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U.S. Nutra Saw Palmetto Extract Rated High Quality by Independent Laboratory

EUSTIS, Florida (May 28, 2003)—Saw palmetto extract produced by U.S. Nutra™, a leading manufacturer of supercritical fluid extracts for the dietary supplement and functional food industries, was recently certified as high quality by a major independent testing service company. According to tests conducted by ConsumerLab.com of White Plains, New York, U.S. Nutra USPlus™ saw palmetto liquid extract (90% fatty acids) met the high standards established for this important nutraceutical ingredient.

USPlus™ saw palmetto extract is an all-natural nutraceutical derived from the berries of Serenoa repens, a member of the palm family native to Florida. U.S. Nutra utilizes environmentally friendly carbon dioxide to extract and concentrate the full spectrum of health-promoting constituents in saw palmetto berries. Multiple clinical studies have proven that saw palmetto extract helps support normal prostate function in men.

U.S. Nutra submitted its saw palmetto extract to ConsumerLab.com for in-depth analysis to demonstrate that the ingredient met quality standards set by the nationally renowned certification company. According to Stephen Hill, Technical Services Manager for U.S. Nutra, test findings on the company’s saw palmetto extract exceeded specific quality criteria established by ConsumerLab.com and other science-based entities, such as the United States Pharmacopoeia (USP). “This credible third party validation confirms that U.S. Nutra saw palmetto extract is exceptionally high in the specific constituents believed responsible for the benefits of saw palmetto oil,” stated Hill. Specifically, the analysis revealed a fatty acid content of 91% and phytosterol levels of 0.3%. Details on the testing procedure and the listing of the approved U.S. Nutra saw palmetto liquid extract is posted on the ConsumerLab.com web site at www.consumerlab.com/results/rawing.asp.

“We congratulate U.S. Nutra for holding its product to this high standard,” stated Tod Cooperman, M.D., ConsumerLab.com President. “There are many products on the market that do not contain an ingredient of this quality.”

Mark Blumenthal, founder and Executive Director of the nonprofit American Botanical Council in Austin, Texas (www.herbalgram.org), noted that saw palmetto is one of the more thoroughly researched, efficacious, and safe dietary supplement ingredients available. “Saw palmetto has been clinically proven to provide a reasonable measure of relief from the symptoms of benign prostatic hyperplasia—equal, in fact, to many pharmaceutical treatments. It’s also free of undesirable side effects. Saw palmetto enjoys a revered place among the useful plants native to the southeastern United States, as a botanical sold for centuries in global commerce.”

Stephen Hill can be reached at the main U.S. Nutra offices in Eustis, Florida at (352) 357-2004, or by e-mail at [email protected]

About U.S. Nutra
U.S. Nutra is the leading saw palmetto processor worldwide. The company owns and operates the only supercritical fluid extraction facility in North America devoted exclusively to production of high-value nutraceutical ingredients for the dietary supplement, functional food and cosmeceutical industries. U.S. Nutra also produces a number of other nutraceuticals, including astaxanthin (Zanthin® brand of astaxanthin complex), valerian, ginger, and rosemary, as well as a line of certified organic spice extracts. Visit the U.S. Nutra website at www.usnutra.com

About ConsumerLab.com
ConsumerLab.com is a leading provider of consumer information and independent evaluations of products that affect health and nutrition. It has no ownership or interest in companies that manufacture, distribute or sell consumer products. Subscription to ConsumerLab.com is available online. Contact Lisa Sabin, Vice President for Business Development, at [email protected], for information on ConsumerLab.com’s Voluntary Certification program, group subscriptions or Technical Reports.

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California Senate Casts Historic and Decisive Vote In Favor of Licensing Naturopathic Doctors

(Sacramento, Calif.) --- Natural health advocates across California chalked up another victory late last week, as legislation to expand statewide access to naturopathic medicine was passed for the first time by the California Senate. The bill, which would extend state licensure to clinically trained naturopathic doctors in California, has now advanced to the State Assembly.

