From a reviewer, "Some needed fresh air to lend to a stale debate. Dr. Miller and Mr. Conko have done a tremendous service to all of those who care about intellectual honesty. This is a no-holds barred, gloves-off attack, not of the critics of biotechnology, but of the intellectual dishonesty and rampant hucksterism that passes for enlightened debate about issues of complexity nowadays.

Some readers will find the frank, prescriptive nature of some parts of the book unsettling. Good. That is precisely what is required today, to balance the gusher of not-so-frank, less than honest and dictatorial "information" and policy recommendations coming from the other side of the debate.

This book is long overdue, and I cannot recommend it more highly. Miller and Conko challenge you to disagree, and you should feel free to do so. Just make sure you have facts and empirically-based arguments, rather than vague principles in hand, before you venture forth."

Proposed FDA Regulation - Irradiation on Food Labels

On April 4, 2007, FDA issued a proposal to revise the Agency's regulation for the labeling of foods treated with irradiation. The proposal deviates from current regulation published April 18, 1986, in part by:

·         requiring labeling only for food in which the irradiation causes a material change (change in organoleptic, nutritional, or functional properties that the consumer cannot identify at point of purchase)

·         requiring explicit language on the label describing the material change caused by irradiation

·         allowing use of alternate terms for irradiation, such as "pasteurized" that would be accompanied by explicit language describing the change in the food or why it is used e.g., "irradiated to inhibit sprouting"

·         a firm could use the term “pasteurized” in lieu of “irradiated,” provided it notifies FDA that the irradiation process being used meets the criteria specified for use of the term “pasteurized” in the Federal Food, Drug, and Cosmetic Act (FDCA) and FDA does not object to the notification.

The proposal requires that the "radura" logo be present on the label of affected foods, as does the current regulation.

Are 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.
          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 doesn’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.

FDA updates health claim for calcium and osteoporosis: Proposal would give consumers more information to make healthy food choices, http://www.fda.gov/bbs/topics/NEWS/2007/NEW01543.html (Jan. 7, 2007). The Food and Drug Administration (FDA) is proposing to allow new claims on foods and dietary supplements containing calcium and Vitamin D to show their potential to reduce the risk of osteoporosis. The proposed rule would allow manufacturers to include new information on their food and supplement labeling and to eliminate certain other information, described below.
          “This is important information for all citizens,” said Robert E. Brackett, Ph.D., director of FDA’s Center for Food Safety and Nutrition. “All persons lose bone with age, and the loss can influence an individual's risk of developing osteoporosis. Maintenance of an adequate intake of calcium and vitamin D in all stages of life can help lower one’s risk.”

The proposed rule would amend one of the first health claims authorized in 1993 through the Nutrition Labeling and Education Act of 1990 for the relationship between calcium intake and osteoporosis. The proposal would amend this existing health claim by allowing for claims of a reduced risk of osteoporosis with the consumption of both calcium and vitamin D.  Specifically, FDA is proposing to change the calcium and osteoporosis health claim to:

• Add a claim for calcium and vitamin D together and a reduced risk of osteoporosis.
Shorten the claim language by:
• Dropping the reference to sex, race, and age since the benefits apply to both sexes at all ages and race categories.
• Dropping the need to identify the mechanism by which calcium reduces the risk of osteoporosis.
• Dropping the requirement that the claim state that there are limits to benefit of calcium intakes above 200% of the Daily Value.

The Food Allergen Labeling and Consumer Protection Act: The Requirements Enacted, Challenges Presented, and Strategies Fathomed, 10 Journal of Medicine and Law 126 (Spring 2006).  The Food Allergen Labeling and Consumer Protection Act (“Food Allergen Act”) was signed into law on August 3, 2004. Allergic consumers, parents of allergic children, and consumer groups laud the new law for making it easier to identify potentially deadly allergens in foods and for unveiling allergens previously hidden in foods. Although the statute is relatively simple and straightforward, it has some surprising twists. The paper introduces the problem of food allergens, describes the history of food allergen labeling and the reasons leading up to the enactment of the Food Allergen Act, explains the provisions of the Act, and examines the challenges presented by the requirements of the Act. The full paper may also be downloaded (the link is at the bottom of the page) from http://papers.ssrn.com/sol3/papers.cfm?abstract_id=948727.

GRAS substances database
FDA posted their Select Committee on GRAS Substances (SCOGS) Database online.  This database allows access to opinions and conclusions from 115 SCOGS reports published between 1972-1980 on the safety of over 370 Generally Recognized As Safe (GRAS) food substances. The database allows users to search for the SCOGS opinion and conclusion, and includes the United States Code of Federal Regulations (21 CFR) citation for those GRAS food substances that have been codified in the CFR. The SCOGS conclusions were made by scientific experts outside of FDA. The complete background of the Select Committee is described in the History of GRAS and SCOGS that is also posted on the site. http://www.cfsan.fda.gov/%7edms/opascogs.html.

Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4) Food and Drug Administration (FDA) (Oct. 2006) http://www.cfsan.fda.gov/~dms/alrguid4.html.

Vitamin A and osteoporosis
It has long been known that high doses of  vitamin A can cause liver abnormalities. Now researchers are examining an excess intake of vitamin A as a potential risk factor for osteoporosis.  Animal, human, and laboratory research suggests an association between greater vitamin A intake and weaker bones. The large doses of vitamin A may impair the ability of vitamin D to promote calcium absorption. The high doses are associated with reduced bone mineral density and increased risk of hip fracture. There is no evidence of an association between beta-carotene intake, especially from fruits and vegetables, and increased risk of osteoporosis.
          In the 1970s, FDA considered writing regulations for some mega-dose vitamin products because of their potential health risks. The supplement industry waged a lobbying effort against the FDA’s attempt, and the Proxmire Vitamin and Mineral Amendment of 1976 expressly prohibited the FDA from establishing maximum limits on the potency of any vitamin or mineral.
          “Osteoporosis, a disorder characterized by porous and weak bones, is a serious health problem for more than 10 million Americans, 80% of whom are women. Another 18 million Americans have decreased bone density which precedes the development of osteoporosis. Many factors increase the risk for developing osteoporosis, including being female, thin, inactive, at advanced age, and having a family history of osteoporosis. An inadequate dietary intake of calcium, cigarette smoking, and excessive intake of alcohol also increase the risk.”  http://ods.od.nih.gov/factsheets/vitamina.asp#h7.

