Quality Management of Nutraceuticals: Intelligent Product-Delivery Systems and Safety through Traceability

Transcription

1 Chapter 1 Quality Management of Nutraceuticals: Intelligent Product-Delivery Systems and Safety through Traceability Downloaded via on October 7, 2018 at 15:05:10 (UTC). See for options on how to legitimately share published articles. Paul A. Lachance and Raymond G. Saba Department of Food Science, Rutgers, The State University of New Jersey, 65 Dudley Road, New Brunswick, NJ Nutraceuticals are naturally derived, bioactive (usually phytochemical) compounds that have health benefits. The nutraceutical consumer product may be delivered as a dietary supplement and/or as a functional food. Functional food products, either naturally occurring or fortified, containing nutraceuticals must be managed to assure quality from "farm gate to plate." Assurance of nutraceutical quality requires a systems approach, commencing with the optimization of the agriceutical crop. Intelligent product-delivery systems philosophy requires identity of the crop botanically, with farm site identification (via Global Positioning Systems), biodata records, agronomic practice records (Good Agricultural Practices). Phytochemical fingerprinting data requires analyses and tracking of the bioactive nutraceutical components and/or biomarkers. This knowledge requires the development of rapid assay methods and tools to assure real time compliance and standardization with documentation and monitoring for changes during handling, harvesting, processing and production (manufacture into product). Rapid assays can also be used to assure microbiological and chemical safety throughout the shelf-life of the product. Issues currently American Chemical Society

2 3 limiting full quality management need to be established and implemented before out-dated approaches become policy by default. The passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) stimulated a number of larger purveyors of vitamin/mineral supplements to enter or increase their market presence in the field of herbals. Partnerships and acquisitions occurred as the market mushroomed and shifted from primary presence in health food stores to expanded presence in pharmacies and discount stores. It took a while to fill-up the pipeline into the medicine cabinets of consumers who purchased these natural remedies with structure function claims! The U. S. market for dietary supplements moved from 8 Billion dollars in 1993 to 14 Billion dollars in However, the market flattened or "has gone South." Consumer confidence in dietary supplements is eroding and the number of critics is increasing and they are gaining media attention. One of the major criticisms is that the products are of questionable quality, especially since pre-market safety testing and FDA preapproval are not required, and thus value to the consumer becomes an issue. Further the consumer is becoming more educated in this area and is wary of the offering of products, purportedly "standardized" to provide specific quantities of a biomarker and associated with certain functional expectancies, but delivered in widely different market forms under the same product name. The Council for Responsible Nutrition (CRN) believes the industry must address these and related concerns by a proactive, coordinated and cohesive plan that (a) establishes a credible mechanism to ensure safety and quality of all dietary supplements; (b) places all product value information and claims on sound science; (c) implements the educational component of DSHEA with consumer and professional programs; and (d) expands the science base with new and collaborative research efforts. This symposium, aimed at adding new science to the monitoring of quality, offers an opportunity to introduce the value of the application of intelligent product-delivery systems to ensure and sustain quality. Definitions NUTRACEUTICALS are naturally-derived, bioactive (usually phytochemical) compounds that have health promoting, disease preventing or medicinal properties. Nutraceutical compounds or substances can be delivered in the form of food (functional food) or as a dietary supplement, or in both forms (1-3).

3 4 QUALITY (of a product) is a measure of how closely the attributes of the product compare to established standards (however the standards may be emerging and therefore can be periodically upgraded). Product quality is measured, in hard terms, by the data that support the product attributes. As shown in Figure 1, the overall and final value of the product needs the input of safety and stability, etc. to assure product efficacy and therefore product quality. However the quality of a complex product hinges on the quality of each ingredient and, their formulation, and it is limited by the lowest quality provided by the supplier(s), and therefore the need for supplier quality management at the earliest source level. Therefore, QUALITY MANAGEMENT of a product requires an integrated set of procedures or practices, as to specific description, agronomic or equivalent practices, harvesting techniques, holding and manufacturing procedures, etc, that are developed and implemented for the purpose of assuring a level of product quality (efficacy, stability and safety). QUALITY MANAGEMENT is needed. Defining a product in terms of consistent quality is the basis for establishing final product value. Generating reliable scientific data is a must but the data must be based upon sustaining the assurances of safety and efficacy throughout the stages involved in the source and stages in the progress to the final product and thus product value. The conduct of clinical trials on poorly defined complex botanical materials provides highly questionable data. Issues which drive the demand for a quality management mechanism are public, technological and financial. The public issues are issues such as (a) the increased global sourcing of nutraceutical/botanical/food/ingredients; (b) the increased health concerns of baby boomers; (c) the increase in government funding of safety concerns. The technological issues are: (a) Memory capacity and miniaturization, information sharing systems, (b) "smart" devices (information gathering/sharing), (c) dynamic (read/write) mediums, (c) Internet capabilities, (etc). The financial issues relate to marketing "narcissism" and the desire of rapid return on investment with minimal costs for implementing and maintaining quality management. The challenges pertain to (a) available technology; (b) the benefits to the industry of standardization; (c) decisions concerning quantitative research needs; (d) regulatory "paranoia", (e) education variability; (f) claims compliance; Incorporating traceability makes possible the standardization of product quality and value. Intelligent Product-Delivery Systems IPDS is a program (4-5) that uses information technology to deliver greater product value throughout the resource/product supply chain.

