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Articles from 2004 In December

Delicious Living

January 1, 2005

FDA rules: too risky to ignore

Supplements manufacturers who don?t follow Food and Drug Administration rules for introducing new dietary ingredients are leaving themselves open to attack in the courts. W Patrick Noonan and Chris Noonan explain

Is it better to be old or new? Most would say ?new.? But if you asked any dietary supplements manufacturer who is about to begin marketing a new dietary ingredient, the answer will probably be ?old.?

The regulations for marketing old vs new ingredients under the Dietary Supplement Health and Education Act of 1994 establish distinct mandatory requirements for both, but the requirements are far less arduous for an old ingredient. Up to this point, most manufacturers assume their ingredients are grandfathered because of a ?long history of use? and proceed directly to market. But an incorrect assessment of a newly marketed ingredient, not in accord with the Food and Drug Administration regulations, can lead to troublesome legal issues.

Under Section 8 of DSHEA, a new dietary ingredient (NDI) means ?a dietary ingredient that was not marketed in the US before Oct 15, 1994.? In contrast, an old dietary ingredient (ODI) is one that was lawfully marketed before that date. For NDIs, companies must notify the FDA 75 days before the introduction of the ingredient with sufficient data to provide substantiation of its safety. For ODIs, no new safety notification is required. The ingredient is presumed to be safe unless evidence suggests otherwise.

Defining terms
In order to understand the significance of NDIs, there are several terms that merit definition. The term ?lawfully? is certainly one for discussion. According to informal FDA guidance, a lawfully marketed supplement requires written evidence showing that the ingredient is chemically identical to a dietary ingredient that was marketed in the US before Oct 15, 1994. However, the FDA has indicated some written evidence upon which the dietary supplements industry has historically relied may not be sufficient.

The FDA stated in correspondence to one manufacturer, when responding to a 75-day notification, that ?inclusion in a published list is not sufficient to show an ingredient is old.? Such lists include the American Herbal Products Association?s Herbs of Commerce (1992),1 the ?Old Dietary Ingredient List? from the Utah Natural Product Alliance, and the ?List of Dietary Ingredients Grandfathered Under DSHEA? from the Council for Responsible Nutrition.

According to the FDA, a seller must be able to demonstrate that the inclusion of the ODI in these publications is based on reliable evidence that the ingredient is old. The FDA considers independent documentation to show an ingredient is old to be a product invoice, bill of lading, product label or labelling, or catalogue with a date to show evidence of marketing before Oct 15, 1994.2

Widely consumed
Another way to gain exemption from NDI legal status is to demonstrate the ingredient is widely consumed in food in a form that has not been chemically altered. But what if one extracts an ingredient from its source? Is the ingredient chemically altered? The FDA says that if the extract is present in the food supply, the seller must prove it.

Incidental presence of an extract as an inherent component of articles used for food does not establish that the substance itself is ?an article used for food.? In essence, just because an ingredient may have been consumed as part of a food for centuries, it does not mean that substance is exempt under the NDI requirements.

Therefore, if a dietary ingredient is not proven to be old, as discussed above, it is by law an NDI and cannot be lawfully marketed without the required 75-day notice. For that reason the FDA has issued a regulation: New Dietary Ingredient Notification.3 In this, the following requirements are needed for an NDI submission to the FDA:

  • name and address of manufacturer or distributor of the NDI
  • name of the NDI
  • description of the NDI, including a full characterisation of the ingredient
  • level of NDI in dietary supplements, which would include the amount included in dosage form products and expected daily consumption
  • conditions of use recommended in product labelling, which includes the labelled suggested population for the ingredient (ie, adults only or to all age groups)
  • history of use of other evidence of safety establishing that when used at the level of use and under the conditions of use, the NDI will reasonably be expected to be safe, including citations of published articles or other evidence.

The FDA believes there will be minimal burden on the industry to generate the data to meet these requirements. This is because the FDA is only requesting information that the manufacturer or distributor should have already compiled to support that the ingredient or product is ?reasonably expected to be safe under the conditions of use recommended or suggested in the labelling of the dietary supplement.? The FDA believes the industry burden is approximately 20 hours of work per submission.4

Each NDI submission is specific to the submitter. Other companies intending to market the same ingredient would have to prepare their own NDI submission.5

Legal minefield
Some companies have ignored DSHEA requirements either on the basis that there is no FDA enforcement, or, if questioned, they would argue that their ingredient is ?grandfathered.? But this logic exposes manufacturers to other legal problems.

The first is potential product liability. If a manufacturer is selling a product subject to a liability lawsuit, it is possible the lawyer for the plaintiff will hire an expert to review the product for compliance with DSHEA. If the product contained an NDI legally subject to the 75-day requirement, which was not accepted by the FDA, the expert can argue to a jury that the product was adulterated as a matter of law.

A second problem involves the definition of a dietary supplement. DSHEA amended the Food, Drug and Cosmetic Act by providing a legal definition of a dietary supplement. This definition, as a matter of law, excludes a dietary ingredient approved as a new drug. It also excludes an article authorised for investigation as a new drug, antibiotic or biological.6 According to this definition, if a marketed ingredient were investigated as a new drug and studies were published before the NDI notice was submitted, the ingredient is disqualified as a dietary supplement and further marketing is unlawful.

This is not a theoretical discussion. In the case of US v Synthrax Innovations, the government discovered an investigational new drug (IND) application had been in effect for tiratricol since 1990. (Tiratricol was an over-the-counter thyroid preparation marketed as a metabolic accelerator and fat loss aid.) The court held that this IND precluded tiratricol from being a dietary supplement.

Many companies use the FDA?s tepid enforcement policy as justification to rush new ingredients to market. Responsible members of the industry are slowly integrating a more thorough scientific approach for new dietary ingredients, but the first-to-market mentality runs counter to this practice. Requiring new ingredients suppliers to present significant scientific documentation to establish whether the ingredient is old or new under FDA requirements would be a step in the right direction.

California-based W Patrick Noonan is an attorney specialising in FDA product regulations. Chris Noonan is president of HealthGuidance, a consulting firm. They are founding partners of Mercura LLC, a product innovation, intellectual property creation team.

