Dietary Supplements and the Food Chemical Codex: A Look at Tomorrow's Standards for Botanicals

The demand for products incorporating pomegranate, açaí, and other plant-derived material shows no signs of slowing down, in large part due to these products’ purported health benefits. That’s indicative of the perceived high (and increasing) value of natural ingredients to consumers.

While the question of what exactly constitutes a “natural” ingredient is hotly debated, for the sake of this article, natural is used as a synonym for plant-derived material. Preserving the quality, purity, and authenticity of these ingredients as they move through complex supply chains is a key factor. Yet, the variability of natural substances and the range of environmental and handling conditions plants are subject to (climate, soil, harvesting, and storage) add a significant level of complexity to any standard-setting effort.

Unfortunately, because of their high demand and limited supply, many of the plant-derived ingredients are vulnerable to economically motivated adulteration, putting both manufacturers and consumers at risk. This is a much more nefarious threat, as it presents hazards that a manufacturer may not have included as part of routine quality-control operations. Let’s not forget that adulteration, illegal and hidden by definition, is performed with the intent to avoid its discovery during routine testing.

At the core of an ingredient’s quality and safety is its identity: is the ingredient in fact what it claims to be? This is a fundamental question that is not asked as frequently as it should be, and much less answered. The Food Chemicals Codex (FCC), published by the U.S. Pharmacopeial Convention (USP), is a compendium of standards to help ensure the authenticity of a food ingredient-defining its identity, quality, and purity. It accommodates standards for food ingredients or additives that are legally authorized for use in food in the United States or internationally, including colorings, flavorings, emulsifiers, nutrients, preservatives, and processing aids.

The importance of verifying that ingredients are of the expected identity and purity cannot be overstated, from both a quality and safety perspective. Ingredients are the building blocks of a finished food product, and a quality problem in a single ingredient will likely compromise the final product. Today’s globalized supply chains, increasing price pressures, and the constant need for innovation using new ingredients, among other factors, all contribute to a perfect breeding ground for adulteration.

Science-based third-party standards can assist the markets and facilitate trade by providing a neutral measure to compare suppliers, as well as providing a common ground for agreements between manufacturer and supplier about expected quality. The FCC provides such written specifications for identity, quality, and purity, and, almost equally important, it also provides test methods suitable for the verification of these standards, and in some cases reference standards that verify the proper execution of the test method.

With quality checks especially critical-and complex-for natural ingredients, plant-derived ingredients are a major focus for future expansion in the FCC. The FCC strives to serve as a resource for manufacturers and buyers of food ingredients, and will thus focus on ingredients of growing interest to manufacturers and consumers. Here are some glimpses of the emerging standards-setting activities for which USP will seek stakeholder input as they reach the proposal and public comment stage:

• Pomegranate Juice-Responding to the voracious consumer appetite for pomegranate products, work is advancing on written and physical reference standards for authentic (guaranteed, unadulterated) pomegranate juice. Written standards comprise both a monograph with quality specifications for pomegranate juice as well as an extensive appendix with a host of possible test methods that will allow testing for an individual adulterant of concern. The appendix will function as a decision tree-including tests to detect the undeclared addition of various sugars, or those of other fruit juices. These tests will employ marker compounds for specific adulterants, as well as other suitable approaches. Adulteration of pomegranate juice continues to be a formidable challenge in the food industry. A public standard with associated reference standards has so far been commercially difficult or unavailable. An FCC standard will fill that gap.

• Spices-Spices can be particularly vulnerable to adulteration, given their (high) expense per quantity. Saffron and vanilla beans are among those that have been targets historically. Paprika powder is still found to be adulterated with Sudan red dyes, a carcinogenic material that is not approved for use in food. Spices are not currently a component of the FCC, but USP is in the early stages of developing such standards, and will seek significant industry engagement in this area.

• Natural Colors-Many factors contribute to the intense interest in natural food colors, including the general trend towards products consumers view as healthier or sustainable, and concerns about the association (whether perceived or real) between synthetic colors and hyperactivity in children. Natural colors have historically presented challenges with stability, but industry has been making important advances. Many natural colors are derived from spices such as paprika and turmeric, and the issues are the same as those with spices noted earlier. USP is in the early stages of expanding work here on a variety of fronts, from developing better identification methods for natural colors to evaluating the need to develop better methods to test for impurities in Caramel, widely used in products such as soft drinks.

In all these categories, straightforward economic adulteration is a major problem and danger to all. Using pomegranate as an example, the addition of apple juice likely does not present a safety concern, though it does cheat customers out of what they expect and pay a premium for. That being said, if a manufacturer doesn’t know apple juice was added to its product, it cannot verify how it was produced and account for potential problems. The finished product will contain undeclared ingredients, which may violate regulatory requirements for labeling. Furthermore, there is a potential safety risk to sensitive portions of the consumer population (e.g., those who are allergic to an undeclared ingredient).

These three areas-and the larger problem of adulteration-are among the case studies to be explored at a November 2011 USP workshop on Adulteration of Food Ingredients and Dietary Supplements, which will look at the prevalence of adulteration in foods and dietary supplements, non-targeted approaches to preventing adulteration, methods of analysis, and the role of compendial standards and industry in grappling with adulteration. More information is available at www.usp.org/meetings/workshops. USP welcomes broad participation as it seeks to evolve compendial approaches to detecting and preventing adulteration.