4 5 Why is Quality Management needed? Product Value z I Product Efficacy - j 1 Stability, Safety, ctc7 Product Quality Product Standard r Ingredient Quality i i. f Supplier Quality Management Figure 1. A quality management infrastructure is needed to assure product value. Traceability permits and assures a degree of scientific underpinning vital in this era of global sourcing. Standardization to date has been primarily based upon botanical and biomarker information with little reference to the precise source and conditions at that source and throughout the "travel" of the article of trade. The significant quality attributes assuring safety (microbiological, chemical and physical), as well as quality assuring efficacy of the product (or its constituents) can be optimized by a resource traceability system (RTS) as part of an Intelligent Product-Delivery System (IPDS). With such systems in place from field (farm gate) to plate and consumer disposal, the purveyor provides extensive accountability and substantially increases the probability that the product will be in compliance with preset standards. Further, if a recall becomes necessary, it can be rapidly and effectively executed. "Accidents" are thwarted, and death, as a negative variable, is avoided. As shown in Figure 2, IPDS provides product tracking and therefore traceability by gathering information (I.D. tags in the form of chips, sensors, bar codes, portable data files, etc.) from source to disposal. Between agriculture and consumption, IPDS makes possible rapid traceability through I.D. tags with portable data and tabulation of related information describing the origin, harvest and history of the product.

5 6 Food Traceability: Information links through I.D. tags (portable data files, intelligent bar codes, etc.) for rapid traceability of food in both directions between agricultural source and consumption. Agricultural Info III (1) à ^ {Added Info.} Raw Ingredients Info., e.g., HACCP Mill (2) {Added Info.} Mfg'd. Food Info., e.g., HACCP mini (3) {Added Info.} Distributed Food lllllllll (4) {Added Info.} Consumer Food Info. minimi (5) Figure 2. Food traceability information linkages in an Intelligent Product- Delivery System.

6 7 As shown in Table I, to assure quality in terms of both safety and efficacy, a series of key standards for resource traceability are needed: Table I. Standardization Needs of a Quality Management Plan. QUALITY MANAGEMENT (a) (b) (c) (d) (e) (f) TO ASSURE SAFETY & QUALITY, STANDARDIZATION MUST BE ESTABLISHED: Materials defined by Latin name (or) chemical entity w/cas# or chemical source/synthesis location GIS descriptors of plant material Sample verification of plant material by systematic botanist or chemical certification Certification of below tolerance levels of: organics (e.g., pesticide residues) heavy metals (e.g., lead, mercury) microbiological pathogens, etc. If known, content of bioactive(s)/biomarker(s) Documentation of GMP; institution of HACCP and monitoring of FDA database for adverse effects First, the material (e.g., plant) must be defined by the Latin descriptor (or) the chemical entity defined in Chemical Abstract System nomenclature. Secondly, a descriptor of the place of origin (e.g., field, or a manufacturer's facility for a synthesized entity) must be provided. For a plant material, use of a Global Information System (GIS), as shown in Figure 3, provides the latitude and longitude map of the field in which the plant cultivar was seeded, cultivated or harvested. The GIS information can now be linked to weather history at this location with identification of the cultivar and data on the applied fertilizers, pesticides, etc. Thirdly, it is imperative that a sample of the plant material be verified botanically or that the chemical entity commodity be certified. Fourthly, certification must exist that the parameters that assure biochemical and microbiological safety are below national/international tolerance levels. This applies to relevant microbiological pathogens, heavy metals and organic chemical residues (e.g., pesticides). Bio and chemical assays are under development permitting rapid and repeated monitoring for safety and efficacy. Fifthly, if known, the bioactive and /or biomarker content and concentration can be recorded.

7 8 Fifthly, if known, the bioactive and /or biomarker content and concentration can be recorded. Lastly, there must be documentation of Good Manufacturing Practices (GMP), compliance with the principles of Hazard Analysis and Critical Control Points (HACCP) and linkage to FDA, or similar international databases, for monitoring adverse effects that may be reported. Figure 3. A global Information System (GIS) representation of an agriceutical crop. Fields are represented by polygons delimited by black lines. Fields of the same shade are planted with the same cultivar. Information can be linked to different farms, fields within farms, or even to regions within fields. Growers apply pesticides and fertilizers on a field-by-field basis and this information is easily mapped. In a GIS map each point (pixel) (1,2,3 and 4) has an accurate location (latitude & longitude) reference (6). The coordinate system used is UTMNAD 83. In this model of Quality Management, IPDS/RTS reveals and documents: Agricultural data Raw ingredient data Manufacturing data Distribution data

8 9 In summary, the state-of-the-art of the emerging nutraceuticals industry requires an emphasis on novel approaches to quality management. IPDS, with RTS, provides a unique and dynamic approach that can help to deliver the promise that nutraceuticals can provide: major reductions in the pathogenesis of chronic disease and in the associated costs of health care; and thus, a better quality of life. Acknowledgement A contribution of the Nurtraceuticals Institute, a joint program of the New Jersey Agricultural Experiment Station, Rutgers University, and the Center for Food Marketing, St. Joseph's University. References 1. Guhr, G.; Lachance, P. A. In Nutraceuticals: Designer Foods III Garlic, Soy and Licorice; Lachance, P. Α., Ed.; Food & Nutrition Press, Inc.: Trumbull, CT, 1997, pp Dillard, C. J.; German, J. B. J. Sci. Food Agric. 2000, 80: Essentials of Functional Foods; Schmidl, M. K.; Labuza, T. P., Eds.; Aspen Publishers, Inc.: Gaithersburg, MD, 2000; pp Yam, K. L.; Saba, R. G., Packaging Technology & Engineering, 1998, 7 (3), pp Yam, K. L.; Saba, R. G.; Lachance, P. Α.; Delprat, J., U.S. Patent Application 09/099,862, Oudeman, P. Rutgers University, personal communication.