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Absorption, distribution, excretion and tissue uptake demonstrated of hyaluronan (HA) in vivo

Results To Be Presented At 2008 Annual Conference of the Federation of Societies for Experimental Biology

PUYALLUP, WA, March 27, 2008 - High-molecular weight HA (HyaMax®, 1 MDa) labeled with 99mTechnetium (99mTc-HA) or free 99mTechnetium pertechnetate (99mTc) was administered to Wistar rats and Beagle dogs per os to confirm an earlier study finding uptake of oral HA, and control for possible loss of label. Distribution of radioactivity in blood and tissues of rats was determined at 5, 15, 30 minutes, 1, 2, 4, 6, 12, 24, 48 and 72 hours. Urinary and fecal excretion was determined in rats at 12, 24, 48 and 72 hours. Blood and urinary clearance was determined in dogs.

Scintigraphic imaging, autoradiography of tissue pieces and SPECT/CT scans to evaluate tissue uptake were determined in rats. 99mTc-HA was labeled with 85% efficiency and stable for at least 48 hours. Blood levels of radioactivity for 99mTc-HA peaked at 2-4 hours in rats and dogs. Most tissues examined showed incorporation of radioactivity starting at 15 minutes and persisting for 48 hours. After 72 hours, 86.7% of radioactivity from 99mTc-HA was recovered, almost all in feces, and 94.4% from 99mTc, almost all from urine.

Autoradiography showed incorporation of radioactivity from 99mTc-HA, but not from free 99mTc, into skin, bones and joints at 24 hours. Absorption and distribution of free 99mTc was completely different from 99mTc-HA, showing an expected pattern of rapid absorption and excretion, with accumulation in thyroid glands, and removal via urine.

These controleled experiments indicate that the radioactivity in tissues after 99mTc-HA was not due to free 99mTc-HA. This report presents evidence for uptake of 13.3% of an oral dose of high-molecular-weight HA (HyaMax™), with particular accumulation in connective tissues.

AIBMR Adds GMP Compliance Consulting Services

PUYALLUP, WA. March 7, 2008 - AIBMR Life Sciences, Inc., one of the world’s oldest and most respected nutraceutical consulting firms, has added Dietary Supplement cGMP Compliance to its extensive list of consulting services.

The long-awaited Final Rule on Current Good Manufacturing Practice (cGMP) for Dietary Supplements was issued by the Food and Drug Administration (FDA) on June 25, 2007. This rule applies to all firms—in the U.S. and globally—that manufacture, package, label or distribute dietary supplements.

Welcomed by the nutraceutical industry, the cGMP Rule is intended to ensure that dietary supplement products meet quality standards. Anyone who manufactures or handles supplements must have controls in place to assure product identity, purity, strength and composition—from initial processing to the end of shelf life.

On the manufacturing side, facilities must be properly designed, constructed and maintained. Processing, blending and testing equipment must be suitable for use, correctly installed, cleaned and calibrated regularly. Raw materials must be safe and tested to confirm identity. Specifications and quality control procedures for in-process materials and finished products must be established, followed and documented. Plant personnel must be properly trained and adhere to basic standards of hygiene.

Firms that distribute dietary supplements under their own labels are fully responsible for ensuring their products comply with cGMP requirements throughout the entire product life cycle, regardless of whether or not they manufacture the products in their own facilities. Companies employing contract manufacturers must monitor the cGMP compliance of their contractors and retain batch records for every lot. Standard Operating Procedures (SOPs) must be implemented for handling product complaints and returns. And complete, traceable records must be kept at every step of the way.

AIBMR Life Sciences guides dietary supplement firms in the design, implementation and maintainence of SOPs in the critical areas of cGMP compliance. AIBMR Life Science’s highly qualified technical staff functions as a third party quality assurance department, assisting with cGMP compliance at all phases of product development, manufacturing and distribution.

