* * 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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FOOD AND DRUG ADMINISTRATION (FDA)
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN)
OFFICE OF NUTRITIONAL PRODUCTS, LABELING, AND DIETARY SUPPLEMENTS
(ONPLDS)
**** DIETARY SUPPLEMENT & FOOD LABELING ELECTRONIC NEWSLETTER ****
November 2004 (#8)
IN THIS ISSUE:
HIGHLIGHTS
* 1. Public Meeting: New Dietary Ingredients Meeting on November 15,
2004
* 2. Press Release: FDA Announced Major Initiatives for Dietary
Supplements
* 3. Regulatory Strategy for the Further Implementation and Enforcement
of the Dietary Supplement Health and Education Act of 1994
* 4. Draft Guidance for Industry: Substantiation for Dietary Supplement
Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and
Cosmetic Act
* 5. Speech: FDA Acting Commissioner Lester M. Crawford before Council
for Responsible Nutrition Annual Conference, October 25, 2004
ONPLDS MANAGEMENT UPDATE
* 6. Barbara O. Schneeman, Ph.D., Director, CFSAN's Office of
Nutritional Products, Labeling, and Dietary Supplements (ONPLDS)
* 7. Camille E. Brewer, M.S., R.D., Associate Director, ONPLDS
* 8. Susan Walker, M.D., Director, Division of Dietary Supplements,
ONPLDS, and CFSAN Lead Scientist for Dietary Supplement Safety
* 9. Kathleen Ellwood, Ph.D., Director, Division of Nutrition Labeling
and Programs, ONPLDS, and CFSAN's Lead Scientist for Nutrition
* 10. Updated Description of ONPLDS, Including Organizational Chart and
Contact Information
RESOURCES FOR EDUCATORS AND CONSUMERS
* 11. New and Improved - "How to Understand and Use the Nutrition Facts
Label"
* 12. Power of Choice
* 13. "What Dietary Supplements Are You Taking: Does Your Health Care
Provider Know? - It Matters and Here's Why"
FOOD LABELING AND NUTRITION
* 14. Qualified Health Claim to Decrease Risk of Coronary Heart Disease
* 15. Qualified Health Claim for Omega-3 Fatty Acids
* 16. Food Label and Package Survey 2000 - 2001
DIETARY SUPPLEMENTS
* 17. Bovine Spongiform Encephalopathy (BSE) Safeguards
INFANT FORMULA
* 18. FDA Alerts Consumers Not to Feed Infants Chinese Infant Formula
PUBLIC MEETINGS & HEARINGS
* 19. U.S. Preparatory Meeting for 26th session of the Codex Committee
on Nutrition and Foods for Special Dietary Uses
* 20. Food Advisory Committee/Dietary Supplements Subcommittee (on
osteoarthritis)
* 21. Nutrition Subcommittee of the Food Advisory Committee (on health
claims and trans fat)
* 22. "Dietary Supplement Safety Act: How is FDA Doing 10 Years Later?"
============================== ============================== ============
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HIGHLIGHTS
~~~~~~~~~~~
1. Public Meeting: New Dietary Ingredients Meeting on November 15, 2004
FDA has announced a meeting and is soliciting comments on FDA's
premarket notification program for new dietary ingredients (NDIs). The
public meeting will be held on November 15, 2004, from 9:00 a.m. to 5:00
p.m. at FDA's Center for Food Safety and Applied Nutrition, Harvey W.
Wiley Building, 5100 Paint Branch Pkwy., College Park, MD 20740.
Attendees must register to attend. Individuals wishing to speak must
register before November 9, 2004. Attendees may register on site on
November 15, 2004. Written or electronic comments must be submitted
(before or after the meeting) by December 3, 2004. FDA is soliciting
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
is holding 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.
* Federal Register Notice: Dietary Supplements; Premarket Notification
for New Dietary Ingredient Notifications; Public Meeting:
http://www.cfsan.fda.gov/~lrd/fr041020.html
* Meeting Information and Pre-Registration Form:
http://www.cfsan.fda.gov/~dms/ds-ndi.html
2. Press Release: FDA Announced Major Initiatives for Dietary
Supplements
FDA announced three major initiatives designed to further implement the
Dietary Supplement Health and Education Act of 1994 (DSHEA). These
initiatives -- a regulatory strategy, an open public meeting, and
guidance for industry -- are significant steps FDA has taken in the
implementation of DSHEA.
