Natural Standard Blog

Natural Standard Training Sessions

Natural Standard subscribers are invited to attend online training sessions to learn more about the resources available to them.

The summer training sessions are designed to help clients understand Natural Standard's mission, methodology and Evidence-based Validated Grading Rationale™. These guided tours will also demonstrate how to navigate the various databases and cross reference medical conditions and therapies.

The manufacturing/regulatory training sessions are specifically tailored for branded ingredient manufacturers, brand owners, pharmaceutical companies and law firms. Natural Standard provides custom research reports, white papers, clinical trial protocol design and grant writing services. Featured topics will include: GRAS certification, cGMP compliance initiatives, product compliance and submission, litigation, advertising claims, efficacy claims, health maintenance and structure function claims, functional ingredient claims, FDA/FTC warning letters and ingredient identification supporting health maintenance claims.

To sign up for a complimentary session, please click the links below.

Natural Standard Summer Training Sessions:

• Tue, Aug 17, 2010 2:00 PM - 2:40 PM EDT
• Thu, Aug 19, 2010 2:00 PM - 2:40 PM EDT
• Tue, Aug 24, 2010 2:00 PM - 2:40 PM EDT
• Thu, Aug 26, 2010 2:00 PM - 2:40 PM EDT
• Tue, Aug 31, 2010 2:00 PM - 2:40 PM EDT

Manufacturing/Regulatory Training Sessions:

• Thu, Aug 19, 2010 1:00 PM - 1:40 PM EDT
• Thu, Aug 26, 2010 1:00 PM - 1:40 PM EDT
• Thu, Sept 2, 2010 1:00 PM - 1:40 PM EDT
• Thu, Sept 9, 2010 1:00 PM - 1:40 PM EDT
• Thu, Sept 16, 2010 1:00 PM - 1:40 PM EDT
• Thu, Sept 23, 2010 1:00 PM - 1:40 PM EDT
• Thu, Sept 30, 2010 1:00 PM - 1:40 PM EDT
• Thu, Oct 7, 2010 1:00 PM - 1:40 PM EDT
• Thu, Oct 14, 2010 1:00 PM - 1:40 PM EDT
• Thu, Oct 21, 2010 1:00 PM - 1:40 PM EDT
• Thu, Oct 28, 2010 1:00 PM - 1:40 PM EDT

For more information, please e-mail questions@naturalstandard.com.

Natural Standard Contributes to NAPLEX® Review

Prepare for the North American Pharmacy Licensure Examination (NAPLEX®) with Mosby's Pharmacy Review for the NAPLEX.

The guide outlines important test topics, such as patient communication, clinical evaluations and preparing and dispensing medications safely and effectively.

The book also features evidence-based dietary supplement data from Natural Standard. The information will help individuals prepare for NAPLEX® questions about the documented uses, adverse effects and toxicities of these products.

Key features include:

• Focused and comprehensive outline format
• Content organized according to NAPLEX®
• New topics introduced by the NABP, such as dietary supplements
• Tips on how to prepare for the NAPLEX®
• 2,000+ review questions
• Patient-profile questions modeled after the NAPLEX®
• Two practice exams, each with 185 multiple-choice questions
• Appendices that summarize drug interactions
• Flashcards with generic and brand-name drugs

To order a copy of Mosby's Pharmacy Review for the NAPLEX, please visit http://portals.elsevier.com/portal/naturalstandard.

Journal of Dietary Supplements: Call for Papers

Natural Standard, an international research collaboration that aggregates and synthesizes data on complementary and alternative therapies, invites researchers to submit articles to Journal of Dietary Supplements (JDS) - an international peer-reviewed forum for original research and review articles that focus on vitamins, minerals, herbs and other substances that make up the multibillion-dollar dietary supplement industry. The journal addresses important issues that meet a broad range of interests, not only in integrative healthcare, but also in academic, regulatory and industrial sectors.

The journal has an online submission system available at http://mc.manuscriptcentral.com/wjds. Full instructions for uploading submissions will appear online.

Natural Standard subscribers are eligible to receive a 60 percent discount on a one-year subscription to the journal. Subscribers will receive four issues for $100. Natural Standard also invites JDS authors to present their findings in webinars, which will be posted on the Natural Standard Web site (www.naturalstandard.com/webinars).

For more information, please e-mail jds@naturalstandard.com.

Catherine Ulbricht, PharmD: Chief Editor, Journal of Dietary Supplements, Co-Founder, Natural Standard Research Collaboration (ulbricht@naturalstandard.com).

Wendy Chao, PhD: Associate Editor, Journal of Dietary Supplements, Science Editor, Natural Standard Research Collaboration (wchao@naturalstandard.com).

