AOAC Research Institute Certification for Proprietary Rapid Vitamin Test Kit; Biacore Folic Acid Kit Internationally Certified as a Performance Tested Method

UPPSALA, Sweden, Sept. 18, 2002 (PRIMEZONE) -- Biacore International AB (Biacore) (Stockholm:BCOR) (Nasdaq:BCOR) today announced that its unique food analysis kit, indispensable for the rapid routine testing of the vitamin food supplement folic acid, has now been fully validated and certified as a Performance Tested Method(SM) by the AOAC (Association of Analytical Communities) Research Institute.

This internationally recognized certification of Biacore's Folic Acid kit means that food manufacturers worldwide now have a trusted and effective routine means to rapidly meet legal requirements on vitamin fortification. As the foremost independent body determining food testing standards worldwide, AOAC Performance Tested Methods status assures the user that a totally independent third-party review has been undertaken and the test kit fully meets all performance claims.

The Folic Acid Kit from Biacore routinely measures this important B- vitamin in hours rather than the days that it takes traditional microbiology-based assays (MBA). This enables manufacturers to closely control vitamin dosage and to minimize wastage. Used with Biacore Q, a dedicated system for concentration analysis, the ready-to-use kit provides accurate and reliable measurements of folic acid in a variety of foodstuffs, including: cereals, milk powder, pre-mixes, as well as milk and soya-based infant formulas.

Utilizing the principal of Surface Plasmon Resonance (SPR) biosensor technology, used widely in the pharmaceutical industry, the Biacore Folic Acid Kit is based on the principle of inhibition assay. In addition to providing faster results, higher productivity and lower costs, this also delivers increased specificity and sensitivity of great benefit for testing in the food industry.

"As a supplier to the food analysis industry, international certification of our technology is of immense importance to us. It provides potential users of our unique high performance, but cost saving methodology, with the confidence that Biacore analysis offers a really effective rapid testing alternative to the traditional methods largely used in the food industry today," said Esa Stenberg, Vice President and Head of Business Unit Food at Biacore.

"Biacore is expanding the number of kits it offers to cover analysis of a range of water soluble vitamins and residues of increasing concern in the area of food safety," he added. "These include tests for biotin, vitamin B12, streptomycin, clenbuterol, and the newly launched ractopamine kit, amongst others."

For further information, please contact:

Scientific/Trade Press Enquiries:
Sarah Perceval, HCC De Facto Group
+44 (0) 20 7496 3300
s.perceval@hccdefacto.com

Cautionary Statement

This press release contains certain forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, which, by their nature, involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements.

About Biacore
Biacore is a global market leader in Surface Plasmon Resonance (SPR) technology based systems with its own sales operations in the U.S., across Europe, Japan, Australia and New Zealand. A strong patent portfolio protects Biacore's SPR technology, which gives unique real-time insights into biomolecular interactions. Target groups for the Company's products consist primarily of medical and life science research laboratories and pharmaceutical and biotechnology companies around the world. Biacore is focusing on drug discovery and development as its prime areas for future growth. The Company currently has seven systems on the market, the most important of which are: Biacore(R)S51 for applications downstream of high-throughput screening (HTS) including rapid characterization of HTS hits, and the comprehensive pre-clinical evaluation of lead compounds, and Biacore(R)3000, which offers flexibility in key life science research and drug discovery applications upstream of HTS. The recently introduced Biacore(R)C is specifically designed for compliant concentration analysis of biopharmaceuticals in GLP/GMP applications. A new SPR array chip system, which will provide higher information content, is expected to reach the market in 2004.

Based in Uppsala, Sweden, the Company is listed on Stockholmsborsen and Nasdaq in the U.S. In 2001 the Company had sales of SEK 544 million and an operating income of SEK 64 million.

Further information on Biacore can be found on the web: www.biacore.com

Address and phone: Biacore International AB Rapsgatan 7, SE-754 50Uppsala, SWEDEN Phone: +46 (0)18-67 57 00 Fax: +46 (0)18-15 01 10e-mail: info@biacore.com

About AOAC Research Institute
AOAC Research Institute was incorporated in December 1991 as a subsidiary of AOAC INTERNATIONAL.