The bill, SB 907, was introduced earlier this year by Senate President Pro Tem John Burton (D-San Francisco). “California is a leader in the emerging natural healthcare field,” Senator Burton said upon introduction of the measure. “To continue prohibiting Californians from seeing qualified providers of natural healthcare and receiving the benefit of the services they provide just doesn’t make sense,” he continued. “Consumers deserve a range of quality healthcare options, and this bill helps make that happen.”

With Senate approval clinched, the bill will begin working its way through the Assembly. Assemblymember Lou Correa (D-Santa Ana), who chairs the Business and Professions Committee, presided over an informational hearing on naturopathic medicine last fall. “Naturopathic medicine may offer valuable health care options for identifying ways to diagnose and treat diseases with an emphasis on health promotion,” stated Correa. “The naturopathic approach could very well reduce the need for recurrent and expensive medical interventions by maximizing the body’s intrinsic capacity for self-healing and repair.”

Naturopathic medicine is a healing-oriented approach to healthcare that focuses on science-based lifestyle, nutritional, and botanical therapies. The four years of naturopathic medical education include basic medical sciences, such as anatomy, biochemistry, and pathophysiology, as well as the study and application of natural therapies, such as clinical nutrition, botanical medicine, homeopathy, physical medicine, and health counseling. The naturopathic approach is dedicated to health promotion and disease prevention, using the best of what both conventional and alternative medicine have to offer.

The bill is sponsored by the California Association of Naturopathic Physicians, which has launched a grassroots advocacy campaign to promote the bill and fight for its passage. For more information on the campaign, or to enlist in the CANP’s efforts to bring natural medicine to California, visit the campaign’s website at www.NaturalMedicineNow.org.

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Walnuts Top the Chart as Plant Food Source Rich in Omega-3s

SACRAMENTO, Calif.--May 27, 2003--Although the health benefits of omega-3 fatty acids have captured media and public attention, many consumers are not aware that walnuts are a convenient and delicious plant source of these essential fatty acids. Our bodies can't create omega-3 fatty acids, so we have to get them from the foods we eat.

For those who can't or don't want to eat fish every day, walnuts are an excellent alternative. According to family nutrition expert, Liz Weiss, MS, RD, "Americans eat virtually no omega-3s on a daily basis, yet this fat is surprisingly easy to include in the diet. It's simple. All you have to do is grab for a handful of walnuts and enjoy them as a snack or toss them over your breakfast cereal or into your salad at lunch. It's that easy."

Dubbed the 'Mega Nut by many leading scientists because of their highly concentrated omega-3 content, eating just one small handful a day meets the Nutrition Board of the National Academies of Science (NAS) guideline for omega-3 intake ... and without a lot of fuss.

Clinical studies have proven that omega-3 fatty acids reduce the risk of heart disease and stroke. In fact, the American Heart Association recommends a diet rich in seafood, walnuts, and other foods rich in omega-3 fats. In addition to lowering blood lipid levels, reducing the risk of sudden cardiac death, and lowering blood pressure, these essential fats have also been shown to reduce the symptoms of rheumatoid arthritis and depression. Their importance in the diet is so strong that last year, the NAS recommended a daily intake of 1.6 and 1.1 grams for men and women, respectively.

A. Glenn Braswell's Dietary Supplement Enterprise Targeted

FTC Challenges False and Unsubstantiated Claims

The Federal Trade Commission has filed a complaint in federal district court against A. Glenn Braswell and four of his corporations challenging allegedly false and unsubstantiated advertising claims for numerous dietary supplements marketed under the Gero Vita and Theraceuticals brand names. The complaint also names as a defendant corporate officer Ron Tepper. The complaint challenges claims that five dietary supplements treat or cure respiratory disease, diabetes, Alzheimer's disease, obesity, and erectile dysfunction. The FTC is seeking permanent injunctive relief, consumer redress, and a permanent ban against Braswell's participation in any business engaged in the advertising or sale of health-related products.