Founded in 1978, AIBMR Life Sciences has helped over 500 nutraceutical companies with services that include: raw material sourcing; analytical testing; concept and intellectual property development; formulations; prototype testing and validation; manufacturing scale-up; science, technical, and regulatory review; QA/QC program development; as well as safety and efficacy studies.

According to Alexander Schauss, CEO of AIBMR Life Sciences and noted industry expert, “Complying with the cGMP rule starts at the first stage of product development and continues through to the retail purchase and ultimately consumption.” The cGMP rule strongly emphasizes that quality must be an integral part of the manufacturing process and may not simply be tested for at the end. “Quality-minded companies have always understood this,” Schauss points out. “The new rule codifies this basic principle into law as it applies to dietary supplements,” he adds.

AIBMR’s cGMP Compliance Consulting services include:

• Specifications for raw materials and finished products
• SOPs for raw material and finished good testing
• Master Manufacturing Record (MMR) and Batch Record review and analysis
• SOPs and documentation for product complaints and returns
• cGMP Self-Evaluation and Process Improvement
• Site visits: assessment and gap analysis
• Quality Assurance Master Plans
• Documentation and record keeping

AIBMR Life Sciences Announces New Hires and Promotions

PUYALLUP, Wash., October 30, 2007 — AIBMR Life Sciences, Inc., a full-service natural and medicinal products research institute, today announced the appointments of Kathryn Millhorn, B.A., M.L.I.S., to Director of Library Services, Kathleen Jade, N.D., to Research Associate and Sara Parent, N.D., to Research Assistant.  Additionally, John Endres, N.D., has been promoted to Director of Research Services and Amy Clewell, N.D., has been promoted to Senior Research Associate. 

“Our company has experienced tremendous growth over the past year, and we are excited to have these three tremendously talented individuals join the AIBMR team,” stated Alexander G. Schauss, Ph.D., FACN, senior director of natural and medicinal products research, AIBMR Life Sciences, Inc. “It is also a pleasure to announce the promotions of Dr. Endres and Dr. Clewell, both of whom have been instrumental in AIBMR’s continued success.”

Kathryn Millhorn holds a bachelor’s degree in English from Saint Martins College in Lacey, WA, and a master’s degree in Library and Information Science from the Pratt Institute in Brooklyn, NY.  Millhorn has extensive experience working as a reference librarian and will assist in literary collection maintenance and development, as well as project research. 
Kathleen Jade holds a bachelor’s degree in International Studies from Seattle University, a doctorate in Naturopathic Medicine from Bastyr University.  Prior to joining AIBMR Life Sciences, Dr. Jade worked as a naturopathic physician in private practice in Washington and served as a supervisor at two Seattle-based holistic health centers.  She is a member of the Washington Association of Naturopathic Physicians and the American Association of Naturopathic Physicians. 

Sara Parent holds a bachelor’s degree in Biology with a minor in Psychology from Rensselaer Polytechnic Institute in Troy, NY, and a doctorate in Naturopathic Medicine from Bastyr University.  Dr. Parent has expertise both as a clinician in private practice and as a consulting naturopathic physician.  She has a special interest in the interactions between human and plant biochemistry and how these interactions play a roll in improving health.   

Since its inception in 1978, AIBMR Life Sciences, Inc., has worked with more than 600 nutraceutical companies in the United States and throughout the world. It maintains one of the largest nutraceutical research libraries in the world. The firm specializes in nutraceutical research, foreign and domestic regulatory compliance, preclinical and clinical trials management, safety testing, product pharmacokinetics and product development. For more information visit www.aibmr.com.

