Introduction

The current surge of research effort in algal cultivation is centered on the push towards large scale production of biofuels. This will require extensive land, innovative processing techniques and perhaps unique strains of algae. However, the cost of current fossil fuels is still low enough to make it difficult for such new production operations to be economically successful producing for fuel products alone. Alternative products have helped move algal biotechnology ahead before, and may yet again provide revenue in the short term while the more expansive goal of affordable energy production is approached.

Beginning in the 1950s large scale algal production was directed to wastewater treatment systems (Chapman and Gellenbeck 1989). Here, the basic goal was to produce oxygen that would support microbial metabolism to break down organic matter along with the uptake of released nutrients, notably nitrogen and phosphorus. Those same systems were then modified to commercially produce some of the most successful algal products to date. In the area of nutraceutical products (algal extracts and powders used for human nutritional supplementation) there have been many examples. The production of beta-carotene from Dunaliella in open raceway ponds was made possible by the organism’s ability to withstand extremely high salinity conditions which limits competition. Today the output of this natural product on a pure basis is valued around US$1,500 kg−1. Beta-carotene’s function as a non-toxic Vitamin A precursor has made it a mainstay in multivitamin and specialty formulations. The freshwater alga Haematococcus which has been more challenging to culture in open systems without the protection of salinity produces another carotenoid, astaxanthin. This pigment has found extensive use in fish aquaculture (e.g., the red coloration of salmon) as well as innovative anti-inflammatory and antioxidant applications in human nutrition. It is currently valued around US$10–12,000 kg−1 though improvements in cultivations techniques show promise in reducing this cost.

Other microalgae find use with less extraction/processing and find application mostly as a dried powder. Spirulina (Gershwin and Belay 2008) has been a mainstay in nutritional products for many years with the dried biomass valued at about US$15–50 kg−1, depending on a variety of production and market driven variables. Lipid can be more complex. The lipids of Nannochloropsis have already found use in cosmeceutical and skin care applications and efforts are underway to move into nutrition applications. The more specific components of some algae known as omega-3 fatty acids are very important in products directed at maintaining heart health. Their value in an extracted and purified form, around US$260 L−1, provides an illuminating comparison to biofuels valued at around US$1 L−1. This type of lipid based product is perhaps the most direct path for biofuel production systems to provide biomass, either directly or as a side stream, which could be processed for nutraceutical applications.

In addition, seaweed species have been utilized for both nutraceutical and cosmeceutical applications. The majority of these have been from wild harvests such as Ascophyllum, Fucus, Laminaria and Macrocystis that are used as dried powders, suspensions or simple extracts. Controlled plantings on ropes or other substrates have helped improve the harvests of other species such as Porphyra and Ulva. Onshore cultivation of seaweed species in tank and pond systems with species such as Chondrus has resulted in many additional product applications.

Can today’s further development of culture systems turn out biomass acceptable for additional novel nutraceutical and cosmeceutical applications in the same way as these past efforts? Most assuredly the answer is yes. However, there are many considerations in creating an acceptable natural raw material to be used for human applications, and consideration must be given to the many facets of support and information needed by consumer product companies to bring a new ingredient into their product line. “New” in this case can simply be a new supplier of a currently existing raw material, a material new to that company that is already used by others, or a completely novel ingredient.

Efficacy

The most basic question to be considered for a new ingredient is efficacy—does it achieve its intended function in the human body? Though it may have been acceptable in the past for a plant based raw material to be included in a commercial nutrition or skin care product based on an exotic sounding name or origin, today’s formulators seek concrete evidence of the functional activity of an ingredient. This support can come from many different types of investigation, all of which are more compelling when published in reputable, peer reviewed journals. Supporting data can come from chemical comparisons and analysis, chemical activities (e.g., ORAC or oxygen radical absorbance capacity), in vitro bioassays, genomic/gene expression studies, testing in animal models, and most compelling of all, human clinical testing. An example can be found in the development of Haematococcus as a source of astaxanthin (Guerin et al. 2003). Known as a pigment with demonstrable antioxidant activities, further research has expanded to provide mechanistic and clinical support of skin health, immune function, joint health and cardiovascular function. This linkage of demonstrated function to an underlying mechanism of action is a powerful combination supporting product development.

Sourcing

Understanding the ultimate source of a raw material has always been important to companies, but recent changes in the regulatory environment have increased the need for a thorough understanding of the supply chain and the nature of growth and production. A basic need is botanical identification, verification of the genus and species and at times, variety, of the source feedstock. This can be difficult once the material is processed and may need to be verified by inspections of process intermediates at the source facility. Methods to eliminate or minimize contamination of cultures and harvests are needed to prevent dilution of the intended crop with invading species. Consistency is also imperative. Once a material is launched into a market, the raw material supply must be maintained. If the supply is interrupted and a product is not available to consumers for even a short period of time, sales will frequently not recover when supplies are once again available.

