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Leading Pharmaceutical Company Chooses Emagia to Optimize Cash Inflow

Leiner Health Products Inc. Chooses Emagia Collaborative Finance Suite 2.1 To Tame Collections and Chargebacks

SANTA CLARA, Calif.---Emagia Corporation, the enterprise cash flow management software company, today announces that Leiner Health Products Inc., America's largest manufacturer of vitamins and nutritional supplements, has chosen Emagia Collaborative Finance Suite 2.1 to manage its collections and deductions and for its cash forecasting functionality. Leiner, which manufactures and distributes supplements to more than 64,000 retail outlets worldwide, also will use Collaborative Finance Suite for end-to-end customer financial service that will integrate its collections operations with customer service and sales operations.

"With Emagia Collaborative Finance Suite 2.1, we believe we have given our finance staff a tool that will not only speed our collections and charge backs management processes, but that also will help to communicate more efficiently with other internal departments to better serve our customers," says Ivette Santiago, Leiner treasurer and vice president of finance. "Collaborative Finance Suite also gives us greater visibility into our cash flow, which is a significant advantage in financial planning."

"We are pleased to announce Leiner Health products as our customer," said Harnish Kanani, COO of Emagia. "This once again confirms that Emagia delivers best-of-breed functionality and a leading technology platform for gaining better visibility into and control of cash flow processes around receivables. Leiner not only wanted a strategic solution to manage their cash flow goals, but it also wanted a modern operational tool to manage age-old collections processes. Emagia is able to provide its customers with both."

Emagia Collaborative Finance Suite 2.1 is available today through Emagia Corporation. For pricing and further information, call 866/EMAGIA-1.

About Emagia Collaborative Finance Suite
Emagia Collaborative Finance Suite provides enterprise cash flow management around receivables, payables and other areas to optimize working capital for companies. Emagia Collaborative Finance Suite 2.1 offers complete invoice-to-cash management of accounts receivables. It is the only web-based product offering receivables portfolio management, collections management, deductions management and online customer financials service. Collaborative Finance Suite 2.1 streamlines day-to-day accounts receivables activities and enables connectivity and collaboration between sales departments, customer service departments and customers.

About Emagia
Emagia Corporation is a leading provider of collaborative e-business software solutions that streamline and automate cash flow processes for medium-to-large enterprises. Headquartered in Santa Clara, Calif., Emagia's products integrate with leading back-office ERP financial systems and most legacy systems. Pre-built Emagia EAI kits are available for most ERP systems.

About Leiner Health Products Inc.
Leiner Health Products Inc. is one of the world's largest private label manufacturer of vitamins, minerals, nutritional supplements and over-the-counter pharmaceuticals (OTCs). More than a hundred years before the 1970's, when demand for nutritional supplements exploded around the world, Leiner was already thriving and writing new chapters in the industry's history. Today, as the most innovative manufacturer of supplements and herbal products, Leiner Health Products continues to set the standards as it leads the way.

Note to Editors: Emagia is a registered trademark of Emagia Corporation.

CONTACT:
Emagia Corporation,
Santa Clara
Irwin Soonachan,
408/551-4903 (Media)
For general information, call 866/EMAGIA-1

Phytomedics and DNAX Research, Inc. Enter Biopharmaceutical Collaboration

DAYTON, N.J., Jan. 18 /PRNewswire-FirstCall/ -- Phytomedics Inc., a private biotechnology company, is pleased to announce signing a feasibility agreement with DNAX Research, Inc., of Palo Alto, California, Schering-Plough Corporation's biotechnology center for immunology and molecular biology, to produce therapeutic proteins in plants using Phytomedics' proprietary Recombinant Protein Secretion Technology (REPOST). Phytomedics Inc., an exclusive licensee of this technology, has been funding the development of REPOST at Rutgers, the State University of New Jersey.

