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for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act Draft Guidance (Oct. 2007) available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0388-gdl0001.pdf.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

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