RANDOMIZED CONTROLLED STUDY CONFIRMS MONAVIE ACTIVE™ AÇAI JUICE HAS HIGH ANTIOXIDANT CAPACITY
Results To Be Presented At Fruits and Vegetables Health 2007 Conference

PUYALLUP, WA, October 9, 2007 — The results of recent research surrounding MonaVie Active™, a juice containing açai berries and pulp, as well as other nutrient-rich fruits, will be presented in a session entitled “Antioxidants in Fruits and Vegetables and Improving Human Health” at the 2nd International Symposium on Human Health Effects of Fruits and Vegetables on Wednesday, October 10, 2007, 10:15 a.m. – noon, in the Grand Salon East at the Omni Hotel in Houston, TX.  Alexander Schauss, PhD, FACN, will highlight findings of in vitro studies evaluating the antioxidant capacity of MonaVie, as well as in vivo studies to determine antioxidant absorption and bioactivity. 

This three-part study examined whether the fruit antioxidants in MonaVie are in a form able to enter into and protect living cells in vitro and also examined the bioavailability of MonaVie and its effect on serum biomarkers of oxidative damage after ingestion.  An initial in vitro study was performed to evaluate the antioxidant capacity of MonaVie in a cell-based antioxidant capacity (CAP) assay, as well as using the TEAC assay that found it to be 28,421 µmolTE/L.  MonaVie showed a clear dose-dependent antioxidant effect in the CAP assay, indicating that compounds in MonaVie are able to cross the plasma membrane of living cells and subsequently provide significant protection from oxidative damage within the cells.   

In the second stage of the study, four ounces of MonaVie was administered to six participants on a single day to identify the time course for antioxidant absorption and bioactivity.  Blood samples were collected immediately prior to ingestion and at 30, 60 and 120 minutes post consumption.  Evidence of absorption, based on increased antioxidant bioactivity and antioxidant compounds in serum was found in all six subjects.  A third randomized, double-blind, placebo-controlled, cross-over study of 12 healthy adults was then conducted.  Participants fasted overnight and a baseline blood sample was drawn.  Immediately afterward, four ounces of MonaVie or a placebo was consumed.  Blood samples were drawn at one and two hours after ingestion, and CAP and thiobarbituric acid reactive substances (TBARS) assays were used to evaluate serum antioxidant capacity and serum lipid peroxidation, respectively.  Consumption of MonaVie resulted in an increase in the serum antioxidant capacity in 11 of 12 participants within two hours of consumption.  Results also found that ingestion of MonaVie resulted in a decrease in serum lipid peroxidation within two hours of consumption in 10 of the 12 study participants, most likely due to the increased serum antioxidant capacity. 

Alexander G. Schauss, PhD, FACN, senior director of natural and medicinal products research for AIBMR Life Sciences, has held faculty appointments at four institutions of higher learning, including that of associate professor of behavioral sciences, associate professor of research, clinical professor of natural products research and adjunct research clinical professor of botanical medicine. He now concentrates on research. In 2005, he was the recipient of the Linus Pauling Lecture Award from the American College for the Advancement of Medicine for “contributions to the medical sciences.” The author of 12 books on health and nutrition, and the senior co-author of four others, Dr. Schauss lives in Tacoma, Wash.

Founded in January 2005 and headquartered in Salt Lake City, Utah, MonaVie develops and markets scientifically formulated, premium quality nutritional juices.  The company’s flagship product, MonaVie Active™, is a proprietary blend of the açai berry, which independent studies have shown has the highest antioxidant activity of any fruit or vegetable in vitro, and other nutrient-dense fruits including pomegranate, goji berry, camu camu, passion fruit, aronia, acerola, bilberry, blueberry, apricot, purple grape, white grape, nashi pear, lychee, banana, kiwi, pear, cranberry and prune, each selected for its unique, beneficial properties.  Açai contains concentrated levels of anthocyanins, a powerful family of antioxidants that assist in neutralizing harmful free radicals.  The açai berries used to make MonaVie are processed in a cGMP, ISO certified and U.S. FDA-inspected food manufacturing facility in Brazil.  For more information visit www.monavie.com.