USDA FSIS Regulations and Policies http://www.fsis.usda.gov/Regulations_&_Policies/index.asp.

Senator Harkin introduces Safer Food Act, (Jul. 10, 06) National Meat Association, Elliotte Bowerman, Ed., Herd on the Hill http://m1e.net/c?8593932-SULOxYPUjVVsw%401761054-eqyud413UHEls. Senator Tom Harkin (D-IA) introduced the “Safe and Fair Enforcement and Recall for Meat, Poultry and Food (SAFER) Act.” S. 3615 would give the USDA and FDA mandatory recall authority. It would also require companies to notify USDA or FDA if they have reason to believe the product is contaminated. The bill would set a scale of civil penalties if a company violates federal meat, poultry or food laws. “We can do a much better job in protecting Americans from the dangers of contaminated or unsafe meat, poultry and other foods,” Harkin said. “Part of the problem is that USDA and FDA don't have the tools they need to enforce basic food safety standards. This bill would change that.”

Is a Picture Worth More Than 1,000 Words? The Fourth Amendment and the FDA’s Authority to Take Photographs Under the Federal Food, Drug, and Cosmetic Act, Neal D. Fortin,  1 Journal of Food Law and Policy 239-268 (Fall 2005), also available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=910581.

Pelman et al. v. McDonald’s Corporation, http://www2a.cdc.gov/phlp/docs/Order-m-dism-3.PDF.

Food Additive Regulations: A Chronology, Donna U. Vogt, Analyst in Life Sciences, Science Policy Research Division Congressional Research Service Report 95-857 SPR (Updated September 13, 1995) http://www.ncseonline.org/nle/crsreports/pesticides/pest-5.cfm.  

FDA guidelines on biotech plants, “Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use,” Food and Drug Administration (FDA) http://www.cfsan.fda.gov/%7edms/bioprgu2.html. The guidelines provide recommendations to developers of new plant varieties, including bioengineered plant varieties, on the early food safety evaluation of new non-pesticidal proteins. Procedures for submitting an early food safety evaluation of such proteins to the agency are also detailed.

Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records, FDA (June 7, 2006) http://www.cfsan.fda.gov/~dms/recguid3.html.  The U.S. FDA has posted its latest "Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records (Edition 3)".

Nicole Coutrelis, European Union Food Law Update, 2 Journal of Food Law & Policy 493 (2006) available at: http://www.nationalaglawcenter.org/assets/articles/coutrelis_euupdate2.pdf.

Nicole Coutrelis, European Union Food Law Update, 1 Journal of Food Law & Policy (2005) available at: http://www.nationalaglawcenter.org/assets/articles/coutrelis_euupdate.pdf.

Symposium on Risk Analysis of Agro-product Safety, Beijing, China, May 11-12, 2006, http://www.iqsttap.com/List.asp?ArticleID=288.

NIH State-of-the-Science Conference on Multivitamin/Mineral Supplements and Chronic Disease Prevention (May 15-17, 2006). People may be getting too much of certain nutrients.  Taking Multivitamin/Mineral Supplement (MVM) consumption with eating fortified foods, and consuming single vitamins or minerals in large doses, may lead to unwittingly exceeding the Upper Levels (ULs) of nutrients, which can be harmful. Given these safety concerns and the limitations of the available evidence, the panel advocated for changes in the regulation of dietary supplements — including MVMs — by the Food and Drug Administration (FDA). Specifically, the panel recommends that Congress expand FDA’s authority and resources to require manufacturers to disclose adverse events, to ensure quality production, and to facilitate consumer reporting of adverse events by including reporting information on dietary supplement labels. The panel also made several specific recommendations regarding future research, including but not limited to the following: Design and conduct rigorous randomized, controlled trials of the impact of individual supplements to test their efficacy and safety in prevention of chronic disease, using well-validated measures. Develop a strategy to support a better understanding of possible interactions between MVMs and prescribed or over-the-counter medications.http://consensus.nih.gov/2006/2006MultivitaminMineralSOS028html.htm.

Natural products database now online, University of Illinois at Chicago (May 18, 2006). A comprehensive database containing extensive scientific and clinical literature on herbal medicine and natural products compiled by researchers at the University of Illinois at Chicago is now available via the Internet. NAPRALERT, online at http://www.napralert.org,  includes information on more than 200,000 published studies in the field of natural products representing organisms, including marine organisms, from countries throughout the world. By accessing NAPRALERT via the Web, researchers, educators and clinicians can find information on the pharmacological, ethnomedical and phytochemical properties of these organisms. "NAPRALERT is the world's largest database on herbs and medicinal plant research, and it is a compilation of natural products used for health purposes and the development of new medications," said Norman Farnsworth, distinguished professor of pharmacognosy and director of the Program for Collaborative Research in the Pharmaceutical Sciences at UIC. Most, but not all, of the natural products included, he said, are derived from plants.

International Bibliographic Information on Dietary Supplements (IBIDS) Database, The International Bibliographic Information on Dietary Supplements (IBIDS) database provides access to bibliographic citations and abstracts from published, international, and scientific literature on dietary supplements. Users can choose to search the Full IBIDS Database, a subset of Consumer Citations Only or Peer Reviewed Citations Only.