1. 68 Fed Reg 51696 (2003, Aug 28) where the FDA states: ?In addition, Herbs of Commerce, 2nd Edition (2000), does not represent an authoritative compilation of botanical dietary ingredients that are marketed before October 15, 1994 (ie, botanicals that are new dietary ingredients under Section 413 (c) of the Act).?
2. FDA Docket No. 95S-0316 ? Report 84. See letter 4 ? for New Dietary Ingredient submission for Glucose Metabolism Modulator p2.
3. 21 CFR ? 190.6.
4. Fed Reg 50774-50777 (1996, Sept 27).
5. FDA Web site, New Dietary Ingredients in Dietary Supplements, and 61 Fed Reg 50777 (1996, Sept 27).
6. Section 201 (ff)(3)(A) of the Food, Drug and Cosmetic Act

11 reasons the FDA turns down NDIs
1. Exposure studies on the source of the ingredient were not conducted on actual ingredient.
2. Ingredient was represented for a therapeutic indication. Therefore, the ingredient is legally a drug that requires a new drug application.
3. Ingredient is represented in the NDI submission as a conventional food, and therefore does not meet the definition of a supplement.
4. Data submitted in the NDI notification was for use of the ingredient for disease conditions. Such studies have limited use for long-term use in a healthy population.
5. Clinical studies submitted utilised a non-oral dosage form; therefore, those studies are not comparable for oral use.
6. Ingredient met the legal definition of a biological product according to the FDA; therefore, it is not a dietary supplement.
7. NDI notification contained historical and foreign references wherein the ingredient was studied for use in disease conditions, but not for consumption and use as a food.
8. Studies submitted show pharmacological effects, but were not designed to study toxicity or safety for food use.
9. Description of the ingredient is insufficient to show specific qualitative and quantitative characteristics. Studies submitted describe an ingredient that is not proven to be the same ingredient subject to the 75-day notification.
10. Submission does not discuss safety concerns mentioned in the studies submitted.
11. Reference to Chinese herbal medicine as a basis to show safety is not sufficient. These references show pharmacological, clinical or toxicological information on the source ingredient, but there are no studies on the ingredient per se or on the exact dose exposure.

Soy Story 2: a mainstream hit?

US sales are predicted to remain in double figures while in Europe the category is also showing strong growth. Shane Starling assesses what?s driving the market and investigates the latest applications

The bulk of the world?s soy consumption occurs in China, Korea and Japan, generally in the form of sauces, curds, soups, milks, flours and oils. It?s a stable market — fundamentally unchanged in centuries.

Soy?s Western history is far shorter and far less stable, and in recent times, quite remarkable for its rise to prominence. If your regular Western citizen doesn?t know about probiotics; doesn?t know about plant sterols, herbal infusions or fibre; salt replacers or reduced trans fat oils; about anything functional foodish at all, chances are they will know something about soy. How it can be good for certain women. How it can benefit cholesterol reduction and the heart. Bone health. Cognition. The list goes on (even if the science always doesn?t).

A recent consumer study conducted by the United Soy Board found 74 per cent of Americans perceive soy as being healthy. The study also found 90 per cent of Americans recognise soy milk, with one quarter consuming soy foods or soy milk at least once a week.

?Shifts in perceptions tend to occur ?on the fringes? — and that is precisely what we saw with soy,? says Cargill Health Food and Technologies marketing manager, Kristin Heimerl. ?In the 1960s and ?70s, soy won the interest of the counterculture and became the darling of the health food industry. Today the heart health claim in some markets and the worldwide avalanche of publicity have driven soy increasingly mainstream.?

This is especially so in the US and Australia, as well as parts of Europe, such as the UK and Belgium. In the US, the soy foods and beverages market has been growing at about 20 per cent or more per annum for 20-plus years. That growth appears to be levelling out somewhat but growth will remain in double figures for some years to come according to most estimates. The US soy ingredients market will double and push through $1 billion for the first time by 2007, according to market researcher Freedonia. Indeed, soy protein topped a list of ingredients top food executives said will grow their business in a 2004 Prepared Foods survey — followed by calcium, dietary fibre, omega fatty acids, probiotics, whey protein, high oleic and fats/oils.

?Soy isoflavones will experience robust growth, with increases of nearly 23 per cent yearly through 2007, stimulated by increasing use in nutraceuticals to alleviate menopausal symptoms, maintain bone density and aid in other health applications,? Freedonia predicts.

Isoflavone-rich soy offerings like Acatris? non-GMO Soylife ingredient are also increasingly being used in foods. ?Better technologies mean we can put ingredients like Soylife into a greater range of food and supplements matrixes — even cosmetics,? says Laurent Leduc, president of ingredients supplier Acatris North America?s health division.

Technological advances have opened up new development opportunities for frontier applications such as sub-beverage categories. Ingredients like Cargill?s Prolisse soy isolate are aimed at just such producers. At the time of writing, Cargill had collaborated with two US beverage manufacturers, including a chai tea with 10g of soy protein per serving, and a women?s sports beverage with 6.25g of soy protein per serving.

In Europe, PROSOY Research and Strategy estimated the soy foods market at $1.85 billion in 2003 and expanding at 20 per cent. ?The demand for soy-based milks, yoghurts and desserts is growing as a result of changes in lifestyle, growing food intolerance and allergies, as well as the positive health image of soy,? observes Gerard Klein Essink, PROSOY senior researcher. ?New regulations are also likely to have an impact. A pan-European acceptance of the UK health claim (Joint Health Claims Initiative approval of August 2002) would certainly be a major platform for more innovation.? Germany and Spain are the fastest growing Euro markets, he notes.

Datamonitor Productscan Online reports a sharp rise in European soy product launches with 648 introductions in the first 10 months of 2004, compared with 563 in 2003, 372 in 2002 and 188 in 2001. Klein Essink points to Belgium as a good example of a sophisticated soy market, where end-product advertising has driven interest. ?Alpro has been able to convey the message about the health benefits of soy,? he states. ?They have a product range consisting of 13 different soy drinks, 11 desserts, seven yoghurts, ice cream, cream alternatives and spreads. Household penetration and per-capita consumption of dairy-free is higher in Belgium than any other European market.?

A similar situation is occurring in the UK. Although Alpro had a long-life soy milk on the UK market for many years, it was the arrival of So Good International, a UK-based joint venture between DuPont and Australian health foods company Sanitarium, that energised a new category. ?What kick-started the market was the launch of So Good chilled soy milk in 2000,? says Nigel Duffin, So Good?s technical director. Within weeks of that launch, Alpro debuted its own chilled soy milk. ?Now there are quite a few chilled soy milks. The rest of the market is own-label and the branded share of the business is increasing as the own-label share decreases,? notes Duffin.