The AOAC Research Institute is an independent nonprofit corporation with a mission to promote and carry out activities related to the development, improvement, and understanding of analytical practices and procedures affecting public health and welfare. The institute is a subsidiary of AOAC INTERNATIONAL (formerly the Association of Official Analytical Chemists) established specifically to independently administer the Performance Tested Methods(SM) program. Further information on AOAC can be found on the web: www.aoac.org

Heintzman Farms Receives Endorsement from the Center for Advancement in Cancer Education

ONAKA, S.D. -- September 18, 2002 -- Heintzman Farms, producer of Dakota Flax Gold flaxseed and flaxseed products, has received the endorsement of the Center for Advancement in Cancer Education. This endorsement comes on the heels of the several medical studies using flaxseed to help control specific cancers.

Recent research suggests that flaxseed may have myriad health benefits including positive effects on hormone-related cancerous tumors. Two flaxseed components may be responsible for this action: omega-3 fatty acids (flaxseed is the richest plant source), and antioxidant plant hormones called lignans. With 100 times more than any other plant, flaxseed is the richest source of lignans.

Researchers first observed flaxseed's anti-cancer properties in both animals and humans. One study showed that rats fed a diet supplemented with flaxseed produced fewer and smaller tumors when exposed to cancer-inducing agents. In a University of Toronto study completed in December 2000, flaxseed-enriched muffins were as effective as pre-surgery tamoxifen at reducing the proliferation of estrogen receptor-positive breast cancer cells. In a Duke University study in 2001, flaxseed supplementation was used preoperatively to slow the growth of prostate cancers.

Lignans are found in the seed's hull. According to research from Optimal Labs, lignans are not present in high quantities in flaxseed oil, even so-called "high-lignan" oils. To get the benefit of flaxseed lignans, whole flaxseed is recommended.

About Heintzman Farms:

Heintzman's golden flaxseed is direct-marketed under the trademarked "Dakota Flax Gold" label to consumers, medical clinics, hospitals and health food stores.

Heintzman Farms produces golden flaxseed, "Jet Caps" flaxseed supplement capsules, whole-flaxseed snack bars called "Bite Me! Bars," and "Fairy Flax" flaxseed snack packets. With a milder flavor, golden flaxseed has the same or greater nutritive benefit in comparison with brown flaxseed. For more information, including purchasing online, go to www.heintzmanfarms.com .

About the Center for Advancement in Cancer Education:

The Center for Advancement in Cancer Education is a non-profit cancer information, counseling and referral agency specializing in nutritional, immunological and psychological support for cancer prevention and control. It sponsors educational programs for both lay and professional groups, and has served thousands of persons in the United States and abroad.

--30--mcc/sf*

Lonza Announces New Dietary Supplement Ingredient PepZin GI™

Basel, Switzerland and Fair Lawn, NJ, (September 18, 2002) – Lonza, Inc., announced that the US Food and Drug Administration has allowed the sale of PepZin GI™, the subject of a new dietary ingredient submission to the federal agency. PepZin GI™ is a patented zinc-carnosine complex supported by abundant human and animal data.

Lonza has an exclusive distribution agreement with Hamari Chemicals Ltd. (Osaka, Japan), to market the ingredient in North America and Europe. PepZin GI™ has been used in Japan for over a decade as an ulcer-healing drug under the generic name Polaprezinc (INN). Hamari Chemicals manufactures and holds the patents on this unique compound. PepZin GI™ offers exceptional, “drug-like” patent protection, in that the molecule itself is claimed. This provides Lonza’s strategic marketing partners exceptional exclusivity.

PepZin GI™ is a coordination complex of zinc with the dipeptide L-carnosine. “PepZin GI™ is a unique molecular entity, with biological activity different than that of zinc mixed with carnosine,” offered Anthony L. Almada, MSc, President and Chief Scientific Officer of IMAGINutrition. He added, “We believe PepZin GI™’s data and intellectual property package will usher in a new category of evidence-based dietary supplements.”

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Lonza Group is a Life Sciences driven chemical company headquartered in Switzerland, with sales of CHF 2.5 billion in 2001 and operating 21 production and R&D facilities in 9 countries. It employs 6200 people worldwide and is the leading supplier of active chemical ingredients, intermediates and biotechnology solutions to the pharmaceutical and agrochemical industries. It also offers a broad catalogue of organic intermediates for a wide range of applications such as pharmaceuticals, agrochemicals, vitamins, food and feedstuff, dyes and pigments, adhesives and fragrances. Furthermore the Group manufactures specialty biocides and oleochemicals and develops and produces specific polymer intermediates, unsaturated polyester-resins, compounds and composites. For more information on Lonza Group please visit the company’s website at www.lonzagroup.com.