Environmental concerns have a high profile in consumer’s minds in almost all product areas. The key attribute is environmental sustainability. Does the culture operation exist in harmony with its environment? Water quality is most relevant to aquatic operations. Does the system rely on local water supplies and are outflows from the cultures contained or treated before returning to the local water basins? In any land-based phases of the production operation all the same concerns of resource utilization and waste production need to be addressed as with any non-aquatic operation. Algae have basic “green” attributes that make them attractive for development. Operators have the chance to take advantage of this reputation in the marketing of their product and even enhance it through their action in all phases of what they do.

Ethics are also part of the supply equation. Consumer product companies are looking at how supplier organizations are structured and how workers are treated. Humane working conditions, lack of child labor, and healthcare considerations are often verified during inspections.

Consumers are making it clear that they must monitor their entire supply chain to assure that these ethical and environmental imperatives are considered. The final product companies cannot afford to have “issues” uncovered by any regulatory or media that reflect any negative image. If something does arise, ignorance of the situation is not an acceptable defense so many questions are asked ahead of time.

Quality assurance

There are a wide variety of quality concerns for any component in a consumer product. Together, these are delineated in specifications listed by both the supplier and the buyer. These must be compatible so that testing at both ends confirms a quality product. No matter what the measurement, alignment of the methods used to measure each specification between laboratories is imperative. Use of compendium methods (USP and European Pharmacopoeia) simplifies the process and provides the results of an extensive validation process. At any point in the process, the involvement of a neutral third party laboratory can solidify results and overcome differences. Table 1 provides detail on the major quality categories that need to be considered.

Table 1 Quality categories for nutraceutical ingredients
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Regulatory requirements

Most companies market products in more than one country, and large ones can produce for as many as 70 or more countries. Each country can have a specific set of regulations that a product must adhere to. These rules apply to the completed consumer product, but since compliance follows from the attributes of the component ingredients, the more widely approved the ingredient, the more desirable it is to formulators. The ideal situation is for the ingredient supplier to complete clearance through the target country’s regulatory agency prior to its inclusion in formulas. If this has not been completed a joint effort between the supplier and product manufacturer will be required to achieve market approval. In either case, a substantial amount of information about the ingredients needs to be exchanged to support the registration of a product in a given country or region. Table 2 provides a summary of the various regulatory areas that require verification. Attempts have been made to standardize the form of all this information, but none have been completely successful. On-line input of information from suppliers to product producers is becoming more common. Having all the information available quickly and easily can speed the acceptance and inclusion of a new material.

Table 2 Regulatory information requirements
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It is not possible in this brief account to cover the myriad of regulatory bodies and laws covering nutraceutical and cosmeceutical products worldwide, but the major guiding documents for the United States and Canada provide a start to the field. For nutraceutical products DSHEA, the Dietary Supplement Health and Education Act of 1994, administered by the US Food and Drug Administration (FDA 2011a) and Natural Health Products Regulations (Health Canada 2011) provide the regulatory framework for products in those markets. Both rely heavily on previous use of a material in the marketplace. For completely new materials the NDI, New Dietary Ingredient Guidelines, are the controlling regulations in the US. This document is currently being revised by the US Food and Drug Administration and comments are being taken from industry (FDA 2011b). Any new ingredients being brought to market in the current climate should be reviewed in light of these revisions. For cosmeceuticals there is a different regulatory environment, less restrictive than dietary supplements in most cases, but more restrictive in others. The major controlling regulations for the US are under the Food, Drug, and Cosmetic Act (FDA 2009) and the Fair Packaging and Labeling Act (Federal Trade Commission 2011). The registered names for acceptable ingredients are found in the INCI, International Nomenclature of Cosmetic Ingredients, allocated by the American Cosmetic Association (Personal Care Products 2010). The INCI lists materials that can be used in cosmetics and how they must be referred to on the labels. Petitions need to be made for any new ingredients to be added to the list. Overall, the regulatory arena has substantial complexity and it is recommended that experts in the area be consulted for specific applications.

Procurement/purchasing

The culmination of all this information exchange is the actual purchase of the raw material for product inclusion. Once again there is more complexity than there initially appears. The first consideration is supply. Is there enough of the raw material available, and in reserve, to meet the product producer’s needs on an on-going basis? Sales forecasts can be inaccurate due to a new product’s success. Inability to make sufficient product due to lack of supply can doom a new product launch as mentioned earlier.

In the global climate, material frequently needs to cross international borders. This can be difficult where plant materials are concerned. A supplier must have the capability to deal with shippers and Customs clearance issues. In addition, basic customer relations issues of on-time delivery, invoice accuracy and fast response to inquiries smooth the business relationship. And of course, pricing negotiations need to be successfully completed.

Summary

The road to successful inclusion of a new algal derived product in nutraceutical or cosmeceutical consumer products can be long and complex, but the rewards of quality, innovative, high value products can support growing companies and provide a mutually successful partnership between suppliers and manufacturers.