Managing Food Safety, Litigation & Risk

Originally Published: May 1, 2014
Last Updated: February 14, 2021
The illustration of a law concept represents the balance food manufacturers strive for in managing food safety versus avoiding litigation and regulatory risk.

What is clean labeling? There is no uniform definition, but in part, clean labeling is a response to consumers’ lack of knowledge regarding food science and safety, explained Anthony Pavel of Morgan, Lewis & Bockius LLP in his presentation titled “When Natural isn’t Good for You: Managing Food Safety, Litigation & Regulatory Risk. “Clean labels” tend to involve: 1) reducing the number of ingredients generally; 2) eliminating “chemical sounding” ingredients; and 3) implying “natural” without necessarily using that term.

Xanthan Gum - Bob's Red Mill

Xanthan gum was used as an example of the subjective nature of the term “natural.”

Clearly, there is pressure on industry from consumers and advocacy groups for labels with pronounceable words. “The exception is if the ingredient is ‘hip’ and sounds natural; for example, ‘açai’ where the pronunciation gets a pass,” noted Pavel. Clean label is a subjective term influenced by consumers’ lack of knowledge or misunderstanding of ingredients, said Pavel. Take, for example, xanthan gum. Xanthan gum is the product of fermentation of sugars and, depending on the production technique, can be considered a “natural” ingredient. Nonetheless, there has been some level of reformulation to remove xanthan gum, because it sounds artificial. However, xanthan gum ironically assists in the formulation of gluten-free baked goods, another consumer trend based at least somewhat upon misunderstanding.

Consumers are also interested in good prices; however, many are willing to pay a premium for organic and “natural” products. Taste, texture, healthfulness, good shelflife—yet minimal processing and safety—are all desirable properties. Labels also must comply with FDA and FSIS requirements.

For example, ingredients are still required to be listed by the common and usual name, unless a regulation provides for a different term. Sugar is still sugar; highfructose corn syrup is not simply “corn syrup.” Exemptions to listing are limited in number and include incidental additives and processing aids that are present at insignificant levels with no function in the finished product. An insignificant level is not clearly defined, except with sulfites; they are considered to be incidental only if present at less than 10ppm.

Ingredients many consider to be “natural” and organic have some overlap, but not always. For example, the USDA’s National List of organic ingredients currently allows ammonium bicarbonate, calcium hydroxide, potassium carbonate, tetrasodium pyrophosphate and xanthan gum in certain organic products, even though they likely wouldn’t be considered “clean label” ingredients.

Pavel stressed that when reformulating to create a clean label product, safety should be the number one concern. Formulation changes that affect shelflife and stability need to be validated and reviewed in the context of final labeling. For preservatives, there are not always effective clean label alternatives.

“Labels must be truthful and accurate, not misleading or false in any way. Omission of material facts can be misleading. FDA places a big emphasis on front-of-package claims, and FTC has increased scrutiny of foods. Health-related claims are becoming more prevalent in food advertising, and so are being given increased scrutiny,” advised Pavel. Statements that claim to treat or prevent disease are a big target, he added.

Specific food additives are also under attack by consumer pressure groups. For example, CSPI has a Food Additives mobile app which warns consumers about ingredients. The app warns that caramel coloring may sound innocent, but may made with ammonia, sulfites or both. All issues discussed here are potential targets. FDA is picking its labeling battles as a result of strained resources.

At this point, natural claims are a lower priority than safety issues. A gap has been created by FDA’s inaction on developing a definition of “natural,” but lawyers in the plaintiffs’ bar are filling that gap and suing companies directly over their labeling and marketing claims.

In conclusion, there is a need to respond to consumer demand for clean labels, but reformulation requires a holistic review of safety, shelflife, product attributes and related label claims. Regulatory requirements must still be met, and consumers need to be educated.

When Natural Isn’t Good for You: Managing Food Safety, Litigation & Regulatory Risk, Anthony Pavel of Morgan, Lewis & Bockius LLP 

This is an excerpt from the 2013 Clean Label Post Conference Magazine.