“Warning on tuna cans is rejected” Marla Cone, Los Angeles Times (05/13/06) http://www.latimes.com/news/local/la-me-tuna13may13,1,825453.story?track=rss. Last week, San Francisco Superior Court Judge Robert L. Dondero ruled that tuna companies do not have to warn consumers about mercury in their products under California’s Proposition 65. The California law, adopted by voters 20 years ago, requires companies to warn consumers of products containing chemicals that can cause reproductive harm or cancer. In 2004, State Attorney General Bill Lockyer sued Starkist, Chicken of the Sea, and Bumble Bee to force them to issue warnings on store shelves or can labels. But Judge Dondero ruled that the California law is preempted by a U.S. Food and Drug Administration (FDA) advisory and that mercury levels in tuna are not high enough to require warnings. The judge also ruled that tuna is exempt from Proposition 65 because mercury is naturally occurring. The tuna companies applauded the ruling. “Consumers are really the winners in this case,” said Forrest Hainline, a San Francisco attorney who represented the companies. “The judge has made a common-sense ruling based on nutrition and science.” But the attorneys who represented the state were surprised by the ruling. Deputy Attorney General Susan Fiering said, “It’s a devastating decision, particularly for poor women. The people who will be most hurt are women who don’t know about the FDA advisory on the Internet and don’t have access to good medical care so they won’t know about the danger of mercury in this fish.” Dondero’s ruling came after 20 days of testimony on the health risks and sources of mercury. To read the FDA’s position on mercury in fish, visit http://www.fda.gov/oc/opacom/hottopics/mercury/backgrounder.html.

Questions and Answers, Final Guidance (May 12, 2006) http://www.cfsan.fda.gov/~dms/qhcqagui.html. FDA issued a Guidance on its Implementation of "Qualified Health Claims," noting that more information is needed before the agency can establish final procedures to provide for qualified health claims, and therefore issued an Advanced Notice of Proposed Rulemaking (ANPR) to solicit comments on the agency's options.

Cherries pack an anti-inflammatory punch, Agricultural Research Service, USDA, (May 11, 2006) www.ars.usda.gov/is/pr. A study by Agricultural Research Service confirms that cherries may help fight the inflammation of arthritis, heart disease and cancer. For the research, 18 healthy men and women volunteers, aged 45 to 61, ate a total of about 45 fresh Bing cherries throughout the day for 28 consecutive days. Blood samples indicated that levels of three telltale indicators of inflammation--nitric oxide, C reactive protein and a marker for T-cell activation, termed "RANTES"--dropped by 18 to 25 percent by the end of the cherry-eating stint.

Perspectives on Marketing, Self Regulation, & Childhood Obesity. The Department of Health and Human Services and the Federal Trade Commission (April 2006).  A report calling on the food, advertising, and entertainment industries to voluntarily limit the marketing of junk food to children; intensify their efforts to create products lower in calories, more nutritious; help consumers control portion sizes and calories through smaller portions, single-serving packages, and other packaging cues; generally explore ways to improve efforts to educate consumers about nutrition and fitness, with simple and effective messages; and review and revise their policies to improve the overall nutritional profile of the products they market and sell in schools. http://www.ftc.gov/os/2006/05/PerspectivesOnMarketingSelf-Regulation&ChildhoodObesityFTCandHHSReportonJointWorkshop.pdf.

100 years of meat inspection commemorative web page http://www.fsis.usda.gov/100years/.  The FSIS launched a new Web page to commemorate the 100^th anniversary of the Federal Meat Inspection Act (FMIA).

FDA, Draft Guidance for the Safe Production of Fresh-Cut Fruits and Vegetables, http://www.cfsan.fda.gov/guidance.html. To minimize microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers in a ready-to-eat form, The Food and Drug Administration (FDA) published a draft guidance document for producers of fresh-cut produce entitled "Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables."

Guidance for Industry and FDA Staff: Whole Grain Label Statements, Draft Guidance, FDA (Feb 17, 2006) http://www.cfsan.fda.gov/~dms/flgragui.html.  The Food and Drug Administration has issued draft guidance on what the term “whole grain” may include. The FDA document clarifies that the agency considers “whole grain” to include cereal grains that consist of the intact, ground, cracked or flaked fruit of the grains whose principal components -- the starchy endosperm, germ and bran -- are present in the same relative proportions as they exist in the intact grain. Such grains may include barley, buckwheat, bulgur, corn, millet, rice, rye, oats, sorghum, wheat and wild rice.  In contrast, in the grain refining process some of the bran and germ is removed resulting in a loss of dietary fiber, vitamins and minerals.

“Food Marketing to Children and Youth: Threat or Opportunity?” http://www.nap.edu/catalog/11514.html.  The Institute of Medicine has published a comprehensive scientific review of how food marketing influences the diets of children and youth. The review found that food marketing aimed at kids can lead to poor nutritional choices. It recommends broad efforts to promote healthier foods and diets.

Drinks with caffeine need warning labels, study,
Chris Mercer (Mar. 17, 2006) FoodProductivity.com http://www.foodproductiondaily.com/news/ng.asp?n=66486&m=1FPD317&c=forwionisnpkxrx.  The caffeine content of all carbonated and energy drinks should be clearly labelled on drinks packaging to avoid unnecessary risk for vulnerable consumers, argues a new study in the US.

Citizen Petition for New Labeling Requirements for Caffeine in Food, FDA Docket # 2006P-0039 http://www.fda.gov/ohrms/dockets/dockets/06p0039/06p-0039-cp00001-01-vol1.pdf. Citizen Petition: To Issue a Regulation that would Efficaciously Inform the General Public about the Quantitaive Caffeine Content of the Foods they Consume

Ale and hearty? Try the new health tipple 11 March 2006, New Scientist Print Edition, http://www.newscientist.com/channel/health/mg18925424.900.html. Beer may, according to this story, be as good for your health as red wine and green tea, damping down the arterial inflammation that leads to heart disease. It might even make you happier. Dietmar Fuchs and colleagues of Innsbruck Medical University in Austria knew that tea and wine could suppress the inflammation in white blood cells, and wondered whether beer might have the same effect. Sure enough, when they mixed beer with white blood cells that had been tricked into turning inflammatory, the activated cells calmed down again.Exposed to alcoholic or non-alcoholic beer, the inflammatory cells stifled production of neopterin, a substance that leads to inflammation when it is overproduced. At the same time, the cells cut their consumption of tryptophan, an amino acid depleted by inflammatory cells. Although the active compounds in beer are unknown, the researchers think that humulone, the substance from hops that makes beer taste bitter, may be involved (International Immunopharmacology, vol 6, p 390).

