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Articles from 2003 In August


Delicious Living

September 1, 2003

Will ephedra speed a DSHEA shakeup?

As the ephedra crisis deepens in the US, the supplements industry is bracing itself for a 'full-scale legislative assault' on the ten-year-old Dietary Supplement Health and Education Act (DSHEA), as an increasing number of government members begin to question the industry's ability to self-regulate. A federal bill (The Dietary Supplement Safety Act) to amend DSHEA, introduced in March, is causing concern about how long the current legislative structure can remain.

A poll taken during a recent high-level meeting of senior industry executives in San Diego, California, found 79 per cent thought the industry should prepare for an amendment to DSHEA (See below).

Capitol Hill hearings in July recommended an outright ban on ephedra as well as further amendments to DSHEA that would expand the powers of the FDA to regulate the supplements industry. These have been set out in a bill, introduced in August, the DSHEA Full Implementation and Enforcement Act, which will boost FDA funding. FDA commissioner Mark McClellan, MD, PhD, said it was difficult for the FDA to take action against potentially dangerous products under DSHEA as it stood.

"If this bill is passed, the FDA will have no more excuses for inaction. It will also put to rest the idea that Congress and the industry don't want to see DSHEA fully implemented," said the National Nutritional Foods Association executive director and CEO, David Seckman.

When DSHEA became law in 1994, it was celebrated as a revolutionary piece of legislation that would allow the US supplements industry to achieve maximum innovation with minimum government intervention. The intended result was ultimate variety in consumer choice.

But ultimate variety has meant an industry that is difficult to police. Ephedra has highlighted this situation and led to calls from legislators, some industry observers and consumer groups for the Act to be revised—or scrapped completely. Ephedra has been linked to 100 deaths including a high-profile professional sportsman, which has made it a very public issue, especially when it was revealed that, in addition, 16,000 reports of serious side effects were not acted upon.

So is this the end of self-regulation? San Diego-based Nutrition Business Journal editor, Grant Ferrier, insists the industry must demonstrate to regulators why self-regulation can work, despite ephedra. "The industry has sustained vague threats in the past but the ephedra safety issue seems to have been the proverbial last straw to tip Congress into action and the industry into serious response mode. There is a sense that if industry doesn't come forward and participate with real solutions, government will dictate new market conditions that may be difficult for business."

Even a more vigilant FDA may not be enough to save DSHEA, said the NNFA's Seckman. "Even if the FDA bans ephedra tomorrow, which we believe it has the ability to do under the law, I believe there's already too much momentum in Congress to avoid a full-scale legislative assault on DSHEA," he said.

Nestlé Nutrition Division's vice president of new business, Steve Allen, was less dire. "We'll see more enforcement and specific action against rogue companies and dubious products but I don't think DSHEA is really at risk."

An FDA verdict on ephedra was imminent as FI went to press.

Industry leaders: What they're saying

Top-level executives were polled at the recent NBJ Newport Summit in San Diego

Ephedra
63% believe the industry will be ephedra-free by January 2004

67% support a national ban

DSHEA
79% think the industry must be prepared for legislative amendments

Regulation
63% would support an 'intermediate' regulatory status for herbs (between DSHEA-supplements and drugs)

Functional Foods
54% said they had more confidence in this sector than any other going forward to 2005

69% support a separate regulatory status like Japan's FOSHU

Negative Media Coverage
73% say the best way to respond is to clean up product quality and claims and self-police more effectively

Scientific Research
57% claim research is extremely important

61% say most companies wait for others to fund research, pursuing a 'me-too' product strategy

56% spend more than 6% of net sales revenue on scientific studies to prove product efficacy

29% spend less than 1% of net sales

 

UK Study Suggests Sage Improves Memory

According to an MSNBC story quoting the Alzheimer's Association as the source, British scientists have confirmed that the herb sage can be used to improve memory, a finding which has possible implications for Alzheimer’s treatment.

Scientists at the English universities of Newcastle and Northumbria have found that young adults taking sage oil capsules performed better in word recall tests, confirming centuries-old theories.

