Physician researchers at the University of Texas Southwestern Medical Center have misidentified an illegal drug product as a dietary supplement, and released a sensational press release that erroneously claims that “hormonal dietary supplements” may “promote the progression of prostate cancer.” The researchers were looking into two cases of men who developed “aggressive prostate cancer” after taking an unnamed product that was found to contain unlisted ingredients, including testosterone and estradiol. Both of these hormone ingredients are drugs that are not lawful ingredients in dietary supplements. The researchers refused to name the products.  
 
The press release was issued by the medical center to publicize an article that is pending publication in the journal Clinical Cancer Research. As of January 18, 2008, the article is not yet available at the journal’s website. The press release also notes that the researchers notified the Food and Drug Administration (FDA) of their findings, and that the FDA subsequently forced the product to be removed from the market.  
 
Dr. Shahrokh Shariat, the lead author of the pending article, was quoted in the press release as stating that the current US regulations provide “little oversight or assurances” that dietary supplement labels “provide accurate information for consumers.” This is not accurate, however, since dietary supplement labels are required by law to declare all product ingredients.
 
“I can think of no reason why scientists who do not know the difference between a dietary supplement and an illegal drug insist on protecting the product’s marketer and increasing consumer risk by refusing to identify the specific brand,” said Michael McGuffin, president of the American Herbal Products Association (AHPA).
 
An accurate description of the unidentified product, if the researchers’ analysis was accurate, is that it is an illegal drug that was misrepresented as a dietary supplement. AHPA decries the presence of such products in the marketplace and applauds any and all efforts by the FDA, the medical community and consumers to see that they are promptly removed, and that marketers of such unlawful drugs are dealt with severely.
 
“AHPA has a long-standing policy of encouraging consumers of herbal supplements inform their healthcare provider of such use,” added AHPA’s McGuffin, “and I note that Dr. Shariat and his colleagues are now suggesting that physicians ask their patients about supplement use. But AHPA has also long encouraged healthcare providers to seek out accurate and truthful information about herbs and their regulation, and this press release will do nothing to help meet this goal.”

American Health Science University (AHSU), the distance education institution that offered the Certified Nutritionist (CN) certificate program for the better part of two decades, has closed and and resigned its accreditation with the Distance Education and Training Council (DETC), the US Department of Education authorized accrediting agency exclusively for distance education institutions. Through a cooperative arrangement with AHSU, DETC, the Colorado Department of Higher Education and Huntington College of Health Sciences (HCHS, Knoxville, TN), AHSU students have transferred to HCHS to complete their education. As a result, they will not lose any of their previously earned credits and will be able to apply them all into a HCHS academic program.

HCHS is a DETC-accredited, distance education institution offering Associate, Bachelor and Master degree programs in nutrition. HCHS also offers six, six-course diploma programs including Comprehensive Nutrition, Sports Nutrition, Women’s Nutrition and academia’s first program in Dietary Supplement Science. For more than 20 years HCHS’s coursework in nutrition and the basic sciences have included the breadth of responsible complementary and alternative medicine viewpoints, providing students with a well-rounded and integrative approach to nutrition.

For information visit www.hchs.edu or call (800) 290-4226.

Nutraceuticals International, LLC (NI), an international ingredient supplier known for exclusive nutraceuticals and specialty ingredients with US headquarters in Elmwood Park, NJ, and Amruta Herbals Pvt. Ltd. (AHPL), a manufacturer of ayurvedic herbal extracts (GMP Certified / ISO 9000-2001 Certified Facility in INDORE) have announced the formation of a joint venture to develop, market and sell indigenous Indian products to manufacturers worldwide.

The agreement includes an extensive sales and marketing campaign to co-promote Amruta's "Ancient Ways to Cure Today" to the forefront of the international marketplace.

The agreement promotes a variety of "new" ancient ayurvedic herbal extracts for finished goods manufacturers and consumers.

NI has secured the rights to exclusive supply of Amruta's variety of powdered extracts, soft extracts, granule extracts and standardized oil extracts, as well as an entire line of proplylene glycol (PG) extracts designed specifically for cosmetic use. NI and Amruta are developing new extracts and products in Amruta's facilities for introduction to the market in 2008.

