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Articles from 2003 In November


Van Drunen Farms and Futureceuticals Comply With FDA Bioterrorism Regulation

MOMENCE, ILLINOIS— (November 17 , 2003) —Van Drunen Farms and FutureCeuticals announce their complete compliance with the Food and Drug Administration’s regulation requiring all food processors to register with the agency in accordance with the Public Health Security Bioterrorism Preparedness and Response Act of 2002.

Following the events of September 11, 2001, the FDA passed legislation requiring all food producers, processors, packers and shippers to register with the agency. The legislation also requires all non-US companies to designate a registered agent in the US. Additionally, a further provision requires The FDA be notified of all food shipments coming into the US. Registration will enable the FDA to track threatened or actual terrorist attacks on the US food supply, and enable them to notify quickly the facilities that may be affected.

Tommy G. Thompson, Health and Human Services Secretary says these are “Critical new tools for the FDA to identify potentially dangerous foods and better keep our food supply safe and secure.” Compliance with the regulation is required by December 12, 2003. A recent survey disclosed that more than 50 percent of food industry executives were unaware of the new regulation. Non-compliance could keep thousands of pounds of food shipments being embargoed at the US border.

Van Drunen Farms and FutureCeuticals have registered all of their facilities, five in Illinois and one in California, in accordance with the regulation. Contact Ed Lindquist, Quality Compliance Coordinator with any questions regarding the Bioterrorism Act, or with Van Drunen’s compliance. [email protected], 815-472-3545.

The entire regulation can be found in the Federal Register October 10, 2003, Volume 68, Number 197, www.fda.gov.

###

Joseph A. Levitt Retires as Director of FDA’s Center for Food Safety and Applied Nutrition; Dr. Robert E. Brackett to Succeed Him

Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D., today announced the retirement of Joseph A. Levitt, Esq., as Director of the Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN), and the appointment of Dr. Robert E. Brackett as his successor.

“As a staff attorney, Commissioner’s chief of staff, deputy center director, and center director, Joe has clearly had a unique and lasting impact on the health of Americans,” said Dr. McClellan. “With a career-long commitment to improving America’s health and strengthening FDA, Joe leaves our food and nutrition center as a world class organization, ready to meet the challenges ahead.”

Levitt’s tenure as center director at CFSAN was marked by continuing productivity increases, as a result of innovative and clear management and a rigorous process for setting and achieving priorities. Since 1998, CFSAN has strengthened its capacity to carry out its mission by recruiting a cadre of scientific and regulatory experts, who have helped position the center to deal more effectively with the many public health challenges it faces.

The experts recruited by CFSAN in recent years include Dr. Brackett, who has been crucial to strengthening the center’s scientific expertise in food safety, and he has played a major leadership role in its counter-terrorism program.

“As our food and nutrition center faces more challenges and responsibilities than ever - as well as better science to meet them - FDA is indeed fortunate to be able to call upon Dr. Bob Brackett,” Dr. McClellan added. “As CFSAN’s Director of Food Safety and Security, and with a distinguished background in food microbiology, Bob is the ideal leader to make sure that the safety and security of the U.S. food supply sets the standard for the world. As a proven manager with a knack for applying scientific insights to practical problems, Bob is also the ideal leader to help consumers improve their health through their dietary choices.”

Since June 2001, Dr. Brackett has been in charge of food safety and security at CFSAN, where he has been responsible for food safety policy issues and for coordinating new food safety programs. In addition, he represents CFSAN on counter-terrorism efforts and co-chairs the National Advisory Committee on Microbiological Criteria for Foods - all while maintaining an active research program on food borne pathogens.

Dr. Brackett joined FDA in March 2000, serving as senior microbiologist in CFSAN’s Office of Plant and Dairy Foods and Beverages. Before that, he was a professor of food science and technology in the Center for Food Safety at the University of Georgia. His research has focused on the effects of processing and packaging on the growth and survival of food borne pathogens, and on the development of methods for detection and enumeration of food borne bacterial pathogens, the behavior of food borne pathogens in refrigerated foods, and the detoxification of aflatoxins, toxic substances which occur naturally in certain foods under particular growing conditions.

Dr. Brackett was born in Wisconsin and received a B.S. degree in bacteriology from the University of Wisconsin. He also earned M.S. and Ph.D. degrees in food microbiology from the same university. He has published more than 200 articles in scientific journals and has made numerous presentations at national and international scientific meetings as well as before industry groups.

The many major achievements of the Center for Food Safety and Applied Nutrition under Mr. Levitt’s leadership include:

· Transforming FDA’s food safety mission to address new security threats, through implementation of Bioterrorism legislation to make the U.S. food supply even safer and more secure, and through working closely with industry and public health and security agencies to strengthen the U.S. food security system in the wake of the September 11th attacks;

· Enhancing FDA’s “applied nutrition” program, including new guidance and regulatory oversight for health claims for conventional foods, requiring new “trans fat” information on the food label, and taking further steps to help consumers use their diet to prevent obesity and improve their health;

· Expanding FDA’s food safety program to control disease-causing organisms by creating newer surveillance systems, stronger prevention programs and faster response to outbreaks of food borne illness. During his tenure, the incidence of food borne illness from the leading pathogens decreased significantly.

· Strengthening FDA’s food and nutrition program by successfully moving from CFSAN’s outdated facility near the Mall in Washington, D.C., to a state-of-the art laboratory and administrative facility in the new Harvey E. Wiley building in College Park, Md.

