FDA DIETARY SUPPLEMENT & FOOD LABELING ELECTRONIC NEWSLETTER

[Q.]

This just came in and I really haven't had a chance to look through it but I thought I'd share it anyway.

DIETARY SUPPLEMENT & FOOD LABELING ELECTRONIC NEWSLETTER

April 2004 (#7)

IN THIS ISSUE

HIGHLIGHTS
1. Food and Drug Administration (FDA) Obesity Report: "Calories Count"
2. Department of Health and Human Services (DHHS) Cracks Down on
Steroid-Like 'Andro'
3. FDA Issues Regulation Prohibiting Sale of Dietary Supplements
Containing Ephedrine Alkaloids and Reiterates Its Advice That Consumers
Stop Using These Products
4. Leadership Transitions: FDA and Center for Food Safety and Applied
Nutrition (CFSAN)
5. Trans Fatty Acids in Nutrition Labeling; Consumer Research to
Consider Nutrient Content and Health Claims and Possible Footnote or
Disclosure Statements; Reopening of the Comment Period (SUBMIT COMMENTS
BY APRIL 15, 2004)

FOOD LABELING AND NUTRITION
6. "Trans Fat Now Listed with Saturated Fat and Cholesterol on the
Nutrition Facts Label"
7. Qualified Health Claim for Walnuts and the Reduced Risk of Coronary
Heart Disease
8. Health Claim Notification for Whole Grain Foods with Moderate Fat
Content
9. Advance Notice of Proposed Rulemaking (ANPRM): Ways to Manage
Qualified Health Claims

DIETARY SUPPLEMENTS
10. "Tips for Older Dietary Supplement Users"
11. Court Upholds FDA s Denial of Saw Palmetto Health Claim

INFANT FORMULA
12. National Academies of Science Report - "Infant Formula: Evaluating
the Safety of New Ingredients"
13. FDA Warns Consumers Not to Feed Infants "Better than Formula Ultra
Infant Immune Booster 117"
14. FDA Statement on Reported Health Problems With Remedia-Brand Kosher
Soy-Based Infant Formula

============================== ============================== ============

HIGHLIGHTS

1. Food and Drug Administration (FDA) Obesity Report: "Calories Count"
(3/04)

DHHS Secretary Tommy G. Thompson released a new FDA report outlining the
agency's strategy for combating the epidemic of obesity that threatens
the health of millions of Americans with a focus on the message,
"Calories Count."

The report by FDA's Obesity Working Group includes recommendations to
strengthen food labeling, to educate consumers about maintaining a
healthy diet and weight, and to encourage restaurants to provide calorie
and nutrition information. It also recommends increasing enforcement to
ensure food labels accurately portray serving size, revising and
reissuing guidance on developing obesity drugs, strengthening
coordinated scientific research to reduce obesity and to develop foods
that are healthier and lower in calories.

* FDA's Obesity Report and related information:
http://www.cfsan.fda.gov/~dms/nutrcal.html


2. DHHS Cracks Down on Steroid-Like 'Andro' (3/04)

DHHS Secretary Tommy G. Thompson announced a crackdown on companies that
manufacture, market and distribute products containing androstenedione,
or andro, which acts like a steroid once it is metabolized by the body
and, therefore, can pose similar kinds of health risks as steroids.
These products are generally advertised as dietary supplements that
enhance athletic performance based on their claimed anabolic and
androgenic properties to stimulate muscle growth and increase production
of testosterone.

* Press Release: http://www.cfsan.fda.gov/~lrd/hhandro.html
* FDA Warning Letters: http://www.cfsan.fda.gov/~dms/andrlist.html.
* Questions and Answers: http://www.cfsan.fda.gov/~dms/androqa.html
* White Paper: http://www.cfsan.fda.gov/~lrd/wpandro.html


3. FDA Issues Regulation Prohibiting Sale of Dietary Supplements
Containing Ephedrine Alkaloids and Reiterates Its Advice That Consumers
Stop Using These Products (2/04)

FDA issued a final rule, on February 6, 2004, prohibiting the sale of
dietary supplements containing ephedrine alkaloids (ephedra) because
such supplements present an unreasonable risk of illness or injury.

FDA has also followed up with seizures and injunctions and joint
enforcement actions with the Federal Trade Commission and the Department
of Justice. (More detail on these actions can be found at
http://www.fda.gov/ola/2003/dietarys...nts1028.html.) As a result,
most ephedra-containing dietary supplements advertised for enhanced
sport performance have been removed from the market.