Putting a Healthy Whole In Your Diet, Sally Squires, The Washington Post (2/21) http://www.washingtonpost.com/wp-dyn/content/article/2006/02/20/AR2006022000996.html. “The first federal definition of whole grains could make it easier for you to know whether your favorite bread, cereal, crackers and pasta are whole-grain wonders or merely half-baked.”

Infamous Lawsuit Liability, By Neal D. Fortin, “Anyone can sue anyone over anything. Winning, however, is a different matter. By design, the American legal system weeds out frivolous lawsuits.  .  . with a little knowledge, avoiding legal-liability landmines is relatively straightforward, even if not always easy.” available at: http://www.foodproductdesign.com/articles/466/466_631regs.html#.

Causes of food-borne disease / food poisoning (FAO) ftp://ftp.fao.org/es/esn/food/meetings/NE_report_en.pdf.

FAOLEX database [FAO SEARCHABLE DATABASE OF LAWS FROM VARIOUS COUNTRIES]  http://faolex.fao.org/faolex/index.htm.

Food Safety Research Information Office: http://fsrio.nal.usda.gov/. The Food Safety Research Information Office (FSRIO) at the U.S. National Agricultural Library support the research community by collecting, organizing and disseminating food safety research information.

Food Laws and Regulations http://www.jifsan.umd.edu/PDFs/GAPS_English/IV__Food_Laws_and_Regulatio.pdf

Irradiation, CDC http://www.cdc.gov/ncidod/dbmd/diseaseinfo/foodirradiation.htm.

USDA Labeling Policy http://www.fsis.usda.gov/regulations_&_policies/Labeling_Policies/index.asp.

Good Agricultural Practices (GAPS) http://www.jifsan.umd.edu/gaps.html  

Board Position Paper On National Uniformity For Foods, Drugs, And Cosmetics http://www.afdo.org/afdo/position/5p2001.cfm

National Uniformity For Food Act – Uniformly A Disaster For Consumers! http://www.consumersunion.org/pub/core_food_safety/001400.html
Food Products Association Applauds House Committee’s Markup of “National Uniformity for Food Act” http://www.fpa-food.org/content/newsroom/article.asp?id=362.

Public Health Courses Online. Johns Hopkins Bloomberg School of Public Health has launched project OpenCourseWare, which provides free online access to some of the school’s most popular courses. Courses are not offered for credit and do not count toward a degree or certificate. For more information, visit http://ocw.jhsph.edu/.

The FDA At Work: Cutting-Edge Science Promoting Public Health, Philip J. Hilts, FDA Consumer magazine (January-February 2006) http://www.fda.gov/fdac/features/2006/106_fdawork.html. A short history of the development of the Food and Drug Administration and food and drug law.

“France battles a problem that grows and grows: Fat” The New York Times (01/25/06) Elaine Sciolino http://www.nytimes.com/2006/01/25/international/europe/25obese.html?adxnnl=1&adxnnlx=1138718854-e0vOFxt7dxPXi1gQ/Dzqiw.  January 7 was National Weighing Day for children in France, when hundreds of pediatricians volunteer to weigh, measure, question, and teach children about the country’s growing obesity problem. The doctors fan out to more than 80 cities to measure children’s height, weight, and body mass index, and offer advice on nutrition and exercise for those declared overweight. According to the most recent national figures, childhood obesity rates are climbing at an alarming 17 percent per year, and French lawmakers are beginning to take notice. “It used to be little talked about, and when it was, it was the domain of women complaining that they had put on a little weight,” said Dr. Jean-Marie Le Guen, author of “Obesity: The New French Sickness.” Last September, the country banned soda and candy vending machines in public schools, banned misleading television and print food advertisements, and began taxing food companies that do not encourage healthy eating. Parliament rejected more drastic anti-obesity legislation that would have banned advertising for unhealthy products and required health warnings on food packages. Experts say the increase in obesity rates stems from fast food, sedentary lifestyles, and a cultural shift away from social meals of small portions over several courses.

Dietary Guidelines for Americans 2005 (January 12, 2005) http://www.healthierus.gov/dietaryguidelines/index.html. The Dietary Guidelines for Americans is published jointly every 5 years by the Department of Health and Human Services (HHS) and the Department of Agriculture (USDA). The Guidelines provide authoritative advice for people two years and older about how good dietary habits can promote health and reduce risk for major chronic diseases.

Meat, poultry product inspection directory, USDA FSIS http://www.fsis.usda.gov/Regulations_&_Policies/Meat_Poultry_Egg_Inspection_Directory/index.asp.  The Meat, Poultry and Egg Product Inspection Directory is a listing of establishments that produce meat, poultry, and/or egg products regulated by USDA's Food Safety and Inspection Service (FSIS) pursuant to the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act.

FDA Centennial Website (1906 - 2006) http://www.fda.gov/centennial/history/history.html.  A lot of interesting history, which also shows how far consumer safety protection has come in 100 years—be sure to check out the Poison Squad.

FDA to Require More Safety Data for Medical Devices, Barry Meier, The New York Times  (Jan. 21, 2006) http://www.nytimes.com/2006/01/21/business/21fda.html?_r=1. The Food and Drug Administration announced plans to issue guidelines requiring more product data on medical devices. The plan comes in the wake of increased criticism over the reporting of safety failures connected to Guidant. The new requirements are designed to provide more information to the public but specific details have not been released.