Mr. Levitt joined FDA in 1978 as a staff attorney in the office of the general counsel. In the 1980’s, while in the Office of the Commissioner, he was heavily involved in the “IND/NDA Rewrites” and “Treatment IND” regulations designed to streamline the new drug review process and provide promising new therapies to desperately ill patients. Later, he helped launch FDA’s food labeling initiative, and in 1990 he functioned as the acting deputy commissioner.

From November 1991 until January 1998, he served as deputy director for regulations and policy in FDA’s Center for Devices and Radiological Health, where he was involved in all facets of device regulation and played a key role in implementing new mammography legislation.

Mr. Levitt will become a partner in the law firm of Hogan & Hartson, LLP. His last day at FDA will be December 31, 2003. Dr. Brackett will assume his new duties January 1, 2004.

####

UK Health Food Industry Launches Legal Action Against EU Legislation

A joint application for a Judicial Review on the legality of the EU Food Supplements Directive has been lodged with the Court by leading organisations within the health food industry. They are confident that this interesting and important case will succeed in being referred to the European Court of Justice. The National Association of Health Stores (NAHS) and the Health Food Manufacturers Association (HFMA) are also applying for an injunction to stop the Directive coming into effect in this country. The lobby group Consumers for Health Choice (CHC) and nutrition experts, the Institute for Optimum Nutrition (ION), are supporting the case.

The Directive 2002/46/EC is designed to harmonise the market across all EU Member States and will restrict the sale of the most popular higher dose nutrients, such as antioxidant vitamins C, B6 and E and essential minerals including selenium and zinc, in quantities currently used by UK consumers, limiting them to purchasing very small, yet to be determined, doses.

This Directive will affect 41% of UK adults who currently buy over £335 million worth of vitamins and minerals annually. Consumers wishing to maintain their daily nutrient consumption will be forced to make multiple purchases for their usual intake, paying prices several times their current outlay.

In total, over 5,000 popular vitamin and mineral food supplements will be banned when the Directive comes into force on 1 August 2005. These products are currently available throughout the UK, accepted as safe by the Regulators and with proven benefits.

The Directive dictates which nutrients and nutrient sources will be allowed, and shows these in the form of a Positive List. There are around 270 ingredients widely used in supplements on the British market that are not included. A very small number of products containing these missing ingredients could remain on the shelves till 2009, but only if the manufacturers compile and submit dossiers proving each ingredient's safety before the end of July 2005 - a procedure estimated to cost up to £200,000 per substance.

Ralph Pike, Director of NAHS, said: "Whilst this Directive will be implemented in all EU countries it will be ruinous for the UK. We have a strong and increasing supplements culture and British consumers prefer to buy specialist vitamins and minerals in higher doses than other nations."

Peter Aldis, Managing Director of Holland & Barrett and current Chairman of HFMA, added: "There is a wealth of evidence supporting the safety and efficacy of essential vitamins and minerals. They have been available as supplements for decades and are the subject of thousands of positive research studies."

Sue Croft, Director of CHC, stated: "This Directive has to be stopped. It will cause untold misery for millions of consumers if their supplements are restricted. Nobody would deny that regular intake of nutritional supplements acts as an insurance policy, both as an excellent means of maintaining good health and preventing some diseases. Losing our special products will force thousands of people into the doctor's surgeries, at a time when out health care system is in crisis."

ENDS

For further information:

Ralph Pike, NAHS - 07866 317760 or 0114 235 3478
Penny Viner, HFMA - 0780 317 0200 or 0208 398 4066
Sue Croft, CHC - 01275 374446
Patrick Holford, ION - 0208 877 9993

Delicious Living

December 1, 2003

EU Supplements Directive Faces UK Courts

Europe

The European dietary supplements industry is closely watching separate legal challenges launched against the implementation of the Food Supplements Directive in the UK.

One challenge is being jointly led by the National Association of Health Stores (NAHS) and the Health Food Manufacturers Association (HFMA). A pan-European group, the Alliance for Natural Health, is mounting the other action.

Although there are differences in their arguments, both actions question the right of the Directive, under EU constitutional law, to ban nutrients that don?t appear on the Directive?s positive list.

HFMA chairman Peter Aldis stated: ?There are strong grounds for mounting our challenge. Our case argues that the Directive is disproportionate, discriminatory and irrational and also uses some of the technical arguments that resulted in the overturn of a previous EU Directive.?

Products Blacklisted
It is estimated that 5,000 products and 300 nutrient sources will be blacklisted when the Directive comes into force in the UK in August 2005. A similar situation exists in other liberal European markets such as Sweden, Ireland and the Netherlands where a similar number of local and imported products will have to be reformulated if the Directive becomes law.

For the more conservative EU markets, the Directive will have a liberalising influence and hence resistance is minimal.

NAHS director Ralph Pike said the UK action had to be mounted now because it could take up to two years for a decision to be reached. ?If we don?t win the debate on the submission of scientific dossiers to get nutrients on the positive list, and we don?t win the debate on reasonable maximum permitted levels in food supplements, and we hadn?t mounted this action, all would have been lost. We had to move now.?

Cheryl Thallon, managing director of UK-based supplements manufacturer, Viridian, said legal action, although not popular in all quarters of industry, had been forced upon the industry. ?The industry saw this Directive coming 10 years ago,? she said. ?We thought common sense would have prevailed by now but it hasn?t so finally something is happening. What irritates a lot of people is that we have signed up to this Directive as a country without knowing its detail.?

