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Articles from 2004 In February


Proposed GMP regs under fire

The three biggest industry trade associations have challenged the Food and Drug Administration (FDA) over what they characterise as ?redundant and punitive? requirements under proposed Good Manufacturing Practices (GMP) rules.

In particular, they are seeking to amend three requirements related to employee qualifications, facility equipment and testing of raw materials and finished products. The three groups—the American Herbal Products Association (AHPA), the Council for Responsible Nutrition and the National Nutritional Foods Association—presented the FDA with a dossier detailing their concerns in January.

The proposed rule includes requirements for designing and constructing physical plants, establishing quality-control procedures, and testing manufactured dietary ingredients and dietary supplements. Manufacturers would be required to test five areas: identity, purity, quality, strength and composition of ingredients and supplements.

The testing requirements are the area of greatest concern.

?It doesn?t make sense to us that we must test each finished batch of ingredients or supplements for all five things,? said AHPA president Michael McGuffin. ?We would rather shift the burden to the company bringing the raw material in—the supplier—rather than the manufacturer. It makes more sense for the supplier shipping it to 50 different companies to test rather than all the manufacturers each testing it. This is more reasonable and you still get the same outcome.?

Business impacts
?When it comes down to what?s going to affect the cost of your business, this GMP is as big as anything in DSHEA,? said Loren Israelsen, head of the Utah Natural Products Alliance, which helped the three groups draft their response. ?Small businesses in particular will really get blasted. It would kill small products in any company big or small.?

The FDA said its GMP proposal aims to help consumers get accurately labelled and unadulterated dietary supplements. ?Consumers should have access to dietary supplements that are accurately labelled and are free from contaminants,? said FDA commissioner Mark B McClellan.

The industry contends there isn?t a widespread adulteration problem, and points out the proposed testing standards to confirm unadulterated products are unnecessarily expensive.

?This industry requires novelty and innovation. We?re the nursery of the healthcare industry,? said Israelsen. ?We don?t want to become a Proctor & Gamble in a pharma model—they won?t even think about something if it doesn?t generate x-dollars a year. The FDA badly underestimated the cost and impact on businesses.?

Other disagreements
Another point of contention is the matter of employee qualifications, which for pharmaceutical companies require employees to have adequate training, education or experience, or any combination of the three, to reach the threshold standard for employment.

For dietary supplements, the qualification threshold does not mention the looser ?combinations thereof?. The supplements groups say this represents a higher standard for supplements companies than for pharmaceuticals companies.

The final disagreement is the proposal requiring calibrating instruments the industry says exceeds that for drugs.

?It could be an incredibly expensive additional expense without additional value,? said McGuffin.

The final GMP rule is expected to be published later this year.

Could ephedra ban save DSHEA?

The US dietary supplements industry must improve its manufacturing and marketing processes, police itself more stringently and become more transparent when reporting adverse events if the Food and Drug Administration's ban of ephedra is not to spell the end of the Dietary Supplement and Heath Education Act, according to leading industry figures.

The ephedra furore has become a catalyst for the growing band of critics who for some time have been calling for the liberal 10-year-old legislation to be amended or dismantled. Prominent Michigan Congressman John Dingell has stated he "would like to repeal the whole sorry mess" and many in the industry are preparing for just such an eventuality.

FDA commissioner Mark McLellan told The New York Times that ephedra "was just the tip of the iceberg," noting the agency had issued 75 warning letters to supplement manufacturers, 500 per cent more than in 2002—before he took office. It had also seized millions of dollars worth of illegal supplements.

Bitter orange and aristolochic acid are just two ingredients that have come under FDA scrutiny post-ephedra. Industry groups such as the Council for Responsible Nutrition (CRN), the National Nutritional Foods Association and the American Botanical Council (ABC) have stated they would not oppose a ban of aristolochic acid.

This flurry of activity is exactly what responsible sections of the industry, keen to crack down on unscrupulous operators, have long sought from the FDA. It is not DSHEA that is the problem, they say, but FDA's inability to police it.

