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Articles from 2003 In December


Delicious Living

January 1, 2004

Fortified Foods Proposal Will Not Consider ‘Nutrient Profiling’

Europe

In the latest draft of its proposal on fortified foods, the European Commission (EC) has omitted nutrient profiling as a means to regulate the addition of vitamins and minerals to foods. It had previously questioned the merit of fortifying ?bad foods? such as those high in fat, sugar and salt.

Although the move was welcomed by the food industry, an EC spokesperson said the omission did not mean the EC was necessarily in favour of fortifying foods that failed to meet its healthy criteria. ?The change has occurred because this area is covered in our health claims proposal,? she said. ?Under that proposal, companies can make a health claim only if its product is not too high in sugar, fat or salt.?

The Confederation of the Food and Drink Industries of the EU (CIAA) welcomed the fortified foods proposal. ?The forthcoming regulation on the addition of vitamins and minerals to foods should encourage research and innovation efforts in the food and drink industry to enable it to better respond to evolving lifestyles and allow all Europeans to benefit from this,? declared its president, Jean Martin.

The fortified foods proposal uses the risk assessment procedure employed in the Food Supplements Directive in regard to setting upper safe levels of vitamins and minerals permitted in all foods except fresh produce such as fruit, vegetables, meat and alcoholic drinks.

The proposal may be extended to include other nutrients such as herbal extracts, amino acids and proteins. Any nutrients with an unproven safety record will be placed on a register and granted four years to produce necessary supportive data.

The UK?s Food Standards Agency and the Food Safety Authority of Ireland are requesting comments on the proposal until at least the end of January.

It will gain its first reading by the European parliament next spring.

Axe hangs over DSHEA

This year could see the most significant changes to the liberal US dietary supplements model in a decade, following implementation of the Bioterrorism Act in December and the instigation of several bills now working their way through Congress.

The changes are being promoted as a way of dealing with food and supplements safety, but not all are seen as favourable.

"2004 could be the biggest year that we have seen for as long as we've been in this business," said Loren Israelsen, president of consultancy LDI Group in Utah. "We may see the end of the DSHEA as we know it. That would be an enormously contentious issue for an industry that will be highly divided on what we need to do."

The Bioterrorism Act in particular has already eroded some landmark components of the 1994 Dietary Supplements Health and Education Act (DSHEA).

The act requires, among other things, that all facilities worldwide that do business with the US must register their plants with the US Food and Drug Administration (FDA). An estimated 400,000 facilities must comply—"and 398,000 don"t know it," said Israelsen. "This could really disrupt the supply side, with botanicals coming in from overseas."

The act also requires companies to give the FDA access to their records, something specifically denied by DSHEA. "Now we're finding that DSHEA isn't there anymore," said Israelsen.

The fact that some key components of DSHEA have already been usurped is a major focus for advocacy groups including the American Health Products Association and Citizens for Health. These groups lobbied and marched on Washington in October and are gearing up to "save DSHEA."

Other legislation looms

Other attempts to change the regulatory climate are also moving forward.

Two positive changes for the industry were amendments written into the $79.7 billion agriculture spending bill for 2004. One adds $1 million to the FDA budget to fully implement and enforce DSHEA. The second amendment would provide the FDA with an additional $250,000 to address the ephedra issue. "There has been too much talk that the law handcuffs FDA and too little effort to apply the law," said Senator Orrin Hatch, who pushed the amendment. He urged FDA to decide on ephedra's safety "based on the best available science, not politics."

Another bill, S. 722, is being touted as one that regulates ephedra, but it groups all stimulants, such as synephrine, green tea and yohimbe into that stimulant group. These would be scrutinised at a level that, opponents say, would put many of these ingredients suppliers out of business.

Significantly, the bill would exempt the most popular stimulant—caffeine.

Another proposed bill, HR 3377, would require dietary supplements manufacturers to provide an updated list of all products and ingredients every six months to the secretary of Health and Human Services. It would also require reporting and record-keeping of adverse event reports within 15 days. Critics say some of these requirements exceed even those for pharmaceutical drugs.

Canada Gets New Centre Of Excellence

Canada

The emerging Canadian natural health products, functional foods and nutraceuticals industry is to be further boosted with the construction of a $25 million research centre in western Canada.

The Richardson Centre for Functional Foods and Nutraceuticals is being backed by both government and industry and will be situated on the University of Manitoba campus. It will work in conjunction with the Faculty of Agricultural and Food Sciences, along with the Faculties of Human Ecology, Medicine and Pharmacy.

