========================================================================= Date: Fri, 10 Jan 2003 18:56:59 EST Reply-To: FDA-DSFL@VM.CFSAN.FDA.GOV Sender: FDA-DSFL Electronic Newsletter From: Dietary Supplement/Food Labeling Electronic Newsletter Organization: Food and Drug Administration Subject: FDA-DSFL Newsletter January 2003 * * Dietary Supplement/Food Labeling Electronic Newsletter * * * * * * * FDA-DSFL@vm.cfsan.fda.gov * * * * WHAT IS "FDA-DSFL"? FDA-DSFL is an electronic newsletter from the Food and Drug Administration's Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS), in the Center for Food Safety and Applied Nutrition (CFSAN). Its purpose is to give interested parties access to key information and updates on dietary supplements, food labeling and nutrition issues. +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ JANUARY 2003 (#4) IN THIS ISSUE 1. FDA ANNOUNCES INITIATIVE ON QUALIFIED HEALTH CLAIMS 2. INFANT FORMULA WEB SITE - NEW! 3. INFANT FORMULA FOOD ADVISORY MEETINGS 4. E. SAKAZAKII INFECTIONS IN HOSPITALIZED INFANTS ASSOCIATED WITH USE OF POWDERED INFANT FORMULAS 5. OATRIM HEALTH CLAIM 6. WHITE CHOCOLATE FINAL RULE 7. LABELING OF FOODS TREATED WITH IRRADIATION - Proposed Rule 8. VOLUNTARY LABELING OF RAW FRUITS, VEGETABLES AND FISH - Proposed Rule 9. TRANS FATTY ACIDS: FR NOTICE TO REOPEN COMMENT PERIOD; NAS REPORT; FDA'S NEXT STEPS 10. GUIDANCE ON HOW TO USE LABEL: NOW IN SPANISH 11. NICOTINE WATER: FDA PRESS RELEASE 12. NAS PROPOSED REPORT: FRAMEWORK FOR EVALUATING SAFETY OF DIETARY SUPPLEMENTS. 13. NAS REPORT: EVOLUTION OF EVIDENCE FOR SELECTED NUTRIENT & DISEASE RELATIONSHIPS 14. DIETARY SUPPLEMENT STRATEGIC PLAN COST OUT - Report to Congress 15. CFSAN ADVERSE EVENT REPORTING SYSTEM 16. BIOTERROISM PREPAREDNESS & RESPONSE ACT 17. FARM SECURITY & RURAL INVESTMENT ACT (Includes Food Irradiation Guidance) 18. RELATED FOOD ADVISORY MEETINGS (BIOTECH, METHYL MERCURY) 19. FTC'S NEW WEB SITE - OPERATION CURE.ALL RECENT ANNOUNCEMENTS 1. FDA Announced Initiative and Guidance on Qualified Health Claims On December 18, 2002, FDA announced its new initiative to make available more and better information about foods and dietary supplements, to help American consumers prevent diseases and improve their health by making sound dietary decisions. The Consumer Health Information for Better Nutrition Initiative is comprised of three related actions: issuing guidance on qualified health claims for conventional foods and dietary supplements; strengthening enforcement of dietary supplement rules; and establishing an FDA Task Force on Consumer Health Information for Better Nutrition. * FDA Press Release (December 18, 2002): http://www.fda.gov/bbs/topics/NEWS/2002/NEW00859.html * Guidance for Industry - Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements (December 18, 2002): http://www.cfsan.fda.gov/~dms/hclmgui2.html 2. Infant Formula Web Site - NEW The Office of Nutritional Products, Labeling, and Dietary Supplements is announcing its new Infant Formula Web Site that contains infant formula information helpful to industry, consumers, government agencies, and other interested parties. It includes the following: information about FDA s regulation of commercial infant formulas, commonly-asked questions about infant formulas, information about how to report problems, and links to other relevant resources. See: http://www.cfsan.fda.gov/~dms/inf-toc.html . INFANT FORMULA 3. Infant Formula Meetings - FDA held two Food Advisory Committee Meetings on Infant Formula to discuss general scientific principles related to quality factors for infant formula. * The meeting of November 18 & 19, 2002 focused on assessing and evaluating whether a "new" infant formula supports normal physical growth in infants when consumed as a sole source of nutrition. * The meeting of April 4 & 5, 2002 focused on scientific issues related to the generalization of findings from a clinical study using preterm infant formula consumed by preterm infants to a term infant formula intended for use by term infants. - Federal Register notices, transcripts, questions and briefing materials for both meetings may be found at: http://www.fda.gov/ohrms/dockets/ac/cfsan02.htm . 