Seen in this light, ephedra could well represent DSHEA's saviour rather than its demise, especially if the Hatch-Harkin bill is passed, which will grant the FDA an additional $20-30 million annually to fully enforce all of the safety provisions written into DSHEA.

"For years, some have said that DSHEA has tied FDA's hands from being able to effectively protect the public from unsafe dietary supplements," said Mark Blumenthal, ABC's founder and executive director. "The ephedra ban can be used as evidence that this is not true."

"The controversy about the safety of ephedra has led to much doubt about the safety of dietary supplements," said John Hathcock, PhD, vice president for scientific and international affairs at CRN. "Some of those doubts are legitimate, so getting ephedra resolved is a good thing for the industry. Now the FDA must go ahead and enforce the safety provisions that exist in DSHEA."

If the wheel is to undergo some form of reinvention, Loren Israelsen and Thomas D Aarts, writing in Nutrition Business Journal, highlighted three DSHEA provisions that must be fought for:


  • the definition of dietary supplements
  • the provision that dietary supplements are not food additives
  • the provision that the FDA has the burden of proof to prove a product is unsafe before it can remove it from the market.

Without these tenets a situation may arise, according to Blumenthal, where products are removed "that have the appearance of toxicity based on erroneous information. This might happen as a result of Congress' passage of various measures that are driven more by emotion than science."

SourceOne(TM) Appoints VP of Business Development, Technology and Science

Dr. Richard Staack Joins SourceOne Team

CHICAGO, IL, February 26, 2004 -- SourceOneTM Global Partners, a sales and marketing company providing proprietary branded nutritional ingredients to manufacturers and marketers, has appointed Richard F. Staack, Ph.D., MBA, as vice president of business development, technology and science. Dr. Staack will be responsible for identifying and evaluating new business opportunities and providing expertise on scientific and global regulatory affairs.

"Dr. Staack brings impeccable credentials and a breadth of successful experience in the functional foods & nutritional supplement industry to our company," stated Jesse Lopez, president of SourceOne Global Partners. "I admired and respected Dr. Staack¹s professionalism when we worked together at Cognis, and I¹m confident he will provide the same leadership to SourceOne in the most critical areas of our business."

With 15 years of executive, operations, product development, and research experience in the dietary supplement and functional food area, Dr. Staack has held positions as Business Development Manager for Cognis Nutrition & Health, Assistant Director of Human Nutrition Research Program for NCBA, and as a Senior and Food scientist for global food companies.

Dr. Staack received his Masters of Science and Doctorate in Nutritional and Biochemical Toxicology from the University of Illinois, Urbana-Champaign specializing in anticarcinogenic properties of functional food components. He received his Master of Business Administration with Distinction from Devry University. Dr. Staack has received several honors in the field of nutrition and functional foods including fellowship and environmental toxicology scholar awards. Additionally, he has published several articles on nutrition and toxicology in peer-reviewed scientific journals.

SourceOne Global Partners represents a new breed of ingredient supplier, partnering with manufacturing clients to introduce powerfully branded, science-driven products to market with a unique product positioning and compelling consumer presence. SourceOne was conceived as a company whose core competency would be to integrate legitimate science with strong trade and consumer branding. They partner with leading suppliers worldwide to source and offer patented ingredients supported by proprietary science as part of a turnkey marketing program that dramatically increases the odds for market success.

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Tea Constituent Supports Slumber

Clinical study with Suntheanine® reveals superior sleep quality

Minneapolis – Researchers from the National Institute of Mental Health in Japan have found that taking a pure L-theanine dietary supplement (Suntheanine®) before bed produces a significant improvement in sleep quality. The results were released at the Society of Physiological Anthropology conference in Tokyo in late 2003 and will be presented at the 17th European Sleep Research Society (ESRS) Congress October 2004 in Prague.