The 2nd International Symposium on Human Health Effects of Fruit and Vegetables provides a forum for horticultural scientists, nutritionists, food scientists, biomedical scientists, chemists, biochemists, clinicians, medical professionals and social economists to exchange information and bridge the communication gap between the agricultural sciences, nutrition and health sciences. This symposium, sponsored by the 2nd International Society for Horticultural Sciences (ISHS) and Texas A&M’s Vegetable and Fruit Improvement Center (VFIC) and Center for Obesity Research and Program Evaluation (CORPE), will focus on cultural and genotypic factors affecting the content of bioactive compounds in fruits and vegetables, and will cover a wide range of topics related to the characterization, pharmacokinetics, nutrition and human health clinical aspects of fruits and vegetables.  For more information visit http://favhealth2007.tamu.edu/index.htm.

Health Dangers of Male Potbelly Epidemic Detailed in New Book
Dr. Alex Schauss’ “Obesity: Why Are Men Getting Pregnant?” Available Nationwide

PUYALLUP, Wash., Nov. 29, 2006 — Researcher Alexander G. Schauss, Ph.D., FACN, announced today the release of his book, “Obesity: Why Are Men Getting Pregnant?” that discusses the factors associated with the increase in male obesity and offers health suggestions for those who are plagued by their expanding bellies. Published by Basic Health Publications with a suggested retail price of $18.95 ($24.95 in Canada) the book is available for purchase on Amazon.com and BasicHealthPub.com.

In the book, Dr. Schauss outlines the many factors that make people prone to obesity and potbellies including metabolism, fat cells, the way the body reacts to stress, sleep deprivation, the tendency toward insulin resistance, age, gender, genetics and diet. He explains why this particular type of obesity is so dangerous and discusses the specific diseases and risks associated with the potbelly.

“Why Are Men Getting Pregnant?” includes user-friendly scientific information on how the body processes food and how fat is deposited directly into one’s midsection. Additionally, Dr. Schauss discusses the pros and cons of possible interventions people can take to address their pregnant-looking bellies, such as: appetite control, surgery, dietary supplementation and exercise.

The U.S. Centers for Disease Control and Prevention reports that male obesity rates have jumped considerably over the past decade. In 1995, approximately 15 percent of men were obese, whereas in 2005 nearly 25 percent of men had an obese body mass index (BMI). Female obesity rates experienced a comparable hike. Dr. Schauss hopes this book will help bring this issue to light for both men and women and will provide them with the necessary tools to take control of their health and wellness.

“This book is written for men who despair that they look pregnant and for women who are bothered by the thickness of their midsections,” says Dr. Schauss. “It clarifies what works and what doesn’t in dealing with a potbelly and emphasizes the danger of complacency.”

About the author:
Alexander G. Schauss, Ph.D., senior director of natural and medicinal products research for AIBMR Life Sciences, Inc., has held faculty appointments at four institutions of higher learning, including that of associate professor of behavioral sciences, associate professor of research, clinical professor of natural products research and adjunct research clinical professor of botanical medicine. He now concentrates on research. In 2005, he was the recipient of he Linus Pauling Lecture Award from the American College for the Advancement of Medicine for “contributions to the medical sciences.” The author of 12 books on health and nutrition, and the senior co-author of four others, and a contributor of numerous chapters to textbooks, Dr. Schauss lives in Tacoma, Wash.
           
For more information on the book, visit www.basichealthpub.com or contact Amanda Holty at amandah@imgbranding.com or 801.538.0777, ext. 106.

Nov. 29, 2006 - Dr. Alex Schauss to discuss research on high-metabolite immunogen at A4M's International Congress -- view PDF

1. AIBMR has won the 2005 Nutrition Business Journal’s “Efforts on Behalf of Industry”

“AIBMR has supported scientific integrity in the industry through its involvement with numerous health organizations, including the National Institutes of Health Office of Alternative Medicine Advisory Council (AMPAC); the NIH Office of Dietary Supplements (ODS); and the U.S. Pharmacopoeia Convention (USP) … for garnering high-level legislative visibility for the industry … AIBMR provides research and regulatory guidance to the nutrition industry.”