FAO and Biotechnology, USDA-Foreign Agricultural Service Report (January 12, 2006) http://www.fas.usda.gov/gainfiles/200601/146176552.doc. FAO views biotechnology in the context of its mandate to promote food security and increase agricultural productivity. It recognizes biotechnology as a suite of tools that have great potential to improve the productive capacity of agriculture in the developing world, but also recognizes there are substantial obstacles to be overcome. FAO's general position on biotechnology can be characterized as cautious. It plays an important and useful role in the global dialogue on biotechnology, but lacks a sense of urgency in helping to equip countries with the tools to use biotechnology.

Food Marketing to Children and Youth: Threat or Opportunity? Institute of Medicine (Dec. 6, 2005) http://www.iom.edu/report.asp?id=31330. The report finds that current food and beverage marketing practices puts children's long-term health at risk. If America's children and youth are to develop eating habits that help them avoid early onset of diet-related chronic diseases, they have to reduce their intake of high-calorie, low-nutrient snacks, fast foods, and sweetened drinks, which make up a high proportion of the products marketed to them. The report can be viewed on-line from the following links: http://www.nap.edu/books/0309097134/html/   http://www.nap.edu/books/0309097134/html/R3.html  

Checklist for FDA Bioterrorism Recordkeeping. The website states that the information should be checked for accuracy.  http://www.operationstechnologies.com/downloads.htm.

AHPA Guidance on Supplement Internet Advertising www.ahpa.org/guidelines.htm.  AHPA has recognized the need for particular caution in internet advertising of dietary supplements; this past July, AHPA recommended that websites offering dietary supplements or dietary ingredients provide contact information for the company and the nutrition labeling information that is required on dietary supplement labels, or alternately, provide a statement to the effect that this information is available upon request. The guidance also urges that any website that makes a structure/function claim include the standard FDA disclaimer. Under the Dietary Supplements Health and Education Act of 1994 (DSHEA), all statements of nutritional support for dietary supplements must be accompanied by a two-part disclaimer on the product label: that the statement has not been evaluated by FDA and that the product is not intended to “diagnose, treat, cure or prevent any disease.”

Amid a Lawsuit, Keeping Track of a Candy Wrapper's Fine Print
Joyce Cohen, The New York Times  11/09/2005) http://www.nytimes.com/2005/11/09/dining/09candy.html. After a class-action against Russell Stover was filed for misleading candy labels that describe products as "low carb," the manufacturer has changed the packaging to read "net carb." A company spokesman says the change was not sparked by the lawsuit, but the issue raises a bigger question as to what can be classified under low carb status. Currently, the FDA does not define foods as low carb and prohibits labels on products that advertise products in such a way.

FDA Criticized for Mad Cow Testing Procedures
AP, USA Today (11/09/2005) http://www.usatoday.com/news/nation/2005-11-09-madcowfeed_x.htm. A GAO report concluded that FDA safeguards to prevent an outbreak of mad cow disease are insufficient. The findings cited many weaknesses in testing, including a failure to detect infected strands in a timely matter. The disease is known to spread when found in contaminated cattle feed.

Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA Implemented in 2003 With Recommendations for Making the Program a Better Oversight Tool, GAO, GAO-06-157R, October 11, 2005 (released Nov. 9, 2005) http://www.gao.gov/cgi-bin/getrpt?GAO-06-157R.

(click here to view)

Mike Smith Las Vegas Sun Oct 31, 2005 EditorialCartoonists.com

Herbal energy drink may have caused stroke
Bradford Worrall et al., Neurology 2005; 65: 1137-1138 (October 25, 2005) http://www.incirculation.net/NewsItem/Herbal-energy-drink-may-have-caused-stroke.aspx?usechannel=STR or http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16217079&query_hl=2.  Reported the case of a man who suffered cerebral vasculopathy and concurrent ischemic and hemorrhagic strokes shortly after trying herbal energy drink for the first time.  The 21-year-old man had recently drank 250 ml of the energy drink "XS Cranberry-Grape Blast," which contains numerous sympathomimetic compounds. These include Eleutherococcus (Acanthopanax) senticosis (Siberian ginseng), Schisandra (Wu Wie Zi or Chinese magnolia wine), and various Panax (ginseng) species. All contain phenylpropanoid lignans among other potentially vasoactive compounds.

Several hours after drinking XS the patient developed a profound headache and hemiataxia. Imaging revealed an acute brainstem infarction and bilateral subarachnoid hemorrhage on the cerebral convexities. Cerebral angiography showed multifocal areas of narrowing and dilatation but without evidence of aneurysm.

The Food and Drug Administration banned phenylpropanolamine-containing products in November 2000, Worrall et al note, but exposure to herbal sympathomimetic substances remain a risk factor for cerebral vasculopathy, subarachnoid hemorrhage, and ischemic stroke.

Food CGMP Modernization — A Focus On Food Safety
FDA, Center for Food Safety and Applied Nutrition http://www.cfsan.fda.gov/~dms/cgmps3.html (Nov. 2, 2005).  Report of the Food CGMP Modernization Working Group, which was formed to examine the general food CGMP regulation in 21 CFR Part 110. The working group concluded that there have been changes in both the food industry and in the science of food safety that indicate a need for modernization.

Annual Bibliography of Significant Advances in Dietary Supplement Research, The U.S. Office of Dietary Supplements, National Institutes of Health (NIH) (Oct. 2005). http://ods.od.nih.gov/pubs/ODS_CHPA_Bibliography_2004.pdf. Announcement of the 2004 issue, the sixth issue of the Bibliography, which includes abstracts of the 25 most noteworthy dietary supplement research papers published in 2004, as judged by an international team of reviewers. This is the first issue of the Bibliography to highlight research on phenolics and flavonoids -- compounds found in plant foods such as berries, grains, and tea -- reflecting growing interest in these substances and their potential health effects. In addition to the papers on phenolics and flavonoids, the Bibliography for 2004 includes papers on antioxidants, vitamins, minerals, botanicals, fatty acids, and other ingredients contained in dietary supplements.