New Licensing Agreement for US Sales of PepZin GI™

Laguna Niguel, CA (September 18, 2002) – IMAGINutrition, Inc. announced today that they have orchestrated a patent/distribution agreement between Lonza, Inc., based in Basel, Switzerland, and Hamari Chemicals, Ltd., based in Osaka, Japan. The technology transfer will provide Lonza with an exclusive distribution agreement to market PepZin GI™, a patented zinc-carnosine complex, in North America and Europe. In Japan, PepZin GI™ has been used for over a decade as an ulcer-healing drug under the generic name Polaprezinc. Lonza will be marketing PepZin GI™ as a dietary ingredient in a variety of sales channels in the nutrition industry.

PepZin GI™ is a coordination complex of zinc with the dipeptide L-carnosine. The patented complex is a unique molecular entity, with biological activity different than that of zinc mixed with carnosine. Unlike most patented dietary supplements, PepZin GI™ is protected by a composition of matter claim. Hamari’s suite of patents for the zinc-carnosine complex confers a high degree of intellectual property insulation. In addition, the US Food and Drug Administration has recently allowed the sale of PepZin GI™ as a new dietary ingredient.

Lonza approached IMAGINutrition with an interest in licensing or acquiring nutritional technologies that would complement their own patented and clinically researched ingredients. With its extensive patent protection, numerous human and animal studies and history of clinical usage in Japan, PepZin GI™ is a valuable addition to Lonza’s portfolio of intellectual properties.

“PepZin GI™ is in a very exclusive category. This is a rigorously studied and documented dietary ingredient with numerous product applications,” observed Anthony L. Almada, MSc, President and Chief Scientific Officer of IMAGINutrition. “There is a strong and ever-growing public demand for nutritional supplements supported by this extensive level of safety and efficacy data.”

__ __ __
IMAGINutrition, Inc. is a nutritional technology and demand creation think tank, focused on the dietary supplement, food, beverage, medical food, and cosmeceutical industries. Headquartered in Orange County, CA, IMAGINutrition creates and matures - through clinical trials and additional intellectual property layering - then transfers intellectual properties, which ultimately appear as consumer products in these industries.
www.imaginutrition.com

United Natural Foods Partners with Living Naturally to Provide Innovative Technology & Marketing Solutions to Customer Base

Dayville, Connecticut and Venice, Florida, September 17, 2002. -- Living Naturally, a leading natural products marketing and software company, and United Natural Foods, Inc. (Nasdaq: UNFI), today announced a strategic alliance to provide United Natural Foods’ customers access to Living Naturally’s suite of products at preferred prices and terms. Living Naturally’s products now available to United Natural Foods’ customers include ScanGenius, an intelligent electronic ordering system, as well as turnkey retailer website services.

Commenting on today’s announcement, Daniel Atwood, United Natural Foods National Vice President of Marketing, said, “The Living Naturally comprehensive suite of products and services creates new opportunities for our retailers to increase their inventory turns, reduce their costs, and enhance their profits. Our customers will have access to a wide range of inventory management, marketing and promotional products as well as resources for e-commerce, customer education and state-of-the-art ordering through a universal smart scanner. By leveraging these cost-effective options our customers will have the opportunity to create healthier, more profitable businesses and that’s very good news for this industry.”

Glenn Field, Living Naturally Chief Executive Officer added, “It is very exciting to work with a company such as United Natural Foods which has such a strong commitment to helping their customers. We believe Living Naturally has the best ordering solutions and retailer website services in the natural products industry and our alliance with United Natural Foods allows us to provide our services at a much faster pace than would have otherwise been possible - not only for retailers, but also for manufacturers and other entities within the industry. Overall, Living Naturally and United Natural Foods are both committed to bringing greater prosperity to the wellness community as a whole – fostering the adoption of innovative new technologies while still preserving and enhancing the existing relationships in the industry.”

