Functional Ingredients Offer Great Promise, but Science is Still Emerging

Strolling the aisles of almost any supermarket today, shoppers are deluged with an ever-increasing number of products utilizing new—often plant-derived—ingredients promising benefits to their health, athletic prowess, waistline and more. Whether a probiotic, a so-called superberry such as açaí, pomegranate or goji, an omega-3 or a dietary fiber, these ingredients are being incorporated into almost every food category and command a premium price.

Despite their skyrocketing popularity, the science behind ingredient functionality—that is, an ingredient’s ability to deliver its claimed health benefit—is still evolving, as are regulatory agencies’ opinions of allowable health claims for these ingredients. This leaves a rapidly growing segment of the food industry in a state of ongoing flux. It also creates a confusing environment for shoppers. At the consumer level, regulations are already puzzling and one would have to be extremely well-informed to decipher the nuances of presently allowable marketing claims for functionality. In the United States, these fall under the categories of Significant Scientific Agreement, Health Claims Based on Authoritative Statements, Qualified Health Claims and Structure/Function Claims.

From the scientific perspective, there are a number of gaps in the current body of knowledge regarding these ingredients. These include the fact that the mechanisms of the claimed health benefit (e.g., “enhances cognitive functions”) are not always well understood; functional properties that occur in-vitro (i.e., in the laboratory) may not translate to an in-vivo effect (i.e., an effect in the human body); there is often a lack of adequate characterization for materials evaluated in efficacy studies; and in most cases there is a lack of generally accepted and validated biomarkers to measure the alleged health benefits properly, making any of such measurements difficult to interpret and almost impossible to compare.

A case in point is probiotics. Fundamental research on the human microbiome (the sum of all microorganisms residing in or on the human body) is rapidly advancing, but there is still much to be learned. At present, the lack of validated biomarkers for digestive and immune health benefits is severely limiting the comparability of research. Research can be further hindered when there is insufficient knowledge around how production processes and individual product and human host factors impact probiotic functionality in-vivo. Given this, how can manufacturers make sure that health claims on probiotic products are scientifically backed and communicated appropriately, so that what is stated on the label is not only accurate but also makes sense to the average consumer?  And how can consumers be sure they are receiving the products they expect? Some of these questions were recently considered at a workshop organized by the U.S. Pharmacopeial Convention (USP)—an independent scientific organization that develops standards to help ensure the identity, quality, purity and overall authenticity of pharmaceutical, food and dietary supplement ingredients.

To continue its mission to further science and standards-setting,  USP is hosting a symposium this September 18-20 in Boston on Functional Foods and Dietary Supplements—Global Opportunities and Challenges. Through this symposium, USP will explore developing public standards via its Food Chemicals Codex (FCC) to help ensure the authenticity of these promising functional ingredients and bring consistency to the marketplace across food ingredient suppliers and manufacturers. The availability of independent standards that would allow all parties to verify the functional properties of ingredients could go a long way in grounding health claims for these promising ingredients in sound science.

For more information on USP’s symposium, visit For more information on USP’s work on food ingredient standards, visit


Markus Lipp, Ph.D., is director of food standards for USP. He has 20 years of experience in food and food ingredient issues, bottled water quality standards, and genetically-modified agricultural products.