Opposition Not Unanimous
Other groups, such as the Proprietary Association of Great Britain, which represents both food supplement manufacturers and pharmaceutical companies, have more faith in the Directive. ?The procedure has been defined to allow any additional ingredients and products to be added to the positive list,? PAGB communications director Mike Owen, said. ?It?s up to the companies who are concerned about these products to get the dossiers together.?

Sindy Staesson, government and regulatory affairs manager at the UK division of supplement company, Herbalife, said the legal challenges would alienate industry from the legislative process. ?If the European and UK MPs stop co-operating with industry, where are we then? We are prepared to reformulate some products in the interest of keeping food supplements freely available on the market. We believe compromise is necessary if we are not to lose everything.? For Pike, there is everything to gain by mounting the action. ?We are compelled to take this action and people who don?t understand that are na?ve or have a vested interest in allowing the Directive to pass into law as it is,? he said.

Judicial Reviews of the two actions are expected by January, 2004. If successful, the cases will then be presented to the European Court of Justice at some point next year.

More Help With Scientific Dossiers
The Directive remains open to negotiation in two key areas—upper safe levels (currently being assessed by various scientific bodies) and the positive list of permitted substances.

The European Food Safety Authority (EFSA), responsible for assessing the scientific dossiers, said applicants can communicate with EFSA at any time during the assessment process and the agency will inform applicants of any weaknesses in dossiers as soon as such information becomes available. The EFSA stated that toxicological and biological data can be simplified in three ways:


  1. Data can be shared between nutrient sources where sources are similar to a source already on the positive list (eg, sodium molybdate or potassium molybdate).
  2. Data can be shared for sources included in the Food Additives Directive positive list.
  3. Data submitted under other related Directives could be shared. The EC has indicated it may merge several directives including the Food Supplements and Fortified Foods Directives? lists.

The Whey Forward

Whey protein appears to be the ideal protein source for post-exercise recovery foods and to improve clinical outcomes in certain disease states. But is the hype consistent with the research? Robert Child, PhD, investigates

Much has been written about whey?s potential benefits for general health, athletes and its application for specific clinical conditions. Unfortunately much of the literature in the popular press either favours whey protein or heavily criticises its use. This article provides a brief but contemporary critique of the scientific evidence and explores biochemical mechanisms of whey protein action. Such information is important to optimise the potential benefits of whey protein in applications as a functional food in medicine and sport.

There is increasing scientific interest in whey—the fluid portion of milk obtained by coagulating and removing curd. A number of applications as a functional food to improve health have been described and these effects are not readily apparent when whey is simply considered as a source of protein.

Processing
Whey is a by-product of hard cheese manufacture and, though nutritious, has limited application as a food ingredient in this form. The dry matter in whey is about 55 per cent protein, which is of high biological value. In this unprocessed form whey also contains around 40 per cent lactose and is often referred to as sweet dairy whey.

Additional processing is usually desirable to reduce the lactose content, as many people are intolerant to this sugar. Heating and acid precipitation can be used to purify whey to provide whey protein isolates—a protein content above 90 per cent—but these treatments also denature some of the bioactive proteins so that their functional properties may be lost.1,2 Passing whey through a series of filters can produce whey isolates with a protein content of around 90 per cent, without the use of heat or strong acids.

This process is often referred to as cross-flow microfiltration and minimises damage to important protein molecules, which allows their functional properties to be retained. The lactose content of whey isolates can be reduced to 1?2 per cent, making them suitable for people with poor lactose tolerance. Specific protein fractions can be further purified using a combination of cross-flow microfiltration and ion exchange chromatography.

Whey Vs Other Proteins
Bovine whey is composed primarily of the proteins beta-lactoglobulin (50%), alpha-lactalbumin (20%), glycomacropeptide (20%) and bovine serum albumin (2?3%). These proteins act as excellent sources of cysteine and also have recognised functional effects as intact proteins.3 Despite the similarities in amino acid composition between whey, casein and soy (See Table 1), there are also some important differences. Whey has the highest content of branched-chain amino acids (BCAAs), especially leucine, as well as the most cysteine.

The digestion and absorption of whey and casein also differ, in that casein—unlike whey—coagulates in the stomach due to precipitation by stomach acids.4 Consequently, the gastric emptying time for casein is longer and there is a smaller rise in plasma amino acids relative to whey protein.

In 1997, French researcher Yves Boirie and colleagues introduced the terms ?fast? and ?slow? dietary proteins to describe these differences in whey and casein digestion. The higher concentration of plasma amino acids in the three-hour period following a whey meal results in higher rates of protein synthesis.5 After this period it is casein and not whey that results in higher rates of protein synthesis, a condition which is maintained for several hours. Anti-nutritional and estrogenic factors in soy may make this protein undesirable to some groups, especially male athletes; while the slow digestion of meats, fish and casein may limit their suitability when rapid absorption of amino acids is required.6,7

Exercise Demands
Intense physical activity increases oxidant formation and damage during exertion, which can result in further oxidative damage after exercise, because of muscle injury.8 Oxidant formation during exercise is also associated with muscle fatigue,9 oxidative damage to muscle proteins,10 lipids8 and the rupture of red blood cells.8 Also, prolonged and intense exercise has been shown to suppress the immune system, increasing susceptibility to infection.11