United Natural Foods President Steven Townsend said, "We believe that this relationship will serve to benefit our customers greatly. It is rare to find a solution that can so clearly translate directly into profits for retailers, regardless of store size. Living Naturally’s distinguishing business model delivers the leverage of automation that will allow retailers to have stronger businesses. We are committed to working with Living Naturally to deliver the best solutions to our customers.”

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About United Natural Foods:
United Natural Foods, Inc. carries and distributes over 30,000 products to more than 7,000 customers nationwide. The Company serves a wide variety of retail formats including conventional supermarket chains, natural product superstores and independent retail operators. For more information on United Natural Foods, Inc., visit the Company's web site at www.unfi.com.

About Living Naturally:
Living Naturally is the leading provider of marketing promotion and electronic ordering systems to the natural products Industry. Formed in 1999 to service the needs of retailers, suppliers, and health practitioners in this industry, the company has established itself as a clear market leader with a customer base of retail stores and suppliers now exceeding 500. Living Naturally has a rapidly growing transactional business with endorsements from leading figures throughout the natural products industry. For more information about Living Naturally, visit the Company's web site at www.livingnaturally.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding United Natural's business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, including but not limited to general business conditions, the impact of competition and our dependence on principal customers, see "Risk Factors" in the Company's quarterly report on Form 10-Q filed with the Commission on June 13, 2002, and its other filings under the Securities Exchange Act of 1934, as amended. Any forward-looking statements are made pursuant to the Private Securities Litigation Reform Act of 1995 and, as such, speak only as of the date made. United Natural Foods, Inc. is not undertaking to update any information in the foregoing reports until the effective date of its future reports required by applicable laws.

For more information, please visit the above-referenced web-sites.

FTC Releases Report on Weight-Loss Advertising

FTC to Hold Weight-Loss Advertising Workshop in November

The staff of the Federal Trade Commission today released a "Report on Weight-Loss Advertising: An Analysis of Current Trends." The report concludes that false or misleading claims, such as exaggerated weight loss without diet or exercise, are widespread in ads for weight-loss products, and appear to have increased over the last decade. The Commission also announced that it will hold a public workshop on November 19, 2002, to explore the impact that these ads have on public health and new approaches for fighting the proliferation of misleading claims for weight-loss products.

Many marketers, the report states, use false claims, misleading consumer testimonials, and deceptive before-and-after photos to market their products. According to the report, nearly 40 percent of the ads in the study, including ads that appeared in mainstream, national publications, made at least one representation that is almost certainly false and 55 percent of the ads made at least one representation that is very likely to be false. Often ads promised weight-loss results beyond what is possible. Nearly half of the ads claimed that the users could lose weight without diet and exercise. In one ad, for example, the headline proclaimed: "LOSE UP TO TWO POUNDS DAILY WITHOUT DIET OR EXERCISE!" Other ads cited rapid, prolonged weight-loss claims - such as claims that consumers can lose 8 to 10 pounds per week over an extended period of time.

"We have known for some time now that there is a serious problem with weight-loss product advertising. This report demonstrates the extent of that problem," said FTC Chairman Timothy J. Muris. "Reputable marketers continue to take care to avoid false and misleading claims, but it appears that too many unscrupulous marketers are making false claims promising dramatic and effortless weight loss to sell their products. It is not fair to consumers; it is not fair to legitimate businesses, it is illegal, and it will not be tolerated."

The report, which examined 300 promotions that appeared in all major forms of media between February and May 2001, was prepared with the assistance of the Partnership for Healthy Weight Management (PHWM). The Partnership is a coalition of representatives from science, academia, the health care profession, government, commercial enterprises, and organizations whose mission is to promote sound guidance on achieving and maintaining a healthy weight.

"There is no such thing as a miracle pill for weight loss," Surgeon General Richard Carmona said. "The surest and safest way to weight loss and healthier living is by combining healthful eating and exercising. First eat healthfully - cut fats, eat at least five servings of fruit a day, and cut down on the amount of alcohol you drink. Next, get some physical actvity in yor day. Walking just 30 minutes a day, five days a week can reduce weight, and make you feel better."

According to the report, a comparison of current ads to ads that ran in 1992 suggests that there has been a dramatic increase in the number of weight-loss products and the amount of deceptive weight-loss advertising, during the last decade. The report noted two major trends: 1) a shift away from weight-loss products advertised as "low-calorie meal-replacements" in 1992 to pills and other products that commonly claimed to work without diet or exercise in 2001; and 2) that although ads from both 1992 and 2001 contain deceptive or false claims, the recent ads were much more likely to make specific misleading performance promises.