Its marketing and research development manager, Kelley Fitzpatrick, said the centre ?will work to develop functional, health-enhancing foods and nutraceuticals, from agricultural products of importance to the prairie region of western Canada, including oats, wheat, barley, buckwheat, canola, flax, hemp, pulses, as well as animal-derived products.?

Adding Value To Agriculture
Fitzpatrick, an advisory board member for this magazine, said the centre will initially develop technologies to add value to western Canadian grain.

?The question the government and others asked was: How do we add value to agriculture? The Richardson Centre hopes to provide some answers to this question. It has been set up to specifically develop functional foods and nutraceuticals ingredients for western Canadian crops. But we won?t stop there. We will then be looking at investigating how we can incorporate them into dietary supplements and, longer term, functional foods.?

The centre aims to fully exploit the region?s natural advantages, Fitzpatrick noted. ?For example, the cooler growing season often enhances the synthesis of the inherent bioactives. In the case of polyunsaturated fatty acids, the further north you go, the higher the PUFA content.?

She said the centre would build on much of the activity already being undertaken at the University of Manitoba and would work in four principal areas: agriculture, human nutrition, medicine and pharmacy. Protecting Canadian business interests from multinationals and large companies south of the border will be a likely side effect, she said.

Another objective for the centre is to address the lack of funding that often marginalises entrepreneurs who drive innovation.

Fitzpatrick said Agriculture Canada estimated functional foods and nutraceuticals could save $30 billion in health care costs.

State-Of-The-Art Facility
The 60,000-square-foot facility will house eight research laboratories where food safety, food development, quality control, analytical and molecular biology work will take place. There will also be a plant growth chamber, animal care facility and pilot plant (to facilitate the intermediary step for scale up of processes from lab to commercial scale) as well as full processing capabilities that include:


  • Primary processing: cleaning, size reduction, initial separations, mixing.
  • Secondary processing: separation, extraction, purification, concentration to be distributed amongst five specialized rooms.
  • Packaging: powder tableting and encapsulation, liquid filling, bulk packaging.

The centre is expected to open in 2005.

Protein Ingredients Power Up In Low-carb Era

As the global protein ingredients market tops $10 billion, Shane Starling explores some of the differences between soy, whey and canola, the newest rising star

A good indication of the buoyancy of the protein ingredients market is the recent deal struck between British Columbia-based ingredients developer Burcon and ADM. Under the agreement, Burcon will licence its Puratein and Supertein canola protein ingredients to ADM. The multinational will then have responsibility for developing applications for the products, obtaining regulatory approvals and constructing production facilities. It will also gain exclusive rights to produce, promote, market and sell the products worldwide.

For ADM, one of the three biggest players in plant proteins, it is an opportunity to expand its portfolio in a fast-expanding market. For Burcon, it means the kind of exposure necessary to give its products a chance of gaining a major share in the world?s biggest proteins market—the US, where Nutrition Business Journal (NBJ) estimates the protein foods market at $3 billion.

It is no wonder ADM jumped at the chance to be the one to bring this new plant protein to market: The global proteins ingredients market is in excess of $10 billion, the practise of vegetarianism is growing and wariness of meat products is increasing, and the low-carb explosion has provided another boost.

Canola protein is excellent both nutritionally and functionally and it acts differently to soy
Functionality Differences
?Our process extracts and purifies the protein from the meal,? says Burcon president Johann Tergesen. ?The protein in canola is excellent both nutritionally and functionally and it acts differently to soy. For example, soy works beautifully as a water-binding agent. Canola, in contrast, functions in a similar way to animal proteins such as whey, gelatine and casein, which currently dominate the market. We?ll be complimentary to wheat gluten and soy. ADM already has those two products in its catalogue so it will allow them to use canola to take on the animal protein market.?

He says there is little similarity with the other popular crop-based protein—wheat gluten. ?Wheat gluten is obviously fantastic for bread. But you couldn?t take wheat gluten and whip it and foam it like egg white and you couldn?t use it as an emulsifying agent to create mayonnaise. You can with canola.?

Tergesen continues: ?Protein ingredients are often incorporated into foods for their function as much as their nutritional value. A cake or cookie recipe will call for an egg not only for the taste of an egg, or its nutritional value, but also for its binding properties. That is often the case for proteins. Even the head on a beer is from a protein ingredient. From a food manufacturer?s point of view, another advantage is that plant proteins are cheaper than animal proteins.?