The research team’s findings outline the first human study showing that L-theanine, an amino acid found in green tea, can enhance the quality of actual sleep experienced by young subjects.

“Our clinical study strongly suggests that Suntheanine supplementation of young men can improve both the quality of sleep and the mental state of being refreshed upon awakening,” offered Dr. Shuichiro Shirakawa, a professor at The National Center of Neurology and Psychiatry at NIMH in Tokyo. “These results add to previous human studies showing that Suntheanine supplementation can foster a relaxed state, which may improve one’s entry into, and maintenance of, sleep,” he added.

The Japanese research team first had 22 young men (12 daytime workers, average age of 28; 10 students, average age of 26) undergo 3-day acclimatization period. They then were asked to take 200 mg of Suntheanine or a placebo one hour before bedtime for six consecutive days. After subjects completed this first blinded supplementation phase they were then “crossed over” to receive the opposite treatment. Subjects’ sleep performance was assessed by interviews upon awakening, self-reported questionnaires, and a wrist actigraph, which records bodily movement during sleep.

The entire group reported a statistically significant absence of “feeling exhausted” and a reduced need for sleep during the Suntheanine administration period, relative to placebo. Seven of the ten collegiate males showed a statistically significant improvement in sleep efficiency, an index of actual sleep time enjoyed between the time of falling asleep and the final morning awakening. These subjects also reported a superior mental state prior to falling asleep and a decreased occurrence of nightmares during the Suntheanine phase but not during placebo. Notably, the total time from falling asleep to awakening was unchanged during both placebo and Suntheanine phases.

“We are quite encouraged by the results of this clinical trial with Suntheanine, which marry well with our previous findings of promoting a relaxed state as measured by brain alpha waves,” said Scott Smith, Vice President of Taiyo International’s offices in Minneapolis. “These findings augment the evidence base for our enzymatically produced L-theanine and further distance us from the numerous other ingredients that claim to be “L-theanine”. Research we supported at Dr. Daniel Armstrong’s laboratory at Iowa State University, published last month in Rapid Communications in Mass Spectrometry, underscores the chemical differences between Suntheanine and other theanine ingredients. Suntheanine is chemically unique and the only L-theanine with evidence of human safety and efficacy,” he concluded.

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Taiyo International is the North American sales office for Taiyo Kagaku Japan, a leading manufacturer of functional ingredients for the food, beverage and dietary supplement industries. Taiyo focuses on the development of innovative ingredients, derived from natural sources, to further develop the body’s ability to protect and manage one’s health.

Suntheanine is Taiyo’s exclusive brand of pure L-theanine, supported by extensive clinical trials. Suntheanine is protected by over 40 U.S. and international patents for its various physiological efficacies and L-isomer-specific production processes.

Coca-Cola Unveils Plans For Institute Dedicated To the Role of Beverages in Healthy Lifestyles

The Beverage Institute for Health & Wellness to Support Research, Education and Outreach

Atlanta, March 01, 2004 - The Coca-Cola Company today announced the creation of The Beverage Institute for Health & Wellness. The Institute will be global in scope and support nutrition research, education and outreach, with a primary focus on beverages. The Beverage Institute for Health & Wellness will be based in Houston, Texas, and report to Donald W. Short, Vice President, The Coca-Cola Company, as part of his broad innovation responsibilities.

"The Coca-Cola Company offers consumers a broad array of beverage choices," said Short. "The Beverage Institute for Health & Wellness represents a strengthening of our commitment to better understand the consumer dynamics and science behind beverages, and the role of beverages in health and wellness. The Coca-Cola Company will utilize the results of our research to develop new beverages to meet the nutritional needs of consumers worldwide."

Research and Health Education
While The Beverage Institute for Health & Wellness will not develop new beverages, its research function will help The Coca-Cola Company identify areas of opportunity, new functional beverage ingredients and possible formulations that address a particular health or nutritional need. The Beverage Institute will create and support communication programs, for health professionals and consumers that promote balanced nutrition information, physical activity and health maintenance.

