This comes out monthly (?) and it often has some interesting info in it.
* * 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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DIETARY SUPPLEMENT & FOOD LABELING ELECTRONIC NEWSLETTER
October 2003 (#6)
Our apologies for the issue that went out inadvertantly, in an incorrect
format due to a technical glitch.
IN THIS ISSUE
RECENT ANNOUNCEMENTS
1. FDA Public Meeting on Obesity - October 23, 2003
2. Better Health Information for Better Nutrition Task Force
3. Qualified Health Claims
4. Redesign of Label Claims Web Pages for Conventional Foods and
Dietary Supplements
FOOD LABELING AND NUTRITION
5. Trans Fat Labeling
6. Guidance on How to Use the Nutrition Facts Label - Revised
7. Petition to Revoke Standards for Lowfat Yogurt and Nonfat Yogurt and
to Amend Standards for Yogurt and Cultured Milk
8. Final Rule - Food Labeling: Health Claims; D-tagatose and Dental
Caries
9. Final Rule - Food Labeling: Health Claim; Oatrim and Coronary Heart
Disease
10. Changes to Olestra-containing Product Labeling
DIETARY SUPPLEMENTS
11. Proposed and Direct Final Rule - Food Labeling: Ingredient Labeling
of Dietary Supplements That Contain Botanicals
12. Phosphatidylserine Qualified Health Claim
============================== ============================== ============
RECENT ANNOUNCEMENTS
1. FDA Public Meeting on Obesity - October 23, 2003
FDA's Public Meeting on Obesity meeting will be held on Thursday,
October 23, 2003 from 9:00 a.m. to 5:00 p.m. at the Warren Grant
Magnuson Clinical Center, Masur Auditorium, (Bldg. 10) National
Institute of Health, 9000 Wisconsin Avenue, Bethesda, Maryland. The
purpose of the meeting is to discuss FDA's role and responsibility in
addressing the major public health problem of obesity, promoting better
consumer dietary and lifestyle choices that have the potential to
improve the health and well-being of Americans, and how best to build a
framework for messages to consumers about reducing obesity and achieving
better nutrition.
If you wish to participate in this meeting, you can register online
at:
http://www.fda.gov/oc/opacom/hottopics/obesity.html
For more information on the meeting:
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-25645.htm
2. Better Health Information for Better Nutrition Task Force
FDA's Task Force on Consumer Health Information for Better Nutrition
released a report on July 10, 2003, about qualified health claims in the
labeling of conventional foods and dietary supplements. The agency
seeks to help consumers improve their understanding of how their dietary
choices influence their health, to promote competition among product
developers to find better ways to help improve health through better
diets, and ultimately, to prevent serious life-threatening diseases
through better dietary choices by Americans. The Task Force report
details the following areas: possible regulatory frameworks for
qualified health claims, interim evidence-based ranking system for
scientific data, resources for review of scientific data, consumer
studies research agenda, and interim procedures for qualified health
claims.
Documents related to the Task Force's report:
Press Release -
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00923.html
Full Report -
http://www.cfsan.fda.gov/~dms/nuttftoc.html
Backgrounder -
http://www.cfsan.fda.gov/~dms/nuttfbg.html
Summary of Recent Dietary Supplement Enforcement Actions
http://www.fda.gov/oc/whitepapers/chbn_summary.html
Guidance Document: Interim Procedures for Qualified Health Claims in
the Labeling of Conventional Human Food and Human Dietary Supplements
http://www.cfsan.fda.gov/~dms/hclmgui3.html
Guidance Document: Interim Evidence-based Ranking System for Scientific
Data
http://www.cfsan.fda.gov/~dms/hclmgui4.html
Notice of Availability of Guidance Document
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-17702.htm
3. Qualified Health Claims
FDA's 2003 Consumer Health Information for Better Nutrition Initiative
provides for the use of qualified health claims when there is emerging
evidence for a relationship between a food, food component, or dietary
supplement and a reduced risk of a disease or health-related condition.
In this case, the evidence is not well enough established to meet the
significant scientific agreement standard required for FDA to issue an
authorizing regulation. Qualifying language is included as part of the
claim to indicate that the evidence supporting the claim is limited.
Both conventional foods and dietary supplements may use qualified health
claims. FDA uses its enforcement discretion for qualified health claims
after evaluating and ranking the quality and strength of the totality of
the scientific evidence. Also, FDA now has a process for the public to
view qualified health claim petitions, comment on these petitions, and
submit comments on these petitions through its web site.