Whey protein could be a useful supplement for athletes because some of the reported functional effects could directly counteract some of the undesired effects of exercise. These include reduced oxidative damage, muscle fatigue, red blood cell lysis and the ability to increase cellular glutathione levels.12,13 The conditions that exist in the body after exercise also have many similarities with disease states, which can increase tissue breakdown, compromise antioxidant protection, suppress the immune system and even produce gut injury.8

The combination of increased protein damage and oxidation of leucine, isoleucine and valine (BCAAs) during exercise increases whole body protein requirements. The provision of amino acids after training (and in particular leucine) appears important for protein synthesis14,15 and to maintain muscle mass.16

There is clear scientific evidence that whey protein5,17,18 and in particular the BCAAs19,20,21 exert anabolic effects in muscle. Establishing pathways of action are important for any functional food; however, the most important end-point is whether the cellular changes translate to measurable benefits to body function.

To that end, Larry Lands and co-workers performed the first study on healthy males and females assessing the biochemical effects of whey supplementation and its effects on exercise performance in 1999.13 Twenty subjects were divided into two equal groups and supplemented with 20g/day of either whey protein or casein, over a period of three months. The authors found significant improvements in peak power and work output and indirect evidence for increased muscle mass. However, it was not clear if these changes arose from improved muscle strength and/or fatigue resistance; theoretically, whey supplementation could produce both of these effects.

In 2003, researchers investigated the effects of 70 days supplementation with either 40g/day whey protein isolate or 40g/day ovalbumin, in two groups of healthy males, each comprised of 12 subjects. Although the participants were not involved in a training programme, a 10 per cent improvement in muscle fatigue resistance was observed in the whey group, without changes strength or body mass.12

Studies specifically addressing the effects of whey protein supplementation on muscle mass and performance have generally reported positive findings. A 2001 study involved supplementation of two groups of 12 males with either whey or maltodextrin (both 1.2g/kg daily).22 Over the six-week supplementation period, the subjects also participated in a resistance training program. Whey supplementation during the training period produced significantly greater improvements in upper body strength measures, knee extension peak torque and lean tissue mass, relative to a maltodextrin placebo.22

In contrast, a recent study on whey supplementation in patients with HIV did not find gains in muscle mass or strength in sedentary subjects or those involved in training.24

Daily consumption of casein has been reported to produce greater gains in lean mass and greater reductions in weight and body fat loss relative to subjects consuming a whey hydrolysate.23 In this study, two groups of 14 overweight males participated in a resistance training study and consumed a hypocaloric protein-enriched diet for 12 weeks. The additional protein was provided by taking 1.5g/kg daily of either whey hydrolysate, or what the authors referred to as ?casein?. This was in fact a mixture of milk protein concentrate, calcium sodium caseinate, L-glutamine, whey protein concentrate, dried egg white, vitamin E, beta-carotene, selenium and additional minerals. This combination supplement produced greater gains relative to the whey hydrolysate for lean mass (4 kg vs 2 kg), total strength (59 per cent vs 29 per cent) and increased fat loss (-8 per cent vs -4 per cent).23 Although these findings are impressive, they reflect the effects of supplementing with a number of bioactive compounds (including whey and casein), rather than the effects of casein per se.

Despite the theoretical basis that whey protein can increase muscle growth more effectively than other protein sources, studies assessing long-term supplementation are not totally conclusive. Existing research has highlighted the importance of protein timing relative to exercise, to maximise protein synthesis and strength gains.25

It is possible that some conflicts regarding the ability of whey protein to increase muscle mass during training may have arisen from the failure to ensure that whey was taken immediately after exercise.

Maintain Muscle Mass
Whey protein appears to be the ideal protein source for incorporation into post-exercise recovery foods designed to return the body to its pre-exercise state as quickly as possible. Consumption of only 10g protein immediately after training can be effective at increasing muscle mass and strength.25

Whey would also appear suited to maintaining muscle mass, reducing muscle fatigue, minimising infection, improving gut health and even increasing antioxidant protection. The potential benefits of whey supplementation would be of importance to athletes and to improve clinical outcomes in disease states. Currently the most studied is HIV26,27 but beneficial effects have also been reported in patients with chronic hepatitis B.28

It must be stressed that the effects of any protein will be dependent upon its bioactive components. In whey these include alpha-lactalbumin, growth factors, bioavalable seleno-compounds and lactoferrin, the effects of which will reflect processing methods.1

References

1. Kinsella and Whitehead. Proteins in whey: chemical, physical, and functional properties. Adv Food Nutr Res 1989;33; 343-8.

2. Bounous and Gold. The biological activity of undenatured dietary whey proteins: role of glutathione. Clin Invest Med 1991;14:296-309.

3. Hambraeus, et al. Nitrogen and protein components of human milk. Acta Paediatr Scand 1978;67;561-5.

4. Miller, et al. Casein: a milk protein with diverse biologic consequences. Proc Soc Exper Biol Med 1990;195;143-159.

5. Boirie Y, et al. Slow and fast dietary proteins differentially modulate postprandial protein accretion. Proc Natl Acad Sci 1997;94;14930-5.

6. Grant. Anti-nutritional effects of soybean: a review. Prog Food Nutr Sci 1989;13;317-48.

7. Cassidy, et al. Biological effects of soy protein rich in isoflavones on the menstrual cycle of premenopausal women. Am J Clin Nutr 1994;60;333-40.

