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Articles from 2003 In February


Delicious Living

March 1, 2003

Dietary supplements: what are the safe levels?

The formulation of vitamin and mineral supplements has been self-regulated in the UK since 1985 by the Health Food Manufacturers' Association (HFMA). A decade later the European Federation of Associations of Health Product Manufacturers (EHPM) published recommendations for self-selection of vitamin and mineral supplements by consumers.1 In this publication, the term 'upper safe level' was used to define the greatest daily quantity of a supplement that could be consumed by an adult without giving rise to a possible adverse effect. It was not a recommendation for consumption—it was a guideline for safe use.

Also in 1995, the US and UK branches of the Council for Responsible Nutrition (CRN) began an international collaboration on the scientific assessment of risk.2 They made risk management recommendations regarding the role vitamin and mineral supplementation could play in the improvement of health worldwide.3Around this time, the Food and Nutrition Board in the US, the Food Standards Agency in the UK, and the European Union's Scientific Committee for Food (now called the European Food Safety Authority) also began reviewing the consumption of vitamin and mineral supplements.

American studies have been the most wide-ranging, reviewing not only safety but also requirements to prevent the classical deficiency diseases and, for the first time, assessing the dietary intakes of micronutrients associated with improved health, a concept of optimising health through diet.4,5,6,7 European studies have more often been confined to scientific risk assessment of micronutrient consumption. Their conclusions are currently available on official Web sites.8,9 Encouragingly, most of both governmental and industy studies' findings concur, which should induce a high degree of confidence in the consuming public.

Risk and safety
It is not possible to guarantee safety for all individuals in all circumstances. A safe road is one on which an accident is unlikely to occur, but an accident-proof road is beyond the possible. Similarly with foods: a sample will give an indication of, for example, the presence of a poisoning bacteria. Assumptions can then be made about the batch of food from which the sample came. This process is termed 'risk assessment.' Once this kind of assessment has been performed, it is then the responsibility of managers to interpret the scientists' conclusions in the context of the market for which the product is intended.

There are thus two stages in assessing the safety of a product before it is released for sale to the public: the scientific stage of 'risk assessment' and the subsequent management stage of 'risk management.'

The principles of risk assessment and risk management are the same for nutritional supplements as for all foods—but there is a difference in the detail. Supplements in tablet or capsule form have so little bulk that there is no control over the amounts consumed from the natural process of satisfying hunger. Consequently, guidelines are necessary to indicate what might be the maximum levels that can be consumed without harm on a daily basis over a lifetime.

Water-soluble vitamins, such as C and the B group, are not stored in the body, and for these there is no problem with reference to the period of consumption, but there is another consideration. If an adverse effect is the consequence of a relatively long period of consumption, several years for example, then there may be cause to limit the consumption of the product, not necessarily to its maximum amount in a tablet or capsule but by limiting the period over which it may be consumed.

It is not possible to guarantee safety for all individuals in all circumstances. A safe road is one on which an accident is unlikely to occur, but an accident-proof road is beyond the possible
Vitamin B6 presents this challenge to the regulator. It has a record of successful intermittent use over many years. There is also evidence of toxicity at high dietary intakes and further evidence that the development of the adverse effect (neurological damage) is cumulative. The regulatory problem is thus to relate an upper safe level for consumption to the frequency of consumption. In the case of vitamin B6, it would appear that daily consumption for one week in four at levels up to 200mg is both effective and safe, but there is no scientific proof. The risk manager must therefore evaluate evidence using market knowledge to interpret the limited scientific data available from the risk assessment. His goal is to meet the dual consumer requirement of safety and continued availability of a relatively high-potency product for regular but intermittent use.

Risk assessment and risk management
The B6 dilemma illustrates the difference between risk assessment and risk management. The starting point for ensuring safety is a risk assessment of the micronutrient obtained by a review of the scientific literature. Human studies are preferred. Animal data must be interpreted for the human circumstance. Typically, an upper safe level obtained from animal data is divided by 10 unless there is compelling evidence to demonstrate that human and test animal sensitivity are essentially similar.