Since 1990, the Commission has filed 93 cases challenging false and misleading weight-loss claims involving over-the-counter drugs, dietary supplements, commercial weight-loss centers, weight-loss devices and exercise equipment. Despite the unprecedented level of FTC enforcement over the last decade though, misleading and deceptive ads continue to saturate the market.

According to health and nutrition experts, many of the weight-loss products and programs most heavily advertised are either unproven or unsafe, and frustrate efforts to promote healthy weight-loss efforts by promising unrealistic results.

"As health professionals, we are concerned about the epidemic of obesity and are equally concerned about false and misleading claims in advertising of weight-loss products and services," said George L. Blackburn, M.D., PhD, chair in nutrition medicine at Harvard Medical School and a member of the PHWM. "Many promise immediate success without the need to reduce caloric intake or increase physical activity. The use of deceptive, false, or misleading claims in weight loss advertising is rampant and potentially dangerous. Many supplements, in particular, are of unproven value or have been linked to serious health risks."

Weight Loss Advertising Workshop

To address this growing problem of deceptive weight-loss advertising, the FTC is separately announcing a one-day workshop on November 19, 2002 to provide a public forum to explore the impact that these ads have on public health and new approaches for fighting the proliferation of misleading claims for weight-loss products.

Consumer Education

The weight-loss report, as well as resources for consumers, businesses, and the press, is available at www.ftc.gov/dietfit. The FTC has the following tips for consumers who are interested in weight-loss products or programs:

  • Products and programs that promise quick and easy weight loss are bogus.
  • To lose weight, you have to lower your intake of calories and increase your physical activity.
  • The faster you lose weight, the more likely you are to gain it back.
  • Experts recommend a goal of about a pound a week.
  • There are no miracle weight-loss products.
  • Be skeptical of products and programs that claim they can keep weight off permanently.
  • Be skeptical about exaggerated claims.

Consumers who wish advice on how to find a healthy weight loss plan should visit the PHWM Web site at www.consumer.gov/weightloss.

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Copies of the weight loss report, the complaint in the Bio Lab case, and the consumer education materials are available on the FTC's Web site at 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.

MEDIA CONTACT:

Brenda Mack
Office of Public Affairs
202-326-2182

STAFF CONTACTS:

Richard Cleland
Bureau of Consumer Protection
202-326-3088 Walter Gross
Bureau of Consumer Protection
202-326-3319
(FTC Matter No. P014510)

FTC Charges Canadian-Based Company with Making False Weight-Loss and Cellulite-Treatment Claims

The Federal Trade Commission charged a Canadian corporation operating in the United States under the name Bio Lab and its president with deceiving consumers through false advertising for their weight-loss and cellulite-treatment products in violation of the FTC Act. The FTC announced today a law enforcement action against No. 9068-8425 Quebec, Inc., doing business as Bio Lab, and its president, Jean-Francois Brochu. The FTC alleged that the defendants, using mainstream U.S. media, targeted U.S. consumers by advertising and selling "Quick Slim" - a purported weight-loss product which they claim causes users to lose rapid and substantial weight without dieting or exercise; and "Cellu-Fight," a product which they claim completely eliminates cellulite without any effort by users. The FTC filed the case in the United States District Court for the Northern District of New York on September 3, 2002.

In its complaint, the FTC alleged that the defendants advertised Quick Slim in Glamour and TV Guide magazines, in free standing inserts (weekend coupon inserts) distributed through newspapers, such as Philadelphia Inquirer, the Dallas Morning News, the San Francisco Examiner, the Los Angeles Times, and the Washington Post, and on the Internet. Quick Slim is a dietary supplement advertised as a "fat blocker" that uses apple pectin to control weight. Promotions for Quick Slim, which costs $70.00 for a bottle of 180 caplets, promised rapid and substantial weight loss without diet and exercise. The defendants' ads contain statements such as, "Lose Up to 2 Pounds Daily Without Diet or Exercise," and claims that the weight loss would be permanent. In fact, the FTC alleged, Quick Slim does not cause rapid or significant weight loss without the need for diet and exercise, and does not cause permanent weight loss.

