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Articles from 2002 In February

Delicious Living

March 1, 2002

Prescription-only Status For Kava Looks Likely In Germany

BONN, Germany—Germany is set to reclassify kava (Piper methysticum) as a prescription-only drug following a recommendation by the country's top government health agency to the German Health Ministry.

A German Federal Institute for Drugs and Medical Devices (BfArM) spokesperson said the herb's new status will take effect July 1 if the Ministry approves the recommendation. This was likely, he added.

The move follows ongoing speculation about kava's safety. BfArM issued an alert last year highlighting cases of liver toxicity that may have been related to kava consumption. The alert precipitated the withdrawal of the product in many European countries.

These cases, plus other evidence, are being scrutinised by health authorities in Europe as well as North America, Australia, New Zealand and parts of Asia. Verdicts on the herb's legality and usage in these regions are expected later this year.

These verdicts are likely to be influenced by the German position, said Maurice Hanssen, director of the UK-based Council for Responsible Nutrition. "The Germans look as if they are taking the precautionary principle to extreme ends," he said. "It seems like a knee-jerk reaction and it may well start a domino effect throughout Europe and maybe the rest of the world."

Hanssen said he was concerned all kava products would be forced behind pharmacy counters when the evidence implies it is only kava extracts that are potentially hazardous.

Berndt Kunz, director of the Organisation for German Health Food Stores, agreed. "Maybe the best situation is for lower-dose products to be freely available while higher-dose extracts should be available by prescription."

Mark Blumenthal, executive director of the American Botanical Council in Austin, Texas, said he is confident the move will not have a major effect on kava's status in the US because it is classified as a dietary supplement there, not a drug, and hence freely available.

Canada Liberalises Supplements Rules

OTTAWA, Canada—Following industry and consumer pressure since the mid-1990s, Health Canada has revamped its antiquated natural health products regulations. Beginning this month, Canadian companies have a two-year transition period to register and label their products with approved health claims and establish GMPs for manufacturing facilities.

"We're hoping this initiative will be recognised as an appropriate approach to product health claims and improved access to products that are useful to consumers," said Philip Waddington, N.D., directorate general of Health Canada's Office of Natural Health Products (ONHP).

In the past, Canadian natural products with health claims were regulated as drugs; otherwise they fell under food regulations. The ONHP's 30-member staff consulted with industry experts to develop a front-end approach that ensures scientific evidence exists to support a product's health claim. ONHP has developed monographs on vitamins, minerals, botanicals and other supplements that will be expanded as research supports new health claims. The level of evidence will be proportionate to the level of the claim, meaning more scientific evidence will be required for a product that attempts to treat a disease than for a product that helps prevent or assists in disease prevention.

"We looked at the US under its Dietary Supplements Health and Education Act (DSHEA), but its claims are not adequately supported by evidence," said Waddington.

Still, the US market obviously weighed on the government's decision to liberalise its markets. An estimated 40 per cent of the products sold in the US have not been allowed in Canada.

Although much of the feedback on the new rules is positive, Waddington noted concerns about what constitutes an appropriate good manufacturing practise (GMP) as well as appropriate standard of evidence for scientific research.

"The world is watching Canada," says Kelley Fitzpatrick, president of Saskatchewan Nutraceutical Network. "We're trying to avoid the US mistakes regarding quality issues, consumer education and media misinterpretation."

Institut Rosell-Lallemand of Montreal, a supplier and manufacturer of probiotics, has hundreds of products for which to obtain product licensure, GMPs, site licensure, new labelling and packaging. Lallemand's regulatory affairs coordinator, Donna Clements, while optimistic about the domestic market, expressed concern about overseas export markets where probiotics are regulated more stringently as a drug.

The proposed regulations can be found at Health Canada's Web site,

Insider Info: Get To Know Your Supplements

Insider Info: Get To Know Your Supplements

Ever wonder if your supplement contains all of the nutrients stated on the label? When in doubt, check out Tod Cooperman, MD, started Consumer Lab in 1999 with a mission: to help consumers, academia and the natural products industry objectively determine the best quality products on the shelves. With the help of William Obermeyer, PhD, formerly of the FDA and an expert in pharmacognosy (the science of natural products), Cooperman and his staff began a systematic evaluation of the best-selling vitamin, mineral, and herbal supplements. Using independent labs throughout the country, CL tests a randomly selected list of supplements (manufacturers can also pay for testing) both for what they contain—the appropriate amount of active ingredients—and what they do not—such as contaminants, including lead and pesticides.