It is also desirable for the risk assessment to be made by directly reviewing the consequences of consumption of the micronutrient supplements in addition to an otherwise complete diet and for the sample and length of study to be as great as possible. Any groups of individuals who might be unusually sensitive to the vitamin or trace mineral should also be identified. Pregnant women and nursing mothers are important groups to consider, but there may be other, less prominent, groups that could be at risk and whose presence in a risk category may only become apparent from a study of the scientific literature.

The conclusion of the scientific risk assessment will provide a highest safe daily consumption level as a supplement by the majority of the adult population, together with an itemisation of and label warnings directed to any minority groups that might be expected to be sensitive to it.

There are occasions when it might not be possible to provide a recommendation based on the scientific data. For example, there may never have been recorded an experience of an adverse effect, which is the case with B vitamins. In such a situation, the highest scientifically acceptable recorded consumption has to provide the baseline guide with the understanding that higher levels also may be, or not be, without adverse effect. In other situations, the scientific data are simply inadequate, either because they are of low quality, as with vitamin B6, or because studies have not been undertaken at all.

In most cases, the risk manager has to focus attention on the possibility of small but sensitive groups and consider whether they can be protected by clear product labelling or by other means. In such considerations, the risk manager must recognise that the scientific assessment has already taken account of the quality of the scientific literature and has applied caution to its interpretation.

Hence, the regulator is unlikely to find it necessary to invoke a further 'precautionary principle.' Indeed, the object of the scientific risk assessment is to provide an objective assessment and thereby define a rationale for an upper safe level for the general public. The risk manager's task is to take account of any minority group that is potentially at risk according to the scientific risk assessment, and advise formulation of regulations to protect them from adverse events whilst providing the scientifically determined 'upper safe levels' for all others.

Derek H Shrimpton is scientific advisor to the European Federation of Associations of Health Product Manufacturers.
Email: [email protected]

References

1. Shrimpton DH. Essential Nutrients in Supplements. Euro Health Prod Mfg. Assn, Office of the President, PO Box 223A, Surrey (UK); Thames Ditton, 1995.

2. Hathcock JN. Vitamin and mineral safety. Washington, D.C.; Council for Responsible Nutrition 19973. Vitamins and minerals: a scientific evaluation of the range of safe intakes. Council for Responsible Nutrition, 63 Hampton Court Way, Thames Ditton, Surrey KT7 0LT (UK), 1997.

3. Richardson DP. Nutrition in transition: the role of micronutrients. International Alliance of Dietary/Food Supplement Associations, (IADSA) 50, Rue de l'Association B-1000, Brussels (Belgium).

4. Dietary reference intakes for: calcium phosphorus, magnesium, vitamin D and fluoride. Washington DC; Food and Nutrition Board, National Academy Press, 1997.

5. Dietary reference intakes for: B-vitamins and choline. 2000, Ibid.

6. Dietary reference intakes for: vitamins C & E, selenium & carotenoids. 2000, Ibid.

7. Applications in dietary assessment. 2001, Ibid.

8. Safe Upper Levels for Vitamins and Minerals: Report of the Expert Group on Vitamins and Minerals 2003, Website: www.foodstandards.gov.uk

9. Opinions of the Scientific Committee for Food on tolerable upper intake levels, Web site: http://europa.eu.int/comm/food/fs/sc/scf/index_en.html

New bio-terror law to change import rules

Food and supplements manufacturers have until the end of March to comment on proposed Food and Drug Administration regulations under the Bioterrorism Act that would require companies to register and notify the FDA of food shipments to be imported into the United States.

Under the proposal, FDA must be notified by noon the day before the imported food arrives at the US border or port of entry. FDA anticipates an average of 20,000 'prior notices' every day.

"Everyone in the food and dietary supplements business must make understanding their obligations a top priority," said Tony Young, general counsel for the American Herbal Products Association. "Any company importing raw materials or products needs to set up systems so that these regulations can be complied with once they become final."