Chilled soy milk now accounts for about 0.5 per cent of the UK chilled milk market and is growing at 20-25 per cent annually. Long-life soy milk still has 70 per cent of the market, but chilled soy milk is growing at a faster rate.

On the ingredients front, Leatherhead Food International valued the European market at $170 million in 2003, with the UK accounting for 61 per cent of sales, followed by France with 24 per cent. Processed meat, functional and weight control foods, bread, and supplements were the most popular categories.

Back in the US, Frost & Sullivan industry analyst Kathy Brownlie notes: ?Soy protein is catching up with whey protein in terms of usage. Efforts are on to bring out improved versions of soy protein that enable better assimilation and utilisation of protein by the human body."

Yet, despite cost advantages, soy has a long way to go before it is valued as highly as whey protein by the majority of food manufacturers, according to Anthony Almada, president and chief scientific officer of consultancy IMAGINutrition. ?There needs to be a bunch of studies comparing soy to whey protein in humans, looking at a variety of parameters including estrogens and testosterone. Two studies have shown soy protein drops blood testosterone in males,? Almada states. ?Soy needs to overcome flavour issues among mass consumers, whey protein counter-attacks and the perception by males that soy equals female.?

There are further problems, he believes, in communicating soy?s purported benefits. ?The favourable science has been communicated effectively — but only to women,? he notes. ?Yet several National Institutes of Health studies showing soy protein or soy isoflavones promote breast cancer have been suppressed and the soy industry needs to deal with the ramifications of that.?

On a positive note, the world?s premier soy brand, Dean Foods-owned White Wave, expects to be the first billion dollar soy brand by 2007. White Wave?s Silk soy milk is available in 97 per cent of US supermarkets and is also the most deeply penetrated organic food in the US — proof that soy brands have big business potential.

?Consumers have a strong opinion about what kinds of foods are appropriate for soy,? adds Cargill?s Heimerl. ?Consumers today accept soy in products such as bars, veggie burgers, yoghurts and meal replacement beverages. Forces such as time, trial and industry innovation will slowly transform deep-seated consumer perceptions — broadening mindsets and extending acceptance to other product arenas. We?re seeing it already.?

New ingredients, varieties, matrixes, formulations and categories have reinvented the ways in which soy is being consumed — and by whom. In its second pitch for public acceptance, soy has truly become the versatile bean soy zealots have said it was all along.

High fructose corn syrup divides food and beverage industry

The negative publicity directed at high fructose corn syrup (HFCS) over its link to obesity is presenting opportunities for other sweetener suppliers — even if much of the criticism aimed at the corn-derived sweetener is not backed by science.

Natural low-calorie sweeteners such as sucralose, stevia, xylitol and erythritol are finding a wider range of food and beverage producers willing to replace traditional sweeteners such as sucrose, fructose and HFCS, which is a disaccharide combining the two sugar polyols.

In the case of HFCS, the fact it is derived from corn via a chemical process is thought by many to account for the backlash against it, rather than all high-calorie sweeteners as a group, as there is little difference between them in composition and how they are processed in the body.

?Manufacturers are returning to cane sugar and other natural sweeteners because they don?t like the fact HFCS is not a natural sugar,? said beverage specialist Jim Tonkin at Arizona-based Tonkin Consulting. ?The health retail chains that have banned HFCS-containing products have strict criteria about what can be sold in their stores. Sucralose is also outlawed in Wild Oats and Whole Foods, although it is my understanding sucralose is going to be accepted.?

Another health food retail chain, Earth Fare, has banned all products containing HFCS. Wild Oats has not banned HFCS, but is refusing new products containing the sweetener whose biggest asset is its cost — about 11 cents a pound. ?The only thing that would make the major soda bottlers change from HFCS is if there were a disastrous corn crop and the price of HFCS went through the roof,? Tonkin said.

Coca-Cola defended HFCSs. ?There is no causal link between HFCS and obesity or diabetes,? said Kari Bjorhus, director of health and nutrition communications in the US. ?Given HFCS? composition is almost identical to table sugar, it is hard to understand why it is being singled out.?

?People are linking HFCS with obesity but the science doesn?t really show it to be any worse than any other sweetener,? said Jack Roney, director of economics and policy analysis at the American Sugar Alliance.

Libby Mikesell, executive director of communications at the US Corn Refiners Association, stated: ?We have recorded no drop in demand from our members and there is no indication soft drink bottlers are changing their formulations.? However, Dr Tom Davis, technical director at California-based Hansen?s Soda, believes a shift is occurring. ?We?ve got no problem with HFCS, we use it in many of our sodas, but we are moving to products with lower calorie content — period. That means using other lower-calorie sweeteners like acesulfame potassium, sucralose and xylitol. We are going in this direction because it is what the American public wants. They want sodas that don?t make them fat and are still sweet.?

A spokesperson for aspartame manufacturer Ajinomoto said the diet category had grown by six per cent in the past year, compared to a drop of one per cent for regular sodas, a shift facilitated by the improved taste of low-calorie sweeteners. ?We see that as the major opportunity rather than anyone taking pot shots at HFCS,? he said.

HFCS rose to prominence in the 1970s and ?80s as a cheap alternative to rising sugar costs.

Glucosamine’s side effects investigated

Denmark is investigating potential links between glucosamine use and elevated cholesterol levels. Possible heart and lung clotting side effects are also being assessed. The Danish Medicines Agency (DMA) called for input from companies marketing glucosamine in Denmark, where it is sold as an over-the-counter drug, as well as medicines agencies and glucosamine supplement manufacturers in other European member states.

Heading the investigation, DMA chief medical officer Doris Stenver was due to deliver her report to the European Union body, the European Medicines Agency, as FF&N went to press.

The DMA stated there was no action planned in the meantime and asserted that it was an investigation, not a trial. ?It is important to examine whether there is a connection between treatment with glucosamine and increased cholesterol count. So far, it is only a suspicion, and there might be other explanations for the increase in cholesterol count.? Swedish medical authorities were also conducting inquiries.

The Danish probe was sparked by a doctor who reported high cholesterol in three female patients who had been prescribed glucosamine supplements for joint problems.