In the study, funded by Oxford Natural Products, 44 healthy, young adults were given either the sage oil capsules or placebo.

Original Article: http://www.msnbc.com/news/958833.asp?0cv=HA00#BODY

Carrington Stock Jumps 13%

Source: Roger Yu , The Dallas Morning News

Positive test results, revenues boost investor optimism

Optimism over its developing drug injection technology and a return to profitability are sending shares of Carrington Laboratories Inc. to new highs.

The Irving-based biomedical research company saw its shares jump nearly 13 percent Wednesday even though it released no formal news. They rose 59 cents to finish at $5.29, a 52-week high. That's a far cry from $1.60, where the stock was trading as recently as May 27.

Chief financial officer Robert Schnitzius said the company has "two types of investors looking at us" – ones interested in its nascent research and development efforts and others keen on the revenue of its more established products.

Last week, Carrington announced that animal testing of its injection technology rendered favorable results. The company is aiming to develop a method in which a liquid medicine can be injected and become gelatinous once it comes into contact with the body's cellular fluids.

Certain types of medicines are best distributed over a period of time, rather than all at once. And injecting in the gelatinous format is an effective distribution method for such drugs, Mr. Schnitzius said.

The tests showed that the injected substance was distributed in a period of seven days and the polymer that becomes the gel substance was absorbed into the body after delivery, he said. "People are starting to get interested in drug delivery technology," he said.

Still, the company has a long way to go before commercializing the product. The animal testing phase precedes Phase I of the Food and Drug Administration approval process, which requires three rigorous testing phases.

For the quarter ended June 30, Carrington's revenue rose 83 percent to $7.96 million, largely due to increased sales at its Caraloe Inc. division that sells aloe vera related raw materials and other cosmetic products. Caraloe's revenue skyrocketed 181.2 percent in the second quarter. Carrington posted net income of $339,000 in the quarter, compared with a net loss of $858,000 a year ago.

Original Article: http://www.dallasnews.com/business/stocks/stories/082803dnbuscarrington.65130.html

New Clinical Study Uncovers Mechanism By Which Chromium Picolinate May Enhance Insulin Sesitivity In Patients With Type 2 Diabetes

Effective and Safe Complementary Nutrition Therapy Presented at 18th International Diabetes Federation Congress

PARIS, France, August 28, 2003 (Nutrition 21, Inc. Nasdaq: NXXI) – The results of a new double-blind randomized placebo controlled human trial of people with type 2 diabetes revealed a potential mechanism that may explain the ability of chromium picolinate to improve insulin resistance in human skeletal muscle – the primary site for glucose metabolism. These data suggest that when chromium picolinate is added to the diet, insulin sensitivity improves for people with diabetes, a chronic disease that affects 194 million people worldwide. The findings were presented by Dr. William T. Cefalu from the University of Vermont College of Medicine, USA at the 18th International Diabetes Federation Congress.

Research suggests that the potential in vivo mechanism of chromium picolinate on insulin action in human skeletal muscle may occur by increasing the activation of Akt phosphorylation -- an intracellular insulin dependent protein that facilitates the uptake of glucose into cells.

“This study demonstrates that those individuals with type 2 diabetes who supplemented their diet with chromium picolinate had an enhanced activity of the protein compared to those who were on placebo,” stated Dr. Cefalu. “As this intracellular pathway is implicated in contributing to insulin resistance, this represents a possible mechanism to explain chromium picolinate’s beneficial effect on insulin sensitivity as observed in several clinical studies.”

The clinical trial
The double-blind, placebo controlled trial, included two cohorts of subjects with type 2 diabetes who were treated with either sulfonylureas (a class of diabetic drugs that increase insulin secretion), or a diet program. Both groups were randomized to receive either chromium picolinate (1000 mcg) daily or placebo. The most accurate measure of insulin sensitivity, hyperinsulinemic, euglycemic clamp studies, were used to assess the efficacy of glucose uptake on all subjects prior to randomization and at the end of the study. Of the 16 subjects, those randomized to chromium picolinate had a mean increase in insulin sensitivity of 8.9%, while the placebo group had a mean decrease of 3.6%. In addition, insulin-stimulated Akt activation was significantly increased at the end of the study compared to those subjects on placebo. No adverse events were reported.