8. Child R. Running and tissue damage. In Improving performance in middle and long distance running: A scientific approach to race preparation. Eds. Fallowfield and Wilkinson, John Wiley and Sons, Chichester, 1999. p122-39.

9. Reid. Muscle fatigue: mechanisms and regulation. In. Exercise and oxygen toxicity: a handbook. Eds. Sen, Packer and Hanninen, Elsevier Science, Amsterdam, Holland. 1999.

10. Saxton, et al. Indices of free-radical-mediated damage following maximum voluntary eccentric and concentric muscular work. Eur J Appl Physiol Occup Physiol 1994;68;189-93.

11. Bassit, et al. The effect of BCAA supplementation upon the immune response of triathletes. Med Sci Sports Exerc 2000;32;1214-9.

12. Child R, et al. Physiological and biochemical effects of whey protein and ovalbumin supplementation in healthy males. Med Sci Sports Exerc 2003;35,S270.

13. Lands, et al. Effect of supplementation with a cysteine donor on muscular performance. J Appl Physiol 1999;87;1381-5.

14. Layman. Role of leucine in protein metabolism during exercise and recovery. Can J Appl Physiol 2002;27;646-63.

15. Jefferson and Kimball. Translational control of protein synthesis: implications for understanding changes in skeletal muscle mass. Int J Sport Nutr Exerc Metab 2001;11;S143-9.

16. Phillips, et al. Resistance training reduces the acute exercise induced increase in muscle protein turnover. Am J Physiol 1999;276; E118-24.

17. Dangin et al. The rate of protein digestion affects protein gain differently during aging in humans. J Physiol. (in press).

18. Dangin, et al. The digestion rate of protein is an independent regulating factor of postprandial protein retention. Am J Physiol Endocrinol Metab 2001;280; E340-E348.

19. McLean, et al. Branched-chain amino acids augment metabolism while attenuating protein breakdown during exercise. Am J Physiol 1994;267,E1010-E1022.

20. Louard, et al. Overnight branched chain amino acid infusion causes sustained suppression of muscle proteolysis. Metabolism 1995;44:424-9.

21. Blomstrand, et al. BCAA intake affects protein metabolism in muscle after but not during exercise in humans. Am J Physiol Endocrinol Metab 2001;281:E365-E374.

22. Burke, et al. The effect of whey protein supplementation with and without creatine monohydrate combined with resistance training on lean tissue mass and muscle strength. Int J Sport Nutr Exerc Metab 2001;11;349-64.

23. Agin, et al. Effects of whey protein and resistance exercise on body cell mass, muscle strength and quality of life in women with HIV. AIDS 2001;15;2431-40.

24. Demling and De Santi. Effect of a hypocaloric diet, increased protein intake and resistance training on lean mass gains and fat mass loss in overweight police officers. Ann Nutr Metab 2000;44;21-9.

25. Esmarck, et al. Timing of postexercise protein intake is important for muscle hypertrophy with resistance training in elderly humans. J Physiol 2001;535;301-11.

26. Buchman. Glutamine for the gut: mystical properties or an ordinary amino acid. Curr Gastroenterol Rep 1999;1:417-23.

27. Micke, et al. Oral supplementation with whey proteins increases plasma glutathione levels of HIV infected patients. Eur J Clin Invest 2001;31;171-8.

28. Watanabe, et al. Nutritional therapy of chronic hepatitis by whey protein (non-heated). J Med 2000;31;283-302.

Robert Child BSc, MSc, PhD is CEO of Alimentarius Ltd., an independent consultancy, specialising in obtaining advertising approval for health claims for functional foods and nutraceuticals.
Respond: [email protected]

Typical amino acid composition of whey, casein and soy isolates

Values are expressed per 100g of product

Amino acid

Whey

Casein

Soy

Alanine

4.6

2.7

3.8

Arginine

2.3

3.7

6.7

Aspartic acid

9.6

6.4

10.2

Cysteine/Cystine

2.8

0.3

1.1

Glutamic acid

15.0

20.2

16.8

Glycine

1.5

2.4

3.7

Histidine*

1.6

2.8

2.3

Isoleucine* +

4.5

5.5

4.3

Leucine* +

11.6

8.3

7.2

Lysine*

9.1

7.4

5.5

Methionine*

2.2

2.5

1.1

Phenylalanine*

3.1

4.5

4.6

Proline

4.4

10.2

4.5

Serine

3.3

5.7

4.6

Threonine*

4.3

4.4

3.3

Tryptophan*

2.3

1.1

1.1

Tyrosine

3.3

5.7

3.3

Valine* +

4.5

6.5

4.5

*Essential amino acid. +Branched chain amino acid


Wheying The Applications
Whey protein has greater similarities with human milk than either soy or casein, making it an excellent base for infant formulas.1,2 The functional characteristics of whey protein also make it an ideal ingredient for post-workout recovery foods. Its faster digestion relative to casein results in higher rates of protein synthesis for the first three to four hours after ingestion.3,4,5 The increased provision of BCAAs (in particular leucine) and cysteine by whey may be of even greater importance during severe stress, such as exercise or illness.

