So much of what is perceived as valuable from a consumption perspective is dependent upon taste. If broccoli and kale tasted like cotton candy and gummy bears, the matter of vegetable consumption would not be topical. The obvious is that sweet things are often more appealing, at least to the typical U.S. consumer.

The flavors industry includes manufacturers of not only flavoring agents designed to replicate different foods but also flavor masking agents designed to counteract specific, less desirable flavor notes. This discussion is not about the science behind these compounds although there is a scientific requirement. Instead, the focus is on the use and acceptability along with the subsequent labeling of these ingredients.

Colors and flavors: Natural vs artificial

Flavors and colors receive special attention within the regulations, which define what constitutes an artificial or natural flavor. The emphasis is on the artificial flavors and their employment. Recent developments in flavor technology include improvements of artificial flavors—if it does not meet the definition of a natural flavor, it is “artificial” regardless of the composition of the material being made up exclusively of natural components—and the expansion of flavor masking agents. All of these have one thing in common: They are all food additives, so there are specific requirements for the use of these items as generally recognized as safe (GRAS) or as a food itself.

Consider that the addition of any substance to a food first requires the assessment of the material itself as to its status and availability for inclusion. The use of the flavor enhancer is governed by these regulations regardless of whether the product is a food or a dietary supplement. This presents specific requirements for the developer of the flavor enhancer or masking agent as well as for the customer to whom the developer ultimately sells the component.

Developer responsibility

Looking first at the responsibilities of the developer, we find the standard material identification and review for suitability. The sequence described here is not ideal but is most often reflective of initial steps in development. Then the determination is made as to what the individual component of the enhancement system is relative to acceptability from among the food itself, GRAS or acceptable direct food additive. Proceeding without these two determinations cannot occur.

In this example, the product being delivered is a combination of individual components that have not been further processed. Adding processing that alters the composition of the output product could result in generation of a separate food additive. Cautionary evaluation of how the masking agent is produced, if it is not a single entity, must be performed before commitments to further development can be made. Even the dissolution of individually acceptable components for presentation as a masking agent must be considered as to whether the resultant product is a material that requires regulatory evaluation. Take that same liquid and spray dry it with another acceptable component and the potential for identification of the product as requiring notification increases further.

Labeling consideration

Without proper regulatory evaluation of the flavor system, whether the purpose is to enhance or mask or mimic specific tastes, there can be no consideration of the second aspect—labeling. This returns us to the definitional regulation. There is no definition of “flavor masking agent” or similar term. The categorization for flavors is either natural or artificial. Careful evaluation of the makeup and composition of the blend or individual substance against this section of the regulations takes things halfway to labeling conclusion. The other half distance involves the user of the substance.

In nearly all instances the use of these flavor masking or enhancing components will be called out on the label of the product in which it is used. This is owed to the regulatory determination of what constitutes determination of the “characterizing flavor.” At that point, the purpose of the masker/enhancer no longer fits into the same flavor and could be identified on the label as “with other natural flavor.” Thus, the identification of these materials as natural does not automatically remove the obligation to note its presence on the principal display panel (PDP).

Listing of ingredients

Lastly, the requirements of the regulations call for the listing of all the ingredients directly added to the product during manufacturing that remain in the product. In the case of the flavor agents, they may fall within the “Natural Flavors” declaration, “Ingredients,” or “Other Ingredients” lists, or listed separately, along the lines of “natural vanilla flavor, ascorbic acid, natural flavor enhancer.”

An additional resource or tool is a GRAS determination from the Flavor Extract Manufacturers Association (FEMA), which has a longstanding program focused on flavors and their safety in a process akin to FDA’s review of such notifications. While not a direct equivalent of a notification to FDA, the assurance provided by such a FEMA review is worth consideration should the need arise.

We all want things that taste good and, even if a secondary consideration, things that are good for us. The advancements in flavor technology and expertise over recent years has presented numerous new options to achieve the flavor profile goals desired. This does not remove any of the regulatory obligations in evaluating the ingredient or blend of ingredients and food additive regulations, along with the labeling regulations, still apply.

As chief operating officer, Jim Lassiter oversees all consulting operations at REJIMUS, formerly Ingredient Identity. He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries.