Coughs, sniffles, sneezes, these annoyances are all too common during the fall and winter months when cold and flu season hits.  In any given year, 5-20% of the U.S. population suffers from the flu, according to the Centers for Disease Control and Prevention (CDC).  That is equivalent to approximately 15 to 63 million people, with about 200,000 requiring hospitalization.  On top of that, about one billion colds occur annually.  With these statistics and the fear of other contagious diseases, consumers have become more and more interested in ways to strengthen their immune systems.

The immune system is one of the most complex in the body.  As such, scientists continue to investigate ways to enhance immunity in warding off disease.  Pharmaceutical, dietary supplement and food ingredient companies are engaged in identifying and evaluating various substances for their ability to boost the immune system. This effort could result in a potential “blur” of the lines of distinction between a food ingredient or dietary supplement versus a drug, keeping in mind that the FD&C Act defines drugs, in part, by their intended use as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)].  Together with other selection criteria, this definition is critical to the ability of food scientists to develop food or beverage products which make a claim for immune support.

This article outlines six criteria for consideration when selecting ingredients that provide immune support.  Concluding the article is a list of a few ingredients that may be used to practice applying the criteria.

1.  Clinical Efficacy

The foundation for any product claim concerning health and wellness rests on positive results from well-designed clinical studies.  Whether the claim will be on-pack, in a brochure or on a website, clinical substantiation is the only way to ensure that the claim meets all requirements set forth by the FDA for on-pack labeling and websites and the FTC for advertisement. 

Many ingredient companies conduct clinical trials on ingredients marketed for their health and wellness benefits.  The challenge faced by food scientists and marketers, alike, is to fully understand the clinical study design and the validity of the ultimate conclusion of the study.  This evaluation is critical to minimizing risks associated with product claims.

Working with the supplier to obtain copies of clinical studies for review and having the results reviewed by a competent authority will go a long way in reducing risks and maintaining brand equity.

2.  Analytical Determination

There is plenty of negative media coverage of products claiming to contain a particular active ingredient, such as an herb or extract, only to find that the component is completely absent or found at levels well beyond what is stated on the label.  To avoid such scenario, it is imperative that a well-established analytical method be used to detect the presence of the active ingredient.  Ideally, the method should have the approval of an accrediting body, such as AACC or AOAC.

3.  Regulatory Status

Many ingredients that have purported health and wellness benefits are found in dietary supplements.  The Dietary Supplement Health and Education Act (DSHEA) sets the requirements for labeling of dietary supplements.  Ingredients permitted in dietary supplements may not necessarily be permitted in products marketed and sold as foods or beverages.  If the active ingredient is going into a food or beverage product, it must have GRAS status, and the supplier should be able to clearly demonstrate proof of that.

4.  Physical Attributes and Organoleptic Properties

Imagine trying to formulate a beverage with an immune-enhancing ingredient only to find that it is not soluble at the level required for efficacy or, worse yet, that it imparts an unacceptable, stubbornly persistent bitter note when added to a fruit smoothie.  Before committing to adding any immune-enhancing ingredient to a product, be sure to determine the impact the ingredient may have on the formulation, processing and the product’s organoleptic properties. Although obvious as this selection criterion may sound, ignoring these effects could mean many stressful hours of corrective action, which would only hamper the all-too- common shortened development timeline.

5.  Shelflife

Product shelflife may be another source of surprise when dealing with ingredients that impart health and wellness benefits.  Often, food scientists will assume that the added ingredient is stable over time and does not interact with other ingredients as the product ages.  Although it is important that the active ingredient be included in the product at the label-stated level, it is just as critical that the ingredient retain its biological activity during its shelf life.

To prevent undesirable surprises, shelflife testing should include both design elements for monitoring organoleptic properties and an assessment of biological activity.

6.  Cost vs. Benefit

Ultimately, the selection of any ingredient providing a health benefit comes down to cost and the benefit imparted by that ingredient.  Many times, cost can be a show-stopper to including an ingredient.  For that reason, a cost-benefit analysis should be undertaken at the beginning of the ingredient selection process rather than after development has begun.

Food scientists have quite an array of ingredients to choose from when making claims associated with immune health.  Most of these ingredients reside in the broad categories of prebiotics, probiotics, yeast derivatives, vitamins and minerals, and botanicals.  The selection criteria listed above should help in identifying the ingredient best suited for a given product application.