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Date:         Fri, 10 Jan 2003 18:56:59 EST
Reply-To:     FDA-DSFL@VM.CFSAN.FDA.GOV
Sender:       FDA-DSFL Electronic Newsletter <FDA-DSFL@VM.CFSAN.FDA.GOV>
From:         Dietary Supplement/Food Labeling Electronic Newsletter
              <DSFL@VM.CFSAN.FDA.GOV>
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.
 
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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: <http://thomas.loc.gov>, 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.
 
 
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