*Press Release: http://www.cfsan.fda.gov/~lrd/fpephed6.html
*Final Rule: http://www.cfsan.fda.gov/~lrd/fr040211.html
*Press Release: http://www.cfsan.fda.gov/~lrd/hhsephe2.html
* Seizure of three ephedra-containing dietary supplement products:
http://www.cfsan.fda.gov/~lrd/fpephed5.html.


4. Leadership Transitions: FDA and Center for Food Safety and Applied
Nutrition (CFSAN) (11/03-3/04)

On February 20, 2004, President George W. Bush announced his intention
to nominate Mark McClellan, Commissioner of the FDA, to be the
Administrator of the Centers for Medicare and Medicaid Services at DHHS.
On March 12, 2004, Dr. McClellan was confirmed for this position by
Congress. Dr. Lester Crawford will serve as Acting Commissioner of the
FDA, a position he held prior to the appointment of Dr. McClellan as
Commissioner.

*White House Press Release:
http://www.cfsan.fda.gov/~lrd/whp0402.html
*DHHS Press Release: http://hhs.gov/news/press/2004pres/20040312c.html

****************************** ****************************** ************

On December 1, 2003, FDA Commissioner, Mark B. McClellan, M.D., Ph.D.
announced the retirement of Joseph A. Levitt, Esq., as the director of
the Center for Food Safety and Applied Nutrition (CFSAN) and the
appointment of Dr. Robert E. Brackett as his successor, effective
January 1, 2004. Dr. Brackett has been CFSAN's Director of Food Safety
and Security with an outstanding academic career in food microbiology.
He has been crucial to strengthening the center's scientific expertise
in food safety, and has played a major leadership role in its food
counter-terrorism program.

* Announcement: http://www.cfsan.fda.gov/~lrd/fpmgmt.html

****************************** ****************************** ************

On November 12, 2003, FDA announced that Dr. Christine Taylor, the
Director of the Office of Nutritional Products, Labeling, and Dietary
Supplements (ONPLDS) in FDA s CFSAN, has accepted a two-year assignment
to head a special project on nutrition issues for the World Health
Organization in Geneva, Switzerland. Laura M. Tarantino, Ph.D. is now
serving as the Acting Director, ONPLDS while the search for a permanent
director is being conducted. Before this, Dr. Tarantino served as the
Center's Acting Director of the Office of Food Additive Safety.

*Press Release: http://www.cfsan.fda.gov/~lrd/fptaylor.html

****************************** ****************************** ************

5. Trans Fatty Acids in Nutrition Labeling; Consumer Research to
Consider Nutrient Content and Health Claims and Possible Footnote or
Disclosure Statements; REOPENING OF THE COMMENT PERIOD (3/04)

FDA has reopened the comment period for an advanced notice of proposed
rule making (ANPRM) published in the Federal Register of July 11, 2003
(68 FR 41507), FDA has reopened the comment period to receive comments
that consider the information in the Institute of Medicine/National
Academy of Sciences' (IOM/NAS) report specific to this ANPRM and trans
fat labeling. Information and data obtained from comments to this ANPRM
may be used to help draft a proposed rule on trans fat. Submit written
or electronic comments by April 15, 2004.

Submit written comments to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. Submit electronic comments to
http://www.fda.gov/dockets/ecomments.

*ANPRM: http://www.cfsan.fda.gov/~lrd/fr040301.html


FOOD LABELING AND NUTRITION

6. "Trans Fat Now Listed with Saturated Fat and Cholesterol on the
Nutrition Facts Label" - Web Article (3/04)

FDA posted a new consumer-friendly article on its Web site to help
consumers gain a better understanding of trans fat and how it will
appear on Nutrition Facts labels. This Web article has features that
engage consumers through enhanced graphics and interactive learning
activities. Called "Trans Fat Now Listed with Saturated Fat and
Cholesterol on the Nutrition Facts Label," the article explains which
foods often contain trans fat; how to choose foods with lower combined
amounts of saturated and trans fats and lower amounts of cholesterol for
heart-healthy choices. It also contains practical tips for daily use,
plus a pop quiz and label comparisons of actual products to help
consumers use the NFP to make sound food choices.

*Web Article: http://www.cfsan.fda.gov/~dms/transfat.html


7. Qualified Health Claim for Walnuts and the Reduced Risk of Coronary
Heart Disease (3/04)

FDA announced that a qualified health claim will soon appear on product
labels for walnuts and the reduced risk of coronary heart disease. This
qualified health claim is part of the FDA s initiative to provide
Americans with better information to help them make healthier dietary
choices. Thus, FDA will consider exercising enforcement discretion for
a qualified claim as presented below:
Supportive but not conclusive research shows that eating 1.5 ounces per
day of walnuts, as part of a low saturated fat and low cholesterol diet
and not resulting in increased caloric intake, may reduce the risk of
coronary heart disease. See nutrition information for fat [and calorie]
content.