``We are very pleased to be working with DNAX, a leader in the research and development of innovative therapeutic products,'' said Dr. Bertold Fridlender, CEO of Phytomedics Inc. ``DNAX's biopharmaceutical candidates and Phytomedics' unique REPOST manufacturing technology complement each other and should further demonstrate the value of our molecular farming capabilities.''

Innovative REPOST technology uses genetically transformed green plants to synthesize and continuously secrete large quantities of biopharmaceutical proteins from roots into a hydroponic solution. The technology, which is conceptually similar to natural rubber or maple syrup production, allows environmentally safe, continuous and efficient production of recombinant biopharmaceuticals. It was developed to provide a rapid and cost-effective solution to large-scale manufacturing of recombinant proteins. ``With the sheer number of biopharmaceutical product candidates under development there is a major shortfall of manufacturing capacity for these life-saving drugs, '' says Fridlender. ``The multi-million dollar cost and time required to build a conventional 'bricks-and-mortar' biopharmaceutical facility creates a major opportunity for the fast and economical REPOST approach.''

DNAX is a wholly-owned subsidiary of Schering-Plough Corporation (NYSE: SGP - news) of Kenilworth, N.J., a research based company engaged in the discovery, development, manufacturing, and marketing of pharmaceutical products worldwide.

Phytomedics Inc. is a privately held biotechnology firm located in Dayton, N.J. Phytomedics conducts its R&D under the leadership of Professor Ilya Raskin, Ph. D., at the Biotech Center of Rutgers University, who is also a founder and Chairman of the Company. Phytomedics' research staff is comprised of twenty scientists, mostly Ph. Ds, working in state-of-the-art facilities. Phytomedics has a broad research and licensing agreement with Rutgers University that allows the Company to exclusively license its core technologies and products.

In addition to business activities in the area of protein bio-farming, Phytomedics has also developed a broad range of plant-based biotechnologies targeted for the discovery and manufacturing of novel pharmaceuticals, botanical drugs, and nutritional health care products. Phytomedics has several products in various stages of development, including products for viral, inflammatory and cardiovascular diseases, cancer, diabetes, erectile dysfunction and sleep improvement, some of which are in clinical trials.

SOURCE: Phytomedics Inc.

Have You Eaten Enough Bacteria Today?

AMERICAN FORK, Utah, -- With the cold and flu season in full swing, people need to start eating more bacteria. No, you did not accidentally open to the middle of a science fiction magazine that deals with the nutrition needs of Klingons. Bacteria really do help the human immune system build the strength it needs to fight colds and flu.

According to Ron Williams, President of Whole Living, Inc. dba Brain Garden (www.thebraingarden.com), "Most people believe bacteria are evil germs to be avoided or destroyed. What we don't realize is that the primary cause of infection is not enough friendly bacteria."

The human body hosts an ecosystem of millions of bacteria -- both good and bad. A proper balance helps the body resist many diseases by keeping harmful microorganisms in check. It also regulates hormones and keeps your immune system running smoothly. A lack of "good" bacteria give the harmful bacteria run of your body.

Studies suggest that healthy bacteria can help ward off bladder infections, vaginal infections, sexually transmitted diseases, and stomach aches. Some evidence even suggests lactobacillus, friendly bacteria, can lower the risk of respiratory infections in children.

A recent article published in Newsweek points out treating every minor infection with antibiotics can actually harm your health by killing the friendly bacteria in your body.

So what are friendly bacteria? They are microorganisms that have a beneficial effect on intestinal function, and that maintain and promote good health.

To build up levels of friendly bacteria you can eat yogurt or kefir, which contains lactobacillus acidophilus, fermented soy products, sauerkraut, and organically grown produce. Or you can get it in powdered form.

Whole Living, Inc. dba Brain Garden, makes a product called Dynamic Flux, the only probiotic formula with the complete balanced spectrum of 12 friendly bacteria that you can mix in fruit or vegetable juices, yogurt or milk, or with a small amount of water. The good bacteria found in Dynamic Flux are organic and taken from fruits and vegetables.