All US facilities engaged in 'manufacturing, processing, packing, or holding of food for consumption' must register with FDA by December 12. More than 400,000 companies will be forced to register. Non-US facilities are exempt if food from the facility undergoes further processing or packaging by another foreign facility before it is exported to the US. However, if the processing or packaging activities of the subsequent facility are limited to affixing labels to a package or other minimal activity, both must register.

Non-US producers are worried about the implications for their business. "The logistics sound enormously complicated," said Anthony Bush, chairman of the European Federation of Associations of Health Product Manufacturers. "We are deeply concerned that this new legislation may create a barrier to trade between the two continents. We must ensure that there is some international debate on this and that the requirements are both reasonable and acceptable for manufacturers of food supplements."

The proposals can be accessed, and commented upon, at www.fda.gov/oc/bioterrorism/bioact.html.

Japan Seeks Western Ingredients And Supplements

Regulatory changes that have liberated the Japanese nutraceuticals market are presenting Western ingredient suppliers with fresh opportunities to gain a foothold or to increase their market share in the world's second biggest market.

Changes in the law, implemented by the Ministry of Health, Labor and Welfare in November 2002, saw more than 40 ingredients re-classified under food law where previously they had been classified as drugs. As a result many products containing these ingredients have become much more widely available.

Some of the re-classified ingredients include L-carnitine, astaxanthin, MSM, chitosan-oligosaccharides, L-ornithine, Co-Q10, chondroitin sulfate as well as 42 botanical ingredients. Kava kava, which formerly came under food law, was re-classified as a drug.

According to Paul Yamaguchi, a New York-based expert on the Japanese nutraceutical industry, this is an opportune time for Western ingredient suppliers to move into Japan, either by setting up joint ventures or trade agreements with Japanese companies, or by establishing independent operations.

Ingredients suppliers such as OGB Corp (USA), Capsugel (USA), Metabolic (USA), Contact Minerals (Australia), Maypro (USA), Covex (Spain), Bonheur (Germany), Indena (Italy), Chr. Hansen (Denmark), Roche Vitamins (USA) and ADM Nutrition (USA) have already done so, he said. American multi-level marketers such as Amway, Nuskin, Hebalife, Shaklee and Nature's Care have also established a presence there.

He said there was strong interest in Western-style ingredients in Japan, especially among younger people. "There are two main streams of nutraceuticals consumers in Japan," he said."Firstly, there are traditional herbal and botanical consumers. They are interested in Chinese, Japanese, Okinawa and, more recently, Brazilian botanicals. They are mostly elderly people with chronic diseases. Their favourite delivery methods are powders mixed with tea or mixed with other liquid drinks."

"Then there are new consumers who want and expect scientifically proven Western ingredients including vitamins, minerals, Western botanicals and chemical ingredients. These consumers are younger—25 to 45 years old. This is where the potential for growth lies."

Botanicals make up about 70 per cent of the overall nutraceuticals market in Japan but the gap is closing as more younger people take an interest in consuming these kinds of products.

The nutraceuticals market in Japan has been growing at approximately 10 per cent for the past decade, according to a report recently compiled by Yamaguchi's consultancy. It valued the Japanese nutritional supplements market at $8.2 billion, making it the second biggest in the world. Japan's functional foods market came in at about $11 billion.

China Gets Tough On Quality

In the first of new series on China, FF&N looks at how the home of Traditional Chinese Medicine is seeking to shed the image of poor quality control on its herbal products. Shane Starling investigates

The modernisation of China's traditional medicines industry continues to gather pace as its government-sponsored Good Manufacturing Processes (GMPs) and Good Agricultural Processes (GAPs) policies begin to take effect.

Back in the 1980s, the Chinese government recognised that its TCM industry needed upgrading if it was to compete in the international market, but only now are the benefits of this strategy coming to fruition.

All companies involved in the manufacture of TCM must comply with guidelines laid down by China's State Drug Administration (SDA) by 2004 and farms producing raw ingredients must comply with SDA-imposed standards by 2007.