Information Statement Food Allergy, Institute of Food Science and Technology, (Oct. 2005) http://www.ifst.org/allergy.pdf.

The Right to Know-Nothingism Law, Sandy Szwarc, Tech Central Station (Oct. 10, 2005) http://www.techcentralstation.com/101105E.html. Proposition 65 deserves to be renamed "the law of mythological food fears."

Effects of Strength of Science Disclaimers on the Communication Impacts of Health Claims, FDA (Sept. 2005) http://www.fda.gov/OHRMS/dockets/dockets/03N0496/03N-0496-rpt0001.pdf. The FDA study about consumers understanding of qualified health claims suggests that:
Qualifying statements that used only words to convey the strength of science underlying a claim were not understood by consumers; Qualifying statements that included a "report card grade" were understood by consumers to convey a rank order of the strength of science underlying a claim, but ‘B' grades were understood to convey greater scientific certainty than unqualified health claims (i.e., claims that meet the significant scientific agreement standard). Even when qualified health claims were understood as intended, qualifying statements had unexpected effects on consumers' judgments about the health benefits and overall healthfulness of the product bearing the claim. Sometimes, these qualified health claims led to more positive product perceptions.

Food Allergen Labeling, expanded version of Allergen Labeing on the Horizon, FOOD PRODUCT DESIGN 168 (June 2005).  Under the Food Allergen Labeling and Consumer Protection Act (FALCPA), food manufacturers must declare the common name for allergenic substances for food labeled on or after January 1, 2006.  The article summarizes the requirements. 

Free searchable database on food content
What nutrients were in the smoothie you just consumed? Was it a two-cup serving made with fruit? Or was it a 20-fluid-ounce smoothie made with fruit and yogurt? The answers can be found on the Internet, where free access is now available to nutrient information on thousands of foods typically eaten in the United States. The U.S. Dept. of Agriculture's Agricultural Research Service (ARS) scientists have launched an online searchable database where users can view a 60-nutrient profile for each of more than 13,000 foods. The new resource is called "What's in the Foods You Eat—Search Tool."  http://www.ars.usda.gov/Services/docs.htm?docid=7783

HACCP-Based Standard Operating Procedures (SOPs) http://sop.nfsmi.org/HACCPBasedSOPs.php.  The National Food Service Management Institute (NFSMI) has developed HACCP-based SOPs in conjunction with USDA and FDA. Although the NFSMI SOPs include HACCP-based principles, you should remember that SOPs are only one component of an overall food safety program.

No attacking Big Mac: ‘Cheeseburger law’ fends off lawsuits
Joel Mathis, Lawrence Journal World (July 14, 2005) http://www2.ljworld.com/news/2005/jul/14/no_attacking_big_mac/?city_local. Kansas is the 18th state to pass a cheeseburger law, designed to protect the food industry from customers who might sue them for obesity-related medical conditions.

CSPI calls for health warnings on sodas
CSPI press release http://www.cspinet.org/new/200507131.html. According to the Center for Science in the Public Interest (CSPI) data show teenagers are drinking more high-calorie soft drinks. The group is calling on the U.S. FDA to place health warnings on soda labels.

FDA clarifies “and/or” ingredient labeling
The Food and Drug Administration (FDA) has received several inquiries regarding the status of "and/or" ingredient labeling of nutritive sweeteners in soft drink products in light of the November 26, 2004 Federal Register (FR) Notice (69 FR 68831) withdrawing the proposed rule to permit "and/or" labeling for nutritive sweeteners in soft drinks. FDA has issued a letter providing clarification on the ruling.  www.cfsan.fda.gov/~dms/fl-ltr5.html.

European court upholds limits on sales of food supplements, Paul Ames, Associated Press    (07/12/05) http://news.yahoo.com/news?tmpl=story&u=/ap/20050712/ap_on_bi_ge/eu_vitamins_2.  A European Union (EU) law restricting the sale of food supplements, including certain vitamins and minerals, was upheld by the European Court of Justice last week. The EU said that such restrictions would protect consumers and provide standards for companies selling supplements throughout Europe. But groups like the Alliance for Natural Health, which comprises manufacturers, distributors and consumers of the supplements, opposed the legislation, arguing that it would ban thousands of vitamins and minerals. The court ruled, “certain restrictions can be justified by the protection of public health,” and that it “considered the measures in question to be necessary and appropriate for the purpose of achieving that objective.” The court held that a product should be banned only “on the basis of a full risk assessment, established on the basis of the most reliable scientific data,” and “consistent with the principles of sound administration and legal certainty.” The EU law will take effect on August 1, 2005, and will provide a “positive list” of food supplements approved for sale.

Proposed Rule: Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements, FDA, 68 Federal Register 12157-12263 (March 13, 2003) available at: http://www.cfsan.fda.gov/~lrd/fr030313.html.  SUMMARY: The Food and Drug Administration (FDA) is proposing current good manufacturing practice (CGMP) regulations for dietary ingredients and dietary supplements. The proposed rule would establish the minimum CGMPs necessary to ensure that, if you engage in activities related to manufacturing, packaging, or holding dietary ingredients or dietary supplements, you do so in a manner that will not adulterate and misbrand such dietary ingredients or dietary supplements. The provisions would require manufacturers to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements. The proposed rule is one of many actions related to dietary supplements that we (FDA) are taking to promote and protect the public health. 

Pot-flavored candy takes a licking. Anti-drug forces angry over treats made with hemp oil.  Associated Press (June 21, 2005) http://www.msnbc.msn.com/id/8305249/.  Marijuana-flavored lollipops with names such as Purple Haze, Acapulco Gold and Rasta are showing up on convenience stores shelves around the country.

