New FDA Labeling Regulations are Here – Are you Prepared?

The new FDA regulations for the Nutrition Facts labels and Supplement Facts labels went Covance FDA Regulations Nutrition Food Solutionsinto effect this month. With a refreshed design reflecting updated information about nutrition science, the new label is intended to better inform consumers about their choices.

While manufacturers have two or up to three years to revise or correct their product labels, we’ve seen many proactive companies consider the impact of these regulations on their future ingredients, processes and claims.

Understanding the Primary Revisions

Beyond the new visual format of the facts panels, many other notable changes include:

  • Nutrients: New nutrients, considered of public health significance (Vitamin D and Potassium), are now required to be listed on labels, while others (Vitamin A and C) are no longer required.
  • Added Sugars: Added sugars, with a % Daily Value, is now required.
  • Recommended Daily Intake (RDI): The RDI for 23 nutrients have updated, affecting nearly all Daily Value percentages (% daily value).
  • Units of Measure: Units of measure are changing for five nutrients, moving away from International Units (IU). Additionally, there are changes to the equivalence of carotenoids to Vitamin A as well as differing potencies for folic acid and folates.
  • Dietary fiber: Dietary fiber has been formally defined by the FDA. This impacts what is considered a fiber and label claims for fiber content.
  • Records: New records and record-keeping requirements are necessary to make determinations of nutrition facts since analysis alone cannot determine the type of some nutrients, for example, added sugars.
  • Reference Amounts Customarily Consumed (RACC): Several RACC have changed and new reference amounts have been created to guide proper serving size declarations.
  • Serving Size: New requirements have been instituted concerning serving size declarations and rules around dual–column labeling.

Responding to the Changes

With these major revisions, some manufacturers may choose to reformulate or make other changes to respond to these new rules and best position their products among competitors. Regardless of the route, it helps to work with a trusted leader in nutritional testing to determine the most effective strategy for your product. At Covance, we are uniquely positioned to help you with reformulation, supplier and specification support, shelf life and stability studies and comprehensive label review.

The label changes have triggered many questions, so we have made our experts available to discuss your needs or concerns. You can reach us at 1-800-675-8375 or If you are an established Covance client, simply contact your designated Business Development Director or dedicated Client Service Associate.

For more information on the change, see our FAQ.