By the end of last year, 1,470 companies had registered for GMPs while 570 failed to meet the standards. Three thousand applications are still pending.

"With the full implementation of GMPs and GAPs in the next few years, we expect Chinese botanicals and their extracts to significantly improve in quality," said Dr Albert Wong, president of the Modernised Chinese Medicine International Association (MCMIA), a Hong Kong-based trade association. "Meanwhile, Hong Kong, with its long tradition as the most important exporting city of Chinese herbs and proprietary Chinese medicines, is assuming the role of gatekeeper for their quality with the help of modern technology."

Larry Wong, chairman of the Modern Medicine Foundation, a US-based body that promotes the exchange of knowledge between the East and West, said the changes would force many smaller players out of the Chinese TCM industry, but that they were necessary if the industry was to survive.

"Manufacturers with money are responding well," he said in regard to the imposition of GMPs. "But many manufacturers don't have the money and they might close down. The larger companies that remain are ready to increase production and will take up the slack."

It has been estimated that companies will need to spend approximately $2.4 billion to upgrade their facilities.

While some companies are unhappy at being forced to change their work practices, Larry Wong said the SDA would not backtrack from its implementation plans and knew from the outset there would be casualties.

"Products that don't meet the GMP standards will simply not be allowed onto the market," he affirmed. "China needs quality control for both the export industry and the domestic market. Right now, the standards are not very high and the quality is not very good. For this reason, the international image of TCM has not been very high."

Quality As A Competitive Edge
Both the government and the industry are concerned about the loss of competitiveness internationally, according to Bill Liang, managing director of California-based China Healthcare Consulting. "They strongly believe that China should have a very distinct advantage in TCM and they are very disappointed to see the world market being dominated by other Asian competitors," he said.

Only once GMPs and GAPs are in place could the industry hope to improve its image and start to build on its current five per cent share of the world botanicals market, according to Larry Wong. An estimated 40 per cent of the Chinese population take TCM regularly.

Wong highlighted the importance of implementing GAPs in conjunction with GMPs. "There's no point in having high-level GMPs if the quality of the ingredients is poor. That's why it is important that these two initiatives are put in place simultaneously," he noted. "The GAPs are basically a set of guidelines for herbal farmers to follow," he pointed out. "There will be qualified people at the sites to pass on the knowledge to the farmers as to the best way to grow the various kinds of herbs.

"It will be difficult for the small farms because as a rule they are further behind than the bigger farms. They don't have the machinery, the technology or the capital to make the necessary changes, so many of them will amalgamate or be taken over by larger farms."

Clinical trials are also being funded to provide the kind of scientific evidence the Western market demands for its medicines.

Larry Wong said China welcomed Western interest in TCM. "The Chinese government is happy to have Western companies come in and set up operations or joint ventures to help raise standards," he stated. "Western companies have valuable knowledge, especially about GMPs, and the Chinese government is keen to exploit this as much as possible."

Canada Liberalises Regulations

Food manufacturers doing business in Canada have been granted sweeping new means of communicating health benefits of foods on labels.

Health Canada, the Canadian government's regulatory body for foods, is mandating consistent nutrition labeling on most food labels and is permitting, for the first time in Canada, a short list of five diet-related health claims for foods.

"The goal here is to provide better information and more consistent information to Canadian consumers so they can make good decisions about healthy eating," said Health Canada spokesman Ryan Baker.

The five health claims relate to calcium and osteoporosis; sodium and hypertension; dietary fat and cardiovascular heart disease; fruits and vegetables and cancer; and dietary sugars and alcohols and dental caries. These five claims are also permitted in neighbouring US markets.

"We're moving toward greater harmonisation with the US," said Kelley Fitzpatrick, director of the Centre for Functional Foods and Nutraceuticals at the University of Manitoba in Winnipeg.

The nutrition labeling will closely mirror the "Nutrition Facts" tables on US food labels—with the notable addition of trans fats. Health Canada is still looking at other health claims allowed in the US, according to Fitzpatrick, including folate and neural tube defects; fibre-containing fruits and vegetables and cancer; and soluble fibre and cardiovascular heart disease.