The Braswell enterprise, which operates out of Marina Del Rey, California, is comprised of numerous affiliated companies, including JOL Management Co., G.B. Data Systems, Inc., Gero Vita International, Inc., and Theraceuticals, Inc., all named as defendants in the complaint. According to the FTC, Braswell's operation is one of the largest U.S. direct marketers of health-related products. The FTC's complaint alleges sales totaling approximately $800 million since 1998.

"These defendants built their businesses on false and outrageous claims aimed at older consumers and those with chronic illnesses," said Howard Beales, Director of the FTC's Bureau of Consumer Protection. "Today's action demonstrates the Commission's continuing commitment to attacking fraud in the dietary supplement market."

Braswell is already under a 1983 federal court settlement resolving charges that he and several of his corporations violated the FTC Act and the FTC's Mail Order Rule in connection with the advertising and sale of various health-related products.

The FTC's complaint alleges that Braswell and the other defendants market numerous dietary supplement products through false and unsubstantiated claims. According to the FTC, the defendants' multi-page direct mail advertisements deceptively tout their products as "scientific breakthroughs" that can treat or cure a host of serious illnesses and medical conditions. The products identified in the FTC's complaint are: Lung Support Formula, claimed to cure or ameliorate nearly all respiratory problems, including asthma, emphysema and smoking damage; Antibetic Pancreas Tonic, claimed to treat or cure Type I and Type II diabetes, and to lower blood sugar levels by repairing the pancreatic cells that produce insulin; G.H.3 and Theraceuticals GH3 Romanian Youth Formula, claimed, among other things, to reverse and prevent Alzheimer's disease and other forms of dementia, and to increase lifespan; Chitoplex, a chitosan-based product purported to cause weight loss and reverse obesity without diet or exercise; and Testerex, claimed to treat erectile dysfunction in 62% to 95% of men.

In addition, the FTC complaint challenges the defendants' use of deceptive advertising formats and expert endorsements to market its products. Specifically, the complaint alleges that the defendants deceptively portrayed their "New Life Nutrition Magazine" as an independent health magazine, when in fact it was advertising written by the defendants for the purpose of selling their products. The complaint further alleges that the defendants claimed that an independent organization, the "Council on Natural Nutrition," conferred its "Golden Nutrition Awards" on the defendants' Arthro 7, ChitoPlex and G.H.3 products, when in fact, the defendants had established the "Counsel on Natural Nutrition." In addition, the complaint alleges that the defendants' representation that Dr. Ronald Lawrence, Director of the Council on Natural Nutrition, endorsed the defendants' products based on his independent, objective evaluation of the products, when in fact, Dr. Lawrence was a paid endorser of the defendants' products and was a member of defendant G.B. Data Systems' Board of Directors.

The Commission vote to authorize staff to file the complaint was 5-0. The complaint was filed in the U.S. District Court for the Central District California, Western Division, on May 27, 2003.

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NOTE: The Commission authorizes the filing of a complaint when it has "reason to believe" that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The complaint is not a finding or ruling that the defendant actually has violated the law. The case will be decided by the court.

Supplements Industry Supports Post-War Relief Effort

One Million Vitamins Donated to Vitamin Angel Alliance for Children of Iraq

Tishcon Corporation has stepped forward as the first donor in an industry-wide campaign to collect vitamins for post-war relief efforts in Iraq, announced Vitamin Angel Alliance president Howard Schiffer at the Dietary Supplement Education Alliance (DSEA) breakfast reception on March 7th during SupplySide East in Secaucus, N.J.

Schiffer, who kicked off the campaign at the DSEA event, said children in Iraq are presently at risk of severe malnutrition due to critical food shortages. "We're enormously grateful to Raj and Arun Chopra for responding to our call with their generous donation," said Schiffer. "Half the population of Iraq is under the age of 15 and our industry is in a unique position to save many young lives. We hope other companies will follow Tishcon's lead and provide the multi-vitamin, children's chewable vitamins and Vitamin C needed for this effort."