It is well documented that protein is more ?filling? (ie, satiating) per kJ than carbohydrate or fat.6 This makes protein an important component of diets designed to facilitate fat loss. The faster digestion of whey relative to casein would be anticipated to be less effective at reducing feelings of hunger. However, recent research has shown that whey protein increased subjective feelings of satiety compared to an equivalent casein meal.6

The authors proposed the greater satiating capacity of whey was due to greater stimulation of the aminostatic satiety mechanism, triggered by higher plasma amino acid flux and/or increased satiety gut hormone secretion. Interestingly, the satiating effect of whey does not appear to be detrimental in clinical conditions associated with tissue breakdown, such as HIV, where reduced food intake would be anticipated to produce adverse consequences.

In the UK, the Committee of Advertising Practice assesses claims relating to functional food products. This independent regulatory body has already accepted claims relating to whey?s ability to quickly deliver amino acids and improve exercise performance. Increased understanding of whey protein?s functional effects will lead to more diverse claims, which will undoubtedly help establish whey protein as an important functional food with the consumer.

—RC

References

1. Hambraeus, et al. Nitrogen and protein components of human milk. Acta Paediatr Scand 1978;67;561-5.

2. Lien. Infant formulas with increased concentrations of alpha-lactalbumin. Am J Clin Nutr 2003;77;1555S-1558S.

3. Boirie, et al. Slow and fast dietary proteins differentially modulate postprandial protein accretion. Proc Natl Acad Sci 1997;94;14930-5.

4. Dangin, et al. The digestion rate of protein is an independent regulating factor of postprandial protein retention. Am J Physiol Endocrinol Metab 2001;280;E340-E348.

5. Dangin, et al. The rate of protein digestion affects protein gain differently during aging in humans. J Physiol. (in press).

6. Hall, et al. Casein and whey exert different effects on plasma amino acid profiles, gastrointestinal hormone secretion and appetite. Brit J. Nutr 2003;89;239-48.


Vegetable Lasagna

Vegetable Lasagna

Serves 10–12 / Loaded with nutrients, this lasagna contains lycopene in the tomato sauce, calcium in the tofu and cheeses, and powerful phytochemicals and vitamins in the vegetables. For more protein, add cooked ground turkey or beef to the sauce. You can also make the lasagna wheat- and dairy-free by using rice noodles, all tofu instead of half ricotta, and soy-based “mozzarella.”

16 ounces lasagna noodles
1 cup part-skim ricotta or small-curd creamed cottage cheese
1 cup tofu, mashed
1 egg
1 cup shredded zucchini
1 tablespoon chopped fresh parsley, or 1 teaspoon dried
2 cloves garlic, minced
1 small red bell pepper, thinly sliced
1 small green bell pepper, thinly sliced
1 cup thinly sliced onion
1 cup chopped broccoli
1 tablespoon olive oil
5-1/2 cups chunky marinara sauce (about 52 ounces)
3 teaspoons anise seed
1 ncup shredded part-skim mozzarella cheese (8 ounces)
1/4 cup grated Parmesan cheese

1. Cook pasta according to directions; drain and lay flat to cool. Preheat oven to 375º.

2. In a medium bowl, combine ricotta, tofu, egg, zucchini, and parsley. Set aside.

3. In a medium nonstick skillet, sauté garlic, peppers, onion, and broccoli in olive oil for 5 minutes.

4. Spread 1/2 cup marinara sauce in a 13x9x2-inch pan. Arrange four noodles lengthwise over sauce, overlapping edges. Spread one-third ricotta mixture over pasta, followed by 1-1/3 cups marinara sauce. Sprinkle 1 teaspoon anise seed over sauce, then layer one-fourth of the vegetables. Repeat layers twice, ending with pasta. Spoon remaining vegetables over pasta. Spread remaining sauce over top and sprinkle with cheeses.

5. Cover with foil and bake 40 minutes. Remove foil and bake 10 more minutes or until hot and bubbly. Let stand 10 minutes before serving.

Editorial: Five Years Ago

By Len Monheit
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This month we celebrate the fifth anniversary of NPIcenter as an on-line business resource for the natural and nutritional products industry. Perhaps it’s an appropriate time to reflect on what has been a continuous evolution of the role of the Internet in business in general, and in this industry specifically.

Five years ago, companies had begun promoting the Internet as the medium of the future, capable of altering business processes, replacing paper-based systems with immediate round the world communications capabilities. You would buy, you would sell, you would source, you would decide, you would meet, you would facilitate, you would publish, you would approve – all in a matter of moments. Paper and print costs would be driven down, the pace of business would accelerate, profitability would magically appear and those that completely embraced ‘technology’ would have in place the fundamental element for business success.

As we fast-forward five years (yes, only five years) we see a changed business landscape yet the basic principles that define success have not changed one iota. The technology boom and bust sequence which created such an investor ride have reaffirmed the lesson that if it sounds too good to be true – it probably is. And, as we know from numerous other business experiences, no program can offer everything to everyone. There are certain critical aspects which can add value and these need to be carefully selected and integrated into a company’s overall operation. Nowhere is this more true than in the embracing of the Internet and ‘technology’ as business enablers.

While I’ll conclude with a comment about NPIcenter’s evolution over the course of the past five years, I'd first like to comment on some of the business-important applications of the Internet and technology we have observed in the natural and nutritional products industries.