Granted, you might not want to tell everyone exactly what you're putting in his or her drink. But if you want the best defense against the common cold and flu season, you may want to take the uncommon approach of fighting back with bacteria.

SOURCE CFG Media, Inc.

CONTACT:
Jodi Braucher
Columbia Financial Group
+1-614-792-1783
or
[email protected]

Web site: www.thebraingarden.com

Notice of Meeting - White House Commission on Complementary and Alternative Medicine Policy

The Federal Register: DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Office of the Secretary White House Commission on Complementary and Alternative Medicine Policy; Notice of Meeting Pursuant to section 10(a) of the Federal Committee Act, as amended (5 U.S.C. Appendix 2), notice is given of a meeting of the White House Commission on Complementary and Alternative Medicine Policy.

The purpose of this public meeting is to convene the Commission to discuss possible Federal policy regarding complementary and alternative medicine (CAM). The main focus of the meeting is the discussion of key issues before the Commission and the development of the Recommendations, Action Items, and the Draft Final Report of the White House Commission on Complementary and Alternative Medicine Policy. Major issue areas to be considered by the Commission prior to completion of its Final Report include the following Coordination of CAM Research; Access to and Delivery of CAM Practices and Products; Coverage and Reimbursement for CAM Practices and Products; Training and Education of Health Care Practitioners in CAM; Development and Dissemination of CAM Information for Health Care Providers and the Public; CAM in Wellness, Health Promotion, and Disease Prevention; Coordinating and Centralizing Private Sector and Federal Sector CAM Efforts; and the Definition of CAM and the Commission's Guiding Principles. Comments received at the meeting may be used by the Commission to prepare the Final Report of the President as required by the Executive Order.

Opportunities for oral statements by the public will be provided on February 22, from 3 p.m.-4 p.m. (Time approximate).

Name of Committee: The White House Commission on Complementary and Alternative Medicine Policy.

Date: February 21-22, 2002.

Time: February 21 8 a.m.-6 p.m., February 22 8 a.m.-5 p.m.

Place: Double Tree Hotel Rockville, Plaza I and II Conference Rooms, 1750 Rockville Pike, Rockville, MD 20852, Telephone: 301-468-1100.

Contact Persons: Michele M. Chang, CMT, MPH, Executive Secretary, or Stephen C. Groth, Pharm.D., Executive Director, 6707 Democracy Boulevard, Room 880, MSC-5467, Bethesda, MD 20892-5467, Phone: (301) 435-7592, Fax: (301) 480-1691, E-mail: [email protected]

Because of the need to obtain the views of the public on these issues as soon as possible and because of the deadline for the report required of the Commission, this notice is being provided at the earliest possible time.

SUPPLEMENTARY INFORMATION: The White House Commission on Complementary and Alternative Medicine Policy was established on March 7, 2000 by Presidential Executive Order 13147. The mission of the White House Commission on Complementary and Alternative Medicine Policy is to provide a report, through the Secretary of the Department of Health and Human Services, on legislative and administrative recommendations for assuring that public policy maximizes the benefits of complementary and alternative medicine to Americans.

Public Participation The meeting is open to the public with attendance limited by the availability of space on a first come, first served basis. Members of the public who wish to present oral comments may register by faxing a request to register at 301-480-1691 or by accessing the web site of the Commission at http://whccamp.hhs.gov no later than February 12, 2002.

Oral comments will be limited to five minutes, three minutes to make a statement and two minutes to respond to questions from Commission members. Due to time constraints, only one representative from each organization will be allotted time for oral testimony. The number of speakers and the time allotted may also be limited by the number of registrants. Priority may be given to participants who have not yet addressed the Commission at previous meetings. All requests to register should include the name, address, telephone number, and business or professional affilation of the interested party, and should indicate the area of interest or issue to be addressed:

Any person attending the meeting who has not registered to speak in advance of the meeting will be allowed to make a brief oral statement during the time set aside for public comment if time permits, and at the Chairperson's discretion. Individuals unable to attend the meeting, or any interested parties, may send written comments by mail, fax, or electronically to the staff office of the Commission for inclusion in the public record.