New Offerings include:
• standardized ayurvedic herbal extracts
• standardized oil extracts
• proplylene glycol (PG) extracts for cosmetic use
 
All materials are tested using physiochemical and macroscopic analysis as well as chromatographic fingerprinting by TLC, HPLC and UV methods.
 
Other new products to NI's bulk ingredient line are akarkara, jamun, varuna, jivanti, arjuna, ashoka and more.

The cosmetics ingredients line offers: henna, rose flower, myrrh, aloe, orange peel, papaya, citron, red sandal, apple, hibiscus and chakunda.
 
For more information call (888) 541-1284 or (201) 796-4041.

The American Botanical Council (ABC) has recently added 14 new members to its Advisory Board. This board assists in the content and editorial development of various ABC publications such as HerbalGram, HerbalEGram, HerbClip, etc., as well as other contributions.

“We are honored and deeply grateful for the inclusion of these friends and colleagues to the ABC Advisory Board,” said ABC Founder and Executive Director Mark Blumenthal. “In many ways, the appointment of these herb experts to the ABC Advisory Board reflects an already strong cooperative relationship that has existed for many years.”

The 14 new members include five herbalists (each of whom have over 20 to 30 years of contributions to the American herbal landscape), four physicians with extensive experience in botanical medicine and five people with doctorates in areas of ethnobotany, pharmacognosy, pharmacology, natural products research and nutrition.

Stacey J. Bell, DSc, is a nutritionist and research scientist for IdeaSphere, Inc. She also serves on the board of Kids Can Cook, a nonprofit agency that offers basic cooking instruction and nutrition education to Boston middle-school-aged children. A registered dietitian for 35 years, Dr. Bell received her doctorate in nutrition from Boston University, with honors in 1994.

Keith I. Block, MD, is the medical and scientific director of the Block Center for Integrative Cancer Treatment, a center that integrates Western medicine with scientifically sound complementary therapies. Block is the editor-in-chief of the peer-reviewed journal Integrative Cancer Therapies and received his MD in 1979 from the University of Miami’s School of Medicine in Florida.

Ray Cooper, PhD, is the chief science officer of PhytoScience Inc., a consulting company he co-founded. In 1978, he received his PhD in organic chemistry from the Weizmann Institute of Science in Israel. Cooper is also a fellow of the Royal Chemical Society in the UK and an adjunct professor at Hong Kong Polytechnic University.

Paula M. Gardiner, MD, MPH, is an assistant professor in the department of family medicine at Boston University Medical School. She has also been a clinical research fellow at both Harvard Medical School’s Osher Institute and the Children’s Hospital in Boston, MA. Gardiner received her MD from Tufts University School of Medicine in 1995, and her MPH in 2006 from Harvard School of Public Health in Boston.

Bill J. Gurley, PhD, is the director of the Clinical Pharmacokinetics Research Laboratory and a professor of pharmaceutical sciences for the College of Pharmacy at the University of Arkansas for Medical Sciences (UAMS, Little Rock, AR). He has also been an adjunct professor for the College of Arts and Sciences’ Department of Biology. He received his PhD in 1989 from the University of Tennessee in Memphis. Much of his research has focused on herb-drug interactions.

Freddie Ann Hoffman, MD, is the president and CEO of HeteroGeneity, LLC in Washington, DC. Hoffman received her MD from the University of California at Davis School of Medicine in 1976, and in 1986 she joined the US Food and Drug Administration (FDA). In 1989, she became deputy director of the medicine staff in the Office of the Commissioner where she developed policies for botanicals, alternative medicine and dietary supplements.

Uwe Koetter, PhD, is the principal and founder of Dr. Koetter Consulting Services in Switzerland. He formerly served as the head of research and development and chief development officer at Max Zeller Söhne AG in Switzerland, a manufacturer of clinically tested phytomedicines. In 1993, he received his PhD in pharmaceutical biology from Freie Universität in Berlin, Germany under the mentorship of Prof. Heinz Schilcher, PhD, vice-president of the German Commission E.

