| Dr Joseph Lewis |
Regulatory activity and changes are at its peak in India today. While price control, ethical practices are under review, another major change is emerging with dietary supplements and nutraceutical being brought under the purview of the Food Safety and Standards Act 2006 (FSSA). The manner in which these products are going to be looked at from licensing and product approvals to claims rightfully made when marketing these are expected from imminent regulations. Some of the concerns and deliberations that need focus are being explored for consensus.
Like the Act suggests, the focus for these products, are slated for dramatic shifts – the first being safety. If one googles ‘food safety’ today, the FSSA 2006 pops up, to be followed by the Food Safety and Standards Authority of India. No other regulator gets such a prominent position on food safety. The primary object of the Act is to ensure safety of consumers a basic human right. To ensure this right of ‘safety’ for the consumers, all producers, traders and marketers of nutraceutical and dietary supplements have to understand that they are a part of the ‘chain’ starting from the ingredient to the final pack, with all steps in manufacturing, transportation and storage included in the chain. They are all in it together – to put it succinctly.
And this means ‘Quality Assurance’ at every step in the process. While the word ‘quality’ and ‘quality assurance’ is not new to the pharmaceutical industry, the nutraceutical and dietary supplement products are now produced in units having different licensing requirements and ingredients procured from different vendors, who may not understand the requirements of food law. Moreover, nutraceutical ingredients can have variations in quality based on source, which may be a natural extract of variable potency or with contaminants, toxicants gathered along the supply chain. Plant sources bring their own quality issues arising from seasonality, soil conditions, pesticides applied and tested for, extraneous impurities etc. Such issues are new to this sector and need attention. Good manufacturing practices of all players in the chain are to be well documented and verifiable by third parties. A few important issues to be considered are as below.
Traceability
Safety is all about prevention of an adverse event happening. The Food Safety and Standards Authority of India (FSSAI) has its task cut out with the need to lay down a risk framework to manage the chain – a mandate of the Act. In the ultimate analysis – it’s the chain that assures consumers that the nutraceutical/supplement/functional food they consume is safe, of reliable quality and capable of self correction (traceability).
Nutraceuticals are a new food category that has a rather entangled supply chain from ‘plant to pillbox’. This category of foods leaves complex trails. Apart from the wide spectrum of ingredients, multi-component formulations, it is the globalisation of the industry that has turned traceability into a veritable labyrinth. This is further compounded by imports into the country of vitamins and botanicals from obscure sources. Unlike commodity ingredients which are revealing when sensory attributes distort, dietary supplement ingredients do not – deficiencies lie hidden. Good brands owe it to their customers to use standard and well characterised ingredients.
To elaborate, many dietary supplements are multi component systems comprising anywhere from 2-20 ingredients, obtained from a few dozen suppliers. Hardly any processing happens at the final manufacturing end except for formulation, mixing, encapsulation and packing. The product safety profile is dependent on the supplier food safety policy. Special mention may be made regarding metal contaminations that add on to the daily intake. For example, FAQ/WHO considered that it was not acceptable if 30 per cent or more of the acceptable daily intake of a particular heavy metal derived from food or drinking water or both was accounted for by the additional consumption of dietary supplements. This is a food category that may be patronised by vulnerable groups and thus where contaminants are known to pose high risks; these should be set at a level which is As Low As Reasonably Achievable (ALARA).
Further some of these nutrients may find their way into formulations for infants and young children—it is expected that the chain will establish the lowest levels, which are achievable through a strict selection of the raw materials used for the manufacturing of nutrients/supplements for infants and young children. Nutrient suppliers would need to demonstrate up front, their good manufacturing practice, by declaring the maximum limits of metal contaminants or toxins in their product specifications.
Functional foods with enhanced function benefits are another emerging category, which will involve specific nutrients that have proven ‘ingredient—health relationships.’ Ingredient must be sufficiently characterised for risk assessment and manufacturers should ensure that only such ingredients are supplied to them where convincing evidence of safety is demonstrated.
Unlike general foods that are mostly sourced locally, dietary supplement ingredients start in all parts of the world and intersect on their way to the final product. Very few supplements on the market have linear manufacturer- supplier relationships from start to finish. Even a single ingredient can work its way from the original source to final product through a series of mixings, additions, and processes sufficient to make traceability a hopeless pursuit.
Botanical extracts or concentrates are even more ‘traceability challenged’ where even the same name could present different histories of cultivation, geographies, extraction techniques, identity uncertainties and purity issues. Ginseng that is found in many supplement formulations could either be sourced from American ginseng (Panax quinquefolium) or Asian ginseng (Panax ginseng) or Siberian ginseng (Acanthopanax senticosis). They differ in their major chemical constituents and differ in their end benefits. More importantly as an ingredient, their conformance to safety criteria such as microbiological quality, contaminants or heavy metal limits are not yet regulated. Sourcing these plants from several countries could leave pesticide residues that are either illegally present or are at unacceptable limits. How does one establish the integrity of a batch if its botanical extracts are from several cultivations spread around the globe? Further, some supplement manufacturers access materials from brokers who aggregate supplies according to price and availability. Documentation may be inaccessible, unverifiable and traceability a challenge.
In this complex and layered supply chain, dietary supplements and nutraceutical manufacturers are burdened with heightened responsibilities of identifying safe and pure ingredients that they can reliably use in their formulations. A formidable task no doubt, but the need to build safety management systems to overcome this hurdle is a prerequisite for this industry sector.
Reputed brand owners will set up prerequisite systems and obligations on their suppliers and inevitably source from reliable suppliers who can demonstrate verifiable document systems, identity tags, and third party audits. These manufacturers can raise the bar in the market if their product can demonstrate systems of where the plant was grown or harvested, its purity and safety indices—differentiating themselves in the market. Traceability can become a subtle and effective way of gaining consumer trust.
Traceability in India is now an essential business activity under the Food Act which requires FBO’s to provide for traceability systems. For example Section 26 requires that all FBOs engaged at all stages of production, processing, import, distribution and sale shall ensure that foods (including nutraceuticals and dietary supplements) satisfy the requirements of food law within the businesses under their control. This provision covers the entire chain including transporters and storage operators and is in accordance of the classical liability rules. These legal provisions require each FBO in the chain to verify that the ingredient he is receiving is safe and in compliance with the requirements of the Act. There is also another side to it—building confidence in products.
Reliability
For decades, the food/ supplement manufacturing industries were concerned with their own Quality Control System without much control on suppliers or other members in the supply chain before HACCP was developed. Most HACCP activity appeared to focus around the processing site where the product was ‘assembled or processed’ for the marketplace. However with emergent categories like dietary supplements and nutraceuticals, it is now likely that HACCP may be focused around the suppliers ‘product’ and less on the ultimate manufacturer to market. When you think ‘chain’ – you see the weakest or the strongest link and where risks and safety lie.
Consumers today are living in anxious times often believing that products bought are safe to consume, and hence ‘Reliable’. There are hardly any marks that help them identify these products with Quality. When outbreaks and recalls occur they understandably panic and refuse to buy any item associated with it. Everyone in the chain suffers – producer to consumer – good reason to shift to a new concept in safety – fellowship of the chain.