Product-specific health claims remain unaddressed, and popular ingredients in the US such as lutein and plant sterols also remain disallowed.

Pre-snooze Rituals

Robert Ballard, MD, director of Denver's Sleep Disorders Center at National Jewish Medical and Research Center, says the majority of patients he and his colleagues see have spent years—and hundreds of dollars—on pharmacological and herbal remedies for sleeplessness. Although these approaches work for some people, they clearly don't cure everyone; the Sleep Disorders Center remains busy with desperate patients.

If you are chronically sleepy, you cannot expect to improve your sleep with a quick fix, says Ballard. Having researched and treated sleep disorders for almost 20 years, he asserts without hesitation, "Behavioral interventions are the most effective approach." If you suspect you have insomnia, Ballard suggests trying these tips to train your brain and your body for restful sleep.

1. Limit bedroom activities to sleep and sex. Don't use the bedroom to read, watch television, or work.

2. Before you go to your bedroom to sleep, spend 15 to 45 minutes relaxing by engaging in a comfortable ritual: reading, soaking in a warm bath, listening to music.

3. Create an atmosphere in your bedroom that is conducive to sleeping: low lights or darkness, a humidifier for dry climates, a comfortable temperature, and a good sleep surface.

4. Avoid stimulants, such as caffeine (after noon), chocolate (six hours prior to bedtime), and strenuous exercise (four hours before bedtime).

5. Go to bed and wake up at the same time every day, even on weekends.

6. If you cannot fall asleep after 15 minutes or so—despite deep breathing, progressive relaxation, or comforting imagery—leave your bed to go relax again. In a softly lit room, read another chapter of your book or listen to soft music—whatever it takes to make you sleepy again.

—W.D.



Sugar Snap Peas with a Single Herb

Sugar Snap Peas with a Single Herb
March, 2003

Serves 4-6 / Sugar snaps—those chubby, edible pea pods—are so good raw or lightly cooked, there's no need to gussy them up too much. Also from Mollie Katzen's Vegetable Heaven (Hyperion, 1997), this recipe is a great choice for cooks who hate to chop; just snip the chosen herb with scissors. Dried herbs work, too, if you can't find fresh ones.

1 pound fresh, tight sugar snap peas
2 teaspoons butter
Salt and pepper, to taste
1-2 tablespoons minced fresh herb (marjoram, mint, savory, tarragon, or thyme.)

1. Remove tops from peas and pull off strings. Melt butter in skillet over medium-high heat. Add pea pods, keeping heat fairly high. Cook quickly for about 1 minute. Sprinkle with salt, pepper, and the herb of your choice. Cook about 1 minute longer.
2. Transfer to a bowl and eat as soon as possible, while pods are still bright green, puffy, and hot.

Calories 66,Fat 2,Perfat 29,Cholesterol 5,Carbo 9,Protein 3,Fiber 3,Sodium 154

Event Review: Health Strategy Network North America

Name of Event: Health Strategy Network North America

Annual: Yes
Date: February 20-22, 2003.
Location: Blue Mountain Resort, north of Toronto, Ontario, Canada
Estimated or confirmed attendance: 45

Business Case Discussions and Networking:

General overview of event:
Hosted by Health Strategy Consulting, and sponsored by Euromonitor, DSM, BASF, IMAGINutrition and NPIcenter, the two plus day conference was organized as the first of an international series to discuss and analyze industry business cases.

An interactive two day event with participants discussing four business case studies with relevance to small to large companies and covering both dietary supplements and functional food categories.

Ingredients and finished product strategy were considered.

An intimate atmosphere prevailed with feedback and discussion points provided by participants. The Nestle and Snapple case studies centered around marketing strategy, Nurture, as a raw material supplier, had its own issues to navigate such as ingredient branding, health claims issues, technological and formulation advantages and IP. In the Natrol case, a mature company was trying to reach the next growth level in a flat business environment. Elliott Balbert was seeking to change a company with entrepreneurial spirit into a more mature scaleable enterprise with new businesses and new business concepts. The discussion focused on his challenges and analyzed the decisions.