Fish-oil supplements were the focus of recent testing. Of the 20 products examined, only six were lacking in specific omega-3 oils, and none of the products contained mercury. Other products tested have run the gamut from St. John's wort to energy bars. The results of the testing (updated every 36 months) are posted on the Web site, but you can also get the full list of products and additional consumer tips with an annual subscription ($16).

—Barbara Hey

Ant Juice Bites Into UK Energy Drinks Market

MIDDLESBROUGH, UK—An energy drink that has an Asian ant as its principal ingredient has confounded skeptics by making a successful entry into the UK stimulant-drinks market.

Ant Natural Stimulation, launched in the UK late last year, is produced and distributed by independent drink supplier InterContinental Brands (ICB). "We were ready to deal with a lot of negativity to do with the ants, but I can honestly say we haven't had one negative response since the drink was launched," said Marketing Manager Lindsey Booth.

"People expect stimulation drinks to have a bad taste, but that's not the case with Ant," she added. She said the drink has proven popular as an alcoholic mixer, and bar patrons are warming to tipples with names like Lubric-ant (vodka and Ant) and Agony Ant (gin and Ant).

Booth said plans are afoot to establish Ant in other regions, including a soon-to-be-concluded deal with China, where the two breeds of Polyrachis ant used exclusively in the drink are farmed.

The drink is thought to raise energy levels, fight ageing and enhance sexual vigour, as well as fortify the immune, nervous, muscular, digestive, kidney and skeletal systems. It is also believed to possess detoxification properties.

Ant consumption, traditionally popular with middle-aged and older Asian consumers, has become popular among young Asian adults as well.

Ant contains 1.65mL of the herbal formula, which consists of Polyrachis ant plus schisandra (Schisandra chinensis) and lycium (Lycium barbarum, L. chinense) in a blend of 38 per cent fruit juices (passion fruit, lychee, white grape, apple and lemon juice). It retails for about US$1.40 in the UK.

Lifeway Foods Reports Record Year End Results Net Income Rose 32% on 16% Increase in Revenue

MORTON GROVE, Ill., Feb. 27 /PRNewswire-FirstCall/ -- Lifeway Foods, Inc. (Nasdaq: LWAY) today reported record year-end results for the 2001 fiscal year. The company reported net income of $1,220,927 or $.28 per share on sales of $10,683,983 for the year ended December 31, 2001, compared to net income of $927,100 or $.21 per share on sales of $9,176,739 for the year ended December 31, 2000. Those figures represent a 16% increase in sales and a 32% increase in net income over 2000, also a record year.

Michael Smolyansky, President and CEO, attributed the company's strong performance in 2001 to continued expansion in mainstream markets, and the growing acceptance of SoyTreat(TM), the probiotic soy beverage, and Lifeway Organic(TM) lines, as well as the rising awareness of the probiotic health- related benefits of its flagship kefir beverages.

He predicted continued growth in 2002, generated in part by the recent expansion of Lifeway products into the Hispanic market under the brand name La Fruta(TM).

"Our growth in 2001 was almost identical to what we experienced in 2000, and we appear to be on track for stronger gains this year based on our results to date." Smolyansky added, "Our La Fruta products are performing exceptionally well in the Hispanic community, which represents the fastest- growing demographic in the United States, and the rest of our product line continues to sell briskly. We therefore have every reason to believe that 2002 will again break records for sales and profits."

Lifeway is a manufacturer of cultured, probiotic and functional food products in the health food industry, and is America's leading supplier of the cultured dairy product known as kefir. The Company markets 12 flavors of kefir and does a successful business exporting its products to Canada. The Company also participates in the organic and soy markets with Lifeway Organic(TM), Organic Kefir and Kefir Cheese, and America's first soy kefir called SoyTreat(TM).

For more information, contact Michael Smolyansky, President, Lifeway Foods, Inc. at (847) 967-1010 or e-mail at [email protected] or visit .

This news release contains forward-looking statements. Investors are cautioned that actual results may differ materially from such forward-looking statements. Forward-looking statements involve risks and uncertainties including, but not limited to, competitive pressures and other important factors detailed in the Company's reports filed with the Securities and Exchange Commission.

Forbes Medi-Tech Offers to Assist with Take Heart™ Line of Food Products

Vancouver, British Columbia - February 26, 2001 - Forbes Medi-Tech Inc. (TSE:FMI and NASDAQ:FMTI), currently in active discussions with several major food manufacturers regarding the commercialization of its proprietary cholesterol-lowering food ingredients, has been approached by Novartis Consumer Health to help them find a buyer for the Take Heart™ line of food products enriched with Forbes' Reducol™. This follows the decision by Novartis and The Quaker Oats Company to dissolve the Altus Food Company. Altus had originally been set up by Novartis and Quaker Oats as a joint venture to develop functional food products.