*Press Release:
http://www.cfsan.fda.gov/~lrd/fpsupp.html
3. Regulatory Strategy for the Further Implementation and Enforcement
of the Dietary Supplement Health and Education Act of 1994
FDA's strategy for dietary supplements outlines the steps the agency
plans to take to continue implementing and enforcing the Dietary
Supplement Health and Education Act of 1994 (DSHEA). The strategy sets
forth a series of research plans and measures, including guidance for
industry, regulations, and science-based compliance and enforcement
mechanisms. The strategy focuses on three areas: monitoring and
evaluating product and ingredient safety; ensuring product quality; and
monitoring and evaluating product labeling.
* Federal Register-Notice of Availability:
http://www.cfsan.fda.gov/~lrd/fr04119a.html
* Regulatory Strategy:
http://www.cfsan.fda.gov/~dms/ds3strat.html
* Fact Sheet:
http://www.cfsan.fda.gov/~dms/ds3strfs.html
* Questions and Answers:
http://www.cfsan.fda.gov/~dms/ds3strqa.html
4. Draft Guidance for Industry: Substantiation for Dietary Supplement
Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and
Cosmetic Act
FDA's Guidance for Industry is intended to describe the amount, type,
and quality of evidence FDA recommends a manufacturer or distributor
have to substantiate a claim under the Food, Drug, and Cosmetic Act (the
Act). The Act requires dietary supplement manufacturers and distributors
to have substantiation that structure/function, nutrient deficiency, and
general well-being claims on the label of a dietary supplement product
are truthful and not misleading.
* Federal Register-Notice of Availability:
http://www.cfsan.fda.gov/~lrd/fr04119b.html
* Draft Guidance for Industry:
http://www.cfsan.fda.gov/~dms/dsclmgui.html
* Fact Sheet:
http://www.cfsan.fda.gov/~dms/dsclmfs.html
* Questions and Answers:
http://www.cfsan.fda.gov/~dms/dsclmqa.html
5. Speech: FDA Acting Commissioner Lester M. Crawford before Council
for Responsible Nutrition Annual Conference, October 25, 2004
In an industry-sponsored meeting, Dr. Crawford discussed where FDA
stands with respect to ensuring full implementation of the Dietary
Supplement Health and Education Act (DSHEA); some of the ways that the
agency is pursuing its goals of protecting American consumers from
products with false or misleading claims or containing unsafe
ingredients; and empowering consumers with the knowledge to improve
their own health through informed dietary choices.
*Dr. Crawford's Prepared Remarks:
http://www.fda.gov/oc/speeches/2004/crn1025.html
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ONPLDS MANAGEMENT UPDATE
~~~~~~~~~~~~~~~~~~~~~~~~~~~
6. Barbara O. Schneeman, Ph.D., Director CFSAN's Office of Nutritional
Products, Labeling, and Dietary Supplements (ONPLDS).
On April 12, FDA Acting Commissioner, Dr. Lester M. Crawford, announced
that Dr. Barbara O. Schneeman was named to be Director of ONPLDS. She
joined FDA on May 3, 2004. As director, Dr. Schneeman oversees the
development of policy and regulations for conventional food standards,
infant formula and medical foods, nutrition labeling, and dietary
supplements.
Dr. Schneeman comes from the University of California, Davis, where she
served as a member of the faculty since 1976, the last three years as
the Associate Vice Provost for University Outreach, she also held
professorial appointments in the Departments of Nutrition, Food Science
and Technology and Internal Medicine in the School of Medicine. Dr.
Schneeman received her B.S. degree from the University of California,
Davis, in food science and technology, and her Ph.D. in nutrition from
the University of California, Berkeley. She has many professional
activities and honors to her credit.