Another multinational player, DMV International, trades in protein ingredients from the fundamental to highly specialised peptides. The company is excited by the current climate for both animal and plant protein ingredients. ?Soy and dairy whey/casein-based ingredients are very strong,? states company spokesperson Tara Russell.??Also, specialty proteins and peptides such as lactoferrin and bioactive peptides are doing well.?

Dietary supplements, dietetic foods, clinical nutrition products, infant formulas, sports nutrition products and low-carbohydrate items,?such as meal replacements, are showing the strongest growth, especially in Japan, the rest of Asia and the US.

The health benefits of individual ingredients need to be emphasised as they are often very different to the commonly recognised benefits of their sources. ?For example, we have a peptide that helps lower blood pressure (C12 peptide) and another that helps with muscle recovery (glutamine peptide). Their benefit goes well beyond that of the protein from which they are derived,? Russell points out.

Marketing To Different Niches
Deciding what to tell different sectors of the population about ingredients is a minefield that has to be negotiated with the utmost precision. Otherwise, expensively generated information campaigns can fall on deaf ears.

?We find there are highly varied levels of understanding among consumers,? Russell notes.??At one end, there are people with only a very basic understanding of nutrition. At the other end, some people know the differences in rates of absorption, amino acid profiles, the number of grams of protein needed per day, and rate-limiting amino acids for various mechanisms—for example, cysteine needed for the production of glutathione. You have to cater to that difference.?

Of course all the promotion in the world will only get you so far if the quality of ingredients is not of the highest order. ?It?s more important that we as an industry utilise high-quality protein ingredients,? says Russell. ?But the flavour and functionality of proteins is improving all the time and these ingredients can enhance the nutritional quality of processed foods, which is becoming increasingly important in our obese Western cultures.?

Whey To Go
Other protein suppliers such as Arla (milk proteins) and Davisco (whey) are recording similarly buoyant results. Davisco has established the independent Whey Protein Institute to extol the virtues of whey proteins—even those of its competitors. So when clinical studies come in that highlight benefits, such as one recent piece of research that found whey protein isolates could reduce hypertension, the website will publicise them as well as alerting the wider media. The site is also a comprehensive source of information about all aspects of whey production, usage and nutrition.

NBJ estimates the US whey ingredients market at about $470 million in 2002?03, more than double the next best selling animal protein—casein, at $225 million. Gelatin had sales of $200 million while dried egg white notched up $175 million.

Ifendu A Nnanna, PhD, R&D director at the dairy ingredients division of Iowa-based Proliant, notes whey?s rise is not unexpected given its unique properties. It has also benefited from a well-defined differentiation from soy.

?Whey provides bioactive proteins such as immunoglobulin, lactoferrin and peptides in addition to functional proteins (alpha lactalbumin, beta lactoglobulin and bovine serum albumin). Soy provides primarily functional proteins (beta con-glycinin and glycinin). It is a rich source of cysteine, known to help in preventing oxidative damage to body tissues. Whey protein is also a rich source of branched-chain amino acids (BCAAs) that helps reduce protein degradation during heavy exercise.? For this reason whey has become the protein of choice among athletes and gym users, Nnanna says. ?BCAAs contribute to many athletic-improving factors, help decrease protein degradation and increase protein synthesis.?

Whey has become the benchmark protein from a nutritional perspective, according to Phil Vanderpol, business director, nutrition at Washington-based whey specialist Inovatech USA. ?Whey passes into the bloodstream the most quickly without any side effects like indigestion and gas,? he says. ?Eggs used to be considered the best, but research has shown that whey proteins are the most nutritionally complete.?

Whey Awareness Lags
The low-carb explosion has done wonders for business with so many mainstream food companies reformulating with increased protein levels, Vanderpol notes. But he believes whey players have to raise their profile to catch up with soy?s mainstream availability and public awareness.

?I don?t think the dairy industry has done a good enough job of making the public aware of whey and why it is such a good protein, whereas the vegetable protein industry has been very effective at communicating the health benefits of soy. We think the Whey Protein Institute is a great idea to promote the health benefits of whey protein, but in this industry there are a lot of smaller players and I believe many of them are too production-driven rather than market-driven. In soy there are just a few large players who dominate and they have sophisticated marketing campaigns.?