When mailing or faxing written comments, please povide your comments, if possible, as an electronic version or on a diskette. Persons needing special assistance, such as sign language interpretation or other special accommodations, should contact the Commission staff at the address or telephone number listed above no later than February 12, 2002.

Dated: January 18, 2002.

LaVerne Y. Stringfield, Director, Office of Federal Advisory Committee Policy.

Global Botanicals Responds Regarding Ephedra Products

January 16, 2002

Barrie, Ontario, Canada: There has been a great deal of confusion regarding the banning of herbal diet products and herbal energy products since Health Canada issued a public warning and an industry recall on combination products containing ephedra or ephedrine on January 9, 2002.

According to Health Canada’s release, the effected products are those which contain more than 8mg of ephedrine per dose or 32mg of ephedrine per day and, “all combination products containing Ephedra/ephedrine together with stimulants (e.g. caffeine) and other ingredients which might increase the effect of Ephedra/ephedrine in the body”.

Pure-Li Natural is proud to say that we have never manufactured or marketed products which would be subject to this recall. All of our combination weight loss products and energy products contain no Ephedra or ephedrine.

  • Pure-Li Natural Lose-It is an effective weight loss product utilizing Garcinia cambogia as its medicinal weight loss aide.
  • Pure-Li Natural Lose-It Plus is the Ephedra/ephedrine free effective synergistic combination of herbs for safe gentle weight loss.
  • Pure-Li Natural Accelerator Organicaps® utilize the combination of Ontario Red Ginseng, Schizandra and Green Tea to provide energy and stamina, without any ephedra or ephedrine.
  • Pure-Li Natural Dynamic Diet Duo is the Ephedra/ephedrine free combination pack including a weight loss aide (Lose-It Plus) and an energizer (Accelerator Organicaps®) in one convenient package.

Pure-Li Natural’s Super Strength Holistically Standardized Ephedra Extract is a pure unadulterated Ephedra Extract. This product is unaffected by the Health Canada recall because it is marketed without medicinal claims regarding energy enhancement or weight loss, and its dose contains less than 8mg ephedrine.

Small Entity Compliance Guide: ''Structure/Function Claims;'' Availability

[Federal Register: January 9, 2002 (Volume 67, Number 6)]
[Notices]
[Page 1225]
From the Federal Register Online via GPO Access
[wais.access.gpo.gov]
[DOCID:fr09ja02-61]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0044]

Small Entity Compliance Guide: ''Structure/Function Claims;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice
-----------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a small entity compliance guide (SECG) for a final rule published in the Federal Register of January 6, 2000 (65 FR 1000), entitled ``Regulations on Statements Made for Dietary Supplements Concerning the Effect on the Structure or Function of the Body.'' This SECG is intended to set forth the requirements of that final rule in plain language and to help small businesses understand the regulation.

DATES: Submit written or electronic comments on the SECG at any time.

ADDRESSES: Submit written comments concerning this SECG to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Submit written requests for single copies of the SECG to the Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 20204. Send one self-adhesive address label to assist that office in processing your request. See the Supplementary Information section for electronic access to the SECG.

FOR FURTHER INFORMATION CONTACT: Robert Moore, Center for Food Safety and Applied Nutrition (HFS-811), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4605, FAX 202-205-4594.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 6, 2000 (65 FR 1000), FDA issued a final rule defining the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body. The regulation also established criteria for determining when a statement about a dietary supplement is a claim to diagnose, cure, mitigate, treat, or prevent disease. The final rule clarified the types of claims that may be made for dietary supplements without prior review by FDA and the types of claims that require prior authorization as health claims or prior approval as drug claims. This final rule became effective February 7, 2000.

FDA examined the economic implications of that final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-602). The agency determined that the final rule would have a significant economic impact on a substantial number of small entities.