2. Alexander Schauss, Ph.D., Receives 2005 Linus Pauling Lecture Award

Puyallup, WA, June 9, 2005 -- Alexander Schauss, Ph.D., director of natural and medicinal products research for the American Institute for Biosocial and Medical Research, was presented with the 2005 Linus Pauling Lecture Award by the American College for Advancement in Medicine (ACAM) in recognition of his outstanding contributions to the medical sciences.  The award is in honor of Dr. Linus Pauling, the only person in the world to have won two unshared Nobel Prizes, in 1954 for Chemistry and in 1962 for Peace.

"Linus Pauling inspired me to go into research on nutrients and nutraceutical ingredients back in the 1970s, and I greatly respect and admire his work" stated Schauss.  "I am honored to receive this award in recognition of my ongoing research in the field of integrative medicine."

Schauss was selected to receive the 2005 Linus Pauling Lecture Award by a committee at ACAM and was presented with the award at ACAM¹s spring conference in Orlando, Fla.

Schauss is director of natural and medicinal products research for the American Institute for Biosocial and Medical Research, Inc. in Tacoma, Wash., where he has been the lead scientist for 25 years. A former professor of natural products research and associate professor of research at two academic institutions, he is currently adjunct research professor of botanical medicine at the National College of Naturopathic Medicine in Portland, Ore.  He has served on several NIH advisory councils, been a reviewer of botanical monographs for the U.S. Pharmacopeia Convention (USP) and the International Bibliographic Information on Dietary Supplements (IBIDS) database maintained through an interagency partnership with the Food and Nutrition Information Center, National Agricultural Library, NIH Office of Dietary Supplements and the U.S. Department of Agriculture (USDA).

Schauss has studied nutrition and botanical medicine for over 30 years. He has been the author/co-author of more than a 100 scientific papers in a diverse range of journals, and recently completed his twelfth book, on the subject of intra-abdominal obesity in males. Schauss earned his undergraduate, graduate and doctoral degrees at the University of New Mexico at Albuquerque and California Coast University in Santa Ana, respectively.

ACAM is a not-for-profit medical society dedicated to educating physicians and other health care professionals on the latest scientific research and emerging breakthroughs in integrative medicine. Celebrating more than a quarter century of service, ACAM represents more than 1,000 physicians in 30 countries. ACAM is the largest and oldest organization of its kind in the world dedicated exclusively to advancing the field of medicine by educating physicians about groundbreaking research and scientific discoveries in integrative medicine. For more information visit www.acam.org .

3.  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


4.  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


5.  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

6.  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
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7.  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

8.  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.


9.  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.


10.  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.


11.  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


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RESOURCES FOR EDUCATORS AND CONSUMERS
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12.  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


13.  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
 

14.   "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.

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FOOD LABELING AND NUTRITION
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15.  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

16.  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


17.  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
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18.  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
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19.  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/answers/2004/ANS01299.html

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PUBLIC MEETINGS & HEARINGS
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20.  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/FrameRedirect.asp?main=/oppde/rdad/frpubs/04-022n.htm
* Information on Codex Meetings: http://www.codexalimentarius.net/web/current.jsp


21.  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


22.  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

23.  "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

12/9/2003
Federal Trade Commission (FTC)
FTC Releases Guidance to Media on False Weight Loss Claims

The staff of the Federal Trade Commission today announced its “Red Flag” education campaign to assist media outlets voluntarily to screen out weight-loss product ads containing claims that are too good to be true. The announcement is the culmination of a workshop held on November 19, 2002, and meetings with trade associations and individual media outlets over the last year. To support the voluntary initiative, the FTC released a media reference guide entitled “Red Flag: Bogus Weight Loss Claims.”

