FDA-DSFL Newsletter May 2005 (#9)

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Subject: FDA-DSFL Newsletter May 2005 (#9)

* * Dietary Supplement/Food Labeling Electronic Newsletter * *

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* * * * FDA-DSFL@... * * *

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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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May 2005 (#9)

IN THIS ISSUE:

* 1. New downloadable brochure. " What Dietary Supplements Are You

Taking: Does Your Health Care Provider Know? - It Matters and Here's

Why "

* 2. FDA Asking for Public Comment on Food Label Changes, April 1,

2005

* a. Advance Notice of Proposed Rulemaking - Food Labeling:

Prominence of Calories, April 4, 2005

* b. Advance Notice of Proposed Rulemaking - Food Labeling:

Serving Sizes of Products That Can Reasonably Be Consumed At One

Eating Occasion; Updating of Reference Amounts Customarily Consumed;

Approaches for Recommending Smaller Portion Sizes, April 4, 2005

* 3. 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; Reopening of

the Comment Period, April 4, 2005.

* 4. FDA Proposes In-Lid Labeling for Eggs

* 5. Guidance for Industry - A Dietary Supplement Labeling Guide

* 6. Responses to Questions about Codex and Dietary Supplements

* 7. Transcript for Public Meeting: New Dietary Ingredients Meeting

on November 15, 2004.

* 8. Joint FDA-NCI-ODS Workshop on Use and Misuse of Biomarkers as

Indicators of Cancer Risk Reduction Following Dietary Manipulation,

July 12 & 13, 2005.

* 9. The Food Advisory Committee will be meeting, July 13-15, 2005,

in Greenbelt, MD, to evaluate the CFSAN Threshold Working Group

draft report " Approaches to Establish Thresholds for Major Food

Allergens and Gluten. "

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RESOURCES FOR EDUCATORS AND CONSUMERS

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1. " What Dietary Supplements Are You Taking: Does Your Health Care

Provider Know? - It Matters and Here's Why " is the name of a new

educational brochure targeted towards consumers who are taking or

considering taking dietary supplements.

The purpose of the brochure is to encourage consumers to talk with

their doctor or other health care provider to sort reliable from

questionable information about dietary supplements. Dietary

supplement users are urged, among other things, to: remember safety

first; learn to spot false claims; consider that the term " natural "

doesn't always mean safe; and check with their health care providers

before taking a supplement, especially when combining or

substituting them with other foods or medicine. Included in this

brochure are three assessment tools that allow users to list the

supplements, over-the-counter, and prescription drugs they are

taking --important information that should be discussed with their

health care team. This brochure is now posted on CFSAN's Website.

To view " What Dietary Supplements Are You Taking: Does Your Health

Care Provider Know? - It Matters and Here's Why " see:

http://www.cfsan.fda.gov/~dms/ds-take.html

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FOOD LABELING AND NUTRITION

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2. FDA Asking for Public Comment on Food Label Changes, April 1,

2005.

The Food and Drug Administration (FDA) is asking for public comment

on two Advance Notice of Proposed Rulemaking (ANPRM).

a. Food Labeling: Prominence of Calories, April 4, 2005.

The Food and Drug Administration (FDA) issued an advance notice of

proposed rulemaking (ANPRM) to request comment on whether to amend

certain provisions of the agency's nutrition labeling regulations to

give more prominence to calories on food labels. FDA issued this

ANPRM in response to recommendations of the Obesity Working Group

(OWG), which was created by the Commissioner of Food and Drugs (the

Commissioner) to develop an action plan to address the Nation's

obesity problem. Comments on whether and, if so, how to give greater

emphasis to calories on the nutrition label will inform any FDA

rulemaking that may result from this ANPRM.

Federal Register Notice: http://www.cfsan.fda.gov/~lrd/fr05404b.html

b. Food Labeling: Serving Sizes of Products That Can Reasonably Be

Consumed At One Eating Occasion; Updating of Reference Amounts

Customarily Consumed; Approaches for Recommending Smaller Portion

Sizes, April 4, 2005.

The Food and Drug Administration (FDA) issued an advance notice of

proposed rulemaking (ANPRM) to request comment on whether to amend

certain provisions of the agency's nutrition labeling regulations

concerning serving size. FDA is issued this ANPRM in response to

recommendations of the Obesity Working Group (OWG), which was

created by the Commissioner of FDA (the Commissioner) to develop an

action plan to address the Nation's obesity problem. Comments on

whether, and if so, how to amend the agency's serving size

regulations will inform any FDA rulemaking that may result from this

ANPRM.

Federal Register Notice: http://www.cfsan.fda.gov/~lrd/fr05404c.html

3. 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; Reopening of

the Comment Period April 4, 2005.