In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121), FDA is making available this SECG stating in plain language the requirements of this regulation.

FDA is issuing this SECG as level 2 guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG represents the agency's current thinking on the subject. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

I. Comments

Interested persons may, at any time, submit written or electronic comments on the SECG entitled ``Structure/Function Claims; Small Entity Compliance Guide'' to the Dockets Management Branch (address above). Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments should be identified with the docket number found in brackets in the heading of this document. A copy of the SECG and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

II. Electronic Access

Copies of the SECG may also be viewed on a personal computer with access to the Internet. The Center for Food Safety and Applied Nutrition's home page includes the SECG, which can be found at http://www.cfsan.fda.gov

Dated: December 26, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-451 Filed 1-8-01; 8:45 am]
BILLING CODE 4160-01-S

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Structure/Function Claims: Small Entity Compliance Guide (also available in PDF)

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Guidance Documents

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Solid Gains Protein Shake New to HDT Line

PHOENIX, AZ - M.D. Labs announced the release of a new high calorie, high protein weight gainer drink under its Human Development Technologies (HDT) line. Solid Gains contains 5.8 pounds of the number one selling protein blend (Pro Blend 55), along with optimum ratios of carbohydrates and fats, 11 grams of branch chain amino acids and 3 grams of essential fatty acids from flax seeds. Solid Gains is packaged in a large wide mouth canister with an easy built-in carry handle.

HDT will be positioning the product as a premium item that includes a time released blend of instantized whey protein isolates, egg protein and milk protein to deliver 60 grams protein per serving which is aspartame free and mixes easily without the use of a blender. Solid Gains also delivers 100 grams of carbohydrates with only 6 grams of sugar.

"This puts Solid Gains in the 'weight gainer' category as opposed to the sugar laden 'waist gainer' products currently available in the market," said Chris La Fleur, Vice President of Marketing. Completing the formula with a supporting cast of anti-catabolic/anabolic nutrients, Solid Gains expects to quickly gain acceptance as the leader in muscle gaining protein powders. Available in chocolate fudge and vanilla cream, this product is lactose free and tastes great. M.D. Labs has been marketing several successful protein drinks under the HDT line, and is excited to enter the weight gainer category. The product begins shipping immediately. Ordering information can be obtained by calling M.D. Labs at (800) 255-2690.

According to La Fleur, "The weight gainer category has always been dominated by young athletes, beginning body builders and others struggling to put on additional weight. With the latest scientific advancements in protein powder formulations, we feel Solid Gains will complement this market and open itself up to more experienced and nutritional savvy supplement users. Solid Gains is a superior product and the weight gainer category is posed for significant growth in the future as more people opt for a healthy way to increase weight."

The market for protein drinks includes several segments: High-quality expensive whey protein isolates, blended protein sources, single protein sources, high calorie/high protein (weight gainer) and economy products. The HDT line has heretofore focused primarily on the blended protein and economy protein segments. Solid Gains represents the company's initial expansion into the weight gainer segment.

M.D. Labs is a leading manufacturer of unique and high quality sports nutrition and herbal supplements. All M.D. Labs products are based on credible research and superior nutrients in the most efficacious formulations. The Company has established itself as one of the most dynamic companies in the industry as a result of its unique products and commitment to healthy living.

Second Infant Formula Company Announces Plans for U.S. Launch of Formula with Martek's Oils

COLUMBIA, Md., -- Martek Biosciences Corporation (Nasdaq: MATK) announced today that Mead Johnson(R) Nutritionals has announced plans to launch an infant formula supplemented with Martek's nutritional docosahexaenoic acid (DHA) and arachidonic acid (ARA) oils in the United States. Mead said today that the formula, Enfamil LIPIL(TM), will be on store shelves in early February. Earlier today, The Ross Products Division of Abbott Laboratories made a similar announcement of plans in early 2002 for a U.S. launch of formula supplemented with Martek's oils.