“Unfortunately, there are way too many ads for scientifically impossible weight-loss products in the popular media,” said FTC Chairman Timothy J. Muris. “The media should institute screening programs to ‘red flag’ deceitful weight-loss ads and refuse to run them. To help media advertising staff identify bogus claims, we’re providing thousands of free copies of the ‘Red Flag’ booklet.”

The media reference guide builds upon the FTC’s staff report, “Deception in Weight-Loss Advertising Workshop: Seizing Opportunities and Building Partnerships to Stop Weight-Loss Fraud,” also released today. The staff report provides an overview and analysis of the workshop discussion and relevant public comments.

Background – 2002 Weight Loss Product Advertising Workshop

In September 2002, the FTC staff issued a report on weight-loss advertising that concluded that, despite vigorous FTC law enforcement and consumer education efforts, fraudulent and misleading weight-loss advertising was widespread and on the rise. Following up on that report, in an effort to identify alternative approaches to curbing weight-loss fraud, the FTC held a public workshop on deception in weight-loss product advertising on November 19, 2002. The goal of the workshop was to explore new approaches to stop false weight-loss advertising. Participants in the workshop included, among others, scientists with expertise in the study and treatment of overweight individuals and obesity, weight-loss industry members, and media representatives. The workshop consisted of three panels. The first panel considered whether certain weight-loss claims, such as claims that promote substantial weight loss without reducing caloric intake or increasing exercise, are feasible. The second panel considered ways to improve industry self-regulation of weight-loss advertising. The final panel focused on the feasibility and challenges of ad screening.

The Report

The FTC staff report issued today summarizes the proceedings of the November 2002 weight-loss advertising workshop and the pre- and post-workshop public comments, provides an analysis of the scientific feasibility of the eight weight-loss claims considered during the workshop, and offers recommendations for future action.

The staff report concludes that the claims are not scientifically feasible at the current time for nonprescription drugs, dietary supplements, creams, wraps, devices, and patches, and that further guidance would assist the media in screening out these bogus claims. As a result, to assist in media screening, the FTC produced the reference guide released today. The reference guide is designed so that media outlets can screen out weight-loss ads through simple facial review, rather than in-depth investigation.

Media Guidance

The centerpiece of the FTC campaign is educational guidance to the media that identifies seven common weight-loss claims made for products available over-the-counter, including nonprescription drugs, dietary supplements, creams, wraps, devices, and patches that are scientifically infeasible at the current time. These claims include:

*    Causes weight loss of two pounds or more a week for a month, or more without dieting or exercise.
*    Causes substantial weight loss, no matter what or how much the consumer eats.
*    Causes permanent weight loss (even when the consumer stops using the product).
*    Blocks the absorption of fat or calories to enable consumers to lose substantial weight.
*    Safely enables consumers to lose more than three pounds per week for more than four weeks.
*    Causes substantial weight loss for all users.
*    Causes substantial weight loss by wearing it on the body or rubbing it into the skin.

“We know that no publication or station wants to print or air false weight-loss claims,” Chairman Muris said. “This booklet provides specific examples of bogus claims, along with explanations that will allow media advertising personnel to avoid bogus weight loss claims and stop them before they injure consumers. We encourage the media to use it.”

The Commission vote to release the staff report was 5-0.

Copies of the FTC staff weight-loss report are available from the FTC’s Web site at http://www.ftc.gov and also from the FTC’s Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. The FTC works for the consumer to prevent fraudulent, deceptive, and unfair business practices in the marketplace and to provide information to help consumers spot, stop, and avoid them. To file a complaint, or to get free information on any of 150 consumer topics, call toll-free, 1-877-FTC-HELP (1 877-382-4357), or use the complaint form at http://www.ftc.gov. The FTC enters Internet, telemarketing, identity theft, and other fraud-related complaints into Consumer Sentinel, a secure, online database available to hundreds of civil and criminal law enforcement agencies in the U.S. and abroad.