"It is both a privilege and an honor to be able to give a portion of what we make to organizations such as Vitamin Angels and The Healthy Foundation," said Raj Chopra, president and CEO of Tishcon Corporation. "It is people like Howard Schiffer who, through their commitment to humanitarian causes, give us a ray of hope in the midst of hate, hunger and pestilence."

Prior to the war, Vitamin Angel Alliance was already distributing vitamins to needy children in Baghdad through Mother Teresa Orphanage and St. Raphael Hospital. The last delivery before the fighting was a shipment of basic vitamins that took place in early December 2002 according Schiffer. Just last week, Vitamin Angels assembled their first shipment to post-war Iraq which is now on its way to the Northern provinces.

Last year, Vitamin Angel Alliance distributed more than 12.6 million vitamins donated by the industry to people in 40 countries around the world.

"The work of Vitamin Angel Alliance is good for the world, and it's also good for our industry," said Elliott Balbert, president, Dietary Supplement Education Alliance (DSEA). "Journalists who question the health benefits of supplements may reconsider their views when they see that vitamins can mean the difference between life and death in the humanitarian crisis in post-war Iraq."

The Vitamin Angel Alliance (www.vitaminangel.org) provides nutritional supplements and health information to individuals, families and communities that are medically underserved or at risk of a specific condition or illness all over the world.

Anyone interested in knowing more about Vitamin Angel Alliance or how to participate in the post-war relief effort should contact Howard Schiffer at (805)565-9919 or e-mail [email protected].

The Dietary Supplement Education Alliance (DSEA) is a non-profit industry coalition formed to provide consumers, health professionals and policymakers with the latest science-based information on the benefits of dietary supplements.

For further information about the DSEA, contact Deb Knowles at (941)349-9044 or e-mail her at [email protected].

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Vitafoods : New Research Confirms Tonalin® CLA Safe and Effective

Vitafoods 13/5/2003: Long-term study demonstrates significant effects on body composition

The results of the first long-term study on Tonalin® conjugated linoleic acid (CLA) demonstrate that supplementation with CLA may lead to a significant reduction in body fat and an increase in lean body mass. Study co-ordinator, Dr Jean-Michel Gaullier, presented the latest results of his research “Efficacy and safety of oneyear supplementation with conjugated linoleic acid in moderate overweight” at the 94th AOCS* meeting in Kansas City, USA last week.

“This study is particularly significant because, we are able to demonstrate for the first time, long term effects of CLA in humans and on a large population”, he explained. “In addition, this study was performed under the strictly controlled procedure “GCP/ICH” used in all pharmaceutical studies”.

In the 12-month, double-blind, placebo-controlled study, 180 overweight subjects randomized into three groups took CLA either as free fatty acid or as triglycerides, compared with placebo (olive oil). The research found that Tonalin® CLA supplementation reduced body fat by nine percent and increased lean muscle by two percent. The most remarkable effects on body composition were produced by trials performed with a mixture of the bioactive isomers (cis-9, trans- 11 and trans-10, cis-12). Measurements performed with dual-energy X-ray absorptiometry show significant changes over time: specifically, TONALIN® CLA generated a significant decrease in body fat, body weight and body mass index.

The research included analysis of lifestyle factors such as diet and training, and recorded aspects of quality-of-life, in order to evaluate the effect of CLA supplementation on the subjects’ day-to-day lives. In addition, the long-term safety of Tonalin® CLA was confirmed through rigorous recording of any side effects during the overall study, and analyses of blood parameters including blood lipids and diabetes markers. The research is due to be completed later this year.

Dr. Gaullier commented: “Reduction of body fat mass with maintenance or increase of lean mass is not only important for psychological well being but also because it decreases significantly the risk for developing diseases such as diabetes, cardiovascular disease, hypertension, gall bladder disease, osteoarthritis and some cancers.”

According to Kathleen Moran, Market Segment Manager, Dietary Supplements, for Cognis Nutrition and Health, “Numerous studies on Tonalin® CLA have consistently demonstrated its ability to reduce body fat in humans for improved overall body composition. Dr. Gaullier’s study is the first to examine CLA’s efficacy and effects long-term, and revealed the most significant body fat reduction and lean muscle mass increase to date. These results should further confirm the merits of Tonalin® CLA’s proprietary isomer profile to the industry and consumers alike.”