In May 2001, the Food and Drug Administration completed a favorable review of Martek's generally recognized as safe (GRAS) notification regarding the use of its DHA and ARA in infant formula. The FDA's clearance pertained solely to Martek's oil blend and does not extend to any other sources of DHA and ARA.

DHA and ARA are natural components of breast-milk and are believed by many researchers to play a pivotal role in perinatal neural development. Extensive clinical research has demonstrated that Martek's pure, proprietary formulation of DHA and ARA, when added to infant formulas at the proper level, significantly improves the mental and visual development of formula fed babies. Martek's DHA and ARA are currently available in infant formulas in over 60 countries worldwide.

Martek Biosciences Corporation develops, manufactures and sells products from microalgae. The Company's products include: (1) specialty, nutritional oils for infant formula; (2) nutritional supplements and food ingredients that may play a beneficial role in promoting mental and cardiovascular health, and in the development of the eyes and central nervous system in newborns; and (3) new, powerful fluorescent markers for diagnostics, rapid miniaturized screening, and gene and protein detection.

CONTACT:
Pete Buzy
Chief Financial Officer
Martek Biosciences Corporation
+1-410-740-0081

SOURCE Martek Biosciences Corporation

URL: www.martekbio.com

NPI Editorial: Is it really all about price?

Whether you're a manufacturer, raw material supplier, distributor, health food or retail store operator you've got supplier issues. These may not always be problems, but they are issues. You've got to locate, negotiate, manage and get the most from suppliers. And all this time, you’re under pressure to deliver final product or service for the lowest cost possible. Seems like an awkward situation, you need more but can give them less.

Now let's look at the other angle-- you're a supplier at any stage of the supply chain, you've got to differentiate, making it easy for clients to do business with you; you've got to make it desirable. And in this age of high turnover, relationships have to go deep into the organization and your value has to be widely perceived. And clients want more for less.

In many maturing industries, long standing relationships fail and the value of service, rapport and goodwill is overlooked due to cash realities and a “what have you done for me lately” attitude.

Doesn't sound like an environment that builds strong relationships, does it?

It all depends on whether you look at the short or long term. If short term, paycheck to paycheck realities are driving your operation, then an investment in deep, long term relationships with your clients can be difficult. If you can look out a bit longer, you see that the investment pays off quickly.

One of my mentors told me that “what you win solely on price, you will soon lose on price and the cost of acquiring the business will never be recovered.” But what are you supposed to do when your competition sells exclusively on price? What are you supposed to do when the value of quality and service is not realized? Sure, it's appreciated, for the moment, but there's no value assigned to it.

Different models have emerged. We see big box stores pressuring suppliers to reduce final cost of goods and pay for the privilege of doing business with them. In large manufacturing operations, there are quality based partnerships, but the focus is on reducing cost, pressuring suppliers, lowering their margins, while trying not to compromise quality in the process. In other industry sectors, long term supply contracts are drawn up, with decent initial payments to support product research and development, followed with a lower margin as product reaches success in the market.

Can we learn anything from these models? What value research, innovation, customer service, quality?

I keep hearing that consumers buy based solely on price. Will this be the case five years from now, or will the educational and certification activities groups and organizations are launching now change the marketplace? Possibly, when combined with other factors including a building body of accepted science, a critical consumer and a rewarded brand, especially when that brand is supported by strong, reliable, consistent supply, technically savvy client support, seed to shelf responsibility from all supply chain participants, and a marketplace that penalizes those that don't meet the grade.

We're already seeing brand effect, companies investing heavily to build brand identity, and even branded raw material suppliers getting their message to the consumer.

This leads me back full circle to my initial question? What are you going to do about your suppliers—now? How will you position yourself for the long run, with reliable sources of consistent materials? And as suppliers, how do you take the equation from a “price drives” to a “package deal”. How do you take an open tender to a “slam dunk”?