* Press Release:
http://www.cfsan.fda.gov/~lrd/fpschnee.html
7. Camille Brewer, M.S., R.D., Associate Director, ONPLDS
Camille Brewer has been appointed as Associate Director for ONPLDS. As
a part of the Office of the Director she will be involved with priority
setting, budget and office management, and development of education
programs for ONPLDS. Ms. Brewer joined FDA in 1992. Since 1996, she
served as the International Activities Coordinator for Food Safety at
CFSAN. She organized and led FDA and interagency federal teams in over
26 food safety missions around the world. Ms. Brewer was the lead
drafter of the calories, calories from fat, sodium and potassium
sections of the 1993 final rule on nutrition labeling. Additionally,
she was the principal author of a series of proposed and final rules on
the labeling of conventional foods and dietary supplements from 1993
through 1997.
Ms. Brewer earned her Masters Degree in Public Health Nutrition at the
Case Western Reserve University in Cleveland Ohio. She received the FDA
Award of Merit in 2001 for her work in domestic and international Food
Safety and again in 2004 as part of a team responsible for outreach on
the Bioterrorism Regulations. She is a registered dietitian.
8. Susan Walker, M. D., Director, Division of Dietary Supplements,
ONPLDS, and CFSAN's Lead Scientist for Dietary Supplement Safety
Dr. Walker is the Director of ONPLDS' Division of Dietary Supplement
Programs. In addition to being the Division Director, Dr. Walker has
been appointed as the CFSAN Lead Scientist for Dietary Supplement
Safety. Dr. Walker is CFSAN's first Lead Scientist for Dietary
Supplement Safety. CFSAN established a cadre of Lead Scientists to
assist the Center in identifying high priority, unmet scientific needs.
These individuals take the initiative and work with the Center's
Management Council to focus Agency attention on emerging issues. As the
Lead Scientist for Dietary Supplements, Dr. Walker is able to focus on
science and public health issues and serves as an advocate for the
Center's science programs. Dr. Walker also provides scientific advice
to the Center Director, the Center Deputy Directors and the Management
Council. She serves as a liaison to external groups and the scientific
community on matters and inquiries related to dietary supplements and
serves, as needed, as the Agency's spokesperson for matters in this
area.
Dr. Walker received her B.S. degree from the University of Michigan in
Ann Arbor, and her M.D. degree from the Uniformed Services University of
Health Sciences in Bethesda, Maryland. She was a clinical team leader in
the Center for Drugs prior to coming to CFSAN two years ago.
9. Kathleen Ellwood, Ph.D., Director, Division of Nutrition Labeling
and Programs, ONPLDS, and CFSAN's Lead Scientist for Nutrition
As Director of ONPLDS' Division of Nutrition Programs and Labeling, Dr.
Ellwood is responsible for scientific and regulatory review of nutrition
labeling issues, such as health claims and nutrient content claims; and
changes to the Nutrition Facts panel. Moreover, she develops guidance
documents, promulgates and administers regulations, and sets policy
related to nutrition labeling. In addition to being the Division
Director, Dr. Ellwood has been appointed as the CFSAN Lead Scientist for
Nutrition. In this capacity, she will serve as an advocate for and
facilitator of nutrition policy and related science across CFSAN and
with top FDA officials and other officials throughout the federal
government, scientific and research communities, and food industry.
Dr. Ellwood received her Ph.D. in nutritional biochemistry from the
University of Maryland. She was the National Program Leader for Human
Nutrition at the U.S. Department of Agriculture's Agricultural Research
Service prior to coming to CFSAN.
10. Updated Description of ONPLDS, Including Organizational Chart and
Contact Information
CFSAN'S Office of Nutritional Products, Labeling, and Dietary
Supplements has updated its organizational chart, contact information,
and the description of various components and their responsibilities.
This information can be found at:
http://www.cfsan.fda.gov/~dms/onplds.html
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~
RESOURCES FOR EDUCATORS AND CONSUMERS
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~
11. New and Improved - "How to Understand and Use the Nutrition Facts
Label"
The Guidance on "How to Understand and Use the Nutrition Facts Label"
has been updated and improved. It is intended to make it easier for
consumers to use nutrition labels to make quick, informed food choices
that contribute to a healthy diet. This updated version includes a new
approach to the percent daily value, a general guide to calories, and
help with added sugars. A Spanish translation will be available in the
near future.
*To view "How to Understand and Use the Nutrition Facts Label" see:
http://www.cfsan.fda.gov/~dms/foodlab.html
12. Power of Choice
The Power of Choice (POC), an after-school program jointly developed by
FDA and USDA's Food and Nutrition Service, guides pre-teens towards a
healthier lifestyle by engaging them in skill-based activities that lead
to smarter food and physical activity choices in real-life settings.