Will C. McClatchey, PhD, is a professor of botany at the University of Hawaii at Mânoa as well as the coordinator of the university’s ethnobotany interdisciplinary curriculum. McClatchey earned a pharmacy degree from Oregon State University in Corvallis, an MS in ethnobotany from Brigham Young University in Provo, Utah, and a PhD in Botany (Evolutionary Biology) from the University of Florida in Gainesville (1996). He has worked as a community and consultant pharmacist for 10 years.

Simon Y. Mills is the director of Plant Medicine Community Interest Company (CIC), an information resource for healthcare professionals and the public. Mills graduated from Cambridge University in 1970 with a degree in medical sciences and completed professional training at the 140-year-old National Institute of Medical Herbalists. He also co-authored two widely-cited reference books: The Principles and Practice of Phytotherapy (Churchill Livingstone 2000) and The Essential Guide to Herbal Safety (Churchill Livingstone 2005), the latter which received ABC’s James A. Duke Botanical Book Award for 2005.

Paul Schulick is the founder and co-CEO of New Chapter, Inc., a manufacturer of probiotic nutrients and herbal formulations. Schulick received his master herbalist certification in 1982 from the School of Natural Healing in Springville, UT, and worked with its founder, John R. Christopher, MH, ND, master herbalist. Schulick wrote the best-selling book Ginger: Common Spice & Wonder Drug (Hohm Press, 3rd edition 2001, 1st edition 1996).

Ed Smith has worked as a professional medical herbalist since 1973. He is the co-founder, co-owner and chairman of Herb Pharm, a leading manufacturer of liquid herbal extracts. He has taught at the California School of Herbal Studies for 11 years and authored the book Therapeutic Herb Manual: A Guide to the Safe and Effective Use of Liquid Herbal Extracts (self published, 2006).

Jay Udani, MD, is the CEO and medical director of Medicus Research, a contract research organization that serves the pharmaceutical and dietary supplement industries. He is the medical director of the Integrative Medicine Program at Northridge Hospital, and an assistant clinical professor at the University of California in Los Angeles (UCLA)/Geffen School of Medicine. Udani received his MD in 1994 from Northwestern University Medical School in Chicago and his medical acupuncture certificate in 1998 from UCLA.

Roy Upton is the founder, editor and executive director of the American Herbal Pharmacopoeia (AHP). He has been a professional herbalist for over 25 years and is the co-founder, past president and current vice-president of the American Herbalists Guild (AHG). He received the James Lind Scientific Achievement Award in 2004 and co-authored the American Herbal Products Association’s Botanical Safety Handbook (CRC Press, 1997).

David Winston, RH (AHG), president of the herbal manufacturing company Herbalist & Alchemist, Inc., is an herbalist and ethnobotanist with over 38 years of training and over 28 years in clinical practice. Winston is the founder/director of the Herbal Therapeutics Research Library and the dean of David Winston’s Center for Herbal Studies. Winston is the author of Saw Palmetto for Men & Women (Storey, 1999) and Herbal Therapeutics, Specific Indications For Herbs & Herbal Formulas (Herbal Therapeutics Research Library, 8th edition, 2003).

More detailed descriptions of the new ABC Advisory Board Members are available in the January 2008 edition of ABC’s HerbalEGram. Visit http://www.herbalgram.org/.

On January 15, the US Food and Drug Administration (FDA) released a report concluding that meat and milk from clones of cattle, swine and goats, and the offspring of all clones, are as safe to eat as food from conventionally bred animals.
The US Department of Agriculture’s (USDA) National Organic Program (NOP) released two documents to help explain the impact of the FDA’s announcement.

The NOP issued talking points and a Question & Answer for the industry. On the question of whether the progeny of animals produced using cloning technology or clones can be organic under NOP regulations, the USDA said its Agricultural Marketing Service was "preparing the necessary public rulemaking to address the organic status of the progeny of animal clones," based on a recommendation of the National Organic Standards Board, which advises the USDA on organic policy.