Tonalin® CLA - an exclusively licensed product of the Cognis Group - is the brand used in most clinical research confirming CLA’s benefits for human health, including seven published studies on CLA in the past 3 years. Cognis Nutrition & Health is launching the Tonalin® CLA brand in Europe at Vitafoods 2003 [Geneva, May 13-15].

For further information on Tonalin® CLA and details of Cognis international offices and contacts, visit www.cognis.com, or e-mail [email protected].

*American Oil and Chemist Society
Media Contact: Val Holmes
Phone: +44 (0)20 8979 2333
E-mail: [email protected]
Mobile +44 (0)7775 615901 between 12-15 May 2003

Cognis Nutrition & Health
Phone: +49 211 7940 9692
Fax: +49 211 798 2390
E-mail: [email protected]
Internet: www.cognis.com

Cognis Nutrition & Health, a business unit of Cognis Group, provides antioxidant, botanical and nature-based ingredients for dietary supplements; pharmaceuticals and healthcare; functional foods and medical nutrition, and animal nutrition. As a leader in food technology, Cognis manufactures emulsifiers, emulsifier-based compounds and numerous other speciality products for the food industry worldwide.

Cognis Nutrition & Health is exhibiting at stand 4811 at Vitafoods International 2003, Palexpo 5, Geneva, and is also this year’s Executive Exhibition Sponsor. Seminars on Tonalin® and the science of CLA are being held in the Vitafoods theatre at 1435 on May 13th, and 1105 on May 14th respectively.

About Cognis
Cognis is a worldwide supplier of innovative specialty chemicals and nutritional ingredients with almost 9,000 employees in close to 50 countries. The company has dedicated its activities to a high level of sustainability and delivers natural source raw materials and ingredients for food, nutrition and healthcare markets, and the cosmetics, detergents and cleaners industries. Additionally, Cognis provides solutions for a number of other industries, such as coatings and inks, lubricants, textiles and plastics, as well as agro and mining.

Cognis is owned by private equity funds advised by Permira, GS Capital Partners, and Schroder Ventures Life Sciences. In 2002, Cognis recorded sales of 3.1 billion euros and an operating profit before depreciation, amortization and exceptional items (EBITDA recurring) of 393 million euros.

San Francisco Giants Fantasy Senior Baseball Tournament Comes to Fresno with Supplement and Food Industry Vendors

(Fresno, CA) May 28, 2003 – Baker-Dillon Public Relations, a leading supplement and sports industry marketing firm announced it organized The San Francisco Giants Fantasy Senior Baseball Tournament featuring representatives from the Major League Baseball fantasy camps of the San Francisco Giants, Los Angeles Dodgers, Oakland A’s, San Diego Padres and California Angels.

The three-day, nine game event taking place June 6-8 in Fresno, is co-sponsored with AlphaGraphics of Clovis, CA, who also created the event theme and logo—“Field of Screams.” Other Fresno area organizations participating include Sam’s Luggage, Fresno Grizzlies and the Red Owl Group, an advertising specialties company.

Every summer, approximately six baseball tournaments are held throughout California. The new home of the Fresno Grizzlies, the Triple A affiliate of the San Francisco Giants, was the second tournament stop and site of the newest summer fantasy venue.

The weekend includes a player dinner at the Stadium’s 600 Club and attendance by all baseball players and event representatives. For the Fresno tournament, players and other event participants received a travel tote bag filled with an assortment of supplement and food merchandise. A list of participating companies included Wisdom Herbs, SG Naturals, Clif Bar, Sun-Maid Raisins, Kemin Foods, Health Plus, Inc., Joseph’s Lite Cookies, Eternal Natural Artesian Water from New Zealand, SnackMasters Beef Jerky, Lamas Botanicals, SleepWorks, Ridgecrest Herbals, Pita Snax, Grandpa Po’s Originals, The Republic of Tea, Balance Bar, Pavich Organic, Valley Fig Growers, Rembrandt Toothpaste, David’s a division of Con Agra, DeBas Chocolate and the San Francisco Giants.