E-mail
Nowhere in business is there a more classic love-hate relationship. At the same time as executives and small business operators moan about spam, viruses, inability to avoid messages and higher customer expectations driven by e-mail capabilities, they understand that, when used wisely, e-mail is an effective communications tool that can shorten time to offer, buy, sell, negotiate, inform and serve. In numerous cases it has replaced fax, telex, mail and phone, facilitated international communications especially, while at the same time created nightmares and headaches for policy administrators and forced a change in business relationship management.

With spam and unsolicited marketing concerns rising, the future role of e-mail in marketing has yet to be established. Solutions to designate and separate ‘permitted’ mail are being developed and filtering technology, always one step behind, is trying to catch up. As with any technology, abuse will prevent full value from being realized, but the fact remains that some relationships and processes are best supported using e-mail. What is apparent is that the need for policies and standards is clear and these must be part of a continued re-evaluation process.

Websites
First generation websites were reproductions of corporate brochures - on-line. Unfortunately, many organizations have not evolved past this point to use their website as a customer interaction point and the trigger for new business relationships and expansion of existing ones. They also have failed to realize that the company, product or ‘whatever’ site is a dynamic entity that needs to evolve and can never be considered complete.

Some organizations have gone through a defined process in website evolution including considering target audience, desired interaction and process for all viewer groups etc, while others have not. Many have realized that increasingly, potential and existing clients include a company’s website as a tool to determine which companies to interact with and how to interact and the website must facilitate this decision. If it doesn’t, viewers will go elsewhere and so potentially will the relationship.

In the future, we predict that the site will become even more of the launch platform for client interaction across the company. Site zones will gather information to allow better relationship management, new client development, existing client communication, project management and collaboration, buying/selling etc. Site lifecycles will be better defined and pieces of sites will be developed that can be easily and quickly updated by ‘zone managers’ to reflect specials, news and important announcements. Permission-based electronic mailings will be added more frequently to the ways companies maintain contact with existing and potential clients and to make field sales representatives more productive.

On-line communities
The concept of an on-line community is essentially the background of NPIcenter, but in the general business environment, it can be described as an on-line destination with a series of gathered resources for a particular, defined audience. This can be a summary of category resources and links, a destination created specifically for all of your clients, a site built around a brand etc.

We are seeing more of these destinations, and as the Internet proliferates and in fact, becomes more confusing, we believe the benefits of information aggregation and organization will make these destinations more valuable. They can be used to collect intelligence and feedback, disseminate information and to support other fundamental business processes such as relationship management.

Subsets of this approach include both Intranets and Extranets. An Intranet is an on-line destination used within the company for collaboration and information sharing while an Extranet involves use outside of the company (could involve remote employees) possibly including selected clients, suppliers or collaborators using the Internet as a platform to access and exchange large amounts of information, records, files, etc.

Search Engines
Several years ago, the organization of Internet information by search engines was in its infancy. Now these ‘businesses’ represent some of the highest value in the technology world using complex algorithms to decide on rankings. They have evolved their business models to include paid placements and other privileges, have licensed their technologies to other search providers and the ‘space’ has consolidated from fifteen or so dominant engines into about four or five primary groups. The concept of a search engine has become so mainstream that ‘to google’ is often now considered a verb. The concept of organized search has become so important that if your site has more than 10 pages, it’s almost a necessity to have a site search function.

If your objective is to obtain new business on-line, then search engine strategy must be a part of your web-planning. And considering how quickly this aspect is changing, your organization must be extremely flexible.

Summary
Using technology as a business enabler is a path with many pitfalls. Which should you purchase and when should you buy? These decisions impact whether you’ve got a short or long term solution? Whether to develop in house or to outsource is a classic dilemma and if you’ve already got an internal IT (Information Technology) group they probably can handle most of the issues – at least from the technical side. Unfortunately, there’s more than just the technical aspect that determines delivered value. Client expectations and behaviors too are changing and this is probably the most pressing driver for any company and must be factored into the planning process.

NPIcenter
As NPIcenter celebrates its fifth anniversary, we recognize that our audience has evolved, and its needs and desires are similarly changing. We have tried to anticipate and you will certainly find that the NPIcenter of today is quite different from ‘Version 1’ five years ago. Similarly, our next version and the resources and tools it contains will also be altered. What has not changed is the objective of the site and its primary intent to be an aggregation of information that is useful and important to the natural and nutritional products industries.

Most of our registration processes are monitored. If you were to sign up for one of our offerings with a comment that required feedback – you’d get it quickly. We carefully watch user patterns, not on an individual basis, but on a more macro scale. We know that on average, viewers from about 140 countries around the world use NPIcenter each month. We know that over the past three months, almost 2 million NPIcenter pages have been viewed by a quarter of a million viewers.

Initially, the company database and a series of useful links drove site value. Now, these features, coupled with daily and weekly e-newsletter programs, a Career Center, product showcase, International content, articles, searchable database of news, releases and announcements as well as products and categories attempt to meet the needs of a much wider audience.

It’s a work in progress, one that appreciates your support and feedback and looks forward to expanding our relationships by delivering increasing value to viewers, clients and the industry.

Thanks for your support these past five years!

SunOpta Completes Two Previously Announced Acquisitions

TORONTO, Ontario, Nov 27, 2003 (BUSINESS WIRE) -- SunOpta Inc. (SunOpta) (Nasdaq - STKL) (TSX - SOY) today announced it has completed the acquisitions of the business and operating assets of SIGCO Sun Products, Inc. ("Sigco") of Breckenridge, Minnesota and the purchase of 100% of the shares of Sonne Labs, Inc. (operated as "Dakota Gourmet") of Wahpeton, North Dakota.