Bio Lab also marketed and sold Cellu-Fight on the Internet and through direct mail brochures. The ads contained statements such as, "Cellu-Fight ... New Tablet for A Direct Attack on Cellulite," and "New Tablet Completely Eliminates Cellulite." A bottle of 60 tablets costs $40.00. According to the FTC, the ads falsely claim that the product is clinically proven to eliminate cellulite from the stomach, backside, hips and thighs. In fact, the FTC alleges, Cellu-Fight does not eliminate or substantially reduce cellulite.

On September 6, 2002, U.S. District Court Judge David N. Hurd entered a temporary restraining order against defendants prohibiting dissemination of misleading advertising for Quick Slim and Cellu-Fight and freezing defendants' assets. A preliminary injunction hearing is scheduled for September 20th.

The FTC received valuable assistance from the Competition Bureau of Industry Canada in its investigation of Bio Lab.

The Commission vote to authorize the staff to file the complaint was 5-0.

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Copies of the complaint 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.

MEDIA CONTACT:

Brenda Mack
Office of Public Affairs
202-326-2182

STAFF CONTACT:

Richard Cleland or Tawana Davis
Bureau of Consumer Protection
202-326-3088 or 202-326-2755

(FTC Matter No. 022 3167)
(Civil Action No. 1:02:CV-1128

Algry Quimica confirms growing trends of human grade choline salts market

Algry Quimica, the spanish manufacturer of pharma and food grade choline salts confirms growth trends in the human choline salts market, already confirmed with the company first semester results, which were 35% better than 2001 results. At present, Algry Quimica sales are expected to increase by approximately 70% by the end of the year over 2001 results in terms of net sales of the main choline salts used in nutraceuticals and pharma markets.

"The market for choline derivatives has experienced significant growth in recent years, and especially since the FDA's recent decision authorising products containing qualifying amounts of choline to carry a nutrient label. This growth just confirms we are working in the right direction, offering the growing market of choline-based products a reliable source of material", said Guillermo Rodriguez, Sales Manager of Algry Quimica. "We also expect this growth trend to be maintained during 2003, since customers and manufacturers interest in "the newest vitamin" is growing, especially in the US."

Algry Quimica also announced investments during the next year 2003 in their choline salts manufacturing facility in Huelva (Spain), in order to enlarge manufacturing capabilities by around 70-80% to attend this increasing demand, specifically regarding choline chloride and choline bitartrate used in nutraceuticals.

Vitamin E fails to join heart-health regimen

Study shows antioxidant takes no bite out of atherosclerosis in healthy people

LOS ANGELES, Sept. 17-Despite its early promise, taking vitamin E does not appear to slow the progression of atherosclerosis in healthy people, according to researchers from the USC Atherosclerosis Research Unit and colleagues.

Many believe that atherosclerosis, the thickening of artery walls that can lead to heart attack and stroke, results from oxidative damage to tissue in the artery wall caused by fats in the blood.

Epidemiological studies had supported the idea that vitamin E protected against atherosclerosis by fighting oxidative damage, but results from the Vitamin E Atherosclerosis Prevention Study call that into doubt, researchers report in the Sept. 17 issue of Circulation.

"The study showed that vitamin E could reduce the oxidation of LDL cholesterol-the so-called bad cholesterol-in the blood, but that didn't translate into a slower progression of atherosclerosis," says Howard N. Hodis, M.D., professor of medicine and preventive medicine at the Keck School of Medicine of USC and the study's lead author.

More than 300 healthy men and women age 40 or older enrolled in the study, and each took either a daily dose of 400 international units of vitamin E or a placebo. (Drugstore vitamin E supplements typically range from 50 I.U. to 1,000 I.U.) They visited the clinic every six months for three years, and investigators measured the intima-media thickness of their carotid arteries on each visit through ultrasound.

After three years, participants who took the vitamin E showed significantly less oxidized LDL in the blood, but had comparable progression of atherosclerosis to those who took no vitamin E.

"This means there's either something wrong with the hypothesis about oxidative damage and atherosclerosis, or we haven't found the right clinical trial to prove it," says Hodis, director of the USC Atherosclerosis Research Unit.

The study parallels findings from other recent randomized controlled trials.