Whole Foods Market's Southern California Distribution Center Certified Organic

VERNON, Calif.--May 23, 2003--Whole Foods Market, the world's largest natural and organic supermarket, announced today the organic certification of its produce distribution facility in Vernon, Calif., which distributes produce to its stores in Southern California, Arizona and Nevada. The center is certified by Quality Insurance International, the global leader in organic certification. This certification is in addition to Whole Foods Market's bakehouse, which has been certified organic since 1997.

The organic certification ensures that the integrity of product that enters and leaves the facility remains 100% organic. The certification reflects the system of checks and balances that Whole Foods Market has implemented to maintain the organic chain of purity.

"As a leader in organic produce, Whole Foods Market is continuing to implement systems to give our customers the greatest level of confidence in the integrity of the produce they buy," says Michael Besancon, Regional President, Whole Food Market Southern Pacific Region. "We will continue to improve the organic certification process at all levels of our business."

About Whole Foods Market

Founded in 1980 in Austin, Texas, Whole Foods Market is the world's largest natural and organic foods supermarket. In fiscal year 2002, the company had sales of $2.7 billion and currently has 143 stores in the United States and Canada. The Whole Foods Market motto, "Whole Foods, Whole People, Whole Planet"(TM) captures the company's mission to find success in customer satisfaction and wellness, employee excellence and happiness, enhanced shareholder value, community support, and environmental improvement. Whole Foods Market, Bread & Circus(R) and Harry's Farmers Market(R) are all registered trademarks owned by Whole Foods Market IP, LP. Whole Foods Market employs more than 24,000 team members and has been ranked for six consecutive years as one of the "Top 100 Companies to Work for" in America by Fortune magazine.

About QAI:

Independent, third party certification of organic food systems has been the foundation of domestic and international organic food trade. QAI verifies that the organic integrity is maintained. The QAI Certification Program is designed to certify every step of the organic chain -- from the land on which the product is grown; to the producers growing the product; to the post-harvest facilities preparing the product; to the processing and handling facilities transforming the product. Since 1989, QAI's diligence, at every link in the organic production chain, continues to provide assurance that the actual product destined to enter into market distribution is indeed organic.

Irish Supplements Withdrawn from Market

The Food Safety authority of Ireland has requested that 10 herbal supplements be withdrawn from the market due to irraditation during processing and improper labelling of the finished products.

The products affected are: Boots' Dong Quai; Cynara's Turmeric; Good 'n' Natural Raspberry Leaves, Silymarin Milk Thistle and Saw Palmetto; Holland & Barrett's Unique Garlic; Nature's Way Butcher's Broom Root; Rivo's Devil's Claw; Solgar's Devil's Claw and Sona's Black Cohosh.

EU regulations permit only certain constituents of supplements to be irradiated, provided consumers are notified through appropriate labelling. For food products under existing legislation, labelling is also mandatory for products which have been irradiated.

Editorial: Is It Really Just Background Noise Or Should It Be Center Stage?

By Len Monheit
[email protected]
Comment on this Editorial  

SupplySide East a few weeks ago, was a thought-provoking event. Although show-floor activity was mediocre, behind the scenes, there was a lot going on. And what was not being said was perhaps most important of all.

The event began with the FDA presentation and discussion surrounding proposed GMP’s. In several meetings over the next day, business opportunities and challenges were discussed including the fact that many in the industry seem to be waiting for an indication that the industry is out of its ‘funk’ before investing significant time, money and energy into it. This is discouraging and probably accounts for the subdued atmosphere observed by many attendees. True, the show numbers were good – higher than last year with a sold out show floor. But numbers don’t show everything.