Daniel Falatko: Managing Editor, Informa Medicine Journals (Daniel.Falatko@informausa.com).

David DeLuca: Electronic Production Manager, Informa Business Information (David.DeLuca@informausa.com).

The distinguished editorial board includes the following internationally known scientists:

• Brent A Bauer, MD, FACP: Director, Complementary and Integrative Medicine Program, Mayo Clinic, Rochester, MN.
• William Benda, MD: Assistant Clinical Professor, Department of Family and Community Medicine, University of California, San Francisco.
• Mark Blumenthal: Founder & Executive Director, American Botanical Council, Austin, TX.
• William Benda, MD: University of California, San Francisco, Board of Trustees, American Holistic Medical Association.
• Edzard Ernst, MD, PhD, FRCP, FRCP (Edin.): Professor of Complementary Medicine, Peninsula Medical School, Exeter, UK.
• Bradly Jacobs, MD, MPH: Founder and Director, Institute of Healthy Living, Sausalito, CA.
• Karta Purkh S. Khalsa, CD-N, RH: Botanical Medicine, Bastyr University, Eugene, OR.

2010 Publication Schedule

Cover month	Online Publication	Print Publication
Volume 7, Issue 1 (March)	1/29	2/26
Volume 7, Issue 2 (June)	5/1	5/28
Volume 7, Issue 3 (September)	8/1	8/27
Volume 7, Issue 4 (December)	11/3	11/26

Natural Standard Book Earns Rave Review

Patrick Morrison, an Honorary Professor of human genetics at the universities of Queens Belfast, Nottingham Trent and the University of Ulster, recently reviewed Natural Standard Herbal Pharmacotherapy: An Evidence-Based Approach in the Ulster Medical Society Journal, and called it “an excellent guide to herbal pharmacotherapies.”

The reference tool provides practical guidance on the use of herbal therapies for medical conditions. It is designed to be an essential part of herbal pharmacy core curricula for healthcare disciplines.

Chapters are organized by medical condition and present supportive evidence, including potential mechanisms of action and dosing, for selected herbal therapies. The chapters also include integrative therapy plans to help clinicians quickly assess patient needs and create cohesive treatment plans.

“This is an excellent book which fills the large gap in evidence that existed in this area,” Dr. Morrison states.

Several resources, including animations, Appendix C, Appendix D, Chapter 31, Grades A-F Tables and References, are available on the Evolve Web site. To order a copy of the book, please click here.

Natural Standard on CBC News

CBC News in Canada consulted Natural Standard for an investigative report on the controversial Herbal Magic® weight-loss program.

The program includes a healthy, calorie-restricted meal plan and dietary supplements. Clients also receive support from personal health coaches.

The report, Magic in a Bottle, questioned the effectiveness of program, particularly two supplements marketed as WM-2000™ and Chromagic™.

WM-2000™ is an herbal dietary supplement that consists of Siberian ginseng (Eleutherococcus senticosus), brindall berry (Garcinia cambogia), ginger root (Zingiber officinale), gymnema (Gymnema sylvestre), and kelp (Lessonia nigrescens).

According to manufacturer data, the herbs in WM-2000™ are combined to aid in weight loss and are intended to be used as a part of a complete weight-loss program.

Chromagic™ is a dietary supplement that contains chromium, vanadium, biotin and vitamin B6. According to manufacturer data, Chromagic™ is designed to assist in weight loss, proper insulin functioning and blood sugar regulation. It may also help decrease appetite and sugar cravings; increase muscle mass; regulate cholesterol and help break down carbohydrates, fats, and protein.

However, Natural Standard reviewed the scientific data and found that evidence of safety and effectiveness were lacking for both of these products. Although some of the individual ingredients have been studied, overall, supporting evidence is insufficient for these indications.

To watch the investigative report, please click here.

To learn more about the supplements discussed in the report, please visit Natural Standard's Health & Wellness database.

Stevia Sweetener Approved

The U.S. Food and Drug Administration (FDA) recently approved the use of Truvia™ and PureVia™, zero-calorie sweeteners made from the stevia plant, for use in foods and beverages. These newly approved sweeteners are purified forms of stevia called rebaudioside A.

 

The stevia herb is native to Brazil and Paraguay. For more than 20 years, stevia extracts have been sold as commercialized sweeteners in Japan and Brazil.

 

In the United States, Coca-Cola Co. and Pepsico are among the first companies to market new beverages containing stevia. They are working with Cargill Inc. and Merisant Co.'s Whole Earth Sweetener, respectively, to develop products made with the natural sweetener. Both manufacturers have also developed tabletop versions of the sweetener.