About 10 Danish supplements companies submitted comments on adverse event reports and clinical trial data. ?The number of people taking glucosamine during the period in which the three women took glucosamine is not known exactly, but it is in excess of 100,000,? Danish supplements company Pharma Nord said in its DMA submission. ?At least 13 randomised, double-blind trials of glucosamine for osteoarthritis have been made to date. None indicated that glucosamine may have an adverse effect on blood lipids,? said Pharma Nord?s pharmacovigilance manager, Douglas Hunter. ?The medical literature does not appear to contain any case reports indicating an adverse effect of glucosamine on blood lipids despite 20 years? use of glucosamine, including its use in large markets such as the US and UK.? He added: ?While the possibility of an adverse effect of glucosamine on blood lipids in certain individuals cannot be entirely excluded, the available information does not suggest that therapeutic doses of glucosamine have an adverse effect on lipid metabolism.?

UK supplement manufacturer and retailer Holland & Barrett said it had no data suggesting a link between glucosamine use and elevated cholesterol or heart and lung clotting. Its regulatory affairs manager, Sharon Morey, said Holland & Barrett glucosamine supplements (classified as foods in the UK) carried label advice cautioning those with diabetes and shellfish allergies to withhold consumption.

?Even if there were found to be a link, each batch needs to be assessed because not all glucosamine is the same,? she said.

San Diego-based Nutrition Business Journal estimates the worldwide glucosamine market at more than $1.5 billion.

Glucosamine and other joint health supplements such as chondroiton received a boost recently when pharma giant Merck withdrew its $2.5 billion arthritis drug Vioxx after it was found to increase the likelihood of heart attack and stroke.

Vitamin E safe levels under scrutiny

Within a month of a Codex meeting last autumn that announced a deadline for establishing safe upper levels for vitamins, a couple of high-profile studies have questioned high doses of cornerstone nutrients.

The timing of the now-infamous vitamin E analysis, as well as another on vitamin C, has left many in the industry braced for further attacks on the safety record of supplements in the run-up to the July deadline, when the international Codex body is due to submit its final recommendations for safe upper levels for vitamins.

?I think we are in for another round of attacks on vitamins based on this crude analysis of vitamin E, with some medical experts calling for restrictions on vitamin potency,? said Neil E Levin, nutrition educator at Illinois-based manufacturer Now Foods. ?These meta-analyses are by no means definitive proof of anything, due to the lack of uniform protocols and patient groups. But that won?t stop the medical lobby from trying to use these results to limit potencies of vitamins to everyone ?for our own good?.?

The impact of the study has been felt in Europe where a flood of negative media coverage in the UK prompted the Health Food Manufacturers Association to issue a release accusing the authors of ?distorting? the results that the association says have been compounded by ?grossly simplified reporting in some UK media.?

Codex wields enormous influence as far as harmonising regulations around the world. Current US guidelines set an upper tolerable intake limit of vitamin E at 1,500IU per day. The study?s authors believe that should be revised downward.

?Policy makers and government regulators should consider lowering this level, perhaps, to an upper limit of 400IU per day,? said Eliseo Guallar, MD, PhD, senior author of the study and assistant professor of epidemiology at the Bloomberg School of Public Health. ?On the basis of our study, high-dosage vitamin E supplementation is clearly unjustified.?

The study re-analysed 19 studies of vitamin E between 1993 and 2004. Although 18 of the 19 had data that was statistically insignificant on any vitamin E effect — and none of the original studies had all-cause mortality as a primary endpoint — the combined cohort gave greater statistical power to the overall results. Most of the trials involved middle-aged to elderly persons who had heart disease or other serious conditions or were at risk of disease.

?It is shocking how, on the basis of flimsy findings, such sweeping and definitive pronouncements are being made,? said James J Gormley, policy advisor for Citizens for Health. ?A number of landmark epidemiological studies have, in fact, established that vitamin E supplementation reduces cardiovascular disease progression, and, in fact, improves mortality.?

He cited several examples including the Nurses? Health Study of 87,000 nurses, which found 31 per cent reduction of risk of nonfatal infarction as well as death from cardiovascular disease compared to those who did not supplement.

A great concern for industry is that when Codex sets limits, it will take years of overwhelming scientific data to change its recommendations — and even longer for individual governments to change their national regulations.

New Ingredients & Products

Pomegranate rich in ellagic acid
Triarco Industries has released an all-natural pomegranate extract guaranteed to contain not less than 40 per cent ellagic acid. PomAgic is free of carriers and scores 4,600 in ORAC testing, the New Jersey company reports.

+1 973 942 5100

Omega-3s without odours or tastes
Denofa USA has created Denomega 100, an odour- and taste-free natural omega-3 oil rich in DHA and EPA. Denomega is GRAS and OMRI listed. The ingredient works best when added to or replacing other fats existing in foods and is currently found in such functional foods as juice, yoghurt, bread, cheese, spreads, sausage and crackers.

+1 719 201 4641

Stabilizer line for dairy foods
TIC Gums has rolled out a line of TIC Pretested Dairyblend stabilisers for use in an array of dairy foods and beverages. TIC Pretested Dairyblend YG LC Stabilizer was specifically designed to enhance the fibre content and stabilisation of low-carb yoghurt formulations, resulting in products that are gluten-free, yet smooth in mouthfeel. The TIC Pretested Dairyblend IC LC Base powder imparts a rich, creamy mouthfeel while boosting aeration and slowing meltdown.

+1 800 221 3953

Nutrient-packed ingredient Vibracell for vitality and energy
The new food ingredient Vibracell by Belgium-based GDI is being sold in the UK and Ireland under the name Vibraspectrum through New Vista Healthcare. The 100 per cent natural ingredient complex is the result of 10 years of research, and promises to deliver vitality and energy, improving both immunity and cell renewal, its maker says.
Vibracell is made of concentrated, cold pressed juices. Dozens of other important nutrients have been added, such as lecithin, royal jelly, selenium yeast, L-carnitine and co-enzyme Q10.
All ingredients are 100 per cent free of insecticides, pesticides, herbicides and heavy metals.

+ 32 51 31 36 28

An indulgence good for the bones
Hero Nutritionals in California has launched a line of calcium chocolate bites made with real chocolate. Each piece of Healthy Indulgence contains 500mg of calcium, 25 calories, 2 carbs, no trans fats and up to 70 per cent cacao. They also contain vitamin D, which aids in calcium absorption, and come in both milk chocolate and rich dark chocolate varieties.

+1 800 500 4376

Lui Han Kuo fruit with added ginkgo
Longjiang River Health Products, a Chinese herbal health company, has introduced LHK+ with Ginkgo. Derived from Lui Han Kuo, a ?magic fruit? grown only in the Guangxi Province, the supplement promises to enhance mental alertness and memory by promoting blood circulation in the brain and extremities. LHK is also known for its antioxidant effects.