Qualified Health Claims Questions and Answers- New
http://www.cfsan.fda.gov/~dms/labqhcqa.html
Summary of Qualified Health Claims Permitted - New
http://www.cfsan.fda.gov/~dms/qhc-sum.html
Qualified Health Claim Petitions Open for Comment
http://www.cfsan.fda.gov/~dms/lab-qhc.html#petition
4. Redesign of Label Claims Web Pages for Conventional Foods and
Dietary Supplements
FDA's Center for Food Safety and Applied Nutrition (CFSAN) is in the
process of reorganizing its web pages concerning label claims. The new
web pages will combine information in all categories of label claims for
both conventional foods and dietary supplements. This change should
make it easier to find information about regulatory definitions and
various types of claims for use on the label. It will also provide
access to qualified health claim petitions. This section, "Label
Claims," will be linked from the "Food Labeling and Nutrition" and
"Dietary Supplement" Web pages. Please continue to visit this site for
new and updated information.
New Label Claims Page:
http://www.cfsan.fda.gov/~dms/lab-hlth.html
Brief Summary of All Claims that Can Be Made for Conventional Foods
and Dietary Supplements
http://www.cfsan.fda.gov/~dms/hclaims.html
5. Trans Fat Labeling
FDA has amended its regulations on nutrition labeling to require that
trans fatty acids be declared in the nutrition label of conventional
foods and dietary supplements on a separate line immediately under the
line for the declaration of saturated fatty acids. This rule is
intended to provide information to assist consumers to make food choices
that are low in saturated fat, trans fat and cholesterol, all of which
raise LDL ("bad") cholesterol that is associated with an increased risk
of coronary heart disease.
In addition, FDA has issued an advance notice of proposed rulemaking
(ANPRM) to solicit information and data that could be used to establish
new nutrient content claims about trans fat and to establish qualifying
criteria for trans fat in existing claims that have a limit on saturated
fat and health claims that contain a message about cholesterol-raising
lipids. The ANPRM also requests comment on whether FDA should consider
statements as footnotes in the Nutrition Facts panel or in conjunction
with claims to enhance consumers' understanding about how to use the
information to make heart-healthy food choices.
For more information, please see the following:
Press Release-Department of Health and Human Services Press Release:
"HHS to Require Food Labels to Include Trans Fat Contents - Improved
Labels Will Help Consumers Choose Heart-Healthy Foods", July 9, 2003
(
http://www.hhs.gov/news/press/2003pres/20030709.html)
FDA Backgrounder: FDA Acts to Provide Better Information to Consumers
on Trans Fats, July 9, 2003
(
http://www.fda.gov/oc/initiatives/tr...kgrounder.html)
Questions and Answers About Trans Fat Nutrition Labeling, July 9, 2003
(
http://www.cfsan.fda.gov/~dms/qatrans2.html)
Final Rule-Trans Fatty Acids in Nutrition Labeling, Nutrient Content
Claims, and Health Claims, July 11, 2003
(
http://www.fda.gov/OHRMS/DOCKETS/98f...36-nfr0001.pdf)
Examples of Revised Nutrition Facts Panels Listing Trans Fat, July 9,
2003 (
http://www.cfsan.fda.gov/~dms/labtr.html)
Trans Fatty Acid Small Entity Compliance Guide (SECG), August 20, 2003
http://www.cfsan.fda.gov/~dms/transgui.html
Advance Notice of Proposed Rulemaking-Trans Fatty Acids in Nutrition
Labeling: Consumer Research to Consider Nutrient Content and Health
Claims and Possible Footnote or Disclosure Statements, Federal Register,
July 11, 2003
(
http://www.fda.gov/OHRMS/DOCKETS/98f...76-nap0001.pdf )
FDA Consumer article, "Revealing Trans Fats," September/October 2003
(
http://www.fda.gov/fdac/features/2003/503_fats.html)
Coming Soon - Web-based consumer education on trans fat labeling,
check our Web sites often for this article and other news.
FOOD LABELING AND NUTRITION
6. Guidance on How to Use the Nutrition Facts Label - Revised
FDA has revised "Guidance on How to Understand and Use the Nutrition
Facts Panel on Food Labels" to include information on trans fatty acids
and placement of trans fat on the Facts Panel. This guidance provides
consumers with information on how to use the nutrition label to make
informed food choices that contribute to a healthy diet. This guidance
in available in English and Spanish, please try the links below.