Nutrition Labeling in the Food-Away-From-Home Sector: An Economic Assessment
Jayachandran N. Variyam, Economic Research Report No. (ERR4) 28 pp, April 2005 http://www.ers.usda.gov/publications/ERR4/. Americans spent about 46 percent of their total food budget on food away from home in 2002, up from 27 percent in 1962. Such foods tend to be less nutritious and higher in calories than foods prepared at home, and some studies have linked eating away from home to overweight and obesity in adults and children. Current nutrition labeling law exempts much of the food-away-from-home sector from mandatory labeling regulations. Because consumers are less likely to be aware of the ingredients and nutrient content of away-from-home food than of foods prepared at home, public health advocates have called for mandatory nutrition labeling for major sources of food away from home, such as fast-food and chain restaurants. This report provides an economic assessment of a food-away-from-home nutrition labeling policy, including justifications for policy intervention and potential costs and benefits of the policy.

Fats in the Fast Lane: Changes in Fatty Acid Regulation, Labeling, and Allowed Claims, Neal D. Fortin, Food Product Design 148 (March 2005) available at: http://www.foodproductdesign.com/current/0305LR.html.

Guidance for Industry: Pre-petition Consultations for Food Additives and Color Additives, FDA (April 2005) http://www.cfsan.fda.gov/~dms/prepguid.html

FDA Dietary Supplement Label Guide
http://www.cfsan.fda.gov/~dms/dslg-toc.html The U.S. FDA has posted a Dietary Supplement Labeling Guide. The guide represents the Food and Drug Administration's current thinking on the topic.

Nutraceutical Corp v Crawford, # 2:04CV00409 TC (April 14, 2005) Judge Tena Campbell ruling striking down FDA's ban on ephedra http://www.utd.uscourts.gov/reports/204cv409-28.pdf.

Australia New Zealand Trans Fat Labeling FAQ
Food Standard Australia New Zealand, which develops food standards for Australia and New Zealand, has issued a trans fatty acid fact sheet. At present, the Australia New Zealand Food Standards Code does not require manufacturers to label the trans fatty acid content of foods unless they make a nutrition claim. A decision not to mandate the labeling of trans fat content of foods was made based on the relatively low intakes of trans fatty acid consumption and most that a similarly sized reduction in saturated fatty acid intake was more likely to have a larger impact on health outcome compared with reductions in trans fats.  http://www.foodstandards.gov.au/mediareleasespublications/factsheets/factsheets2005/transfattyacids12apr2869.cfm

Risky Business
Cécile Philippe (March 9, 2005) http://www.techcentralstation.com/030905B.htm “Precaution as a principle does not attempt to reduce the risk linked to an activity, but rather to remove it. This could well destroy the potential beneficial consequences of innovation as well as market mechanisms, which have allowed man to reduce the risks he inexorably faces. Used by politicians, this authoritative and centralized means of managing risks, forces all the members of a society to take the risk associated with prohibiting a certain activity. We can only fear disastrous consequences.  There's also an inherent contradiction: as the precautionary principle cannot remove all risks, but only suppress some of them while forcing us into taking others, it should submit to its own test. Its proponents should have to prove that its implementation does not imply any irreversible or damaging risks for the population. This is impossible; so, just to be safe, the principle should be banned.”

Expert Report on Functional Foods: Opportunities and Challenges
http://www.ift.org/cms/?pid=1001247

Future of Dietary Supplements
http://iml.jou.ufl.edu/projects/Spring2000/Kimpel/future.html  

Homeland Security: Much Is Being Done to Protect Agriculture from a Terrorist Attack, but Important Challenges Remain, GAO-05-214, March 8, 2005 http://www.gao.gov/new.items/d05214.pdf. U.S. agriculture generates more than $1 trillion per year in economic activity and provides an abundant food supply for Americans and others. Since the September 11, 2001, attacks, there are new concerns about the vulnerability of U.S. agriculture to the deliberate introduction of animal and plant diseases (agroterrorism). Several agencies, including the U.S. Department of Agriculture (USDA), the Department of Homeland Security (DHS), the Department of Health and Human Services (HHS), the Environmental Protection Agency (EPA), and the Department of Defense (DOD), play a role in protecting the nation against agroterrorism. GAO examined (1) the federal agencies' roles and responsibilities to protect against agroterrorism, (2) the steps that the agencies have taken to manage the risks of agroterrorism, and (3) the challenges and problems that remain.

USDA Report on Canadian Nutrition Labels Regulations
Amendments to Canada's Food and Drug Regulations in 2002 implemented mandatory nutrition labeling on most prepackaged foods. The new regulations outline the labeling requirements for a Nutrition Facts table, update labeling requirements for nutrition content claims and introduce diet-related health claims. Most manufacturers have until December 12, 2005 to comply with the new requirements. The regulations for the Nutrition Facts table are very similar to those found in the United States, with some small, but important, differences.
The USDA Foreign Agricultural Service (FAS) posted a report to help U.S. manufacturers that import into Canada get product nutrition labels ready for Canada's December 12, 2005, mandatory compliance date. The report outlines the new requirements for Canada's Nutrition Facts table, and for using nutrition content claims and diet-related health claims. A side-by-side graphic comparison of United States and Canadian Nutrition Facts is provided; sources for in-depth information are also given.  FAS report:  http://www.fas.usda.gov/gainfiles/200502/146118917.doc

Updated Prior Notice Compliance Policy Guide http://www.cfsan.fda.gov/~pn/cpgpn5.html

Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies Institute of Medicine, p. 3, (1999) http://www.nap.edu/openbook/0309064864/html/3.html