The NOSB recommended that the " ... NOP amend the regulations to add animal cloning technology to the definition of ‘Excluded Methods’ and that the NOP update other sections of the rule to ensure that animal cloning technology is excluded, including all generations of progeny of cloned animals.”�

One question asked was since the USDA does not certify products from cloned animals as organic (such technology is banned under organic production rules), won't consumers be sent the signal that food from cloned animals "are not healthy?"

"No," the USDA said. "It simply reflects the fact that organics is a marketing program. As such, by consensus of the market participants, many production methods and materials are excluded from use."

In response to the FDA’s announcement, the Organic Trade Association (OTA) reiterated that meat, milk and other products produced from cloned animals will not be able to be sold as organic in the US.
 
The national organic standards enforced by the USDA require that organisms be developed and grown by systems that must be compatible with natural conditions and processes—including the breeding and raising of animals for meat and for dairy or other animal production. Cloning as a production method is incompatible with the Organic Foods Production Act (OFPA) and is prohibited under NOP regulations. Thus, animals produced using cloning technology are incompatible with national organic standards and cannot be considered organic.

Organic Valley (La Farge, WI), the nation's oldest and largest cooperative of organic family farmers, stated that it strongly opposes the FDA’s ruling that food from cloned animals and their offspring is safe.

"Organic Valley farmers work in harmony with nature; we don't seek to alter it," said George Siemon, the company’schief executive officer. "Organic Valley and its meat brand, Organic Prairie, will never allow the use of cloned animals on our farms and in our products. And we assume the USDA will never change its organic standards to allow for cloned animals.”

Robynn Shrader, chief executive officer for the National Cooperative Grocers Association (NCGA, Iowa City, IA), which represents 109 natural food co-ops across the nation, stated that “we fundamentally oppose the FDA's decision, based on our core values of governing with the interests of our member stores, customers and farming partners in mind.

"We feel this ruling is geared toward the interests of industrial food manufacturers and marketers of genetically modified organisms, not grocery shoppers or responsible food retailers. Many of our members will be working with us to find alternative solutions to the challenges this will impose upon the supply chain," Shrader added.
 
According to Dr. Chuck Benbrook, PhD, chief scientist of The Organic Center (Boulder, CO), an independent science research organization, there are profound scientific, regulatory, food safety, trade and cultural issues wrapped up in the FDA's decision—including animal welfare issues, as many attempts at livestock cloning still end in fatal birth defects and animals that are often unhealthy.
 
The FDA isn't alone in calling cloned food safe. European regulators last week issued a draft report reaching the same conclusion, and the US National Academy of Sciences has found no cause for concern.

Still, the FDA isn't surprised by the outcry since it pored over 30,500 comments from the public—many of them negative—before issuing Tuesday's ruling. A September 2006 poll by the Pew Initiative on Food and Biotechnology found that 64 percent of Americans were uncomfortable with animal cloning. And when the FDA convened its own focus groups, it found a third of consumers would never eat food from cloned animals, while another third weren't worried and the rest fell somewhere in the middle.

NSF International (Ann Arbor, MI) announced that NSF Draft Standard 305: Organic Personal Care Products is available for public comment until March 3, 2008. This draft standard will be the first US national standard to define organic labeling and marketing requirements for organic personal care products.

Previously, personal care product companies have had to work within the limitations of the United States Department of Agriculture’s (USDA) National Organic Program (NOP) standards, which were written specifically for food. The NSF proposed draft standard might soon be used by companies that would like to make organic label and marketing claims, while meeting the strict requirements of this standard, which includes organic ingredient specifications.

Comments on the proposed draft standard <http://standards.nsf.org/apps/group_public/download.php/263/305i1r6.pdf>  (http://standards.nsf.org/apps/group_public/download.php/263/305i1r6.pdf) may be submitted by visiting: http://standards.nsf.org/apps/group_public/add_comment.php?document_id=263.

The joint committee who developed the standard and incorporated where appropriate, will review these comments. Questions regarding the proposed draft standard or questions on how to submit comments should be directed to Lorna Badman, at (800) NSF-MARK, ext. 6806; (734) 827-6806 or via e-mail at badman@nsf.org

For questions or additional information on the proposed draft standard, contact Greta Houlahan at (734) 913-5723 or houlahan@nsf.org.