While the operations of Altus have ceased, the two companies are reviewing the most appropriate options to continue the brand. Take Heart™ was test marketed in upstate New York in the latter half of 2001. This test market was completed at the end of the fourth quarter. During the test market, Quaker was acquired by PepsiCo Inc.

"The decision to dissolve the Altus Food Company had more to do with the acquisition of Quaker by PepsiCo and Novartis refocusing its businesses than it had with the Take Heart™ line of products themselves," stated Charles Butt, President of Forbes. "In fact, sales of Take Heart™ products during the test launch in upstate New York last fall were reported to be extremely positive and the products were well received by consumers. This decision obviously ties in with Novartis' recent announcement to divest their health and functional food business in order to focus exclusively on the more familiar core pharmaceutical and healthcare business."

Forbes is currently in active discussions with several other major food and dietary supplement manufacturers interested in launching their own line of cholesterol-lowering products using Forbes' proprietary ingredients. Forbes has offered to introduce the possibility of a Take Heart™ acquisition into these discussions where appropriate. "As we were not clear about the direction PepsiCo and Quaker were going to take regarding the expansion of the functional food area, sales of Reducol™ to Altus represented a small percentage of our 2002 budgeted tonnage. We anticipate that the finalization of new food contracts, which are presently under negotiation, will make up for any shortfall," stated Butt.

Reducol™ is one of Forbes' proprietary cholesterol-lowering compositions of non-genetically modified plant sterols/stanols derived from coniferous trees. Forbes licensed the composition to Novartis in 1999 and recently announced its intention to repurchase the worldwide rights to Reducol™ for consumer products. Novartis Nutrition AG, an affiliate of Novartis, has an exclusive option for the worldwide royalty-bearing license to use Reducol™ in medical foods.

Forbes Medi-Tech Inc. is a diversified health sciences company dedicated to the research, development and commercialization of innovative nutraceutical and pharmaceutical products derived from nature. By extracting plant sterols from wood pulping by-products, Forbes is developing cholesterol-lowering agents to be used both as functional food ingredients and pharmaceutical therapeutics in the battle against heart disease. Forbes is also developing innovative fermentation technology that converts plant sterols into pharmaceutical fine chemicals, essential in the production of various pharmaceutical steroids such as contraceptive agents and anti-inflammatories. Phytrol™ is a registered trademark of Forbes Medi-Tech Inc.

Roche Says Vitamin, Fine Chemicals Division Could be Spun Off

Roche Holding AG is talking about spinning off its vitamin and fine chemicals division. The company is currently considering strategic options with this division and much of the market expects an outright sale.

The division's strength lies in its large product range, suggesting that splitting the division into components wasn't likely.

Roche is facing heavy costs of fines and lawsuits over the division's price fixing and selling the vitamins division would also allow the organization to focus on its drug business, whose performance has lagged behind the markets.

Roche apparently has no plans to amend its share structure for the foreseeable future.

Roche shares fell 28 percent last year, despite pharmaceutical sales growth of six percent. Industry average growth was 8 percent.

Investor confidence will be largely dependent on Roche's growth in the pharma business.

Can AlavisMSM Help Maintain and Protect Equine Articular Cartilage? Preliminary Research Results Say “Yes”.

BURLINGTON, ON, — Carolwood Corporation is undertaking a study into the use of AlavisMSM, their ultra-pure MSM specially formulated for the equine industry, for the maintenance and protection of equine articular cartilage. Now 50% complete, the study has already shown that MSM has a positive impact on reducing inflammation and protects the cartilage from further degradation. This is extremely exciting news for owners of equine athletes in the world of racing, show jumping and endurance, as well as those with horses suffering from the pain, heat and swelling associated with joint disease. The study also lends scientific credence to the largely anecdotal evidence that has helped propel LignisulMSM into the Top 5 most popular supplements for arthritis sufferers.

The investigation used articular cartilage which was excised from nine horses which had been euthanised for reasons other than joint disease. The explants were cultured to ensure the continued production of ‘Chrondocytes’ – the cells that form and maintain the cartilage matrix and ‘Glycosaminoglycan’ (sGAG), which are the small molecules that bind with core protein to create ‘proteoglycans’. These are the fundamental building blocks of articular cartilage and the major GAGs are: chrondroitin-4-sulphate, chrondroitin-6-sulphate, keratin sulphate and hyaluronan.