An increase in the number of research studies involving whey ingredients would help this situation, he says. Whey applications are also becoming more sophisticated. ?There are so many components in whey that can be isolated to meet the needs of different groups from infant formula through to geriatric feeding. You manipulate the components of whey to come up with a product that is specifically geared toward target markets. The technology is there but now we need the clinicals to be done to show how each formulation works best.?

The European whey market is seven to ten years behind the US, he estimates. ?But Europe can leapfrog in some cases and we think the future looks good there.?

This view is confirmed by Irish whey ingredient specialist Carberry. It has posted good results and recently launched a whey ingredient, Isolac Clear, aimed at beverage manufacturers. ?This product represents a significant technical breakthrough and offers beverage manufacturers the opportunity of fortifying their drinks with protein without compromising on appearance and taste,? the company says.

Of course, soy remains a strong player and, in the US at least, outsells the other protein ingredients—both plant and animal—by at least two-to-one, according to Burcon figures. It will be interesting to see what happens once the Burcon/ADM canola ingredient hits the market in 2006.

Regulation Nation

Japan is one of the world?s most important and developed markets for functional foods. Yet myriad of regulations and government bodies means confusion blights the industry and consumer understanding, says Kaori Nakajima of the Japan Health Food & Nutrition Food Association. First in a two-part series

In Japan, it is law—and not science—that divides food and medicine
Planning a strategy for functional foods in Japan is not an easy task. Food companies are faced with a bewildering choice of paths to follow in a maze of regulations. As a result, the majority of functional foods, health foods and dietary supplements are not recognised as such, and are kept out of the regulatory system altogether. This problem arises from the notorious difficulties of drawing a clear distinction between drugs and functional foods. And in Japan, it is law—not science—that divides food and medicine.

The best-known system for regulating health claims on foods is called Foods for Specified Health Uses (FOSHU), which was set up in 1991 by the Ministry of Health, Labour and Welfare. Since this time, the public?s interest in the relationship between nutrition, diet, and lifestyle-related diseases and disorders has flourished. Functional foods have proliferated, becoming more diverse and complex. As the market has grown, the government has also had to cope with trade frictions and to comply with international regulatory trends, such as the Codex Alimentarius.

FOSHU Trends
Products developed to improve the gastrointestinal system (with functional ingredients such as oligosaccharides, dietary fibre and lactobacillus) still make up a large part of FOSHU products. But foods that address high blood pressure, high blood-sugar levels and obesity are also gaining popularity.

Food types are also diversifying. One-third of all FOSHU products are drinks, but more variety can be seen now in the market, including instant miso soup, fermented soy beans (natto), soy milk products, margarine, bean curd (tofu), jelly drinks, rice and bread.

There has been an increase in the number of TV commercials that show the FOSHU mark of approval, but consumer awareness is still very low at around 30 per cent
In recent years, there has been an increase in the number of TV commercials that show the FOSHU mark of approval, but consumer awareness is still very low, around 30 per cent, according to a Japan Health Food & Nutrition Food Association (JHFNFA) survey. Because the government is reluctant to put any promotional effort into FOSHU, functional foods companies are pretty much on their own. And this means that consumers are also on their own when it comes to assessing nutrition and picking the right foods for their health condition.

Most people recognise FOSHU by the mark of approval. Many, however, feel that the claims are still very vague and difficult to understand. To help combat this, the JHNFA sets up study groups with member companies to plan and produce promotional pamphlets and videos on FOSHU to be distributed at conferences, trade fairs, schools, and health centres, and to chemists.

Functional foods that have a new specified health use can find it difficult to gain approval under the updated FOSHU system
Where FOSHU Stands Now
In April 2001, the government introduced a new category of foods—Foods with Health Claims—to meet new requirements in the evolving market for functional foods. The new regulatory system aims to provide consumers with truthful information so they can supplement their daily nutrition intake or target specific bodily functions or structures. Health claims must be validated by scientific research and foods must be clearly labelled, so they are not confused with medicines. They must not make any statement regarding diagnosis, mitigation, treatment or prevention of disease.

There are two types of foods that fall under the category of Foods with Health Claims—FOSHU and Foods with Nutrient Function Claims. These are the only types of foods that can now carry some kind of claim that might state one or more health benefits.

With the new regulatory system, FOSHU underwent the following changes.