4. E. sakazakii Infections In Hospitalized Infants Associated with Use of Powdered Infant Formula On April 11, FDA issued a warning, alerting health care professionals about the risk of Enterobacter sakazakii infections in hospitalized newborn infants fed powdered infant formulas. E. sakazakii is an emerging foodborne pathogen that can cause sepsis, meningitis, or necrotizing enterocolitis in newborn infants, particularly premature infants or other infants with weakened immune systems (letter revised on October 10, 2002). CDC investigated a fatal E. sakazakii meningitis case in a neonatal intensive care unit in Tennessee that is reported in the Morbidity and Mortality Weekly Report, April 12, 2002. On November 1, 2002, FDA issued a press release alerting the public of a voluntary recall of powdered infant formula because certain lots of formula may have been contaminated with Enterobacter sakazakii. - FDA Press Release (November 1, 2002): http://www.fda.gov/bbs/topics/NEWS/2002/NEW00849.html - FDA Talk Paper April 12, 2002): http://www.cfsan.fda.gov/~lrd/tpinf.html - FDA Letter to Health Professionals (April 11, 2002; revised October 10, 2002): http://www.cfsan.fda.gov/~dms/inf-ltr3.html - CDC Morbidity and Mortality Weekly Report (April 12, 2002): http://www.cdc.gov/mmwr/PDF/wk/mm5114.pdf FOOD LABELING AND NUTRITION 5. Approved Health Claim on Oatrim FDA amended the "soluble fiber from certain food and risk of coronary heart disease" health claim (21 CFR 101.81) by adding oatrim, in addition to rolled oats, oat bran and whole oat flour, as an eligible source of beta-glucan soluble fiber for the health claim. Oatrim is the water soluble fraction of amylase-hydrolyzed oat bran or whole oat flour. This action was in response to a petition submitted jointly by Quaker Oats and Rhodia Inc. This amendment became effective upon its publication in the Federal Register on October 2, 2002. See: http://www.cfsan.fda.gov/~lrd/fr02102b.html . 6. White Chocolate Final Rule - Standard of Identity FDA published in the Federal Register a final rule establishing a standard of identity for white chocolate. This standard provides for use of the term "white chocolate" as the common or usual name of products made from cacao fat, milk solids, nutritive carbohydrate sweeteners, and other safe and suitable ingredients, but containing no nonfat cacao solids. This standard was established in response to citizens petitions submitted separately by Hershey Foods Corporation and by the Chocolate Manufacturers Association of the U.S. See: http://www.cfsan.fda.gov/~lrd/fr021004.html . 7. Labeling of Foods Treated with Irradiation FDA announced the availability of a document entitled "Guidance; Implementation of Section 10809 of the Farm Security and Rural Investment Act of 2002, Pub. L. No. 107-101, Section 10809 (2002), which explains the process by which interested parties may petition the agency for approval of labeling, which is not false or misleading in any material respect, of a food that has been treated by irradiation. FDA issued this guidance to interested parties who wish to petition the agency for approval of the labeling of a food treated by irradiation. See: http://www.cfsan.fda.gov/~dms/irraguid.html . 8. Proposed Rule on Voluntary Labeling of Raw Fruits & Vegetables A proposed rule was published on March 20th entitled "Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Identification of the 20 Most Frequently Consumed Raw Fruits, Vegetables, and Fish." In this rule, FDA proposed to amend the voluntary nutrition labeling regulations by updating the names and the nutrition labeling values for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States. See: http://www.cfsan.fda.gov/~lrd/fr020320.html , and the correction notice (Docket Number corrected) of June 6, 2002 at: http://www.cfsan.fda.gov/~lrd/fr020606.html . 