+1 888 916 1688

New loose-leaf organic tea line
Te? Teas has unveiled a line of organic, loose, whole-leaf teas sold under the brand name Cha?a Teas. The line includes a variety of white, green, oolong and black premium teas, including Legend Dragonwell Green Tea, Signature Jasmine Silver Tip Green Tea, and Organic Roasted Rice Mountain Green Tea. The tea is packaged in a stainless steel container that includes a tea infuser inside the lid, designed to fit most cups and teapots.
+1 650 592 3108

The wonders of emu oil
Called the ?Wonder From Down Under,? Australian aborigines have believed for centuries that the oil of the emu possesses special properties. Now Thunder Ridge has brought this medicine to the mass market with Thunder Ridge Emu Oil, which comes from the fat of the emu bird.
Refined to an edible grade, it naturally contains linolenic acid (omega-3), linoleic acid (omega-6) and oleic acid (omega-9), along with other essential fatty acids. Studies have shown the oil has anti-ageing, moisturizing and anti-inflammatory properties, the company reports.
The oil is sold in gel caps, containing a mixture of EFAs nearly identical to the fat profile of the human body; it is also sold in a skin care line that promises to penetrate through all seven layers of the skin, helping maintain hydration and elasticity.

+1 703 631 9074

Power of potato to curb appetite
In a newly patented process, scientists have extracted a molecule in potatoes responsible for satiety, the feeling of fullness. Sold as a supplement called Satise, one pill promises to give the feeling of having eaten four potatoes, according to its maker, Kemin Consumer Care. The active ingredient in Satise is a proteinase inhibitor (P12). When taken 30 minutes before a meal, a Satise capsule enhances the body's release of cholecystokinin, a compound naturally secreted into the blood stream in response to eating food. The compound then induces feelings of satiey, reducing caloric intake.

+1 866 319 0464

Soy without taste, colour
Intellisoy, the first completely clear, 100 per cent soluble pure soy isoflavone additive, has been launched by Dick Lamb, the co-founder of Balance Bar and new CEO of Intellisoy. The ingredient also has no calories and no taste. Among its many applications is a new clear beverage called AquaSoya, which contains 20mg of isoflavones per serving.

Fruity flavours for kids? palates
Crazy Scoops, a line of unique fruit-based flavours for addition to milk designed specifically for kids, contain no caffeine, hydrocolloids or added fat. Launched by Danisco, the flavours include banana, grape, berry-blend and tropic, and are designed to be mixed and matched for multiple flavour combinations.

+1 800 255 6837

Sweet syrups
Cerestar Food & Pharma Specialties Europe has developed a range of clean-tasting bio-organic glucose syrups at its joint venture plant Blattmann Cerestar AG in Switzerland, using organic wheat flour treated with traditional non-GMO enzymes. The process has been certified by Bio Suisse.
Called C*BioSweet, the syrups? key properties include sweetness, viscosity and crystallization control. Other properties include freezing point depression, boiling point elevation, osmotic pressure, nonenzymatic browning and fermentability. C*BioSweet is sold as a liquid glucose syrup with 30 DE, 44 DE and 60 DE and as a spray-dried powder (30 DE). The 60 DE offers new opportunities for ice cream producers.

+32 15 400 411

DHA for infants
Supplements manufacturer Twinlab has teamed up with speciality ingredients supplier Nutrinova to incorporate DHA into its multivitamin drops for infants. Each 1ml serving of Infant Care contains 20mg of Nutrinova DHA to support brain and eye health in infants. It also provides 100 per cent of the daily recommended value of 10 vitamins.

+1 732 271 7221

Mega meal bar
Wysong Corp has created the Origins Meal-In-A-Bar, a non-heat-processed bar that delivers food nutrients exactly as they would be found in nature, the Michigan company reports.
Containing more than 125 nutrients, the bar is also free of synthetics, refined sugars, grain starches and non-nutritional additives.

+1 989 631 0009

Soybean oil to replace trans fats
Bunge Limited and DuPont have announced a new soybean oil that enables manufacturers to reduce or eliminate trans fatty acids in their products. Called Nutrium Low Lin Soybean Oil, the product has a low linolenic acid profile of less than three per cent and offers better natural stability and increased shelf life. When used for frying, it eliminates the need for partial hydrogenation.

+1 800 828 0800

Another slice of probiotics, please
Valio-Vache Bleue in Belgium has launched Valio Gefilus, a lowfat Emmental cheese product with Lactobacillus GG. The company recommends eating at least one slice (30g) per day to receive the beneficial dose of LGG.

+358 1038 1121

A gulp of fresh oxygen
Aquagen International in Utah has introduced a new line of liquid oxygen supplements designed to improve energy, endurance and vitality. Designed on the principle that humans have less oxygen in their bodies due to a depletion of oxygen in the Earth?s atmosphere, the five Aquagen products aim to boost oxygen levels in the body. The supplements and oxygenated products are hypo-allergenic, pH balanced and nontoxic. They include a pre-sports drink designed to increase circulation before a workout, and Oxyzone, an oxygenated colon supplement that helps detoxify the intestinal tract by softening plaque on the colon walls, where pathogens can accumulate.

+1 800 699 4336

Full line of mushroom flavours
A new line of mushroom flavour products by Nikken Foods Co in St Louis is now available in powders, bouillon and concentrates. The varieties include Mushroom Extract Powder, providing a mild aroma with a full, clean, non-earthy flavour; Shiitake Powder, made from heads and stems ground into a fine powder, which provides a smoky, woody flavour; and Shiitake Extract Powder, made from the stems and heads, and also with a woody flavour.

+1 636 532 1019

Fresh fruits for furry friends
Castor & Pollux Pet Works has created Ultramix, a dry pet food that includes a resealable package of raw fruits and vegetables, including dried apples, carrots, mangoes, papaya, pineapple, blueberries and cranberries. The canine formula includes dehydrated chicken chunks, and the feline formula uses Alaskan salmon. The Oregon company sells more than 150 natural pet supplies and foods, including its Organix line, which is the first USDA certified 95 per cent organic pet treats.

+1 800 875 7518

Processed oils with 80% less trans fats
Cargill Refined Oils Europe has created an alternative to traditional hydrogenated oils. Losatra oils are processed in a proprietary new hydrogenation technology that reduces trans fatty acids up to 80 per cent, yet offers excellent stability and crystallisation characteristics, the company says. This makes the range ideal for numerous applications, such as frying, bakery fats and spreads.