* For more information:
http://www.cfsan.fda.gov/~dms/lab-poc.html
13. "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 will be posted on CFSAN's
Website soon.
~~~~~~~~~~~~~~~~~~~~~~~~~~~
FOOD LABELING AND NUTRITION
~~~~~~~~~~~~~~~~~~~~~~~~~~~
14. Qualified Health Claim to Decrease Risk of Coronary Heart Disease
FDA announced the availability of a qualified health claim for
monounsaturated fat from olive oil and reduced risk of coronary heart
disease (CHD). FDA intends to consider exercising enforcement
discretion for the following qualified health claim:
"Limited and not conclusive scientific evidence suggests that eating
about 2 tablespoons (23 grams) of olive oil daily may reduce the risk of
coronary heart disease due to the monounsaturated fat in olive oil. To
achieve this possible benefit, olive oil is to replace a similar amount
of saturated fat and not increase the total number of calories you eat
in a day. One serving of this product contains [x] grams of olive oil."
*Press Release:
http://www.cfsan.fda.gov/~lrd/fpolive.html
15. Qualified Health Claim for Omega-3 Fatty Acids
On Sept. 8, FDA announced the availability of a qualified health claim
for reduced risk of coronary heart disease (CHD) on conventional foods
that contain eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)
omega-3 fatty acids. Typically, EPA and DHA omega-3 fatty acids are
contained in oily fish, such as salmon, lake trout, tuna and herring.
These fatty acids are not essential to the diet; however, scientific
evidence indicates that these fatty acids may be beneficial in reducing
CHD. FDA recommends that consumers not exceed more than a total of 3
grams per day of EPA and DHA omega-3 fatty acids, with no more than 2
grams per day from a dietary supplement. The EPA and DHA omega-3 fatty
acid qualified health claim is the second qualified health claim that
FDA has announced for conventional food. In 2000, FDA announced a
similar qualified health claim for dietary supplements containing EPA
and DHA omega-3 fatty acids and the reduced risk of CHD.
* Press Release:
www.cfsan.fda.gov/~lrd/fpqhco3 .html.
* Questions & Answers:
http://www.cfsan.fda.gov/~dms/labo3qa.html
16. The Food Label and Package Survey (FLAPS) 2000 - 2001
FLAPS is an FDA study of processed, packaged food labels in the United
States food supply. FLAPS provides the most reasonable and comprehensive
overview of label information on food products in the United States
today. The FLAPS database includes all significant information from
product labels, including the ingredient list, nutrition label, claims,
as well as food safety and other statements about the product. Using
the FLAPS data, FDA can monitor the food industry's response to its food
labeling regulations and support agency policy, regulatory, and food
safety decisions.
* For More Information:
http://www.cfsan.fda.gov/~dms/lab-flap.html
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DIETARY SUPPLEMENTS
~~~~~~~~~~~~~~~~~~~~~
17. Bovine Spongiform Encephalopathy (BSE) Safeguards
On July 9th U. S. Department of Agriculture (USDA), Department of Heath
and Human Services, and FDA issued a joint press release announcing
three actions being taken to further strengthen existing safeguards that
protect consumers against the agent that causes bovine spongiform
encephalopathy (BSE, also known as "mad cow disease"). The documents
outlining these actions were (1) a joint USDA/FDA Advance Notice of
Proposed Rulemaking proposing strengthened BSE safeguards, (2) an
Interim Final Rule (IFR) banning the use of specified risk materials in
cattle-derived materials in human food, dietary supplements, and
cosmetics, and (3) a proposed rule on record-keeping related to this
IFR.