A Cost Effective Nutrition Therapy
The World Health Organization (WHO) estimates that four to five percent of health budgets are spent on diabetes-related illnesses and that people with diabetes incur medical costs two to five times higher than people without diabetes. According to the Centers for Disease Control (CDC), direct and indirect costs of diabetes are $132 billion a year in the United States.

Chromium is an essential mineral that is a co-factor of insulin. “By applying rigorous science, we hope to show chromium’s potential to improve the quality of patient care for people with diabetes and reduce cost of therapy,” said James Komorowski, MS, Vice President of Technical Services and Scientific Affairs, Nutrition 21, Inc., which supplied Chromax chromium picolinate for the study. Chromax chromium picolinate is the most clinically tested brand of chromium with proven efficacy for support of glucose metabolism. “This new research further supports the large body of scientific evidence showing chromium picolinate is a safe and effective addition to the diet for people with type 2 diabetes seeking optimal control of their blood sugar levels.”

Nutrition 21 provided an unrestricted research grant and Chromax® chromium picolinate for the trial. Nutrition 21 is a leading developer and provider of nutritional products, whose health benefits are substantiated by clinical research. The Company markets Chromax chromium picolinate, the leading brand of chromium, and holds 35 patents for nutrition products, 22 for chromium compounds and their uses. More information is available at www.nutrition21.com. More information about Chromax is available at www.chromax.com.

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New VP of Sales at Traditional Medicinals

Traditional Medicinals is pleased to announce that Darrick Blinoff has been promoted to Vice President of Sales. Prior to his promotion Darrick held the position of National Accounts Manager. During the past twelve years Darrick has worked to maintain and develop Traditional Medicinals as the premier brand of medicinal herb tea in the United States and Canada. He has been an advocate of alternative herbal medicine for over twenty-five years.

"As more and more people turn to alternative modes of health, and seek out natural and preventative health care, our medicinal teas are a perfect lifestyle compliment", says Darrick. "The quality of our tea and ethics of our company are unparalleled, making for a dedicated sales force, and a truly loyal customer base".

Darrick received a BA in English Literature from San Francisco State University, and his previous work history includes stints as a firefighter, wholesale baker, carpenter, and fresh juice salesman. When he is not selling tea, Darrick enjoys camping with his family in the Sierra's.

Traditional Medicinals (http://traditionalmedicinals.com) is a leader in the manufacture and marketing of clinically tested medicinal herb teas for the Specialty Tea market in the United States and Canada.

Editorial: One Industry Voice - Harmony or Discord?

By Len Monheit
[email protected]
Comment on this Editorial

Examining industry releases over the past several weeks, one finds headlines such as ‘CRN Expands Outreach to Congress’ or ‘…. responds to GMP’s’. It becomes quite apparent that groups are working on behalf of the industry in a consistent dialogue with regulators, media, scientists and others to support and improve the sector and its ability to contribute to and support consumer health.

In addition to trade association actions and activities, consumer groups such as Citizens for Health are working diligently to ensure consumer interests are represented and heard and on top of this, other organizations such as The Healthy Foundation and The Dietary Supplement Education Alliance (DSEA) are doing work with and communicating on behalf of the industry. Each group has its own support mechanism, identity, objectives and mission for its constituency. Yet all are part of a total effort to promote health and wellbeing.

These are times that call for action and activity, to challenge convictions and misperceptions and to fight at many levels to preserve the essence of an industry and help to guide it into an uncertain future. The collective mission statement of the industry may involve statements such as ‘freedom of choice’, ‘strong markets’, ‘responsible marketing’, ‘enhancing confidence’, ‘higher standards of quality’, ‘reaching out to media, healthcare professionals, decision makers and consumers’, objectives that most , if not all will agree with, if not actively espouse. There are potential benefits from having several pressure points at work, disseminating information and communicating - providing the message is both simple and consistent.