English -
http://www.cfsan.fda.gov/~dms/foodlab.html
Spanish -
http://www.cfsan.fda.gov/~dms/sfoodlab.html
7. Petition to Revoke Standards for Lowfat Yogurt and Nonfat Yogurt and
to Amend Standards
for Yogurt and Cultured Milk
FDA announced in an advance notice of proposed rulemaking that a
petition has been filed requesting that the agency revoke the standards
of identity for lowfat yogurt and nonfat yogurt, amend the standard of
identity for yogurt, and amend the standard of identity for cultured
milk. FDA is requesting comment on whether the actions requested by the
petition would promote honesty and fair dealing in the interest of
consumers.
The petition is available at
http://www.fda.gov/ohrms/dockets/98f...85-cp00001.pdf
Submit electronic comments to
http://www.fda.gov/dockets/ecomments.
8. Final Rule - Food Labeling: Health Claims; D-tagatose and Dental
Caries
FDA adopted as a final rule, without change, the provisions of the
December 2, 2002 interim final rule that amended the regulation
authorizing a health claim on sugar alcohols and dental caries, i.e.,
tooth decay, to include sugar D-tagatose as a substance eligible for the
dental caries health claim. The final rule published on July 3, 2003.
9. Final Rule - Food Labeling: Health Claims; Oatrim and Coronary Heart
Disease
On July 28th, FDA adopted as a final rule, without change, the
provisions of an October 2002 interim final rule that amended the
regulation authorizing a health claim relating oat soluble fiber to
coronary heart disease risk. This amendment adds oatrim, the soluble
fraction of amylase-hydrolyzed oat bran or whole oat flour, as an
additional source of oat soluble fiber eligible for the health claim
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-19027.pdf.
10. Changes to Olestra-containing Product Labeling
On August 5 FDA issued a final rule to amend the labeling requirements
for olestra-containing food products. Specifically, the rule will amend
the food additive regulations by removing the requirement for the
special label statement on savory snack products containing olestra.
The label statement alerted consumers to the potential for
gastrointestinal effects and that olestra may inhibit some vitamin
absorption. In the same issue of the Federal Register, FDA is issuing a
companion document responding to objections filed by the Center for
Science in the Public Interest. The agency's action is in response to a
petition filed by Procter and Gamble seeking changes in the labeling
requirements.
DIETARY SUPPLEMENTS
11. Proposed and Direct Final Rule - Food Labeling: Ingredient
Labeling of Dietary Supplements That Contain Botanicals
On August 28, 2003, FDA published a proposed and companion direct final
rule on ingredient labeling of dietary supplements that contain
botanicals. FDA is proposing to amend its regulation on declaring
botanical ingredients in dietary supplements to incorporate by reference
the 2000 editions of Herbs of Commerce and the International Code of
Botanical Nomenclature (Saint Louis Code).
Direct Final Rule (
http://www.regulations.gov/fredpdfs/03-21980.pdf)
Proposed Rule (
http://www.regulations.gov/fredpdfs/03-21981.pdf)
12. Phosphatidylserine Qualified Health Claim
FDA formalized, as of May 13, an agreement on health claims relating the
consumption of phosphatidylserine as a dietary supplement and risk of
dementia or cognitive dysfunction in the elderly. FDA will consider
exercising enforcement discretion to permit the use of the claim
statement " Consumption of phosphatidylserine may reduce the risk of
dementia cognitive dysfunction in the elderly. Very limited and
preliminary scientific research suggests that phosphatidylserine may
reduce the risk of dementiaٍcognitive dysfunction in the elderly. FDA
concludes that there is little scientific evidence supporting this
claim." The initial agreement permitting this claim was signed February
24, 2003
Final Decision May 13, 2003:
http://www.cfsan.fda.gov/~dms/ds-ltr36.html
Initial Agreement February 24, 2003:
(
http://www.cfsan.fda.gov/~dms/ds-ltr33.html).
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
* Infant Formula
http://www.cfsan.fda.gov/~dms/inf-toc.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.
NOTE:
* TO GET PAST ISSUES OF FDA-DSFL, go to Electronic Information Networks:
http://www.cfsan.fda.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
* Infant Formula
http://www.cfsan.fda.gov/~dms/inf-toc.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
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