FDA reopened the comment period to allow all interested parties the

opportunity to review its tentative nutrition labeling values based

upon data FDA received within and after the comment period, and to

comment on the additional nutrient data for some of the 20 most

frequently consumed raw fruits, vegetables, and fish. FDA will

evaluate any new data submissions during this reopened comment

period and will consider use of those data in a final rule.

Federal Register Notice: http://www.cfsan.fda.gov/~lrd/fr05404a.html

4. On May 5, 2005, the Food and Drug Administration (FDA) proposed

to amend the egg labeling regulations after the egg industry asked

FDA to allow safe handling statements to be placed on the inside lid

of egg cartons.

FDA proposes to amend its food labeling regulations to permit the

egg industry to place the safe handling statement for shell eggs on

the inside lid of egg cartons if the statement " Keep Refrigerated "

appears on the top or side panel. This proposed rule applies to

shell eggs that have not been treated to destroy Salmonella bacteria

that can cause food-borne illness.

FDA is providing a 75-day comment period on the proposed rule.

Interested persons can submit comments, electronically to

http://www.fda.gov/dockets/ecomments or in writing to the Division

of Dockets Management Branch (HFA-305), 5630 Fishers Lane, room

1061, Rockville, MD 20852.

Press release: http://www.cfsan.fda.gov/~lrd/tpeggs.html

Proposed rule: http://www.cfsan.fda.gov/~lrd/fr050505.html

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DIETARY SUPPLEMENTS

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5. FDA posted A Dietary Supplement Labeling Guide in April 2005.

The purpose of the guide is to help assure that dietary supplements

sold in the United States are properly labeled. This guide applies

to dietary supplements produced domestically as well as those

produced in foreign countries. Under FDA regulations, label approval

is not required to import or distribute a dietary supplement.

The Dietary Supplement Labeling Guide can be found at:

http://www.cfsan.fda.gov/~dms/dslg-toc.html

6. Responses to Questions about Codex and Dietary Supplements.

In March 2005, FDA posted responses to questions about Codex and

dietary supplements. FDA explained why the adoption of Draft

Guidelines for Vitamin and Mineral Food Supplements by Codex will

not restrict U.S. consumers' access to vitamin and mineral

supplements or impose any restrictions that go beyond those

established by U.S. law.

Questions and Answers about Codex and Dietary Supplements:

http://www.cfsan.fda.gov/~dms/dscodex.html

7. Transcript for Public Meeting: New Dietary Ingredients Meeting

held on November 15, 2004.

FDA conducted a meeting and solicited comments on FDA's pre-market

notification program for new dietary ingredients (NDIs). The public

meeting was held on November 15, 2004 at FDA's Center for Food

Safety and Applied Nutrition, Harvey W. Wiley Building, 5100 Paint

Branch Pkwy., College Park, MD 20740. FDA solicited comments from

industry, consumers, and other interested members of the public

concerning the content and format requirements for NDI notifications

made under the Federal Food, Drug, and Cosmetic Act. FDA held this

meeting to give the public an opportunity to provide information and

views on the topics outlined in the Federal Register. The agency

intends to consider all comments received during the meeting and

made to the docket in determining whether any future action is

necessary or appropriate.

Meeting Transcript:

http://www.fda.gov/ohrms/dockets/dockets/04n0454/04n-0454-tr00001.htm

Federal Register Notice: Dietary Supplements; Premarket

Notification for New Dietary Ingredient Notifications; Public

Meeting: http://www.cfsan.fda.gov/~lrd/fr041020.html

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PUBLIC MEETINGS & HEARINGS

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8. Joint FDA-NCI-ODS Workshop on Use and Misuse of Biomarkers as

Indicators of Cancer Risk Reduction Following Dietary Manipulation,

July 12 & 13, 2005.

The Food and Drug Administration, National Cancer Institute, and the

Office of Dietary Supplements are sponsoring a 2-day conference.

The purpose of the Workshop is to review and discuss the most up-to-

date scientific information of possible biomarkers related to cancer

risk that may be influenced by diet.

Meeting Notification: http://www.scgcorp.com/biomarkers2005/

9. The Food Advisory Committee will be meeting July 13 -15, 2005, in

Greenbelt, MD, to evaluate the CFSAN Threshold Working Group draft

report " Approaches to Establish Thresholds for Major Food Allergens

and Gluten. "

Meeting Notification:

www.fda.gov/oc/advisory/accalendar/2005/cfsan10564ddd0713141505.html

NOTE:

* TO GET PAST ISSUES OF FDA-DSFL, go to Electronic Information

Networks: http://www.cfsan.fda.gov/~dms/infonet.html.

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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

* Qualified Health Claims http://www.cfsan.fda.gov/~dms/lab-qhc.html

* Center for Food Safety and Applied Nutrition

http://www.cfsan.fda.gov/list.html

Other Federal Government