Lawsuit to Classify Salt as a Food Additive. The Center for Science in the Public Interest (CSPI) filed a lawsuit asking the U.S. Court of Appeals to order FDA to publish a statement of the Agency's decision to either affirm or revoke the Generally Recognized as Safe (GRAS) status of salt. The suit also asks that FDA be forced to propose and receive comments on guidelines for adding salt to processed foods, such as limits on amounts per serving and special labeling. Presently, FDA classifies salt as GRAS, or Generally Recognized as Safe, which means that it is not closely regulated. If salt were classified as a food additive, as defined by the Food, Drug, and Cosmetic Act, FDA would propose rules on the safe levels and uses of salt in food.  CPSI news release: http://www.cspinet.org/new/200502242.html. View the lawsuit at http://cspinet.org/new/pdf/salt_lawsuit.pdf. “Salt The Forgotten Killer", CSPI (February) a report on the health risks associated with sodium: http://cspinet.org/salt/saltreport.pdf

Mad Cow Disease: FDA's Management of the Feed Ban Has Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness, GAO-05-101, (February 25, 2005) http://www.gao.gov/cgi-bin/getrpt?GAO-05-101.
More than 5 million cattle across Europe have been killed to stop the spread of bovine spongiform encephalopathy (BSE), commonly called mad cow disease. Found in 26 countries, including Canada and the United States, BSE is believed to spread through animal feed that contains protein from BSE-infected animals. Consuming meat from infected cattle has also been linked to the deaths of about 150 people worldwide. In 1997, the Food and Drug Administration (FDA) issued a feed-ban rule prohibiting certain animal protein (prohibited material) in feed for cattle and other ruminant animals. FDA and 38 states inspect firms in the feed industry to enforce this critical firewall against BSE. In 2002, GAO reported a number of weaknesses in FDA's enforcement of the feed ban and recommended corrective actions. This report looks at FDA's efforts since 2002 to ensure industry compliance with the feed ban and protect U.S. cattle.FDA has made needed improvements to its management and oversight of the feed-ban rule in response to GAO's 2002 report, but program weaknesses continue to limit the effectiveness of the ban and place U.S. cattle at risk of spreading BSE. However, various program weaknesses continue to undermine the nation's firewall against BSE.

Capacity of state and territorial health agencies to prevent foodborne illness
Richard E. Hoffman, Jesse Greenblatt, Bela T. Matyas, Donald J. Sharp,§ Emilio Esteban, Knachelle Hodge, and Arthur Liang, Emerging Infectious Diseases Volume 11, Number 1,  (January 2005) http://www.cdc.gov/ncidod/EID/vol11no01/04-0334.htm. The capacity of state and territorial health departments to investigate foodborne diseases was assessed by the Council of State and Territorial Epidemiologists from 2001 to 2002 with a self-administered, Web-based survey. Forty-eight health departments responded (47 states and 1 territory). The primary reason for not conducting more active case surveillance of enteric disease is lack of staff, while the primary reasons for not investigating foodborne disease outbreaks are limited staff and delayed notification of the outbreak. Sixty-four percent of respondents have the capacity to conduct analytic epidemiologic investigations. States receiving Emerging Infections Program (EIP) funding from the Centers for Disease Control and Prevention more often reported having a dedicated foodborne disease epidemiologist and the capability to perform analytic studies than non-EIP states. We conclude that by addressing shortages in the number of dedicated personnel and reducing delays in reporting, the capacity of state health departments to respond to foodborne disease can be improved.

Stricter Rules for Supplements Sought
Associated Press, Thursday, January 13, 2005; Page A03
With nearly one-fifth of Americans taking dietary supplements, the Institute of Medicine yesterday called for tougher regulations to make sure the products are safe and do what their makers claim. The institute expressed concern about the quality of dietary supplements, saying that "there is little product reliability."
http://www.washingtonpost.com/wp-dyn/articles/A4982-2005Jan12.html
The full report from the IOM can be read online at:  http://www.nap.edu/books/0309092701/html/  

Dietary Guidelines for Americans
Published jointly every 5 years by the Department of Health and Human Services (HHS) and the Department of Agriculture (USDA).  http://www.healthierus.gov/dietaryguidelines/

The economics of food safety: The case of green onions and Hepatitis A outbreaks Linda Calvin, Belem Avendaño, and Rita Schwentesius, ERS USDA (December 2004) Using the example of recent foodborne illness outbreaks in the United States associated with green onions from Mexico, this report examines the economics of food safety. Incentives for growers to adopt additional food safety practices are somewhat weak. Because of asymmetric information problems, produce grown with more food safety practices does not receive higher prices. Growers that adopt more food safety practices do so to maintain markets and to reduce risk. Results from a survey before the outbreaks provide a view of the incentives for adopting more food safety practices. Interviews with growers after the outbreaks indicate how the costs of an outbreak vary depending on the food safety practices growers had already adopted. According to growers, the market impact lasted 1-4 months. Policy responses by growers, retailers and foodservice buyers, and governments conclude the report. http://www.ers.usda.gov/publications/vgs/nov04/VGS30501/ Food safety: USDA and FDA need to better ensure prompt and complete recalls of potentially unsafe food Government Accountability Office (GAO, GAO-05-51 (October 7, 2004) GAO Found weaknesses in USDA’s and FDA’s food recall programs heighten the risk that unsafe food will remain in the food supply and ultimately be consumed. Specifically, USDA and FDA do not know how promptly and completely the recalling companies and their distributors and other customers are carrying out recalls, and neither agency is using its data systems to effectively track and manage its recall programs. For these and other reasons, most recalled food is not recovered and therefore may be consumed. GAO’s analysis of recalls in 2003 showed that about 38 percent and 36 percent of recalled food was ultimately recovered in recalls overseen by USDA and FDA, respectively. These agencies also told GAO of instances in which companies were slow to reveal where they had distributed the food or provided inaccurate customer lists. . . Agencies responsible for the safety of products, such as toys, heart pacemakers, and automobiles, have specific recall authority not available to USDA and FDA for food. Full report: http://www.gao.gov/cgi-bin/getrpt?GAO-05-51; Highlights: http://www.gao.gov/highlights/d0551high.pdf