dairy herd, at the behest of his father's mistaken belief that all things natural must be good.

Scores of consumers across North America have adopted what they believe to be a simple approach to good health including the consumption of raw, unpasteurized milk; many are willing to pay between $4.50 and $20 a gallon for what they perceive as the creamier taste and finer flavor.
In the U.S., 28 states permit the sale of raw milk under varying restrictions, but in

Canada, it has been prohibited under the Food and Drug Regulations since 1991. In an article published in 2005 concerning Canada’s rising black market for raw milk, a producer who agreed only to be interviewed if his identity was concealed, told a CTV reporter, “What we're providing is milk at its purest. I would say customers beg for the milk. It’s not even asking. They beg for the milk.” He further claimed that some of his customers drove upwards of 200 kilometers to buy his raw milk products – mostly city dwellers.

On Tuesday, health and law enforcement officials raided Michael Schmidt’s biodynamic farm near Durham, Ontario, armed with a search warrant and power to confiscate his computer hard drives, his milk equipment, and milk products. All of this part of an investigation into Schmidt’s distributing raw unpasteurized milk products.

Schmidt is no stranger to controversy. In 1994, the Owen Sound Health Unit raided his farm, seizing $800 worth of unpasteurized dairy products – charges were laid under the Health Protection and Promotion Act. Yet, for 12 years now Schmidt has continued to sell his raw milk. His clientele includes 120 families in the Toronto area - about 200 kilometers away.

This past September, two children who drank raw milk from a Whatcom County dairy in Washington State became ill with E. coli O157:H7. At the same time, four children, including two 8-year-olds in San Diego County, California were hospitalized with E. coli infection after consuming raw milk products. Despite this, raw milk advocates are adamant that if drinking raw is milk wrong, they don’t want to be right.

Health authorities cannot continue to turn a blind eye to such a defiant attitude. In December 2005, 18 people in Washington and Oregon, including six children were infected with E. coli O157:H7 after drinking an unlicensed dairy’s raw milk – two of the kids almost died. Closer to home, four cases of E. coli linked to unpasteurized milk were reported to Ontario health officials in April 2005; in this case, from an individual who routinely sold raw milk from the back of a vehicle parked in the city of Barrie. There are too many other such cases to mention. Additional outbreaks are listed at: www.foodsafetynetwork.ca/en/article-details.php?a=2&c=6&sc=35&id=384

Raw milk drinkers believe the pasteurized milk found on grocery store shelves lacks the essential enzymes and nutrients necessary to absorb calcium -- yet research shows this is simply not the case. The only things lacking in pasteurized milk are the bacteria that make people -- especially kids -- seriously ill. Adults, do whatever you think works to ensure a natural and healthy lifestyle, but please, don't sneak around and break the rules to impose your dietary regimes on your kids.

Brae Surgeoner is a research assistant with the Food Safety Network at the University of Guelph.
bsurgeon@uoguelph.ca www.foodsafetynetwork.ca

South Korea will follow OIE risk standards for beef, may allow bone-in beef in 2007

South Korea will follow OIE risk standards for beef, may allow bone-in beef in 2007, Pete Hisey, Meatingplace.com (22.nov.06)

South Korea promised to reconsider its restrictions on U.S. beef if the World Organization for Animal Health (OIE) formalizes a change in risk standards when it meets in May 2007. Last May, the organization said it was considering changing the methods for determining the safety of beef in view of the spread of bovine spongiform encepthalopathy from those based on prevalence of the disease in a market and the age of animals meant for export to an overall risk assessment of each market.

That assessment would be made on variables such as strength and longevity of a ruminant-to-ruminant feed ban, slaughter and processing procedures, surveillance testing plans and the like. If the OIE were to decide to switch to such a standard, South Korea said it would be willing to reconsider its import standards, the Korea Herald reported. That would presumably mean an end to a 30-month rule on age and a ban on bones, since most bones are not considered to be specified risk materials. The latter is a key consideration for the United States, since two-thirds of shipments to South Korea prior to the BSE crisis were bone-in beef ribs, used in barbecue rib dishes, which are a national favorite.