For more information on the Beverage Institute for Health & Wellness, please visit our Web site at www.thebeverageinstitute.org.

The Coca-Cola Company is the world's largest beverage company. Along with Coca-Cola, recognized as the world's best-known brand, The Coca-Cola Company markets a wide range of beverages, including regular, diet and light soft drinks, waters, juices and juice drinks, teas, coffees and sports drinks. Through the world's largest distribution system, consumers in more than 200 countries enjoy the Company's beverages at a rate exceeding 1 billion servings each day. For more information about The Coca-Cola Company, please visit our Web site at www.coca-cola.com.

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OrderDog Unleashes New iPOS System At Expo West

OrderDogTM Unleashes New iPOSTM System At Expo West Point of Sale System Provides Connectivity With Suppliers

Lewisville, TX, February 27, 2004 ‹ OrderDogTM, Inc. a technology based company that provides neutral and secure third party business-to-business services and solutions to the natural products industry, will launch their new iPOSTM Point of Sale system at Natural Products Expo West, March 4-7 in Anaheim, California.

"The iPOS is just what the industry has been waiting for. It sets a new standard in customer transaction hardware, software and especially connectivity,"said Darrin Peterson, president and co-founder of OrderDog, Inc. "This is a simple POS system that is self-updating and extremely easy to setup, operate and maintain. We are not just selling a piece of hardware, we are providing a solution."

iPOS is a complete point of sale system designed to simplify and enhance the technology and functions of the POS process. It features a self-updating database, eliminating the need for retailers to update information manually.

The product database automatically self-updates information including pricing, descriptions, UPC's, item identification numbers and new items. In addition, it is the only POS system available that has connectivity to real-time and up-to-date data, allowing retailers to access crucial information remotely via a secure web portal and connecting their business with their inventory and suppliers.

Headquartered in Lewisville, Texas, OrderDog, Inc. is a web-based system that enables manufacturers and retailers to connect online 24 hours a day to order and sell goods. Servicing over 1000 retailers and 250 suppliers across the United States, Puerto Rico and the Caribbean, OrderDog has proven to be the industries foremost expert on supply chain solutions. Stores interested in the OrderDog system can join for a monthly fee of $59.00. All of OrderDog¹s products and services are backed with their customer commitment, providing 24/7 live support, free software upgrades for the life of the system and a 60-day money back guarantee.

To learn more about the iPOS system stop by OrderDog booth #2513.

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CSPHP From Kyowa Hakko Kogyo Receives GRAS Affirmation

CSPHP soy protein/phospholipid complex system may help maintain healthy cholesterol levels.

(New York, NY) February 27, 2004 – Kyowa Hakko Kogyo, and its US subsidiary, Kyowa Hakko U.S.A., have announced the Food and Drug Administration (FDA) considers CSPHP, a soy protein/phospholipid complex system that may help maintain healthy cholesterol levels within the normal range, as Generally Recognized As Safe (GRAS). CSPHP, an abbreviation for C-fraction soy protein hydrolyzate with bound phospholipids, is a newly developed soy peptide.

A recent study by Kyowa Hakko Kogyo at Gifu University and Tokushima University in Japan, suggested that CSPHP helps promote healthy cholesterol levels within the normal range.

According to Yoichiro Sugimura, Kyowa Hakko Kogyo International marketing manager, beverage products in Japan with formulations that include CSPHP, have been approved by Japan’s Ministry of Health, Labor and Welfare as a Food for Specified Health Use (FOSHU).

CSPHP can be provided in tablet form or used as an ingredient in baked goods and baking mixes, breakfast cereals, diary product analogs, fats and oils, grain products and pastas, functional food and beverages, meat products, milk products, plant protein products, processed fruits and fruit juices, processed vegetables and vegetables juices and soups and soup mixes.

For more information contact Kohei Yamamoto at (212) 319-5353, ext. 210. or visit www.kyowa-usa.com.