1. Claim statements are now less wordy and more straightforward. Specified health benefits include:


  • Maintenance or improvement of easily measurable health indexes. This enables claims such as, ?helps maintain blood pressure (blood sugar, neutral fat, cholesterol) at a normal level,? or, ?promotes the breakdown of body fat.?
  • Maintenance or improvement of physiological/structural functions ? eg, ?promotes calcium absorption.?
  • Improvement of a health condition that is easily self-detected, and is only temporary ? eg, ?suitable for anyone who feels body fatigue.?

2. Application material must include an extensive and objective report on the reason for application. This must show how the product can be used to improve the diets of people and maintain or promote good health at a national level. It must also include backup material on effectiveness, and also material that indicates any doubt about effectiveness and safety.

3. FOSHU can now come in capsule or tablet forms.

4. The company that applies for FOSHU must notify the government of changes to the food itself and results of re-examinations.

5. It is now mandatory to gather information after the food is marketed by accumulating scientific data, continually checking the effectiveness/safety of the food product, and keeping a record of consumer opinions and complaints.

New Regulatory Layers
The rules are set and they look very clear, but problems can still arise during evaluation. FOSHU applications for health claims are ultimately judged by the Food Investigation Committee (FIC) of the Pharmaceutical/Food Sanitation Council, and its evaluation criteria are very tough. The FIC tends to view functional foods as if they are medicines, so issues such as excess intake are often a concern. As a result of this mentality, functional foods that have a new specified health use can find it difficult to gain approval under the updated FOSHU system. After thoroughly evaluating the exhaustive scientific evidence for a particular food, the FIC can ask for further substantiation, making the system too long and too expensive.

While the FOSHU system is a product-specific (not ingredient-specific) approval system, foods that contain government-approved levels of certain nutrients are covered by another standard—Foods with Nutrient Function Claims. This regulation currently covers 12 vitamins and two minerals (calcium and iron). If a product contains the correct amount of these nutrients, then it can carry specific claims that are stipulated by the government.

Another system of regulation, Foods for Special Dietary Uses (FSDU), which has been in existence for more than 50 years, was not mentioned in the new Foods with Health Claims system. Yet FSDU still exists and covers foods for medical purposes and foods for pregnant and lactating women, infants, and the elderly.

Unregulated Foods
As we have seen, health claims regulations in Japan can be complex, time consuming and expensive. This may explain why there is a raft of functional foods and dietary supplements that are completely unregulated. These products cannot carry health claims and in the eyes of the law are seen as no better for you than everyday processed foods. But they do often contain extracts and purified substances as their main ingredients, making them different to ordinary food. Indeed, these can often have effects comparable to those achieved by medicines.

It?s this gray area that causes confusion among consumers, who, in the absence of proper information, rely on word of mouth and suspect promotional literatures boasting of miracle cures. Since 1980, the JHNFA has tried to deal with the proliferation of health foods by setting standards for categories of foods and awarding its mark of approval to those foods that meet these standards.

The standards set out the definition of the food, lab test methods and labelling rules, while good manufacturing practice guidelines are at the drafting stage. When a member company submits an application, the product is first taken to the labs for ingredients and toxicity tests. Once that is cleared, it goes through the evaluation committee, which comprises dieticians, pharmacists, policymakers and academics. The entire checking procedure takes about three months and, once the food is approved, it can carry the Japan Health Food Authorisation (JHFA) mark of approval for four consecutive years. On the fourth year, the JHFA mark must be renewed.

The mark acts as a safety stamp that can be used by the consumer to make an informed choice. Presently, there are 53 standards and about 900 approved products, but this is a mere drop in the ocean—there are an estimated 50,000 products on the health foods market in Japan. Our system needs greater promotion, along with the creation of more standards and a constant review of existing standards. In this way consumers will not have to worry about the safety or quality of the products they buy.

The popularity of health foods has recently prompted the Ministry of Health, Labour and Welfare to create an investigation committee solely committed to this sector. Its members come from the government, academia, industry and the media; its role is to investigate how health foods can promote good health in the population and ways to regulate such foods. For the first time, these types of functional foods will be defined and given a clear legal status.

Yet Another Law
In a move that makes the situation even more complicated, the government introduced a new law on May 1, 2003, called the Health Promotion Law. This substitutes the Nutrition Improvement Law set in 1952, which was mainly concerned with improving nutrition deficiencies after World War II.