Inflammatory mediators were than introduced to simulate a pro-inflammatory condition. These included ‘Prostaglandin E²’ (PGE²) which produces the characteristic pain, heat and swelling associated with joint disease and stimulates the release of enzymes that break down proteoglycans and ‘Inducible Nitric Oxide Synthase’ (iNOS) which combines with free radicals and promotes degradation of articular cartilage. ‘Recombinant Human Interleukin 1’ (IL-1), a peptide mediator that increases the degradative metabolic process in cartilage and in vitro explant systems was added to some cultures and Lipopolysaccharide (LPS), a component of the bacterial cell wall that triggers chrondocyte-mediated breakdown of articular cartilage, was added to others.

Introduction of these mediators was expected to have a number of consequences and within a very short time (2 days), it was evident that there was a substantial breakdown of proteoglycans and subsequent loss of GAGs, together with an increase in production of PGE² and inflammatory molecules such as nitric oxide.

When AlavisMSM was added to the culture media obvious therapeutic effects were detected almost immediately:-


There was a marked reduction in the loss of GAGs from cartilage exposed to the inflammatory mediators IL-1 and LPS. Even at very low levels, AlavisMSM has been shown to reduce the production of PGE²s.Carolwood Corporation is confident that this data clearly indicates the protective potential of AlavisMSM on equine articular cartilage and its inclusion in a wide range of dietary supplements and topical applications will bring tangible benefits to animals at risk of joint injury or those already suffering pain.

Full statistical analyses are being prepared by the Company and will be released in a couple of months time.

Carolwood Corporation, Greenville PA is the exclusive manufacturer and supplier of LignisulMSM and AlavisMSM, all-natural, patented nutritional supplements that provides biologically-active sulfur for arthritis, muscle and joint pain.

Nutraceutical Clinical Laboratories International, Inc. Announces Two New Appointments

Burt Sookram, Vice President, Research & Development/Quality Assurance George Merrell, Plant Manager

ST. PETERSBURG, Fla., Feb. 25 -- Nutraceutical Clinical Laboratories International, Inc. (OTC: NCCL) today announced the appointments of Mr. Burt Sookram as Vice President, Research & Development/Quality Assurance and Mr. George Merrell, Plant Manager.

Burt Sookram, Special Projects Manager for United Beverage Group, brings years of experience to a host of leadership roles throughout a distinguished career in the food industry. Previously, he served as president of BAIT Corporation and Catalina Food Ingredients, Inc. Mr. Sookram was General Manager of FlavorTech, a division of Sara Lee. His extensive experience includes research and development, operational management, procurement, quality assurance, total quality management and sales. Mr. Sookram has developed several products for bakery, seafood, sport drinks, snack food seasoning, meats and the pizza industry sold in today's marketplace.

Mr. Sookram received his BS and MS in Chemistry from the University of Toronto, Canada.

George Merrell, Plant Manager for KIK International f.k.a., The Dial Corporation, has over twenty years of progressive, management experience.

Within the consumer products industry, Mr. Merrell has had direct responsibility for manufacturing, safety, quality, engineering, maintenance, and human resources.

Mr. Merrell received a Bachelor Arts in Social Science from Edinboro, University of Pennsylvania.

For complete biographical sketches on Mr. Sookram and Mr. Merrell, click on .

Paul Simmons, CEO, states, "We are extremely happy to welcome these two gentlemen to our staff. Their expertise and experience will enable us to ramp up our production to meet the demanding expectations of our customers."

NCLII is committed to researching, designing, producing, and marketing their line of natural preservatives and anti-aging supplements using the highest quality standards, procedures, protocols, and controls. Our products will be manufactured according to the Food and Drug Administration (FDA) criteria for Good Manufacturing Practices (GMP) and will be backed by thorough scientific testing and clinical trials.

Nutraceutical Clinical Laboratories International, Inc. trades on the OTC market under the symbol "NCCL" and can be found on the Internet at: , , , and . Additional company information may be found at Nutraceutical Clinical Laboratories International, Inc.'s website: .

Special note: Forward looking statements in this press release are made pursuant to the "safe harbor" provision of the Private Securities Litigation Act of 1995. Investors are cautioned that such forward looking statements involve risks and uncertainties, including without limitation, market acceptance of, demand for, the Company's products, manufacturing, development and distribution issues, product pricing, competition, technological changes and other risks not identified herein.