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SourceOne(TM) Completes Phase I of Sytrinol(TM) Long-Term Clinical Trial

Findings From The First Phase Of The Study Confirms Sytrinol's Effects On Heart Health

CHICAGO, IL, - SourceOneTM Global Partners, a sales and marketing company providing proprietary branded nutritional ingredients to manufacturers and marketers, has just completed the first of three phases of a double-blinded, randomized 24-week study on 120 hypercholesterolemic subjects. The results from the completed 12-week (phase I) Sytrinol clinical trial are consistent with previous clinical studies on Sytrinol's heart health benefits.

"SourceOne is delighted with the results achieved in phase I of the Sytrinol clinical study," said Jesse Lopez, President, SourceOne Global Partners. "The results demonstrated that Sytrinol represents unparalleled value to consumers seeking cardiovascular wellness and a natural solution to the cholesterol problem. We look forward to presenting the completed phase I study results in the near future!"

Sytrinol is a new patented, proprietary, branded ingredient from SourceOne.

Scientists have discovered compounds found in citrus and palm fruit extracts that support heart health the natural way. More than 12 years of research including in vitro, in vivo, and in clinical studies, have demonstrated that Sytrinol helps maintain healthy cholesterol, LDL cholesterol and triglyceride levels. Unlike ingredients that attempt to block the absorption of cholesterol in the gastrointestinal tract, Sytrinol works to balance cholesterol production in the liver. Sytrinol is also a powerful antioxidant with anti-inflammatory properties that support a healthy heart.

About SourceOneTM Global Partners
SourceOne Global Partners, headquartered in Chicago, IL, represents a new breed of ingredient supplier, partnering with manufacturing clients to introduce powerfully branded, science-driven products to market with a unique product positioning and compelling consumer presence. SourceOne was conceived as a company whose core competency would be to integrate legitimate science with strong trade and consumer branding. They partner with leading suppliers worldwide to source and offer patented ingredients supported by proprietary science as part of turnkey marketing program that dramatically increases the odds for market success.

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New All-Natural Homestyle Golden Coating from Fortitude Brands Gluten-Free and Better than Bread Crumbs

Coatings Taste So Good Consumers Won’t Even Believe they’re Gluten-Free!

(Miami, FL) Shoppers looking to enhance popular dishes while maintaining gluten-free diet regimens have now found a new best friend in Fortitude Brands’ tasty Homestyle Golden Coatings. Concerned consumers have often scoured the grocery aisle time and again looking for the all-important gluten-free product, but to no avail. To avoid the serious consequences of gluten intake, many shoppers have resorted to bland tasting foods as a last recourse, hoping that someday more choices would be available that would make a gluten-free diet less of a disability and more of a preference. Fortunately, Fortitude Brands, maker of all-natural gluten-free products, announces the availability of their seasoned bread-coating alternative to retailers on the east coast and for consumers online. The Homestyle Golden Coating is the only bread crumb alternative that is gluten-free and available at the retail level.

The coating was created in response to the growing need for gluten-free options among shoppers with gluten intolerances, allergies, or diseases that prevent them from enjoying wheat, rye, barley, and oats found in the majority of foods. It offers an excellent alternative to traditional breading products, enhancing even the most ordinary dishes for consumers with gluten sensitivities. Cooking connoisseurs now have more options for oven, pan and deep frying their favorite foods, worry-free. Consumers will love that it is an all-purpose variety where a bounty of appetizers and main courses can be prepared from chicken and fish, to vegetables and shrimp. It can even be used for onion rings, mozzarella sticks, or as a topping on various dishes that include casseroles and lasagna.

The Homestyle Golden Coating is not just gluten-free, but healthy too. In fact, it is all-natural and has no Trans fats, saturated fat, MSG or cholesterol. After cooking with the coating, customers experience no oil residue, which is normally found and dreaded after pan frying. Instead, the oil stays in the pan while the coating seals in the flavor, not the oil.