The Health Promotion Law aims to improve long-lasting health and counter lifestyle-related diseases through better dietary habits. It also sets out policies for ?secondary prevention?, such as the early detection and treatment of diseases through health check-ups, and ?tertiary prevention?, which covers treatment after the onset of the disease and after recovery.

So far so good, but the law does not mention functional foods except for FOSHU. To be fair, it was amended last August to restrict the exaggerated advertising of health foods, but this came before, and separate to, the draft regulatory system being drawn up by the investigation committee mentioned earlier.

This is a good example of what is wrong with the Japanese system. There is no single policy that encompasses functional foods as a whole. This leaves both industry and the public confused. Despite this lack of clarity, the market is steadily growing. Japanese people are already familiar with functional foods and are willing to take them to maintain and promote good health. Indeed, some foods are so popular that the industry is struggling to meet demand.

To iron out the complexities of the regulatory system, there has to be collaboration and compromise between policymakers, industry and the public, as well as scientists. Policymakers must become more food-oriented, while scientists must determine how much substantiation is realistically possible for functional foods. Science depends on public support, so the public and industry must participate more in the debate on science. Thus the difficult task continues, working toward a better quality of life for everyone.

Kaori Nakajima is chief of staff, scientific and regulatory affairs for the Health Food Department at the Japan Health Food & Nutrition Food Association.
Respond: [email protected]

Japan?s Regulatory System At A Glance
Foods with Health Claims: This government system comprises two sections:


  • Foods for Specified Health Uses (FOSHU), which is the main regulatory system for health claims
  • Foods with Nutrient Function Claims, which covers 12 vitamins and two minerals (calcium and iron)
  • Foods for Special Dietary Uses (FSDU): This was not mentioned in the new Foods with Health Claims system. FSDU covers foods for medical purposes and foods for pregnant and lactating women, infants and the elderly
  • Health Promotion Law: This aims to improve long-lasting health and counter lifestyle-related diseases through better dietary habits
  • Japan Health Food Authorisation (JHFA): The Japan Health Food & Nutrition Food Association?s mark of approval

Comparing Milk Types

Milk

Calories

Total Fat

Saturated Fat

Carbs

Protein

Notes

Soy

100

4g

0g

8g

7g

Closest in nutrient content and mouth-feel to cow’s milk. Creamy, slightly beany taste suited to most cooking needs. Do not boil.

Almond

60

3g

0g

7g

1g

Lowest in calories and carbs; highest in vitamin E. Delicate, nutty flavor ideal in breads, desserts, and smoothies.

Rice

130

2g

0g

27g

1g

Hypoallergenic; tastes closest to skim cow’s milk. Sweet, light taste excellent for ice cream and dessert recipes

Oat

130

2.5g

0g

24g

4g

Highest in fiber (10% daily value). Creamy, sweet flavor good for soups, sauces, or cereal.

Multi-grain

160

2g

0g

30g

5g

High in fiber (7% daily value). Rich and satisfying taste well-suited to sauces and creamy soups.

Cow (2 percent)

120

5g

3g

12g

8g

Buy organic to avoid growth hormones and antibiotics used in conventional dairy-milk production.



Supplements Win Crucial Codex Victory

International

The November Codex agreement to abandon Recommended Daily Amounts (RDAs) as the basis of upper limits in supplements in favour of scientific risk assessment will reverberate around the world, particularly in developing nations.

The debate within Codex —the World Health Organization?s representative body in the supplements area—has raged for the better part of a decade. Although the decision will not become an official giudeline for at least two years, it will have an effect almost immediately in developing nations, where supplements regulations are being formulated for the first time.

The decision is itself influenced by an expanded European Union?s commitment to scientific risk assessment. It will likely add weight to the case for maximum liberalisation in the EU?s yet-to-be-decided upper safe limits, according to one industry observer. It all augers well for an industry that has long battled against the use of RDA multiples as a means of establishing supplement ingredient maximum intake levels.

?We never expected to achieve so much this year,? said Simon Pettman, executive director of the International Alliance of Dietary Supplement Associations, which represents 43 national food supplements associations worldwide. ?It was down to a whole range of factors: the enlargement of the EU; regional conferences and education programmes; the absence of a disruptive extremist element; the growing strength of the industry?s scientific arguments. All these factors made a difference in getting the 75-80 per cent vote.?

The decision was unanimously welcomed by the industry.

?Today?s decision represents the single most important development in the ongoing effort to open the world?s markets to safe, healthy products that have the potential to enhance the quality of life for billions around the globe,? said Mark A. Le Doux, board member of the Council for Responsible Nutrition in the US. ?It is an excellent example of what can happen when the US and EU work in concert for the common good.?