This industry has often been accused of fragmentation with no single voice, and there may be some truth to this observation. One of our industry realities is that the we are composed of such diverse companies with such a range of products, that no single association or group covers the entire constituency base and no voice is truly the ‘industry voice’. Yet at last month’s Newport Summit, industry leaders were told that they needed to speak with one voice to improve the industry’s image - a challenging prospect. The situation is made even more complicated by inertia, apathy and in too many cases, lack of active involvement from those these groups would propose to represent. How can industry have one voice if it’s speaking with shattered vocal chords?

It’s very easy to criticize and say , ‘Why is this happening and what’s the association doing?’ or ‘How come we didn’t know this was coming?’ and ‘What are you going to do now?’ at the same time as you yourself are overwhelmed and wrestling with company challenges required to compete in today’s business environment. Collectively, at some level, many feel relief that there is someone out there, lobbying government, interpreting regulations and challenging the media – so they don’t have to.

Whichever constituency you belong to, whatever your history and circumstance, there has never been a more important time to be aware, to be involved and to add your voice to the collective industry voice by actively participating and supporting these groups. As you participate in industry events, as you read industry publications, as you plan for your future and that of your company, consider carefully the work being done on your behalf by these groups and associations. Consider too the contribution you and your organization could make as well as the risk you face of you are not part of this process.

I confess that I don’t understand the nuances and details of lobbying efforts and the amount of behind the scenes work involved to get ears and attention of those who must be reached. I can only imagine the patience with which such efforts must be employed and understand the frustration which must accompany intention and efforts. And over the past few years, with increasing financial pressures, difficult times for the industry as it has been repeatedly bombarded by media, government and other opponents and critics, there are individuals who have worked tirelessly on behalf of the industry, often with little obvious success, and few small victories to keep themselves and their staff motivated in a larger war.

Kudos to these and other groups working diligently (Editor’s Note: This is partial list only. If there are other groups that should be listed, we salute them.):

Some Problems Persist With Ginseng Supplements But Overall Quality Imporves According to Consumerlab.com

WHITE PLAINS, NY – August 28, 2003 – In contrast to its testing three years ago in which nearly 60% of Asian and American Ginseng supplements were found to have significant problems, testing of recently purchased products by ConsumerLab.com found problems with a far lower percentage – 17%.In one of five products claiming to contain “Korean Ginseng” a high amount of the pesticide hexachlorobenzene was found. In 2000, most Korean Ginseng products showed pesticide contamination. Hexachlorobenzene is a probable human carcinogen and is banned from most crop use throughout the world. One other product that failed the new testing was a liquid “Chinese Ginseng” sold in single-dose bottles.Despite being labeled “EXTRA STRENGTH” this product contained less than 10% of the expected ginsenosides – biologically active constituents of ginseng.In 2000, more than 30% of ginseng products tested low in ginsenosides.

Ginseng is used for many purposes, although most commonly to improve overall energy during times of stress. While there is not much clinical evidence to support an energy boosting effect, there are studies showing its potential value in normalizing blood glucose levels in diabetics, helping to stimulate immunity and treat male impotence, and, when used with ginkgo biloba, improving memory and symptoms of attention deficit-hyperactivity disorder (ADHD) in children.

Remarking on the findings, Dr. Tod Cooperman, ConsumerLab.com’s President, said, “The problems that we identified with ginseng in 2000 were an eye-opener for consumers and the industry.We would like to think that this has contributed to the apparent improvement in quality – although consumers clearly must remain cautious.”

The Review can be found at http://www.consumerlab.com/results/ginseng and includes results for 18 supplements, including twelve tested in the Review and six others that recently passed the same evaluation through ConsumerLab.com’s Voluntary Certification Program. The Review also provides information on how to best choose and use these supplements. Subscription is required for the full report. Reviews of other popular types of supplements are also available online. Soon to be released new Reviews include Muscular Enhancers (Creatine, HMB, and Glutamine), Joint Supplements (Glucosamine, Chondroitin, MSM, and SAMe), Lutein and CoQ10. ConsumerLab.com's Guide to Buying Vitamins and Supplements: What's Really in the Bottle will be released in paperback next month --debuting at the Natural Products Expo in Washington, D.C.

