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Traceability: What’s the Point?

by NaturPro in Quality Comments: 12

Traceability is an industry buzzword, quality issue and regulatory requirement for products intended for human consumption, with the latest focus fueled by adulteration of baby formula with melamine in 2008 and the subsequent signing of the Food Safety Modernization Act (FSMA). Quality issues that can be solved by traceability systems date back at least 2,000 years ago, when Dioscorides developed methods to differentiate Balsamodendron (balsam), Commiphora (myrrh) and Boswellia (frankincense) gum resins. Likely due to early traceability and quality systems, the Magi were able to differentiate among these valuable materials with similar visual and sensory attributes:

Balthazar: Melchior, you say this material is frankincense, but how do you know for sure?

Melchior: This material has met the basic quality requirements of our time: it is easily flammable, with clear smoke and pleasant, characteristic fragrance. Also, my supplier harvested it from his Boswellia tree just this morning. This information is written on parchment with his signature.

Balthazar: Your argument is convincing, and you have established adequate traceability. Let us approve this material fit for its intended purpose.

Today, there is no definition or standard for traceability. Traceability systems are intended to track the flow of materials through the supply chain, and are mainly made of documentation and the supporting legwork done to create and verify the documents. The ISO 9000:2000 guidelines define traceability as the “ability to trace the history, application or location of that which is under consideration.” For some food systems, traceability is maintained back to the farm or even the seed, while in others it is maintained back to a point in a manufacturing process intended to control a key quality attribute—microbial load, for example.

Traceability requirements depend on the type of product and the regulations of various countries. In Europe, documentation is required to identify suppliers of ingredients of foods. In the United States, FSMA requires the country of origin to be labeled. However, for the U.S. dietary supplement industry, ingredient traceability systems at reputable firms go beyond country of origin, requiring the name and address of ingredient manufacturing facilities, and product quality and traceability information that in many cases requires a chain of custody back to the farm.

In general, the requirements for traceability in the industry differ widely, depending on the type of product and market demands. For example, a small volume of conventional chamomile tea made only from dried chamomile flowers sourced from a single farm and sold at a single local market can have a very simple (yet effective) traceability system: “I know the farmer who grew and dried these flowers.”

On the other hand, coffee that is mass-marketed in high volumes for attributes like shade-grown and fair-trade will require a relatively complex and resource-intensive system, particularly as higher volumes are demanded. This is because of the multiple steps in the supply chain and the fact that many coffee farms are small—so a large number of farmers need to be supervised and documented, which can be a costly endeavor. However, coffee that is labeled simply as Arabica need not have any traceability other than that required to maintain product quality and safety.

Even within a traceability system, there are different strengths of the supporting documentation. Statements from the raw material buyer that a fair price was paid to the harvesters serves as one layer of support, but solid verification of this claim may require an in-person audit of the system and periodic visits with the individual farmers and harvesters. How far does a brand want to go?

Ultimately, “full traceability” is difficult to achieve for agricultural products (until we can figure out a way to bar code each individual plant). So, the objectives and costs of an adequate traceability system depends on the nature of the product and market demands. Three main objectives for traceability systems include:

1. To effectively manage the supply chain: Supply chain management aims to determine the most efficient way to produce and procure products. Documentation of the products throughout the cycle from start to finish is key to understanding how they are made and how much they should cost.

2. To support marketing claims: Today’s discerning consumer demands many attributes from their products, which they are not able to taste or otherwise perceive in the product. For example, dolphin-safe tuna can only be verified through the supporting documentation; no analytical test is available to test that the tuna is dolphin safe.

3. To provide information for quality assurance systems or food safety investigations: When product quality issues occur, traceability documents are integral to track back to the root cause of the issue and correct it.

In the world of botanical ingredients, traceability may extend all the way to the farm, while for agro- or petrochemicals, it may extend back to the manufacturing level. Regardless of the level to which a material is traced, one of the key requirements for any system is based on the concept of segregation, which for the purpose of determining GMO (genetically modified organism) status is known as identity preservation. In proper systems, materials have discrete lot number and sizes, and are kept physically separate from other materials or inputs.

In determining lot size, there is a balance that takes into account the level of “precision” required for a product. Too few lots for a given amount of material, and the amount of material may be too large to control and keep consistent; too many lots require legwork and testing that may be too costly. Ultimately, the customer sets the expectation for traceability and will value (and pay for) the benefits and peace of mind that it can offer.

By: Blake Ebersole

This article was originally published in Natural Products Insider in November 2014

How To Create Natural Product Intellectual Property


The longtime policy of the US Patent and Trademark Office (USPTO) to prohibit patenting of natural products is controversial because it has strong arguments both for and against. Now, the patentability of natural products has come under new scrutiny recently, as the USPTO recently offered a new guidance document regarding how natural products patent applications should be examined in response to recent Supreme Court decisions addressing the patentability of genes.

Natural Product Supplement Innovation

On one side, the lack of patentability for natural products allows for greater access to natural products in the form of foods and dietary supplements. The flip side is that the significant investments needed to adequately research and develop many natural products into what the medical establishment considers “evidence-based” therapeutic products are not protected without strong patents. The consumer choice could be viewed as either a completely high-quality bottle of plant extract with fantastic clinical research and validation costing hundreds of dollars and available only by prescription—or the model that we have for most natural products today: accessible and generally high quality, but not quite at the level of pharma.

This dichotomy has led to the pharma and supplement/food industries existing, in a sense, on different planets. And since patents are the critical requirement for large R&D investments, natural products often get left in the dust. Although natural product molecules form the underlying structural skeleton for the overwhelming majority of drugs, adding even a seemingly innocuous carbon group to a natural compound creates something that would never be found in nature, and could never be considered a food or supplement—but is fully patentable.

How can we bridge the gap between “evidence-based” therapies and high-quality, accessible products from natural sources? This remains as the billion-dollar question, one whose answer will hopefully be addressed by future innovations resulting from the new patent law.

Botanical Drug Development

According to the new USPTO guidance, patentable inventions based on natural products are those that are “significantly different” from natural products, principles and phenomena.  How to interpret “significantly different” gets very complicated and is outside the scope of this post, but is described in some detail in the guidance. Here are some key examples given:

  • Composition of multiple natural products that leads to a synergistic or unexpected effect.
  • A process to create a composition containing two or more natural products.
  • A process applying an abstract idea (such as a law of nature) to create a new practical application for a natural product.

While the USPTO guidance is still in a public comment period, there are many on the natural products drug discovery side who believe that the new rules will hurt development efforts.  But there are others who believe that the new guidance will force inventors to be truly innovative and apply new technologies and processes to creating natural products, while continuing to allow Americans access to our trusted herbs at a reasonable price.  This onion has yet to be fully peeled, but it will be interesting to see how this story develops due to its potential impact on our access to effective healthcare.

By: Blake Ebersole

This article was originally published in Natural Products Insider in March 2015.