9. Trans Fatty Acids - FR Notice to Reopen Comment Period for Proposed Rule; NAS Letter Report; FDA's Next Steps On November 15, 2002, FDA announced in the Federal Register that the agency is reopening the comment period to receive comment on a footnote statement that it is proposing be required on the label when trans fat is listed. The document also adds recent scientific reports, such as the National Academy of Science's report on Dietary Reference Intakes for macronutrients, to the Administrative Record; and specifies conditions under which FDA will exercise enforcement discretion for manufacturers who wish to begin labeling the trans fat content of foods prior to publication of a final rule. See: http://www.cfsan.fda.gov/~lrd/fr02n15b.html . The Institute of Medicine/National Academy of Sciences issued a letter report on dietary reference intakes for trans fatty acids. The letter report underscored the relationship between the intake of trans fat and the increased risk of heart disease, and emphasized the need for consumers to limit trans fat in their diets. The report is based on part of the chapter, Dietary Fats: Total Fat and Fatty Acids, contained in the forthcoming IOM report, Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. - FDA's next steps and the Letter Report are available at: http://www.cfsan.fda.gov/~dms/labtrans.html 10. Guidance on How to Understand and Use the Nutrition Facts Panel on Food Labels - In Spanish This award-winning guidance is now available in Spanish as well as English. It emphasizes quick, reliable ways consumers can "use" food labels to make informed food choices. The colored educational graphic, including the Quick Guide To the Percent Daily Value and the easy-to-read graphics and text, helps consumers understand and use the nutrition facts label in the context of a healthy diet. DIETARY SUPPLEMENTS 11. Nicotine Water - FDA Press Release On July 12, 2002, The Food and Drug Administration (FDA) issued a response to a Citizen's Petition regarding the regulation of a product called "Nicotine Water." Based on several factors, including statements contained in the labeling of the product and other evidence of intended use, FDA determined that this product should be regarded as an unapproved new drug and cannot be legally marketed as a dietary supplement. See: http://www.fda.gov/bbs/topics/NEWS/2002/NEW00818.html . 12. NAS Proposed Report on Framework for Evaluating Safety of Dietary Supplements, 2002 The Food and Nutrition Board, NAS, IOM, has issued for public comment a "Proposed Framework for Evaluating the Safety of Dietary Supplements." Two final reports will be issued: 1. the Proposed Framework, expected 12 months after the project start, and 2. prototype monographs expected at the end of the project in about 24 months. To see the Proposed Framework, including the Executive Summary, go to: http://www.nap.edu/catalog/10456.html . 13. NAS Report on Evolution of Evidence for Selected Nutrient & Disease Relationships, June 10, 2002 The Food and Nutrition Board, NAS, IOM, issued a report, "Evolution of Evidence for Selected Nutrient and Disease Relationships" that addresses questions such as: can the scientific method be accelerated to yield confirmed findings for public policy; can patterns of research evidence be observed in identified nutrient-disease relationships earlier in the research process and benefit the public by enabling earlier application of such knowledge; can unpredictable elements be identified to provide caution to consumers. See http://www.nap.edu/catalog/10379.html to access the report on the National Academy Press site. 14. Dietary Supplement Strategic Plan Cost Out (Report to Congress) On May 29, 2002, FDA submitted a report to Congress on the estimated costs for its 10 year Dietary Supplement Strategic Plan. See: http://www.cfsan.fda.gov/~dms/ds-stra2.html . 