* Press Release:
www.cfsan.fda.gov/~lrd/hhsbse4 .html
* Commonly Asked Questions About BSE in Products Regulated by FDA's
CFSAN:
http://www.cfsan.fda.gov/~comm/bsefaq.html
* Fact Sheet about FDA's New Interim Rule and Proposed Rule on
Prohibited Cattle Materials in Food and Cosmetics July 9, 2004:
http://www.cfsan.fda.gov/~comm/bsefact2.html
* Interim Final Rule Prohibiting Use of Certain Cattle Materials that
May Carry Risk of Bovine Spongiform Encephalopathy in Human Foods and
Cosmetics July 14, 2004:
http://www.cfsan.fda.gov/~lrd/fr04714a.html
* Proposed Rule on Recordkeeping Requirements for Human Food and
Cosmetics Manufactured From, Processed With, or Otherwise Containing
Material From Cattle July 14, 2004:
http://www.cfsan.fda.gov/~lrd/fr04714b.html
* Advance Notice of Proposed Rulemaking July 14, 2004:
http://www.cfsan.fda.gov/~lrd/fr04714c.html
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INFANT FORMULA
~~~~~~~~~~~~~~~
18. FDA Alerts Consumers Not to Feed Infants Chinese Infant Formula
The Food and Drug Administration is warning consumers not to feed their
infants infant formula from China because the safety and nutritional
adequacy of infant formula from China is unknown. Recently, infant
formula from China by the name of Guan Wei Yuan was found for sale in an
Asian retail market in New York.
* Talk Paper:
http://www.fda.gov/bbs/topics/answer.../ANS01299.html
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PUBLIC MEETINGS & HEARINGS
~~~~~~~~~~~~~~~~~~~~~~~~~~
19. U.S. Preparatory Meeting for 26th session of the Codex Committee on
Nutrition and Foods for Special Dietary Uses
A public meeting was held on September 9, 2004, in preparation for the
26th Session of the Codex Committee on Nutrition and Foods for Special
Dietary Uses (CCNFSDU). The next session of this Codex committee was in
Bonn, Germany from November 1-5, 2004. Dr. Barbara Schneeman headed the
U.S. delegation. At the public meeting, Dr. Schneeman presented the
U.S. draft positions on approximately 10 agenda items for the upcoming
session and invited comments from meeting participants. Among the items
to be discussed at the next session are the revision of a Codex standard
for infant formula, draft guidelines for vitamin and mineral food
supplements, definitions for dietary fiber and trans-fatty acids, risk
analysis as applied to the work of this Codex committee, and approaches
to the scientific evaluation of health claims.
* Meeting Notice:
http://www.fsis.usda.gov/Frame/Frame...bs/04-022n.htm
* Information on Codex Meetings:
http://www.codexalimentarius.net/web/current.jsp
20. Food Advisory Committee/Dietary Supplements Subcommittee (on
osteoarthritis)
The meeting of the Food Advisory Committee and its Dietary Supplements
Subcommittee was held on June 7 - 8, 2004. FDA sought input concerning
the etiology of osteoarthritis (OA), potential modifiable risk factors
and the relevance of certain types of scientific studies used to
substantiate the substance-disease relationship.
* Federal Register Notice:
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-10589.htm
* Transcript and Summary Minutes:
http://www.fda.gov/ohrms/dockets/ac/cfsan04.html
21. Nutrition Subcommittee of the Food Advisory Committee (on health
claims and trans fat)
On April 27-28, 2004, a meeting of Nutrition Subcommittee of the Food
Advisory Committee was held. The subcommittee discussed the scientific
issues and principles involved in using ``total fat'' as a disqualifying
level for foods that receive a health claim for coronary heart disease;
and to discuss evidence supporting a possible daily value (DV) for trans
fatty acids.
* Federal Register Notice:
http://www.cfsan.fda.gov/~lrd/fr040329.html
* Transcript and Summary Minutes:
http://www.fda.gov/ohrms/dockets/ac/cfsan04.html
22. "Dietary Supplement Safety Act: How is FDA Doing 10 Years Later."
On June 8, U.S. Senate Committee on Governmental Affairs, Subcommittee
on Oversight of Government Management, the Federal Workforce, and the
District of Columbia held a hearing entitled, "Dietary Supplement Safety
Act: How is FDA Doing 10 Years Later?" The Subcommittee examined the
challenges and successes FDA has experienced since the passage of the
Dietary Supplement Health and Education Act of 1994, which established a
new regulatory framework for dietary supplements. The information
generated from this hearing will be used to determine what, if any,
steps are needed to make FDA more effective. CFSAN Center Director Bob
Brackett testified at the hearing for FDA.
* Testimony:
http://www.fda.gov/ola/2004/dssa0608.html
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
* 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 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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