 

This month, Coca-Cola launched Sprite Green®, a reduced-calorie, sparkling beverage made with Truvia™. It is currently available in New York and Chicago. Sprite Green® contains some natural sugar and has 50 calories per 8.5 ounces. Coca Cola also plans to develop some Odwalla® juices with the sweetener.

 

Pepsico launched three flavors of SoBe Lifewater® (Fuji Apple Pear™, Black and Blue Berry™ and Yumberry Pomegranate™) that contain PureVia™. In March, they also plan to release an orange juice containing PureVia™ called Trop50®.

 

Aside from having no calories, stevia may also have some health benefits. The herb has been widely used to treat diabetes in South America, and animal studies have shown promising results. Human studies have reported decreases in blood sugar levels when stevia was taken in healthy volunteers, but there is currently a lack of conclusive evidence of effectiveness when used in patients with diabetes. Additional research is needed in this area to confirm these findings.

 

In addition, stevioside, a natural plant glycoside in the stevia plant, has demonstrated blood pressure-lowering effects. Despite evidence of benefits in some human studies and support from laboratory and animal studies, more research is warranted to compare stevia's effectiveness with the current standard of care.

 

Reported side effects of stevia include muscle pain, muscle weakness, dizziness, nausea and abdominal fullness. These effects resolved after the first week of treatment. Higher doses of stevia may affect kidney activity.

 

For more information about stevia, please visit Natural Standard's Foods, Herbs & Supplements database.

New Antioxidant

Researchers have isolated a new compound with antioxidant potential, pedicularioside G, derived from the Chinese herb Pedicularis striata.

The genus Pedicularis contains several species referred to as louseworts. The common name was derived from the idea that livestock would get lice from eating the plant.

Pedicularis plants are found mainly in temperate northern hemisphere climates, although some are also found in South America.

Although animal studies have indicated that certain chemicals found in the plants may have antiproliferative or antioxidant activity, there is insufficient evidence in humans to support the use of Pedicularis species for any indication.

Researchers from Lanzhou University in Lanzhou, China, found that pedicularioside G inhibited two major angiogenic (involving the growth of new blood vessels from pre-existing vessels) responses, human umbilical vein endothelial cell proliferation and migration in a chicken embryo model. In addition, pedicularioside G inhibited human liver cancer cells proliferation and migration along with transplanting tumor formation and growth.

The study authors concluded that pedicularioside G has anti-angiogenic, antitumour growth and antimetastatic  effects. Additionally, the results suggest that the anti-angiogenic and antitumor effects of pedicularioside G might be partially attributed to its antioxidative activity.

Pedicularis is in the same family as snapdragons (Scrophulariaceae) and also has similar hood flowers. The genus has a wide array of flower designs that are sometimes correlated to the insects or hummingbirds that pollinate them. The plants are also hemiparasitic and produce opportunistic nutrient-absorbing outgrowths upon contact with the roots of surrounding host plants.

For more information on louseworts, please visit Natural Standard's Foods, Herbs & Supplements database.

FDA: Cloned Meat and Dairy Safe to Eat

The U.S. Food and Drug Administration (FDA) has declared that meat and milk from clones of cattle, swine and goats, as well as the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from conventionally bred animals.

However, there continues to be insufficient information for the agency to reach a conclusion on the safety of food from clones of other animal species, such as sheep.

The FDA has issued three documents on animal cloning outlining the agency's regulatory approach: a risk assessment, a risk management plan and guidance for the industry.

The documents were released in draft form in December 2006; since that time, the risk assessment has been updated to include new scientific information that reinforces the food safety conclusions of the drafts, the FDA reports.

The FDA explained that in 2001, U.S. producers agreed to refrain from introducing meat or milk from clones or their progeny into the food supply until the FDA could further evaluate the issue.

The FDA reports that the U.S. Department of Agriculture (USDA) will convene stakeholders to discuss efforts to provide a smooth and orderly market transition, as the industry determines the next steps with respect to the existing voluntary moratorium.

Consumers should be aware that the agency is not requiring labeling or any other additional measures for food from cattle, swine and goat clones or their offspring because the FDA declares that the food derived from these sources is no different than food derived from conventionally bred animals. Should a producer express a desire for voluntary labeling (e.g., "this product is clone-free"), it will be considered on a case-by-case basis to ensure compliance with statutory requirements that labeling be truthful and not misleading.

The FDA reports that the clones would be used for breeding and would not be expected to enter the food supply in any significant number. Instead, their sexually reproduced offspring would be used for producing meat and milk for the marketplace.