* Press Release: http://www.cfsan.fda.gov/~lrd/fpnuts.html
* Letter of Enforcement Discretion:
http://www.cfsan.fda.gov/~dms/qhcnuts3.html


8. Health Claim Notification for Whole Grain Foods with Moderate Fat
Content (12/03)

On August 8, 2003, Kraft Foods submitted a notification (the "Kraft
notification") containing the following proposed claim: "Diets rich in
whole grain foods and other plant foods, and low in saturated fat and
cholesterol, may help reduce the risk of heart disease." The Kraft
notification cites statements from the National Academy of Sciences'
report, "Diet and Health: Implications for Reducing Chronic Disease
Risk," as authoritative statements for the claim. Manufacturers may now
use the specified claim on the label and in labeling of any food product
that meets the eligibility criteria described in the Kraft notification,
unless or until FDA or a court acts to prohibit the claim.

* Kraft Notification - http://www.cfsan.fda.gov/~dms/flgrain2.html


9. Advance Notice of Proposed Rulemaking (ANPRM): Ways to Manage
Qualified Health Claims (11/03)

FDA issued an ANPRM that requested public comment on several topics
involving qualified health claims and other potential initiatives to
help consumers choose a healthy diet. Qualified health claims are based
on the totality of publicly available evidence but the scientific
support does not have to be as strong as that for Significant Scientific
Agreement. Among other issues, the agency is requesting comments on
alternatives for regulating qualified health claims and on the
appropriateness and nature of dietary guidance statements in food
labeling.

*Talk Paper: http://www.cfsan.fda.gov/~lrd/tpqhc.html
*Federal Register Notice:
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-29448.htm


DIETARY SUPPLEMENTS

10. "Tips for Older Dietary Supplement Users" - Web Article (12/03)

This Web article, Tips for Older Dietary Supplement Users, offers
practical tips and sound advice for older consumers who are taking or
are considering taking dietary supplements. This advice includes:
why it is important to talk with a health care provider before using
dietary supplements, how to spot false claims, and what to consider
before buying these products. Although Tips is targeted for the older
user, the messages and information apply to all users as well. Also
included in this article is a chart which allows 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.

*Web Article: http://www.cfsan.fda.gov/~dms/ds-savv2.html


11. Court Upholds FDA s Denial of Saw Palmetto Health Claim (1/04)

On January 9, 2004 the Court of Appeals for the District of Columbia
affirmed the district court s decision in Whitaker v. Thompson,
upholding FDA s denial of a health claim petition. The petition sought
FDA authorization for a claim that Saw Palmetto extract improves certain
symptoms associated with mild benign prostatic hyperplasia. The lawsuit
challenged, on statutory and First Amendment grounds, FDA s authority to
subject dietary supplements bearing disease treatment claims to the
Act s drug approval requirements. FDA found the Saw Palmetto claim
related to treating, rather than preventing, an existing disease, and
therefore, not within the statute s definition of a health claim.

* U.S. Court of Appeals Opinion:
http://pacer.cadc.uscourts.gov/commo...401/040109.htm


INFANT FORMULA

12. National Academies of Science Report - "Infant Formula: Evaluating
the Safety of New Ingredients" (3/04)

The NAS report, prepared at the request of FDA and Health Canada,
addresses the regulatory and research issues that are critical to
assessing the safety of the addition of new ingredients to infant
formulas.

* National Academies of Science Report:
http://www.cfsan.fda.gov/~dms/inf-info.html


13. FDA Warns Consumers Not to Feed Infants "Better than Formula Ultra
Infant Immune Booster 117" (1/04)

FDA issued a warning to consumers that a product, Better Than Formula
Ultra Infant Immune Booster 117, sold over the internet as a dietary
supplement should not be fed to infants.

*FDA Warning: http://www.cfsan.fda.gov/~lrd/fpinf2.html


14. FDA Statement on Reported Health Problems with Remedia-Brand Kosher
Soy-Based Infant Formula (11/03)

FDA is aware of reports by Israeli health officials that infants may
have been injured by the use of Remedia soy-based infant formula -- a
product reportedly made in Germany and exported to Israel. The
preliminary report issued by the Israeli Ministry of Health states that
the Remedia soy-based formula was deficient in the essential vitamin
thiamine. Thiamine deficiency results in a condition known as beri-beri
which can result in a variety of cardiac and neurological problems, and,
if untreated, death.

*For More Information:
http://www.cfsan.fda.gov/~lrd/tpinf2.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
* Qualified Health Claim Petitions
http://www.cfsan.fda.gov/~dms/lab-qhc.html#petition
* 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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