15. CFSAN Adverse Event Reporting System On August 29, 2002, FDA announced that it is developing a new, comprehensive system for tracking and analyzing adverse event reports, including those associated with the use of dietary supplements. Also on August 29, 2002, FDA announced that it removed the Web page for the Special Nutritionals Adverse Event Monitoring System, which was outdated and not user-friendly. - Letter to stakeholders: http://www.cfsan.fda.gov/~dms/caersltr.html - Announcement to remove SN/AEMS: http://www.cfsan.fda.gov/~dms/aems.html GENERAL AND CONSUMER INFORMATION 16. Bioterrorism Preparedness and Response Act of 2002 For information related to FDA on: the provisions related to protecting the food supply, Title III, that requires FDA to issue expedited regulations; how DHHS and FDA will proceed; and the solicitation of comments on areas of concern and suggestions for how best to communicate those concerns, see FDA's Dear Colleague letter at: http://www.cfsan.fda.gov/~dms/sec-ltr.html. You may view the full text of the Act at: , and search for Bill number H.R. 3448. 17. Farm Security and Rural Investment Act of 2002 (Go to: http://thomas.loc.gov and search for Bill number H.R. 2646) For information related to FDA see the following sections: - Ginseng labeling, section 10806. - Pasteurization, that discusses labeling of pasteurized foods, section 10808. - Labeling of irradiated foods, section 10809. 18. Other FDA Food Advisory Meetings (from July to August, 2002) - Methyl Mercury - FDA held a public advisory committee meeting on July 23-25, 2002 to discuss FDA's consumer advisory regarding methyl mercury and seafood. See FR Notice, transcript, briefing materials, etc. at: http://www.fda.gov/ohrms/dockets/ac/cfsan02.htm . - Biotech - FDA held a public advisory committee meeting on August 13-14, 2002, to discuss science-based approaches to assess whether new proteins in bioengineered foods are likely to cause allergic reactions in some individuals in order to assist FDA in developing a draft guidance for industry. See FR Notice, transcript, briefing materials, etc. at: http://www.fda.gov/ohrms/dockets/ac/cfsan02.htm . OTHER ANNOUNCEMENTS 19. FTC's New Health Fraud Web Site - Operation Cure.All FDA, the Federal Trade Commission, and other law enforcement agencies joined forces in "Operation Cure.All" to stop Internet scams for supplements and other products that purport to cure cancer, HIV/AIDS and countless other life-thretening diseases. Following this effort, FTC established the Operation Cure.All web site - see http://www.ftc.gov/cureall. This web site offers information for consumers on how to recognize health fraud, guidance for businesses on how to market health products and services truthfully, and information about the FTC's initiatives. NOTE: * TO GET PAST ISSUES OF FDA-DSFL, go to Electronic Information Networks: http://www.foodsafety.gov/~dms/infonet.html . ******************************** FDA Web Page Addresses: * Dietary Supplements http://www.cfsan.fda.gov/~dms/supplmnt.html * Food Labeling and Nutrition http://www.cfsan.fda.gov/label.html * Center for Food Safety and Applied Nutrition http://www.cfsan.fda.gov/list.html Other Federal Government Links: * Federal Trade Commission http://www.ftc.gov/ * Office of Dietary Supplements, NIH http://dietary-supplements.info.nih.gov/ * US Department of Agriculture - Food Safety and Inspection Service http://www.fsis.usda.gov/index.htm - Food and Nutrition Service http://www.fns.usda.gov/fns/ Non-Federal Government Links: * National Academy of Sciences http://www.iom.edu/iom/iomhome.nsf/Pages/FNB+Reports PLEASE FEEL FREE TO FORWARD THIS ISSUE TO COLLEAGUES AND FRIENDS. Please forward this issue to colleagues and friends and tell them how to subscribe. 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