+32 15 400 456

Bulk ingredient to beat stress
NutraGenesis has launched a bulk ingredient called Sensoril to North American makers of dietary supplements. Derived from the Ayurvedic herb ashwagandha (Withania somnifera), Sensoril contains a minimum of eight per cent withanolides, the known actives responsible for the reputed antistress properties of the plant.
Sensoril has been substantiated for structure/function claims in the areas of stress, weight management, carbohydrate craving, anti-ageing, antioxidant, mental cognition, and adaptogenic and immune support, the Vermont company reports.

+1 802 257 5345

Can Hoodia offer hope for heaviness?

Hoodia species are one of many succulent plants that grow in arid climates. In the Kalahari Desert in Africa, the juice/sap of Hoodia spp. has enjoyed ethnobotanical use as an appetite and thirst suppressant among certain indigenous peoples. In the 1960s, Xhomani tribesmen disclosed the ethnobotanical use of Hoodia to the South African army. The Pretoria-based Council for Scientific and Industrial Research (CSIR), a partially state-funded laboratory in South Africa, then undertook animal studies with Hoodia in the 1980s and found striking weight loss, not due to toxicity but to appetite suppression.1 CSIR later filed its first of several patents on Hoodia spp. and a related succulent, Trichocaulon spp., describing compositions containing a steroidal glycoside bioactive for appetite suppression, weight loss and metabolic syndrome.2

Rights to CSIR?s patent suite were then licensed to Phytopharm PLC, a UK-based botanical pharmaceutical company. In 1998, Phytopharm signed a sublicensing agreement with Pfizer, allowing the pharma giant to commercialise an obesity drug based on Hoodia?s bioactive and related semisynthetic congeners. Five years later, Pfizer ended its relationship with Phytopharm, ushering in the opportunity for Phytopharm to align with food/meal replacement product marketers and pursue a nutritional matrix with Hoodia extracts.

Bioactivity research
Very little bioactivity research on Hoodia has been published. The first report was presented by researchers from the US, where they added four different Hoodia spp. (crude slurry or semipurified) extracts to the diet of a specific genetic strain of lean and obese rats.3 They noted both acute and chronic reductions in food intake, with body weight dropping markedly over three weeks. A follow-up study by the same group found that the addition of a crude homogenate of dried Hoodia gordonii again produced sustained reductions in food intake.4 After three weeks of feeding, body weight among the obese animals, which was initially twice that of the lean rats, was normalised while the lean rats fed Hoodia displayed a 20 per cent drop in body weight. Regional (gonadal) body fat dropped more than 50 per cent in both the lean and obese Hoodia-supplemented rats, compared to those on the conventional diet.

Comparing extracts
Phytopharm has undertaken several clinical trials, assessing pharmacokinetics, safety and tolerability of different H. gordonii extracts and fractions. In one clinical efficacy trial with Phytopharm?s powdered Hoodia extract (P57), 20 overweight individuals were housed in a metabolic ward (to definitively assess energy intake) for two weeks and given either a placebo or P57.5 Subjects were allowed to eat ad libitum and did not engage in any vigorous activity. Average daily energy intake in the P57 group was reduced by 1,000kcal/day, attended by a fat loss of approximately 2kg. Both fasting blood sugar and triglycerides fell in this group.

The prodigious appetite reduction with P57 demands confirmation in longer-term clinical trials, along with a more rigorous assessment of its effect on metabolism and body composition. Animal studies with the purified steroidal glycoside bioactive in Hoodia gordonii have shown that its injection into the brain (intracerebroventricular) dose-dependently induces up to a 50-60 per cent reduction in food intake over 24 hours.6 Injection of the compound into the abdominal lining (intraperitoneal) was without effect on food intake. The investigation also revealed a novel observation: a normalisation of decreased ATP content within the brain and liver as induced by food deprivation and an increase in brain and liver ATP, both by injections of the bioactive into the brain. This suggests that if this Hoodia bioactive is indeed orally bioavailable to the brain, then it could at least acutely alter the brain?s energy-sensing function, an ?ergostat.?

It remains to be seen if Hoodia can exert a sustained, safe, appetite-suppressive effect when integrated into a nutritional matrix like a meal replacement product. To date, none of the available Hoodia-containing dietary supplements appear to contain the bioactive steroidal glycoside and none have been subjected to any controlled clinical trials to confirm efficacy.

Anthony Almada, MSc, is president and chief scientific officer of IMAGINutrition Inc. Respond: All correspondence will be forwarded to the author.

1. Habeck M. A succulent cure to end obesity. Drug Discov Today 2002;7: 280-1.
2. Van Heerden F, et al. Pharmaceutical compositions having appetite-suppressant activity. WO 9846243, 1998 Oct 22.
3. Tulp OL, et al. Effect of Hoodia plant on food intake and body weight in lean and obese LA/Ntul//-cp rats. FASEB J 2001; 15: A404.
4. Tulp O, et al. Effect of plant on weight loss in congenic obese LA/Ntul//-cp rats. FASEB J 2002; 16: A648.
5. Dixey R. Presentation at sixth annual Rodman and Renshaw techvest healthcare conference, 2004 Oct 26, New York City.
6. MacLean DB, Luo L-G. Increased ATP content/production in the hypothalamus may be a signal for energy-sensing of satiety: studies of the anorectic mechanism of a plant steroidal glycoside. Brain Res 2004; 1020:1-11.

Leveraging the science behind tea

Tea is one hot commodity. Product differentiation begins with identifying salient chemical components with specific health effects. It also involves patents, human research and communicating results. Anthony Almada, MSc, tells how

The science and intellectual property circumscribed by tea is enormous. Since the publication of the fourth edition of the ?US Tea is Hot? report in 2001, more than 1,000 research studies have been conducted. With a similar degree of intensity, more than 450 patents on tea or Camellia sinensis were applied for or issued worldwide.

Both science and patents can be harbingers of new product and processing directions and potential — indicator tea leaves of what is to come in consumer products.

Tea?s functional attributes centre around its polyphenol compounds known as catechins — honeycomblike chemical structures that have many phenol components integrated into the molecular backbone. One specific catechin ? epigallocatechin-3-O-gallate (ECGC) — made such an impression on German drug giant Bayer Corp (makers of One-A-Day brand vitamins) that it is now the purported active ingredient in a new Bayer product called One-A-Day WeightSmart. EGCG is the most extensively researched constituent in tea, as well as the most abundant catechin in green tea. However, tea contains hundreds of intriguing bioactive compounds, many with desirable features and attributes.