The coating is visually appealing as it turns a golden brown when cooked and has a crispy texture, sure crowd pleasers for the whole family. In fact, this all-purpose, ready-to-use coating can appeal to gluten sensitive and non-sensitive consumers, making it a mainstream product as well. It is perfectly seasoned with a balance of popular spices that appeals to even the pickiest palate, gluten-intolerant or not.

The Homestyle Golden Coating is available in a 4.25 oz package, has a shelf life of eighteen months, and has a suggested retail price of $3.72. The packaging is a sure eye-catcher on the shelf, with its large product photos and bold colors. Retailers can cross-merchandise the coating and place it in a variety of grocery aisles that can include the natural food, seasoning, or meat departments. The coating was formulated by a leading manufacturer and distributor of coating and complementary products to supermarkets throughout the U.S. In addition to grocer and natural food retailers, Fortitude Brands plans on providing the coating to foodservice industries that may include restaurants and cruise ships.

“We developed the coating for gluten-sensitive individuals who still want to enjoy the flavorful foods that they had grown accustomed to,” states Franco Stanzione, President and Founder of Fortitude Brands. Fortitude Brands understands that is difficult to find gluten-free foods in retail stores and took the initiative to provide more options.

According the Archives of Internal Medicine, roughly 190 million people in the U.S. suffer from a variety of diseases that make a wheat or gluten-free diet key to their well being. A major contributor to this statistic is Celiac Disease, the most under diagnosed disease in the U.S., affecting approximately 1.5 million people. It is a multi-system, multi-symptom disorder that virtually anyone can develop.

Fortitude Brands will also be launching their delicious gluten-free cookies and banana chips. Cookies will come in three mouth watering flavors that include Cinnamon & Orange, Vanilla & Lemon, and Ginger & Spice. Fortitude Brands’ Tropical Banana Chips come in 3 fun flavors: Naturally Sweet, Slightly Salted, and Amazon Chili. The company also provide their Casabe Rainforest Crackers in three flavors: Wild Onion, Garlic, and Original. Fortitude Brands utilizes Yucca as a basis for these products because of its gluten-free status, high fiber content and versatility.

A percentage of the sales of Fortitude Brands’ products go to the indigenous communities of the Amazon Rainforest as part of the Fortitude Brands Foundation, located in the Dominican Republic. Fortitude Brands, L.L.C. is located at P.O. Box 431304, Miami, FL 33243-1304. The company’s toll-free number is 1-866-NO-GLUTEN; the fax is (305) 663-7149. Visit Fortitude Brands on the Internet at www.fortitudebrands.com or call Christie Communications at 805-565-4122 for samples and additional information.

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Trexler Joins Nutra Products, Inc. as Director of R & D

Fairfield, CA - Nutra Products, Inc has announced that Lisa (Westing) Trexler has joined as Director of Research and Development. In that capacity Lisa will be developing new processes and products and providing technical support for its customers.

Lisa applied the assays for Allicin and other key marker compounds in Garlic to develop a commercial process for standardized nutraceutical grade Garlic. She also led the team that developed the process for odor controlled and odorless Garlic for Pure-Gar, when it was owned by Basic Vegetable Products.

Lisa collaborated with Dr. Steven Wood of BYU University, Dr. Larry Lawson and Dr. Bronwyn Hughes of Plant Bioactives, to implement HPLC and qualitative testing of Garlic through all stages of development (from seed to finished product). Because of their pioneering work, Pure-Gar was the first to market nutraceutical Garlic standardized for five key marker compounds.

NPI is a major supplier of nutraceutical Garlic to dietary supplement marketers. New NPI products include: Garli-EzeTM High Allicin, Buffered Garlic and NutraSelectTM SuperFloTM naturally Odor Controlled Garlic. For more information about these new products and/or the standard granulated and powdered Garlic, please visit Nutraproduct's website at www.nutraproductsinc.com.