The answer, as it always has been, is to go the extra mile. Except now, in this market, it has to be a creative mile. The most successful business people have always been the ones who have understood and empathized with others, and valued relationships. If you can successfully place yourself in your clients’ shoes, literally walking to market with them, you'll win more than you lose. Critics will say you never have the chance to do this in the impersonal world of big corporations where cash is king. It's amazing though, how many pieces of the supply chain link directly to the bottom line- if you’re creative.

The ISO 9000 series of quality standards has a section of documentation and process entitled “Cost of Quality”. This section doesn't deal only with product quality, it also deals with quality of process and operation. If you can make it efficient, streamlined and easy for your clients to work with you, you save them money. If you can plan ahead with them, use your experience and industry knowledge as a supplier to help them, you add value, tangible value. If you can provide a body of research, if you let them know how to take advantage of the changing business environment, positioning for future success, then you make them more successful and profitable. If you have documentation to support your products, where it needs to be, almost before it needs to be there, then you save your clients' QA department resources. If you provide services to the industry, and you discover precious information that benefits existing and potential clients, let them know. Do the service, go the extra mile, understand their business and their needs, because with enough of these activities, a margin point here, a dollar there, marginally successful operations become more lucrative, and out of such activities are strong relationships established.

I have been involved in several instances in recent weeks where one of my contacts has gone the extra mile for me, for no obvious immediate return. The best representative I have ever come across frequently sends me valuable information, because he has taken the time to learn my business, my interests and my needs. He has saved us money, made us money and connected us with his network.

That's just one example. Share your thoughts in the NPIcenter Discussion Forum

Len Monheit,
President & CEO
NPIcenter

Comment on this and other Editorials in the NPIcenter Discussion Forum

American Nutraceutical Association Letter to Consumers Union

January 24, 2002

James A. Guest, President
Consumers Union
100 Truman Avenue
Yonkers, NY 10703-1057

Dear Mr. Guest:

The American Nutraceutical Association (ANA) is an organization composed of physicians, pharmacists, academicians, and researchers striving to educate healthcare professionals and consumers about the latest research in the growing field of nutraceutical science.

We've recently read the article titled "Joint Remedies" in the January 2002 issue of Consumer Reports. While we applaud your effort to differentiate glucosamine and chondroitin supplements on the basis of their labeled claims and cost to consumers, we take exception to the concluding statement in this article that advises consumers: "While no one knows which formulation works best, it makes sense to try one of the least expensive combination products." In essence, this recommendation by your respected publication guided the consumer in their purchasing decisions exclusively on the price of products that matched label claim. While price and content of the product as compared to label claim are important issues, they are not enough, for it is equally important to evaluate bioavailability, which in turn can impact the efficacy of these products, especially those containing chondroitin.

Taber's Medical Dictionary defines bioavailability as "the rate and extent to which an active drug or metabolite enters the general circulation, permitting access to the site of action." Bioavailability is determined either by measurement of the concentration of the ingredient in body fluids, or by the magnitude of the pharmacologic response. Simply put, when a product is not absorbed by the body, it will not produce the desired effect.

The board members of ANA are concerned that the approach to product selection suggested in your article does not adequately address the complex issue of bioavailability. We agree that a product must contain the amounts stated on the label. However, the bioavailability and "efficacy" of a nutrient is in many cases dependent on more than the quantity of the ingredient found in the tablet or capsule. This is an important consideration, for the level of bioavailability can affect the cost of the compound. This is especially true for chondroitin sulfate, as discussed in our peer-reviewed journal in a study that evaluated the potential intestinal transport of several marketed sources of chondroitin sulfate. In an original research study published in the Journal of the American Nutraceutical Association (Vol. 3, No. 1, 2000, 37-44.), Adebowale and colleagues at the University of Maryland School of Pharmacy reported that the permeability coefficient for transport of chondroitin sulfate is affected by the molecular weight of the raw materials used, demonstrating that the bioavailability can be related to the size of the molecule. Several products examined in this study that passed "label claim" failed in an absorption model. This means that although a product meets its labeled claim, its molecular weight, size, or configuration can impact its bioavailability, with little or none of the ingredients actually absorbed, negatively impacting the product's intended clinical effect. Well-researched parameters that can affect bioavailability include molecular size, shape, and weight, excipients in the formulation, and the manufacturing process. We have all heard of tablets compressed so hard that they do not dissolve in the GI tract, and therefore have no bioavailability even when they meet label claims for quantity. The University of Maryland study concluded that the bioavailability of chondroitin sulfate is increased by using a product that has a smaller molecular weight. The important point that was not reflected in your article ("Joint Remedies") is that other factors can be just as important as meeting the label claim of a dietary supplement, especially so in the case of chondroitin sulfate.