L-theanine, for example, has some intriguing and consumer-relevant biological effects. Preliminary human studies conducted in Japan have shown L-theanine to produce a state of reduced anxiety in humans and to lower blood pressure and the anxiety-promoting effects of caffeine in animals.1,2 Caffeine is one of three constituents in tea that belong to a class of chemicals called methylxanthines. The others are theophylline and theobromine. In tea leaves, the order of concentration of these methylxanthine compounds starts with caffeine, then down to theobromine and theophylline.3,4 Theophylline is marketed as a prescription bronchodilator drug in its pure form, both as a pill and liquid, for asthma. Theobromine-rich extracts of cocoa have recently been introduced as dietary supplements ingredients claiming to promote weight loss, but no published human evidence exists to support such maverick claims.

Still, the emblematic constituents of tea are its phenolic compounds. Researchers from New Zealand recently conducted experiments to assess the catechin polyphenol chemo-profile of green, oolong and black teas and the effects of various production steps on concentrations of catechin polyphenols in infusions.5

The results showed three significant conclusions. One, green and oolong teas have nearly double the catechin polyphenols and EGCG yields when the water temperature was 100oC, compared with 60o or 80oC. Two, total catechin polyphenol and EGCG contents of the green (136mg/g and 78.1mg/g tea leaves, respectively) and oolong (114.4mg/g and 85.7mg/g) teas, brewed at 100oC, were quite similar. Black tea samples had far lesser concentrations (32.4mg/g and 6.8mg/g). Three, brewing at 100oC generated EGCG and catechin polyphenol concentrations that were 10-14 times higher than those teas brewed at room temperature (20oC).

Processing, brewing, packaging and storage all have an effect on the end result, be it a ready-to-drink, ready-to-brew or ready-to-swallow (pill) format. The body of evidence suggests that the closer to boiling the infusion temperature, the greater the amount of nutrients and phytochemicals that will be present in the brewed tea.

Employing steps to assess how each step in the production chain influences the finished product — and how the consumer uses and stores a product — may exalt your brand and product far above your competitor?s. Communicating to consumers the human and financial capital expended to deliver the genuine tea article will help to underscore the quality and uniqueness of your offering.

What happens to the catechin polyphenols that are in green tea, remain to a large extent in oolong tea, and then virtually disappear in black tea? They form new tea bioactives called theaflavins and thearubigins and appear to be unique to black tea.

Recently, Unilever?s R&D lab in the UK developed a simulated system through which a green tea extract can be oxidised, resulting in theaflavins quite similar to black tea extract.6 If this immobilised enzymatic oxidation method were commercially scaleable, it could usher in a whole new way of producing polyphenol-rich tea extracts under controlled oxidation conditions and relatively free of impurities.

Although these tea pigments have not yet generated high levels of media excitement, they enjoy distinctive bioactivity, some of which may explain the health-promoting and disease-abating effects seen among some populations of copious black tea consumers. From a business differentiation perspective, if one can consistently make a tea product with a signature profile, and employ other value-adding steps, a new category of tea products could be born.

For tea products delivered in a manner that circumvents or masks taste — for example, solid dosage and food forms — or for taste-drive tea products that are seeking taste and ?in the body? performance, demonstrating biological effectiveness may be the equivalent of strapping on a rocket engine to an otherwise laggard product or ingredient. This is an important consideration, based on the increasing use of tea extracts in functional beverages, foods, dietary supplements and skin-care products.

Trials and tribulations
If your company is seeking a respected platform built upon human evidence that your tea product is safe and effective, human studies are the only way to go. However, the biggest hurdle that confronts most small- to mid-sized tea product or ingredient marketers is the mindset and familiarity of the CEO with science and intellectual property. Most of the people at the top climbed up the sales and marketing ladder, not the academic or scientific tower.

Clinical trials, it need be noted, are not nearly as costly, time-consuming or subject to intellectual piracy as you might think. If the results of a human study are positive and they are efficiently communicated, you now have ?Tea That Works? and a branding opportunity to achieve remarkableness. Who cares about the competition?s in vitro ORAC values? Not you, when you have human science on your product. If you?re smart and the tea leaves bear good tidings, your incremental revenues and meteoric sales velocity will fund more and larger human studies, to grow the momentum.

The most critical aspect of a strategic human research undertaking is what you do with the results. If the results are positive, they should be communicated within the scientific community first, announced at least with a more detailed communication than that afforded by a company-issued press release or advertisement. This renders your results far more newsworthy. Now you can orchestrate a media campaign around the scientific communications that can take your results into mainstream media like daily newspapers, large-circulation magazines and even radio and television.

An integrated approach to creating and leveraging knowledge assets for commercial tea products is far less daunting than it may seem. The overwhelming amount of knowledge captured in published tea science and patents offers a freely accessible window into a world of opportunity that very few tea businesses have chosen to explore. For every stage of company maturity, from business plan to business expansion financing, there is a budget and a need to invest. Identifying a unique single paper or patent could produce a change in business direction and strategy of potentially mammoth significance.

With increased revenues and product distribution comes the opportunity to make an investment in more involved, complex and value-adding science. Here, an integrated intellectual property management plan becomes pivotal. Ideally, almost all that you create and ideate will be insulated: trademarks, copyrights, trade secrets, patents and product-specific science. This is when the inimitable evolves into the invincible. And isn?t that what a quality tea product should be?

Derived from: ?The Science of Tea / Tea Is ?Hot? Report? - 5th Ed. ( by Anthony L. Almada, MSc. Published by Sage Group International LLC. Respond: All correspondence will be forwarded to the author.

1. Juneja LR, et al. L-theanine ? a unique amino acid of green tea and its relaxation effect in humans. Trends Food Sci Tech 1999; 10:199-204.
2. Yokogoshi H, Terashima T. Effect of theanine, r-glutamylethylamide, on brain monoamines, stiatal dopamine release and some kinds of behavior in rats. Nutrition 2000; 16:776-7.
3. Bonoli M, et al. Fast determination of catechins and xanthines in tea beverages by micellar elecrokinetic chromatography. J Agr Food Chem 2003; 51:1141-7.
4. Fernandez PL, et al. The use of catechins and purine alkaloids as descriptors for the differentiation of tea beverages. Microchim Acta 2003; 142:79-84.
5. Kilmartin PA, Hsu CF. Characterisation of polyphenols in green, oolong and black teas, and in coffee, using cyclic voltammetry. Food Chem 2003; 82:501-12.
6. Bonnely S, et al. A model oxidation system to study oxidised phenolic compounds present in black tea. Food Chem 2003; 83:485-92.