ConsumerLab.com is a leading provider of consumer information and independent evaluations of products that affect health and nutrition. The company is privately held and based in White Plains, New York. It has no ownership from, or interest in, companies that manufacture, distribute, or sell consumer products. ConsumerLab.com is affiliated with PharmacyChecker.com (www.pharmacychecker.com), an evaluator of online pharmacies. Subscription to Consumerlab.com is available online. For group subscriptions, Technical Reports, or product testing contact Lisa Sabin, Vice President for Business Development, at [email protected].

Stake Technology Announces Closing of US $49 Million Equity Issue

TORONTO, ONTARIO--Stake Technology Ltd. (Stake) (Nasdaq:STKL) (TSX:SOY)announces that it has closed its previously announced offering of 7,000,000 common shares in the United States and in certain provinces of Canada. The price of the offering is US $7.00 per common share or US $49 million.

The net proceeds from the offering will be used for general purposes, including acquisitions, internal expansion projects and working capital requirements and to reduce outstanding indebtedness.

Stake Technology Ltd., soon to be SunOpta Inc., is an owner/operator of high-growth ethical businesses in the natural and organic food markets. The company has three business units: the Food Group, which specializes in sourcing, processing and distribution of natural and organic food products integrated from seed through packaged products; the Environmental Industrial Group, a producer, distributor, and recycler of environmentally friendly industrial materials; and the Steam Explosion Technology Group which engineers and markets clean pulping systems using patented steam explosion technology.

Avalon Organics Sails Through California's First Product Review with Flying Colors

PETALUMA, Calif., Aug. 28 /PRNewswire/ -- Avalon Organics, makers of top-selling natural and organic bath and body care products, announced today that the State of California's Department of Health Services recently completed a three month, comprehensive review of the company's ingredients and labeling procedures. On August 11, 2003, the State notified Avalon Organics, a long-time supporter of organic agriculture and a strong advocate for independent farmers, that their products and labeling procedures are fully compliant with the California State Organic Program.

The State of California, a leader in legislative incentives as they relate to environmental issues, has the only government in the world to enact organic legislation as it applies to personal care products. For this reason, California, more than any other state in the U.S., has taken a proactive stance regarding the use of organic ingredients in bath and body care products.

During the State's examination, a variety of issues, including Avalon's claim of "70% Organic Ingredients" on many of their products, was reviewed. The State concluded that the products did, as the company states, contain a minimum of 70% organic ingredients. According to the written report, "Upon review of the firm's labels and product formulations, the Department was unable to find any instance where there was a statutory or regulatory basis to discount any organic ingredients from the calculation."

Certified Organic Hydrosol is an ingredient found in each of the Avalon Organics' products reviewed by the State. Avalon Organics' uses hydrosols, which are certified organic by the California Certified Organic Farmers (CCOF), and in compliance with the National Organic Program and California law. The company was pleased that the State recognized the use of certified organic hydrosols in their products.

Avalon Organics has demonstrated its commitment to organic standards by being a founding member of the Personal Care Organic Task Force in 1999, now a committee of the Organic Trade Association. The company has maintained its leadership role by investing considerable time and resources to successfully lobby for the passing of The California Organic Products Act (AB 2823), signed by Governor Davis and put into effect in January 2003. The Act is the first to help advance and ensure that organic claims for personal care products are accurate and meaningful. Because Avalon Organics has worked diligently to see the enactment of Organic Standards in California, the company was thrilled to be the first manufacturer reviewed under the Act it helped to create, and extremely pleased with the overwhelmingly positive results of the review.

Avalon Natural Products is a leading maker of a unique line of therapeutic body care products derived from certified organic, aromatic flowers and herbal botanicals. Using 70% to 100% of the finest certified organic ingredients, Avalon products include Vitamin C Skin Care, CoQ10 Skin Care and Hair Care Elixirs. The Avalon Organic Botanicals range includes Skin Care, Lotions, Deodorants, Bath products, Soaps, Hair Care, Cream Shaves and Gift Collections. For detailed product information on the entire range of Avalon products, please visit www.AvalonOrganics.com. Avalon products are available in fine health food and specialty stores.