The state of the industry discussions and educational sessions I attended were informative. In the former, I was amazed at the range of different perspectives presented by participants and struck anew by how diverse an industry we operate in. Many traditional supplement ingredient companies expressed their intention to focus on penetrating the functional food industry, beginning with the IFT show in Chicago in July.

The subject of insurance came up several times, with discussions surrounding the creation of a Captive Insurance Group within

SupplySide East 2003 Poll
 

the industry as a strategy to offset cost-prohibitive or unavailable insurance. One of the offshoots of such a program would be a motivated and proactive risk management approach from within or with the support of the industry with a mandate for minimizing insurance costs. As a part of a self-regulation program, proactive risk management is an excellent concept, and perhaps should not be limited to an insurance cost context.

There were some notable Vendorworks presentations including new science on the Effects of Loders Croklaan’s Safflorin ™ on Human Immune Response, with promising results being displayed and an indication that research and clinical studies are being done to support nutritional and natural products.

On the show floor, one could not help but notice the lack of International participation, possibly partly due to SARS concerns as well as other international issues and pressures.

And also on the show floor for the first time, intellectual property and patents were aggressively protected with Sabinsa’s presentation of a temporary restraining order to Alchem International, Inc. on the very show floor, the only place it could act to prevent the company from displaying and selling patent-infringing products.

Many show attendees were wrestling with the anticipated cost of compliance with new regulations, the possible limiting of markets in Europe due to Codex and EU initiatives, while still others wondered at the apparent demise of Pan Pharmaceuticals in Australia, a major player involved in pharmaceutical, OTC and supplement manufacture, not only in Australia, but with exported products to several other countries too.

Recapping the series of events and its impact on the dietary supplement industry specifically in Australia is alarming and while it was reassuring to hear it being discussed in North America, it reiterates the fact that we truly operate in a global marketplace:

"In every crisis, there is opportunity, and smart, responsible companies see this now."

 

An OTC product triggers an investigation into a company that manufacturers drugs, OTC’s and supplements. Systemic problems are found in the manufacturing and quality control processes despite a drug-like GMP environment under the guidance of the TGA. (Therapeutic Goods Administration). Products are recalled – drugs, OTC’s and supplements, affecting many countries and companies who rely on these goods. Store shelves are depleted, consumer confidence takes another serious blow.

The Complementary Healthcare Council (CHC) of Australia has hired a firm to handle communications to place the Pan Pharmaceuticals issue into perspective. This firm, Client Solutions Pty Ltd, has expertise in crisis management and media relations and is to be the industry voice during the crisis. Its first message re-stated the commitment to consumer safety and product quality in the natural healthcare industry, and, noted that the industry was working with the Therapeutic Goods Administration (TGA).

Industry vulnerability and waning credibility has been the subject of numerous debates over recent years, and certainly has been at recent events including SupplySide. Some argue that two mechanisms ideally operating synergistically would alter the process measurably. The first would be an aggressive campaign to rebuild industry credibility globally including gathering and presenting compelling data supporting science, efficacy and safety. The challenge is the availability of solid irrefutable science, demonstrable efficacy and behavior and products to the contrary. The second is ongoing responsible behavior where, despite the fact that the regulations allow certain things, they provide a baseline and guidance only for industry activities including claims and that a series of voluntary industry programs are applied on top of the regulations themselves, covering both ingredients as well as finished products.

In other recent news and activities of note, the Illinois House unanimously (117-0) passed a bill to ban outright OTC sales of ephedra dietary supplements. In the US, there have been increased calls for self-regulation to augment regulations and rules imposed by FTC and FDA. At the same time, there is evidence that the trade associations are collaborating more effectively, including some trans-North American collaboration. The cost and the process of compliance with the proposed GMP’s in the US and Canada is expected to have serious (possibly fatal) ramifications for small companies with good products.

It is becoming increasingly more obvious that the well informed, networked and managed will be able to survive the challenges the industry faces. This means trade show and trade association activity and building different types of relationships with value chain partners. It also means an awareness of global issues which either are or can impact us here in North America.

In every crisis, there is opportunity, and smart, responsible companies see this now.