An industry under siege

Complementary medicines companies are fighting a desperate battle to stave off new regulations that would see alternative medicines classified alongside conventional ones. Bruce Dennison explores what?s at stake

The South African complementary medicines industry has been stunned by a new draft regulation that may result in complementary medicines being classified in the same way as conventional drugs. The draft regulation, which aims to amend the Medicines & Related Substances Act 1965 (Act 101), was published last July and was open to comments from all stakeholders and interested parties until Oct 16. The industry argued vociferously against the proposal, and the Department of Health has acknowledged receipt of comments from all interested parties and stakeholders. The department has also agreed to hold a series of workshops with government regulators and stakeholders to review the comments and to ensure that an equitable regulatory system for complementary medicines emerges in due course — one that South Africa can be proud of and one that can be promoted throughout Africa and the rest of the world.

The new proposals essentially mean that complementary medicines will be classified alongside allopathic drugs and conventional medicines. Unless exceptions are made, this means that simple substances, such as flower remedies and herbals like garlic, would be called up for registration as a medicine. The regulators have thrown the ?net? unnecessarily far and wide. Act 101 of 1965 was developed to protect the public from dangerous drugs such as thalidomide. It was never intended to incorporate complementary substances. Clearly, complementary medicines fall under a totally different paradigm to allopathic drugs and should be regulated in an entirely different way.

The South African industry, comprising some 110 companies, is in an uproar and has mounted a massive campaign through the Health Products Association and many other stakeholders, including retailers, practitioners and traditional healers.

Traditional healers hit hard
The fact that African traditional medicine (ATM) has been included under the Department of Health?s proposed amendment could have cataclysmic effects on the massive ATM market, which comprises more than 6,000 traditional healers. The strategy adopted by the newly formed Complementary and Traditional Medicine Stakeholders Committee has largely been based on the technical aspects of the regulations and how inappropriate these would be. It has been busy compiling its own set of regulations, which are largely based on what the industry has been attempting to negotiate with government over the last 18 years.

The stakeholders have created a hard working committee, which is generating wonderful energy and communicating effectively with various layers of government, not only in the Department of Health, but also through the Portfolio Committee for Health in Parliament.

Complementary medicines set to be affected by proposed changes to Act 101 of 1965
African traditional medicine
anthroposophical medicine
aromatherapy medicine
Ayurvedic medicine
biochemic tissue salts
Chinese medicine
flower remedies
gemmotherapy medicine
herbal medicine
homeopathic medicine
homotoxicological medicine
plant herbs
sowa rigpa
unani medicine
The amendment potentially has far reaching implications for companies in South Africa that sell complementary medicines. Industry observers say that if the proposed regulation is implemented in full, it will render some 80 per cent of companies selling complementary health products unable to continue in business. In order to comply with the regulations, companies would be required to have full pharmaceutical good manufacturing practices in all respects. There are only a limited number of companies in South Africa that currently comply with these requirements.

It is agreed by all players, both large and small, that regulations are necessary. But it is felt that the regulations need to be appropriate to the class of substance in question. The alternative proposals put forward by the industry are based, in part, on the Australian system, and, in part, on the Canadian system. The need for safety is paramount and suitable GMPs are necessary. Claims should only be made providing they are supported by recognisable and acceptable peer literature.

South Africa could have the most up-to-date, modern system in the world, if substances were regulated separately, as described above. The country already has, through the Allied Health Professions Board, an act that defines all professionals working in complementary and alternative medicines. Through this act, South Africa recognises that chiropractors, naturopaths and homeopaths are different to allopathic practitioners. Why, therefore, shouldn?t the substances they use (ie, complementary medicines) not have their own regulations as well?

Despite the draconian nature of the proposed regulations, the government has indicated that it would be willing to discuss and consider any reasonable and sensible proposals that are put on the table. It is expected that once the amendment is eventually published, separate and specific guidelines will be available for the manufacturer and marketer of complementary substances.

Measuring the market
Aside from concerns about how complementary medicines in South Africa are classified, the industry thunders on with excellent annual growth rates. The market is worth around $376 million per year and is growing in volume by 14 per cent year on year. The breakup of the industry can be seen in the pie chart detailed to the right.

One of the many benefits of a free South Africa, now in its 11th year, is that it is seen by many sub-Saharan states as a continent leader. Although considered a developing nation, South?Africa in comparison to many of its neighbours is very much a ?first world? country. In terms of health foods, dietary supplements and complementary medicines, most countries in the region will almost certainly adopt any regulations that flow from South Africa.

In recent years there has been an increasing flow of South African exports, not only to the immediate neighbouring countries of Zimbabwe, Zambia, Namibia and Malawi, but also to the large East African market, which has a total population of some 100 million people, and the even larger West African market, with a population of 150 million. It is felt that harmonised regulations throughout sub-Saharan Africa will have a massive impetus to the free flow of products and increased sales.

The dietary supplements sector is by far and away the largest and most dominant sub-sector within the South African complementary health industry, valued at $245 million.

Dietary supplements, comprising vitamins, minerals, herbals, botanicals, fatty acids and amino?acids, are widely and freely available in health foods stores, in the country?s 2,300 pharmacies, and all the major supermarkets and food stores.

Research company AC Nielsen, which has been measuring the market for many years, reports that Vital?Health Foods, with its core brand Vital, holds a 40 per cent share of the market. Vital?also produces foods and beverages, in addition to dietary supplements. Other important players include Roche and PharmaNatura. There is also a plethora of very small companies, which makes up around 10 per cent of the market.

The dynamics of the South African retail market has been affected by New?Clicks Holdings? acquisition of 40-50 per cent of the country?s largest independent pharmacies, as well as one of the largest pharmaceutical wholesalers in the country. The toiletries and related products company also has a controlling interest in the Link Pharmacy Brand, which comprises some 450 pharmacies.

Dietary supplements in South Africa, specifically vitamins and minerals, are presently regulated as foodstuffs, subject to approved daily intakes. Products marketed with vitamin or mineral contents above the permitted food levels are regarded as medicines and are, as such, required to be registered. For example, more than 300mg of vitamin C per day should be registered as a medicine, below this level it is food stuff.

In general, the South African market tracks US and UK trends. It is felt that the industry will continue to prosper thanks to unprecedented consumer demand. Suitable regulations are also required for those categories presently not covered.