European Principles
?It?s a great result because it underlines the need for safety over need, so that has to be good for both the industry and the consumer,? said Janet Rees, principal regulatory officer at Solgar UK. She said it was no surprise that Codex would fall in line with Europe eventually. ?It means European principles being established at the moment will reverberate around the world in the coming years.?

Ian Newton, director of business development and regulatory affairs at DSM Nutritional Products, lauded the decision but warned regulatory change may not come as quickly as some hoped in an environment where the influence of Codex was waning. ?It is bringing Codex in line with the prevailing thought on this matter by many recognised bodies such as the Institute of Medicine in the US and the European Food Safety Authority. But now that the EU is moving ahead by itself, I am not sure Codex has the same relevance it had in the past. Nevertheless, it is a very good step forward and it has finally broken the logjam that has existed for eight to 10 years.?

The Challenge Ahead
Countries in Asia, Africa and Latin America are only beginning to develop laws to deal with food supplements. For this reason, groups like IADSA are instituting education campaigns via member associations in many countries.

?The challenge now is to educate governments about what risk assessment means,? Pettman said. ?Governments were utilising the 1xRDA option in the Codex text to justify their laws. But who could argue when they were selecting from the Codex text? Now that option is gone and the promise of global harmonisation is that much closer.?

Some are hopeful that the larger countries in regions such as South America and Asia, like Brazil, Japan and China, can act as anchors for their respective regions. If they can develop risk-based upper limits, the smaller surrounding countries will follow suit in a kind of domino theory.

Dr Rose Schreitle, head of regulatory affairs at the German Medicines Manufacturers Association, noted scientific risk assessment was unlikely to become as arbitrary as the manner in which RDAs were often employed, even in post-Supplements Directive Europe.

?There is still space for interpretation in safe upper levels,? she said. ?It is up to individual countries to determine how large safety margins should be and how they interpret input from other food sources. Conservative countries will choose the higher safety margin and more liberal countries will choose smaller margins.?

Caribou Coffee Introduces Skinny'Bou - The Nation's First Line of Low Carb And Lower Cal Lattes

MINNEAPOLIS, Dec. 30 -- As the New Year approaches, millions of Americans will resolve to get in shape and lose weight. This year, Caribou Coffee Company Inc. makes it a little easier to keep those weight loss resolutions with Skinny'Bou, a new line of low carb and lower cal lattes in vanilla and caramel flavors.

"Whether you're following a low carb or reduced calorie diet in 2004, Skinny'Bou Lattes allow you to indulge a little," says Caribou Coffee's Vice President of Marketing Chris Toal. "At nearly one-third the calories or one- fifth the carbs of our regular lattes, Skinny'Bou is the perfect New Year's Resolution Solution."

Skinny'Bou Lattes will be available in all Caribou Coffee stores starting January 1, 2004. The new coffee drinks come in vanilla or caramel, and are sweetened with Splenda(R), a popular new sugar substitute. A lower calorie caramel Skinny'Bou Latte (made with skim milk and Splenda) rings in at just 80 calories, or 140 calories less than a regular 220-calorie caramel latte. Skinny'Bou's Low Carb Latte, with only 7 grams of carbohydrates, offers a significant reduction from the 33 grams of carbs found in regular vanilla and caramel lattes.

"We've been working on our Skinny'Bou line for some time and feel that we're bringing something new and exciting to the specialty coffee market," continues Toal. "With Skinny'Bou Lattes, our customers can reward themselves with a coffee drink that tastes great while adhering to either a lower cal or a low carb diet. Customers are really excited about Skinny'Bou and so are we."

Todd Lingle of the Specialty Coffee Association of America was quoted recently, saying that Caribou's Skinny'Bou line is the first of its kind among large coffee chains. According to Chris Toal, Caribou may explore expanding Skinny'Bou beyond vanilla and caramel lattes and will continue to seek new ways to meet customers' needs.

Caribou Coffee Company Inc. is the nation's second largest specialty coffee company with more than 250 stores and 3,900 employees. Headquartered in Minneapolis, Caribou Coffee stores can be found in Minnesota, Wisconsin, Illinois, Ohio, Georgia, North Carolina, Michigan, Washington D.C., Maryland and Virginia. For more information, visit www.cariboucoffee.com .