SIGCO is a world wide supplier of sunflower products and is fully integrated from the sale of sunflower seed to farmers through processing the contracted crop into finished in-shell and kernel sunflower products. The company operates four facilities located in Minnesota, North Dakota and Kansas.

SIGCO markets its non-genetically modified sunflower products throughout the United States and to international markets in Europe, Asia and the Americas. The company is a leader in high-oleic sunflower seeds which have a shelf life approximately five times the traditional sunflower kernel, large in-shell sunflower seeds with increasing demand in world wide markets, and bakery kernels, where the company has developed a unique lower cost production process to service North American and International markets.

SIGCO's vertically integrated business model is highly compatible with SunOpta's existing vertically integrated operations. SIGCO's locations in the Mid-Western United States facilitate the integration of management and marketing strategies with SunOpta's Grains and Soy Products Group.

Dakota Gourmet is a small, fast growing company focused on the manufacture of innovative natural and organic snack foods using soy, corn and sunflower ingredients. These products are sold under the Dakota Gourmet brand and are also produced for private label customers.

The company's operational capabilities include roasting, blending and packaging and its products are marketed to the United States school program, various manufacturers, retailers and distributors. Dakota Gourmet and Kettle Valley, a wholly-owned subsidiary of SunOpta will co-ordinate their future marketing and product development programs.

SunOpta Inc. is an owner/operator of high-growth ethical businesses, focusing on integrated business models in the natural and organic food markets. For the last five consecutive years, SunOpta was included in Profit magazine's 'Profit 100' list of the 100 fastest growing companies in Canada. The company has three business units: the Food Group, which specializes in sourcing, processing and distribution of natural and organic food products; integrated from seed through packaged products; the Environmental Industrial Group; a producer, distributor, and recycler of environmentally friendly industrial materials; and the Steam Explosion Technology Group who engineer and market clean pulping systems using patented steam explosion technology. Each of these business units has proprietary products and services that give it a solid competitive advantage in its sector.

Note: This news release may contain forward-looking information. Actual future results may differ materially. The risks, uncertainties, and other factors that could influence actual results are described in the Company's annual report to shareholders and in SEC filings.

Two Nova Scotia Companies Walk Away With Top Awards

At the recent annual Canadian Health Food Association Trade Show in Toronto, Ardefen Inc. from Halifax, Nova Scotia won the Silver medal in the Herbal Supplements category for Ardefen. Ascenta Health Limited from Dartmouth, Nova Scotia was awarded the Bronze medal in the Essential Fatty Acid Supplement category for NutraSea.

Ardefen is an innovative, liquid delivery system containing glucosamine and three standardized herbal extracts. Ardefen is designed to rebuild joint cartilage as well as relieve inflammation, stiffness and painful joints. Ardefen delivers 60 to 70% absorbtion compared to glucosamine tablets that only offer 5 to 20% absorption.

Ascenta has built a reputation based on innovation and integrity with a strong emphasis on product quality. Leslee Klineberg, ND and Vice President for the company said, "The product line truly embodies our philosophy, take your health higher. With a delicious lemon flavor and industry leading purity, NutraSea has become one of the top selling omega-3 fish oils in Canada."

There was a total of 103 natural health products from across Canada competing in various categories.

Alive Awards of Excellence impacts consumer acceptance and confidence. The exposure has a staggering effect on sales, and reflects positively on the manufacturers of winning products.

Ardefen Inc. V.P. of Marketing, Joan Dobbie said, "Winning the Silver alive Award of Excellence for Ardefen is so important because it gives a small company like ours a higher profile. We are thrilled to be given this prestigious award. Small companies can not buy this type of publicity."

Both companies agree that winning the alive Awards of Excellence would mean greater consumer confidence in the quality of their respective products, greater brand recognition and greater retailer confidence in the quality and sales appeal of both products.

Both Mrs. Dobbie and Dr. Klineberg added that the alive Awards of Excellence emblem will be placed on their products' and print advertising to let consumers know that they are purchasing award winning natural health products.

The alive Awards of Excellence was established to promote and recognize excellence in product innovation and to add credibility to natural health products. Since 1994, these prestigious gold, silver and bronze awards have been presented to manufacturers of the best product in a variety of categories during a special ceremony held at the annual Canadian Health Food Association's Trade Show in Toronto. Retailers attending the annual trade show voted for the one product that they liked best in each category.

The alive Awards of Excellence competition is designed to support ethical products of the natural products industry and is open to all suppliers of health products in accordance with the alive Guidelines for Excellence. The award-winning products were displayed on Sunday, October 19th at the alive Awards pavilion at the CHFA Trade Show.

All products entered must be available for sale through Canadian health food stores. Product labeling must be in accordance with the legal requirements of the Canadian Health Protection Branch and the Department of Consumer Affairs.

Winning products in all categories will be showcased in a center spread of the January 2004 issue of alive magazine, Canada's #1 journal of natural health read by 575,000 health conscious consumers.
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Contact Information:

(Mrs.) Joan Dobbie
Ardefen Inc.
tel: 902-429-4449
fax: 902-429-4858
email: [email protected]
Web: www.ardefen.com


Contact Information:
Leslee Klineberg, ND
Ascenta Health Ltd.
tel: 902-435-7329
fax: 902-435-3513
email: [email protected]
Web: www.ascentahealth.com