Attendee feedback:
General feedback was very positive and that the format was unique to the industry. Numerous attendees suggested other cases they’d like to see in future events, the value was exceptionally high (under $700 USD, all inclusive), the networking was of good value with people in the same room and table who might never have been in contact before. The range of issues was broad and the outcome of the functional food marketplace a key discussion point. The validity of business decision making strategies was questioned, both in the Nestle and Snapple cases, and for smaller companies, the potential fallibility of these organizations was interesting to note. Also the high focus on US conditions and cases could be broadened with more international issues.

Most attendees are eager for future events, whether it’s the upcoming Australian stop in the series, or next year’s North American conference.

There were comments received about the relevancy of the business cases. For example, the Nestle LC-1 launch disaster was a while ago, and was a big organization venturing into what was obviously for them, a relatively unknown marketplace. The Cadbury Shweppes / Snapple case, while current, is a marketing positioning issue that may not be totally relevant to supplement or ingredient companies. In this case, having actual product to evaluate, along with indications of strategy and market positioning, led to a lively discussion.

Most agreed however that the discussions and feedback were thought provoking and valuable to business decision makers whatever their business situation.

Key contacts directly responding to attendee feedback:
Nestlé USA
Steve Allen, Vice-President, New Business Development

Natrol, Inc.
Elliott Balbert, President & CEO

Nurture, Inc.
Griff Parker, President & CEO
Phone: (610) 989-0945
Fax: (610) 989-0991
E-mail: [email protected]

Conference Layout:
World-class facilities at Blue Mountain Resort north of Toronto, Canada provided the backdrop including food, fun, and accommodations. Many of the attendees took advantage of the skiing, snow-boarding and tubing opportunities.

The formal event began with networking and an opening dinner and keynote address by Michael Heasman, co-author of ‘the Functional Foods Revolution: Healthy People, Healthy Profits?’ and in the near future, ‘Food Wars: the Global Battle for Minds, Mouths and Markets’.

Two cases Friday and two on Saturday constituted the bulk of the formal schedule, however breakfast, lunch, dinner and entertainment provided ample discussion and networking opportunity.

Attendees were provided the cases and discussion materials in advance, and each case analysis, facilitated by host Tom Clough of Health Strategy Consulting, began with an examination of case issues and factors, comments and discussion from the floor and concluded with comments from the case subjects themselves, with the exception of Snapple, who was not represented at the conference, although feedback to the group is expected.

Improvements suggested:
Some attendees suggested other business cases they’d like to review. Others suggested they’d like cases more directly relevant to dietary supplements. Observations were made that the feedback was gentle on the companies presenting, and could have been perhaps bolder and more critical. Q and A at end of each case may have been an idea, or even breakout sessions for specific discussions and issues.

Conference Organizer’s comments:
Pleased with response and results. Participants could have been even more outspoken and critical in case analyses. A successful launch to the conference series.

Vitamin D can prevent fractures in older people

Effect of four monthly oral vitamin D3 (cholecalciferol) supplementation on fractures and mortality in men and women living in the community: randomised double blind controlled trial, BMJ Volume 326, pp 469-72

Vitamin D supplements reduce fractures in men and women aged over 65 living in the general community, finds a study in this week's BMJ.

Researchers identified 2,686 people (2,037 men and 649 women) aged 65-85 years living in the community. They sent one capsule containing 100,000 IU vitamin D3 (cholecalciferol) or matching placebo by post every four months for five years (15 doses in total). They asked participants to take the capsule immediately and complete and return a checklist of events (fracture or major illness).

Participants in the vitamin D treatment group had a 22% lower rate for first fracture at any site and a 33% lower rate for a fracture occurring in common osteoporotic sites (hip, wrist or forearm, or vertebrae).

Many interventions effective in high risk groups are not feasible in the general population owing to poor compliance or side effects or are not cost effective, say the authors. In contrast, the cost of four monthly vitamin D capsules is less than £1 annually, they conclude.

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