The research team at the University of Maryland School of Pharmacy also evaluated the % label claim of chondroitin sulfate vs. price in retail dollars per daily dose. They found that most products costing less than $1.00/dose of 1200 mg of chondroitin sulfate were significantly below label claim. They also found that products costing more than $4.00/daily dose of 1200 mg were clearly below label claims. This showed that there was no clear relationship between product costs and content. Enclosed for your review is a copy of the Adebowale et al. study.

A problem unique to dietary supplements is that there is no "bioavailability standard" or monograph that dietary supplement manufacturers are required to follow. Good examples of the "bioavailability standard" concept for prescription drugs are digoxin, coumadin, and thyroxine. These generic pharmaceutical products all meet accepted bioavailability standards set by the United States Pharmacopeia (USP). It is important for the consumer to know that quantitative equivalency is not synonymous with either bioequivalency or bioavailability, and no such standards for either currently exist for dietary supplements, or "nutraceuticals."

In our opinion, Consumer Reports inappropriately and incorrectly related truth of label claim and price to bioavailability in its report. By doing this, Consumer Reports may have accomplished exactly the opposite of its intent.

It is clear that when evaluating dietary supplements, each brand should stand on its own original research, and not be assessed by the research of other brands. To compare bioavailability and make an accurate recommendation to buy the least expensive product that is bioavailable when consumed, Consumer Reports would have to test each product for bioavailability. We hope that in future comparisons of dietary supplements containing glucosamine and chondroitin, this fundamental error is not repeated.

We applaud Consumer Reports for attempting to guide the consumer through the maze of dietary supplements now used for joint health. However, when providing consumers with advice on efficacy we refer to the Arthritis Foundation's statement: "When a dietary supplement has been studied with good results, find out which brand was used in the study, and buy that."

In our opinion, until USP or another independent third party develops a "bioavailability standard" or monograph that dietary supplement manufacturers are required to follow for glucosamine/chondroitin products, this is the only safe recommendation to make that incorporates the issues of price, label claim and product content, bioavailability of the product, and efficacy.

Respectfully submitted,

Allen Montgomery, RPh
CEO & Executive Director

Mark Houston, MD
Editor-in-Chief, Journal of the American Nutraceutical Association (JANA)
Clinical Professor of Medicine
Vanderbilt University School of Medicine, Nashville, Tennessee

David S. Hungerford, MD
Member, JANA Editorial Board
Professor, Orthopaedic Surgery
Johns Hopkins School of Medicine
Baltimore, Maryland

Natalie D. Eddington, PhD
JANA Editorial Board Member
Associate Professor of Pharmaceutics, University of Maryland, Baltimore

Chris Foley, MD
Coeditor (medicine), JANA
Medical Director, Integrative Care, St. Paul, Minnesota
Clinical Assistant Professor, University of Minnesota College of Pharmacy
Minneapolis, Minnesota

Barry Fox, PhD
Chair, ANA Consumer Advisory Council
Coauthor, The Arthritis Cure, Calabasas, California

Robert Krueger, Ph.D.
Cochair, ANA Pharmacy Advisory Council
Professor of Pharmacognosy, Ferris State University College of Pharmacy
Big Rapids, Michigan


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