It might come down to finding a specific group of patients who benefit, Hodis says. Antioxidant therapy might work better for people in their 20s, rather than those in their 40s and above, for example. Or perhaps it might only help high-risk patients, such as those with diabetes. A recent study showed that patients with existing heart disease and kidney disease who took vitamin E had fewer heart attacks than those who took a placebo, he adds.

Perhaps vitamin E might help those who have low levels of vitamins in their blood. "It may be that in epidemiological studies showing a benefit from vitamin E, participants didn't have high vitamin E levels to begin with, so supplementing this vitamin up to a point might help," Hodis says. "It may be that after that point, it provides no additional benefit."

Also, though vitamin E clearly acts as an anti-oxidant within the blood, it may not have the same effects within the tissue of the artery wall, where it would be most important, Hodis says. Its mechanisms need further study.

Vitamin E showed no negative health effects in the study.

For now, Hodis says, the best advice for healthy people who want to slow down atherosclerosis is to eat right, maintain healthy blood pressure and exercise. Lipid-lowering drugs prescribed by a physician also can help reduce the risk of heart attacks and strokes.

"We don't want to throw vitamin E out with the bath water," Hodis says. "But we do want to reflect, rethink and figure out where to go next."

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The study was supported by a grant from the National Institute on Aging and Hoffmann-La Roche Inc. Investigators in the study came from the Keck School of Medicine of USC, the USC School of Pharmacy, Kaiser Permanente Medical Center in Los Angeles and the Jet Propulsion Laboratory and Caltech.

Howard N. Hodis, Wendy J. Mack, Laurie LaBree, Peter R. Mahrer, Alex Sevanian, Chao-ran Liu, Ci-hua Liu, Juliana Hwang, Robert H. Selzer and Stanley P. Azen, "Alpha-Tocopherol Supplementation in Healthy Individuals Reduces LDL Oxidation but not Atherosclerosis," Circulation. Vol. 106, No. 12, Sept. 17, 2002.

Japanese Ministry Certifies Covance Labs

Covance One of Select Few U.S. Laboratories to Receive Valuable Certification

September 17, 2002 — Princeton, NJ — Covance, a leader in food and nutritional testing for more than 60 years, announced that the Japanese Ministry of Health, Labor and Welfare has registered Covance as a certified laboratory. Covance is now one of only a select few U.S. labs credentialed for product release testing of food and dietary supplement products for sale in Japan. This development expands Covance's global reach and opens a valuable new market for existing and new Covance customers.

Japan requires its own Certificate of Analysis for the sale of foreign products. Until now, this represented a significant barrier to entry in the Japanese market because very few U.S. facilities meet the standards for Japanese accreditation. The time and expense associated with conducting additional analysis in order to gain approval in Japan can create costly delays.

Randall L. Smith, Vice President of Analytical Services commented, "Previously, if customers wanted to sell their products in Japan, often they were forced to duplicate many of the testing procedures that they had already performed in the United States. Now that Covance is certified by the Japanese Ministry of Health, Labor and Welfare, our customers can consolidate all of their testing needs. This will eliminate costly duplication and reduce time to market in Japan."

Covance initially sought the Japanese government's certification in response to the needs of many of its customers in the dietary supplement arena. However, this new accreditation allows Covance to supply testing data on a full range of food and dietary supplement products for export and sale in Japan.

Smith noted, "Recognition by the Japanese Ministry of Health, Labor and Welfare represents more than just a commercial opportunity for Covance, it is a validation of the high standards and dedication to quality that has become our hallmark. That we were able to meet Japan's rigorous requirements without making any material changes to our operations, only confirms our position as the 'Gold Standard' for food testing data."

All testing will continue to be performed at Covance's Madison, WI laboratory, which is currently undergoing a major expansion. The expansion is projected to increase capacity by 20% and is scheduled to be completed within the next three to four months.

Covance's scientists help food manufacturers navigate the path from development to product release by providing accurate scientific data and dependable regulatory expertise. From nutritional analysis and labeling to stability testing and clinical studies of dietary supplements, Covance adapts to clients' needs by offering complete product evaluation or single nutrient assays.

Covance, with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies with 2001 pro forma revenues of $800 million, global operations in 17 countries, and approximately 7,000 employees worldwide. Information on Covance's products and services, recent press releases, and SEC filings can be obtained through the website, http://www.covance.com in the About Covance area.