Quality Issues In Natural Products

Quality is not a tool for securing a competitive advantage but an absolute requirement for staying in business. That was the principal conclusion of a seminar held recently at Reading Scientific Services. Graeme Coulam reports.

The industry as a whole, and manufacturers individually, need to achieve high standards and to apply best practice to all areas of their work," says Anthony Bush of CAMedica Consulting. "The consumer demands quality products that are produced consistently, and manufacturers need to meet this challenge. The status quo is not an option. Our regulators, both in the UK and the EC are addressing these needs in herbal medicines through the new draft Traditional Use Directive, with functional foods in terms of claims, and with the upcoming Food Supplement Directive."

Quality And Efficacy
Long term growth in the market can only be achieved through extensive, high quality research to understand and characterise natural products and to establish irrefutable evidence for the benefits of each individual product type. Alongside this, manufacturers must also provide more certainty to consumers that the products they make do consistently deliver these benefits. Hence, to produce and to monitor a consistently high quality product is the major challenge for manufacturers. "Quality control from seed to factory is vital," adds Bush.

Unfortunately, consistency may be difficult to achieve given that natural variations in environmental conditions, such as climate and soil quality, automatically introduce variations in the amount and balance of the secondary metabolites contained in plants. Cultivated crops may be less subject to such variations, but the processes of harvesting, storage and transport of these plants may still compromise quality unless best practice is applied. Poor drying regimes, for example, may radically change the chemical composition of some botanicals, and pre-shipment samples do not always agree with the final bulk delivery.

"Sometimes it is difficult to be certain that the crop received at the factory is in fact that which the supplier claims to have sent," says Keith Helliwell, from William Ransom & Son "Visual inspection by experienced staff can at least alert to cases of adulteration or substitution, but the challenge for the industry is to develop reliable and meaningful tests for verifying authenticity and for defining standards."

Lab Techniques
In practice, this means developing reliable assays for a range of unique marker compounds associated with any given plant species. This is no easy business given that all plants contain many hundreds of different chemical compounds whose precise function is unknown, and it would be impossible to test them all. Conversely, most herbalists would argue that it is the synergistic effect of all these compounds that confers pharmacological activity on a plant, rather than it being due to a single 'active' working alone, so there is no option to target analyses at a single chemical compound.

Considerable investment in sophisticated analytical equipment and expertise is therefore needed to determine the constituent compounds that can be used reliably in authenticity evaluations. Such investment is beyond the scope of many manufacturers, in which case the only option is to outsource this work.

Several laboratories, including those at RSSL, are already involved in working alongside the herbal and food supplement companies to develop tests that will verify the authenticity and quality of herbal material. However, there is a great deal more work required in this area.

Quality requirements also extend to the laboratories themselves, of course, and manufacturers looking for a partner laboratory to address quality issues should make their choice carefully argues Jacinta Murphy of RSSL. "It's worth checking to see if the laboratory conforms to the requirements of Good Laboratory Practice, whether it has UKAS accreditation and FDA approval, and if it participates in ring trials," she explains. "There are very few universally agreed procedures at present in the herbals field. Nonetheless, an analytical procedure to verify the quality or authenticity of a natural product is only of any value if the test itself is performed to the highest standards by experienced and expert scientists."

Keith Helliwell's contention is that quality should be 'built in' to herbal products all the way from cultivation or harvesting to the packaging of the product for the consumer. According to Mike Buchanan of UK food retailer, Marks and Spencer, the same criterion should also be applied to functional foods.

A New Food Range
Marks and Spencer recently launched a range of new functional foods under the '... & More' brand. The launch followed a three year research and development programme, during which the company sought to build quality into every aspect of the development of various products, from identifying appropriate ingredients, to claims substantiation and marketing, and of course, in the ultimate taste of the products.

"We set ourselves certain targets before deciding on an appropriate range of functional foods," says Mike Buchanan. "Our aim was to develop a practical and flexible range of products that was easy to incorporate into the customer's lifestyle, at an affordable price. The health benefit had to be proven and easily understood, and the food products had to contain natural ingredients only and be consistent with good dietary habits."

The company focussed its efforts on targeting the UK's high incidence of cardiovascular disease (CVD), and in particular the risk associated with high levels of LDL cholesterol. "We carried out extensive research and found that soy protein stood out from the available clinical evidence as being an ingredient that could lower levels of LDL cholesterol," asserts Buchanan. He points to the epidemiological and clinical evidence that suggest soy protein can reduce the risk of atherosclerosis, as well as more recent research proposing that the isoflavones in soy extracts play a key role in lowering LDL cholesterol.

Having identified soy protein as a useful functional ingredient the company then went to work on developing a range of products that incorporated the ingredient, including cereals, breads and dairy desserts. These products were also supplemented with other ingredients thought to have a beneficial impact on reducing CVD, such as vitamins E and C, selenium and betaine.

The key issues for Marks and Spencer in developing the '... & More' range, which the company believes to be the first functional food range of products, were to protect its brand values, to research and substantiate its claims, and to get the right clinical and medical skills to assist it. "We spent a lot of time and effort in doing the work to support the range, and to ensure that all the products met our claims in terms of taste, shelf-life, and health benefits. It was also necessary to ensure that the product met customer expectations in terms of packaging, ease of use and price."

Marks and Spencer's ability to build quality into its '... & More' range relied largely on the availability of good clinical research to support its claims. The need for more research is clearly a major issue that needs to be addressed in any attempt to drive the market forward for herbals and food supplements. Having said that, even the best evidence would be worthless if it proves impossible to formulate a stable herbal medicine, or to incorporate a given ingredient as a food supplement.

Food Supplementation
Even in the case of single chemicals with well-characterised roles in maintaining health, such as the vitamins, there can still be problems in using them in food products. Certain vitamins are often degraded during processing or storage, and the same is true of other active ingredients. This is another role for the analytical laboratory; to test the stability of products to ensure that they continue to deliver the required performance up to the end of their shelf-life.

"Supplementing foods with vitamins and minerals, or incorporating new ingredients of any kind requires considerable skill and expertise," says Jacinta Murphy. "It is not just a case of adding the ingredient at the start of the process, because it may not be there in any meaningful quantity by the time the consumers come to use the product." Where a legal label claim is to be made, as in the case of vitamin supplementation, analysis is therefore a necessity.

Clearly, there are quality issues to address at every stage in the use of natural ingredients, and a failure to address any of these issues could compromise the end product. Good Manufacturing Practice (GMP) and adequate quality systems are required to avoid potential problems. With the raw materials it is important to realise that samples could be substituted, adulterated or contaminated (e.g. with pesticides, dioxins, and aflatoxins). With formulation and processing, one should understand that the active ingredients could introduce unpleasant flavours to a food product and considerable skill may be needed to mask these flavours. It is also necessary to realise that added ingredients may not survive the process, and be sure that labelling claims can be substantiated.

That is not to end on a negative note. Natural products represent a huge potential market, and this will only increase as more research is carried out that confirms the health benefits of these products. Nonetheless the industry must accept that 'Quality' is the watchword that needs to be applied to every area of its activity to ensure that this potential is fully realised.

Graeme Coulam
19 Ashton Place, Kintbury, Hungerford,
Berks, RG17 9XS
Tel: +44 (0)1488 657083
Fax : +44 (0)1488 608147
Email: [email protected]
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