An animal clone is a genetic copy of a donor animal, similar to an identical twin, but born at a different time. Cloning is not the same as genetic engineering, which involves altering, adding or deleting DNA because cloning does not change the gene sequence. Due to their cost and rarity, clones are intended to be used as elite breeding animals to introduce desirable traits into herds more rapidly than would be possible using conventional breeding, the FDA states.

The FDA is currently working with scientific and professional societies with expertise in animal health and reproduction to develop standards of care for animals involved in the cloning process. Although the agency is not charged with addressing ethical issues related to animal cloning for agricultural purposes, the FDA plans to continue to provide scientific expertise to interested parties working on these issues.

In the guidance for industry, the FDA does not recommend any special measures relating to the use of products from cattle, swine or goat clones as human food or animal feed. The guidance states that food products from the offspring of clones from any species traditionally consumed for food are suitable to enter the food and feed supply.

 

FDA: New Flu Vaccine Approved

The U.S. Food and Drug Administration (FDA) has approved Afluria®, an additional seasonal influenza vaccine for the immunization of people ages 18 and older.

According to the FDA, Afluria® is intended to protect adults from influenza type A and type B flu viruses. Influenza, commonly known as the flu, is a contagious respiratory illness that can cause annual epidemics.

Influenza viruses are transmitted through the air in tiny droplets when someone with the infection coughs, sneezes or talks. Individuals are then exposed to the virus through inhalation, or by contact with objects such as telephones, door handles, railings or computer keyboards. An infection may occur when the virus is then transferred to the eyes, nose or mouth.

Every year in the United States, an average five to 20 percent of the population gets the flu, and more than 200,000 people are hospitalized from flu complications, such as dehydration (loss of water), high fever (over 102 degrees Fahrenheit) and extreme fatigue. About 36,000 people die from flu every year.

Some patients, such as older people, young children and people with certain health conditions that lower immunity, including cancer, human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS), are at high risk for serious flu complications. Children are two to three times more likely than adults to get sick with the flu.

The approval of Afluria®, which is manufactured by CSL Limited of Parkville, Australia, brings the number of seasonal influenza manufacturers licensed for the U.S. market to six, the FDA reports.

The U.S. Centers for Disease Control and Prevention (CDC) estimates that the six manufacturers will supply a record 132 million doses of influenza vaccine for the 2007-2008 influenza season, based on current manufacturing trends.

The FDA suggested that it is best to be immunized as soon as the vaccine is available, usually in September. However, getting a flu shot any time during influenza season is also appropriate because the influenza season often peaks late.

The most commonly reported adverse events associated with Afluria® were tenderness, pain, redness and swelling at the injection site and headache, fatigue and muscle aches.

Afluria® contains inactivated influenza viruses grown in chicken eggs. People who are allergic to eggs or any other component of the vaccine should not receive Afluria®.

The vaccine is administered as a single injection in the upper arm, and is available in both a single-dose, preservative-free, pre-filled syringe and a multi-dose vial with thimerosal, a mercury derivative, as a preservative.

FDA: 15 New Blood Typing Tests Licensed

The U.S. Food and Drug Administration (FDA) licensed 15 new blood typing tests that were previously unavailable in the United States.

According to the FDA, the tests, known as blood grouping reagents, are used to determine the blood type of blood donors, an essential step in ensuring safe blood transfusions and organ donations for patients.

There are four blood types in the ABO blood group: A, B, AB, and O. These blood types are determined by a substance called agglutinogen that is present on the outside of the patient's red blood cells. Patients who have type AB blood are considered universal recipients because they can receive blood or blood products from any other blood type. However, these patients may only donate their blood to patients who have AB blood. Patients who have O blood are considered the universal donors because they can give blood to patients of any other blood type. However, they can only receive blood from patients who have O blood.

In addition, patients have either positive or negative blood. Patients who have a protein called D antigen on their red blood cells are considered Rh-positive. If the D antigen is absent, the patient is Rh-negative. For instance, if a patient has type A agglutinogen but no D antigen, he/she has type A-negative blood.

If mismatched blood is administered to a patient, it may cause a serious and potentially fatal reaction. To prevent such problems, people must receive compatible blood based on the results of blood typing tests.

The newly approved ALBAclone Blood Grouping Reagents include the common ABO and Rh tests, plus tests for rare blood types. The reagents are monoclonal antibodies, highly specific antibodies that ensure product uniformity and availability.

The FDA hopes that the licensing of these reagents will provide more choice for blood establishments and transfusion services and help facilitate testing for rare blood groups.

The reagents are manufactured by Alba Bioscience, Inc. of Durham, North Carolina