The U.S. Food and Drug Administration, along with other federal agencies, subject products to strict regulations in order to keep the public safe and informed. Approximately 55% of survey respondents say they often refer to a product’s label in order to get a general idea of its nutritional content, and it’s thanks to regulatory agencies that manufacturers and distributors are required to include this and other information in convenient locations.

Not only must the shopper be informed for themselves, but they must also be provided with enough information to make the best decisions for their families. For example, products like infant formula must contain certain data and comply with specific requirements in order to become available to consumers. In fact, baby formula is one of the most highly regulated (and therefore, one of the safest) products someone can buy. As such, you’ll need to make sure that your unique labels are completely compliant and contain accurate information. Let’s take a closer look at infant formula labeling and why you’ll need to ensure your label printing company is able to provide what you need to align with industry standards.

How is Infant Formula Regulated?

Since infant formula is categorized as a food, the FDA is in charge of regulating infant formula and associated labeling. In 2016, the FDA released a comprehensive guide for infant formula manufacturers, due to an increasing number of formula products that were mislabeled or misbranded. The agency noticed that many products had similar statements of identity but with different intended uses or compositions, as well as increased instances of nutrient content claims that resulted in the misbranding of products under the Federal Food, Drug, and Cosmetic Act, so this guidance can provide extensive details on infant formula labeling compliance in an effort to ensure products can be brought to (and stay on) the market in a timely manner.

The FDA requires that infant formulas must contain set concentrations of 29 different nutrients. Manufacturers that add any additional ingredients (not included in this list of 29 nutrients) to formula must prove to the FDA that the ingredient is safe and that infants fed this formula grow normally. Keep in mind that “grow normally” essentially means that an infant is above the “failure to thrive” threshold, meaning that they do not need supplemental nutrition to survive. Even infants who gain too much weight being fed a particular formula are still considered to be normal.

What Do Infant Formula Labels Need to Include?

Infant formula label designs do need contain quite a bit of information in order to comply with FDA regulations. They must include:

  • A statement of identity
  • Nutrient ranges
  • Nutrient content claims
  • Health claims
  • Directions and a pictogram for preparation and use
  • A “use by” date
  • Water statements (i.e., whether to add or not add water)
  • Warning statements
  • Physician’s recommendations
  • Foreign language and religious symbols/statements
  • Allergen statements

Because each of these specifications must be detailed, it’s recommended that you consult the FDA’s guidance that provides particular wording and design concepts you’ll need to relay to your label printing company.

What Additional Information May Be Included on Infant Formula Product Labeling?

While these unique labels already contain ample information, many companies choose to include some additional wording on their infant formula labels. For example, Nestle includes information on breastfeeding on their formula labels, as well as advice for mothers, to indicate the benefits of breast milk for infants. Although this information may not be necessary to include, some organizations might have their label printing company include this knowledge on foldout labels for the parents’ convenience. It’s also important to differentiate your infant formula product in its labeling and packaging from “follow-up formulas,” as the latter is intended for older babies and can have health consequences when used as a substitute for breastfeeding in younger infants.

Due to the regulations outlined by the FDA, it’s essential for infant formula manufacturers to educate themselves and work with a label printing company that understands the level of expected compliance. To learn more about how we can ensure your labels will market your product accurately and attractively, please contact us today.