A brand decides to modify its functional beverage formula along the lines of what consumers would expect to be a clean label. That means the product has no unrecognizable or chemical-sounding terminology on the label, among other things.

For many consumers, clean eating is about avoiding things that sound artificial or unnatural, but for some more progressive consumers, the conversation is moving beyond avoiding artificial colors, flavors, sweeteners and preservatives. These consumers are beginning to think about foods or ingredients created through genetic engineering, pesticide residues, antibiotics, sustainability, animal welfare, farming methods and food technologies.

Many food ingredients are suitable for clean labels, but brands must be careful that they are cognizant of what they are using. The use of clean label claims or marketing materials poses challenges for formulators. For example, FDA exempts certain food ingredients from label declaration under certain circumstances, but if a product blends several foods together that contain the same ingredient exempted from labeling, the company may have to declare its presence on the label because it may be present at a functional level.

Regulation 21 CFR 101.100 exempts from label declaration incidental additives that are present in a food at insignificant levels, and that have no technical or functional effect in that food. The regulation goes on to list specifically what incidental additives are:

One way for a brand to truly know its ingredients is to request its suppliers provide a full breakout of the product it is buying, not just a suggested ingredient statement. Some ingredients are processed using substances that may not be declared on an ingredient statement, for example, an antioxidant preservative.

How an ingredient is processed may be another consideration for clean label formulators. Is the ingredient water- or solvent-extracted? If solvent-extracted, the solvent may still be present in the finished product. So, brands need to consider if consumers would take issue with a solvent-extracted ingredient.

Formulators also need to be careful that the ingredient supplier is providing the correct terminology for its ingredient. For example, if a supplier is selling a fermented ingredient, the resulting product needs to be named by the common or usual name of what it is, not by what ingredients were fermented together. Another example would be if a supplier is adding two substances to create a new ingredient, the resulting new ingredient, rather than the reactants, would be the correct name. If sodium hydroxide is added to vinegar, the resulting product is not “buffered vinegar;” it is sodium acetate (a preservative). The process to create an ingredient should not be mistaken for its identity.

Once all the information about a formula has been evaluated, the brand is ready to consider the best way to present the clean label version of its product. The best clean label claims are specific, unambiguous, narrow and thoughtfully focused on the product’s best characteristics.

If “clean” is equated to a negative claim, such as “no preservatives,” the formulator needs to ensure absolutely no presence of any preservative, including natural extractives that could be considered preservatives. FDA’s interpretation of negative claims is the total absence of the subject of the claim. This would include incidental additives that may be present, but not declared in the product.

Negative claims around colors are more complex. In its policy on natural claims, FDA stated the presence of added color in a food is not natural, regardless of its source. For this reason, stating a product contains no artificial colors when it contains naturally sourced color, for example, beet juice, could be problematic. Some firms have chosen to state “no FD&C colors,” to call out the absence of non-food-based color additives.

Fewer firms are using “natural” claims these days, but the term is still a magnet for litigation. Recently, Hint Inc. was sued, accused of falsely advertising its products as “all natural” because it featured natural flavors containing propylene glycol. Propylene glycol is present in some flavoring ingredients as a dispersant and generally is exempt from label declaration as an incidental additive.

Finally, formulators and marketers need to understand that even if a product is made of relatively few simple, understandable ingredients, a product is not necessarily healthier than foods with more complex ingredient lists. The healthfulness of a product should not be intimated unless it meets FDA requirements for a specific claim. “Healthy” is an FDA-defined claim and can be used on a food that meets the definition, but “healthier” is not defined and should only be used in conjunction with claims for nutritional differences between foods.

Betty Campbell is an independent advisor for labeling and claims and April Kates is an independent consultant, both at EAS Consulting Group LLC.