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By Gisela Leon, EAS Independent Consultant and Instructor for Food and Dietary Supplement Labeling Seminar

In times of COVID-19, many people are restricted to staying at home, working from home, and cooking at home more than ever before. Cooking at home requires the consumer to make informed decisions on which foods to buy. The declared ingredients, the Nutrition Facts, as well as the claims help with that decision, but is the information on the label clear?

Clean labeling, for instance, is an industry and consumer trend that uses as few ingredients as possible, no artificial ingredients and easy-to-recognize ingredients.  Clean labeling is a marketing trend, but not an FDA initiative. FDA’s regulations require declaration of ingredients by common name and a declaration of nutrients based on reference amounts so that food comparisons can be made more easily. The claims about nutrient content are limited to those authorized and are based on the same reference amounts used in Nutrition Facts –allowing comparison across brands.

As a food manufacturer, certain regulatory provisions can provide flexibility and help to reduce the number of declared ingredients on the label. These provisions are often not easily understood or even used, resulting in long and confusing lists of ingredients and their sub-ingredients. Regarding the ingredient declaration, there are two regulatory options.

One option is declaring compound ingredients with the parenthetical declaration of their sub-ingredients -found in the regulation 21 CFR 101.4(b)(2)(i), “declaring the established common or usual name of the [compound] ingredient followed by a parenthetical listing of all ingredients contained therein in descending order of predominance ….” [emphasis and parenthesis added]. There are many reasons for declaring compound ingredients this way.  Often, it is much faster to compose a list of ingredients by listing the ingredients as purchased and declaring the sub-ingredients based on the information from the supplier. If the compound ingredient is a discrete component of the food, e.g., chunks of milk chocolate, using the name of the compound ingredient results in a position higher in the list of ingredients and informs the consumer about the composition of the compound ingredient. On the other hand, it can lead to repetitious declaration of some ingredients. For example, the milk chocolate chunks in a cookie contain sugar and milk. These are also frequent components of the dough and, would be declared twice with this option.

The compound declaration of ingredients lengthens the list of ingredients and makes the listing more difficult to understand as the parenthesis distorts information regarding the descending order of the weight of individual ingredients in the product. The manufacturer might prefer to compose the list of ingredients without struggling with the descending order of predominance by weight for the sub-ingredients for ease, but if the compound ingredient is not a discrete component of the food, like a fruit juice or a seasoning blend, the consumer does not profit from that additional information as part of the compound ingredient declaration.

The alternative option is to integrate the sub-ingredients of the compound ingredient into the overall list. Though a time-consuming mathematical challenge, it could shorten the list of ingredients by removing redundancy. It also offers the opportunity to determine whether ingredients in the compound ingredient might meet the definition of an incidental additive which would render it exempt from declaration.

Three types of ingredients can be incidental additives: Ingredients of compound ingredients, processing aids, and substances migrating to food from equipment or packaging. The general requirements for an incidental additive are that they are not functional in the final product and are present in insignificant amounts, (21 CFR 101.100(a)(3)), though FDA has not defined what an insignificant level is. Some say the level of an ingredient is insignificant if it is not detectable in which case a case-by-case decision is necessary. For example, the sunflower lecithin in the milk chocolate chunks does not function once the chocolate is solid. Whether the amount is insignificant depends on the amount of the milk chocolate chunks in the final product. In my opinion at least one, if not two, leading zeros in the percentage are necessary to consider insignificant levels.  Processing aids are added during processing but removed from the food before it is packaged in its finished form, or they are converted into constituents normally present in the food, and do not significantly increase the amount of the constituents naturally found in the food. Determining that an ingredient qualifies as an incidental additive shortens the overall list of ingredients and may make the list easier to read and understand.

The regulations also offer a time-saving tool for declaration of minor ingredients present at less than 2%, (21 CFR 101(a)(2)). After a phrase like “less than 2% of …”, the ingredients are exempt from the requirement for descending order of predominance by weight. When the manufacturer saves time by not arranging the list of ingredients in descending order, there is also an opportunity for cost savings because small formula corrections might not require reprinting of the label. There is also the chance of formula protection by applying any order.

For allergen information, the “Contains” statement that follows the list of ingredients gives concise information about the allergens present. But the eight major food allergens do not include all allergy causing ingredients. A concise list of ingredient helps the consumer to find other potential allergens like sesame or mustard seed quickly.

Consumers might base the buying decisions on labels that are easy to understand and that primarily focus on the list of ingredients, nutrition information, and claims. A Nutrition Facts  panel must follow detailed formatting requirements, e.g., highlighting the calories so that they are easy to recognize and allow for comparison of similar products across different brands. The regulation allows some adjustments to the Nutrition Facts table based on the size and shape of the container, the formulation and declarable nutrients and the ratio of net contents to reference amount. In cases where more than eight nutrients are declared at zero amounts, a simplified format helps to provide concise information.

Claims are big influencers in the buying decision. They give information about how a product is produced, such as “organic” or “pasteurized.” Manufacturers may also inform about health benefits by using nutrient content claims, health claims or so-called structure/function claims. Nutrient content claims highlight the presence of beneficial nutrients or the absence or low level of nutrients that might cause health related conditions. A quick nutrient overview can be provided in a declaration on the front panel and it must repeat the nutrient amounts declared Nutrition Facts Panel.  An often used set of amount claims informs about four key nutrients – calories, saturated fat, sodium, and sugars. Claims about nutrients may require additional disclosure, so that the consumer is guided to the Nutrition Facts panel for complete information.

Clear, “clean” and concise information on a product label can support consumers’ buying decisions by providing easily understood information and an opportunity for nutritional comparisons with other products. Savvy marketers understand how to balance regulatory flexibilities with restrictions in order to put FDA’s requirements to their best use.

Posted in Dietary Supplements, Foods, Issue of the Month.