Developing Compendium Standards for Functional Foods

August 28, 2012

Compendium standards could bolster consumer faith in functional food claims.

Antioxidants. Probiotics. Omega-3s. These terms are familiar to many consumers today, particularly shoppers seeking foods with functional ingredients offering added health benefits. The future of the functional foods market is bright. In 2010, functional foods represented a $24 billion global market, according to Leatherhead Food Research. New products are introduced on a seemingly daily basis. Today, a consumer can seek out a food product for just about any health benefit, whether it is enhanced cognitive ability, improved bone health, increased energy, lower cholesterol-the list is seemingly endless.

But as functional food health claims meet increasing scrutiny, both domestically and abroad, how can the functional food industry further build customer confidence in claims? What can be done to preserve the longevity of the functional food market for years to come?                      


Identifying Ingredients

The integrity of the functional food industry rests on whether products provide the health benefits promised. Ensuring that a product delivers the health benefits promised in turn requires ensuring that a product contains the ingredients it is supposed to-that is, the ingredients for which science supports a benefit. Thus, being able to properly test for and identify ingredients in a functional food is crucial.

Enzymes are a good example of an ingredient for which proper identification is key to determining product performance. An enzyme is always characterized by its activity-i.e., by its function and how well or rapidly that function is performed-rather than by the simple concentration/amount of ingredient in a product alone. Testing enzyme activity rather than concentration is also crucial because enzymes are proteins for which the intact three-dimensional structure is often a prerequisite to their function. This structure, however, can be easily destroyed by heat or other factors common to food manufacturing. Thus, methods to test for enzyme activity, rather than simply concentration, must be in place to ensure an enzyme product still has its expected effect.

Another good example is probiotics. Given the intricacies associated with probiotics as live microorganisms, how can manufacturers ensure that the ingredient that ends up in their final product is the right probiotic strain and has survived harsh processing conditions and conditions in the body to do what it’s supposed to?


The Case for Standards

Independent public standards may play a valuable role in the effort to properly identify ingredients in functional foods.

In assessing the need for standards, one cautionary tale is that of antioxidants. On the surface, many products on the market may tout so-called “antioxidant capacity” to consumers. However, digging deeper, there are multiple, competing methods for measuring antioxidant capacity. These methods differ in their approaches, and as such, they deliver results that cannot be compared “apples to apples.” (This is aside from the industry debate antioxidants face on how to correlate in vitro testing results with any in vivo effects.) In light of these complexities, how are consumers and marketers to make sense of various antioxidant claims and evaluate and compare products? Today, antioxidant capacity is an almost meaningless number absent industry consensus on how to measure this capacity and other factors.

To avoid a similar scenario for the next generation of promising functional food ingredients, independent public standards may help unify methods for quantifying the claimed property of a food ingredient.

The Food Chemicals Codex (FCC), published by the U.S. Pharmacopeial Convention (USP), is a compendium of internationally recognized standards designating the identity, quality, and purity of more than 1,100 food ingredients. Any food ingredient legally marketed anywhere in the world is eligible to be added to the compendium. In addition to ingredient specifications, the FCC provides test methods suitable for the verification of these standards, and physical reference standards that allow parties to verify the appropriate execution of the test method. FCC standards can serve as an indispensible resource to manufacturers, regulators, and others. To meet the unique needs of functional ingredients, some modifications to current standards-setting approaches may be necessary.

For the functional ingredients of today and the future, FCC monographs could be used as a way to ensure that the composition of an ingredient (identity, quality, and purity) is equivalent to that demonstrated to exert a health benefit. This could encompass quantifying a single chemical linked to a health benefit, or measuring the similarity of a chemical “fingerprint” of a complex mixture to that linked to a health benefit, among other approaches.


Critical Juncture

With regulators expressing increased skepticism about health claims, functional food ingredients may be at a critical junction. Standards are needed to demonstrate and measure ingredient identity and efficacy of functional foods, and to link health benefits to defensible science. In addition, good standards could help provide a scientific basis for these claims and create a level playing field among industry and instill consumer confidence. With no one tackling this issue on an international level, USP may be able to help fill a void.

USP will interactively address this cutting-edge topic of developing public standards for functional foods and their ingredients at a symposium, Functional Foods and Dietary Supplements-Global Opportunities and Challenges, on September 18-20, 2012, in Boston. (For more information on USP’s upcoming symposium on functional ingredients, visit

Functional ingredients define the future of the food, beverage, and dietary supplement industries in many ways, but achieving some degree of agreement on the science related to such ingredients is critical to preserve their reputation and integrity. Increased clarity would benefit all.